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MEDROL 100MG TABLETS

Active substance(s): METHYLPREDNISOLONE

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Nervous system
Steroids including methylprednisolone can cause
serious mental health problems.
These are common in both adults and children.
They can affect about 5 in every 100 people taking
medicines like methylprednisolone.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up and
down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and losing
your memory.
• Feeling, seeing or hearing things which do not
exist. Having strange and frightening thoughts,
changing how you act or having feelings of
being alone.
not known
• Irritability.
• Fits.
• Dizziness, a feeling of dizziness or ‘spinning’.
• Headache.
Skin
common
• Acne.
• Poor wound healing.
• Thinning of skin.
not known
• Stretch marks.
• Bruising.
• Sweating.
• Itchy skin.
• Rash or redness of skin.
• Hives (red itchy swellings).
• Dilation of small blood vessels on the surface of
the skin (red spider veins).
• Red, brown or purple, pin point, round spots.
• Brown/purple/red raised patches on the skin or
inside the mouth (Kaposi’s sarcoma).
Vascular disorders
not known
• Increased clotting of the blood
Other side effects
not known
• Feeling unwell.
• Feeling tired.
It is important if you are to have a blood test that
you tell the doctor or nurse that you have been
given treatment with Medrone.
If you experience any of the side effects listed
above tell your doctor straight away.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting effects
you can help provide more information on the
safety of this medicine.

5. HOW TO STORE MEDRONE

PATIENT INFORMATION LEAFLET

Ref: LTT0012/070416/1/F

®

Medrone tablets should not be used after the
expiry date ‘EXP’ shown on the carton and blister
strip. If your medicine is out of date take it to your
pharmacist who will dispose of it safely.
Do not store above 25°C.
Store in the original package.
Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Medrone contains
• The active substance is 100 mg
methylprednisolone.
• The other ingredients are methylcellulose,
magnesium stearate, microcrystalline cellulose,
Aluminium lakes indigo (E132) and sodium
starch glycolate.
What Medrone looks like and contents of the
pack
• Medrone is a blue, round tablet with ‘UPJOHN’
on one side and ‘X’ score mark on the other
side.
• The tablets are packed in blisters containing 10
tablets and comes in boxes of 20’s & 30’s.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer Italia
SRL, Via del Commercio, Marino del Tronto, Ascoli
Piceno I-63046, Italy and is procured from within
the EU. Product Licence Holder: LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, Redditch,
B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
PL 33723/0012 - Medrone 100mg Tablets
Medrone is a registered trademark of Pfizer
Enterprises Sarl.
Leaflet revision date: 07/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

MEDRONE 100MG TABLETS
(methylprednisolone)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Medrone 100mg Tablets
and will be referred to as Medrone throughout the
rest of this leaflet.
What is in this leaflet
1. What Medrone is and what it is used for
2. What you need to know before you take
Medrone
3. How to take Medrone
4. Possible side effects
5. How to store Medrone
6. Contents of the pack and other information
1. WHAT MEDRONE IS AND WHAT IT IS USED
FOR
This medicine contains methylprednisolone, which
belongs to a group of medicines called steroids.
Their full name is corticosteroids. Corticosteroids
are produced naturally in your body and are
important for many body functions. Boosting your
body with extra corticosteroid such as Medrone
can help following surgery (e.g. organ transplants),
injuries or other stressful conditions. These include
inflammatory or allergic conditions affecting the:
• brain (e.g. tuberculous meningitis)
• bowel and gut (e.g. Crohn’s disease and
ulcerative colitis)
• blood or blood vessels (e.g. leukaemia or
arteritis, inflammation of the arteries)
• joints (e.g. rheumatic fever)
• lungs (e.g. asthma, tuberculosis)
• muscle (e.g. dermatomyositis and polymyositis)
• skin (e.g. pemphigus vulgaris, an auto-immune
disorder in which the body’s immune system is
overactive causing the skin to blister)
Medrone may be prescribed to treat conditions
other than those listed above.
You must talk to a doctor if you are unsure why
you have been given this medicine, if you do not
feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MEDRONE
Do not take Medrone:
• If you think you have ever suffered an allergic
reaction, or any other type of reaction after
being given Medrone or any of the other
ingredients of this medicine (listed in section 6).
An allergic reaction may cause a skin rash or
reddening, swollen face or lips or shortness of
breath.
• If you have any serious fungal infection such
as a serious fungal infection in your lungs or
oesophagus (the tube that connects your mouth
with your stomach) or any other infection which
is not being treated with an antibiotic or antiviral
medicine.
• If you have recently had, or are about to have
any vaccination.
If you get a rash or another symptom of an
infection tell your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine if you have any of the following
conditions.
Your doctor may have to monitor your treatment
more closely, alter your dose or give you another
medicine.
• Chickenpox, measles or shingles. If you think
you have been in contact with someone with
chickenpox, measles or shingles and you have
not already had these illnesses, or if you are
unsure if you have had them.
• Worm infestation (e.g. threadworm).
• Severe depression or manic depression
(bipolar disorder). This includes having had
depression before while taking steroid
medicines like Medrone, or having a family
history of these illnesses.
• Diabetes (or if there is a family history of
diabetes).
• Fits or seizures.
• Glaucoma (increased pressure in the eye) or if
there is a family history of glaucoma, or if you
have cataracts.
• Viral (e.g. herpes) or fungal eye infection.
• You recently suffered a heart attack.
• Heart problems, including heart failure.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kidney or liver disease.
• Kaposi’s sarcoma (a type of skin cancer).
• Muscle problems (pain or weakness) have
happened while taking steroid medicines like
Medrone in the past.
• Myasthenia gravis (a condition causing tired
and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal
gland tissue. The adrenal glands are located
above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach or
intestinal problems.
• Thrombophlebitis - vein problems due to
thrombosis (clots in the veins) resulting in
phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered
tuberculosis in the past.
• Cushing’s disease (condition caused by an
excess of cortisol hormone in your body).
• Brain injury due to trauma (injury).
• Unusual stress.
Other medicines and Medrone
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, (including medicines you have
obtained without a prescription).This
could be harmful or affect the way Medrone or the
other medicine works:
• Acetazolamide - used to treat glaucoma and
epilepsy.
• Aminoglutethimide or Cyclophosphamide –
used for treating cancer.
• Anticoagulants - used to ‘thin’ the blood such
as acenocoumarol, phenindione and warfarin.
• Anticholinesterases - used to treat myasthenia
gravis (a muscle condition) such as distigmine
and neostigmine.
• Antibacterials (such as isoniazid,
erythromycin, clarithromycin and
troleandomycin).
• Antidiabetics – medicines used to treat high
blood sugar.
• Aprepitant or fosaprepitant – used to prevent
nausea and vomiting.
• Aspirin and non-steroidal anti-inflammatory
medicines (also called NSAIDs) such as
ibuprofen used to treat mild to moderate pain.
• Barbiturates, carbamezipine, phenytoin and
primidone – used to treat epilepsy.
• Carbenoxolone and cimetidine - used for
heartburn and acid indigestion.

• Ciclosporin - used to treat conditions such as
severe rheumatoid arthritis, severe psoriasis or
following an organ or bone marrow transplant.
• Digoxin - used for heart failure and/or an
irregular heartbeat.
• Diltiazem or mibefradil – used for heart
problems or high blood pressure.
• Ethinylestridiol and norethisterone – an oral
contraceptive.
• Indinavir or ritonavir – used to treat HIV
infections.
• Ketoconazole or itraconazole – used to treat
fungal infections.
• Pancuronium or vecuronium – or other
medicines called neuromuscular blocking agents
which are used in some surgical procedures.
• Potassium depleting agents – such as
diuretics (sometimes called water tablets),
amphotericin B, xanthenes or beta2 agonists
(e.g. medicines used to treat asthma).
• Rifampicin and rifabutin – antibiotics used to
treat tuberculosis (TB).
• Tacrolimus – used following an organ transplant
to prevent rejection of the organ.
• Vaccines - tell your doctor or nurse if you have
recently had, or are about to have any
vaccination. You must not have ‘live’ vaccines
while using this medicine. Other vaccines may
be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood
pressure or water retention (oedema) tell your
doctor as he/she may need to adjust the dose of
the medicines used to treat these conditions.
Before you have any operation tell your doctor,
dentist or anesthetist that you are taking Medrone.
If you require a test to be carried out by your
doctor or in hospital it is important that you tell
the doctor or nurse that you are taking Medrone.
This medicine can affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine,
as it could slow the baby’s growth.
Cataracts have been observed in infants born to
mothers treated with long-term corticosteroids during pregnancy. If you are breast-feeding, ask your
doctor or pharmacist for advice, as small amounts
of corticosteroid medicines may get into breast
milk.
Driving and using machines
Undesirable effects, such as dizziness, vertigo,
visual disturbances and fatigue are possible after
treatment with corticosteroids. If you are affected
do not drive or operate machinery.
3. HOW TO TAKE MEDRONE
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Steroid Cards
Remember to always carry a Steroid Treatment
Card. Make sure your doctor or pharmacist has
filled out the details of your medicine,
including the dose and how long you will
require steroid treatment.
You should show your steroid card to anyone who
gives you treatment (such as a doctor, nurse or
dentist) while you are taking Medrone, and for 3
months after you stop taking the tablets.
If you are admitted to hospital for any reason
always tell your doctor or nurse that you are taking
Medrone. You can also wear a medic-alert
bracelet or pendant to let medical staff know that
you are taking a steroid if you have an accident or
become unconscious.

Adults
The normal daily dose is between 4 mg and 360
mg per day, depending on your condition and how
severe it is. Your doctor will prescribe the lowest
dose possible.
Your doctor may tell you to take your daily dose all
in one go, split your daily dose throughout the day,
or take it every other day at 8.00 am.
Swallow the tablets whole with a drink of water.
The score line is not intended for breaking the
tablet.
Do not eat grapefruit or drink grapefruit juice while
taking Medrone.
If you are being given Medrone because your
body cannot make its own corticosteroids, your
doctor may also want you to take a second type of
steroid to help your salt balance. Your doctor may
prescribe a higher dose at the start of your
treatment to bring your condition under control.
When your doctor is happy that your condition has
improved your dose will be reduced gradually.
Normally the dose will be reduced by not more
than 2 mg every 7 to 10 days.
Elderly:
Your doctor may want to see you more regularly to
check how you are getting on with your tablets.
Children and adolescents:
Corticosteroids can affect growth in children so
your doctor will prescribe the lowest dose that will
be effective for your child. Your doctor may tell you
to give your child this medicine on every other day.
If you take more Medrone than you should
It is important that you do not take more tablets
than you are told to take. If you accidentally take
too many tablets, seek medical attention straight
away.
If you forget to take your Medrone
Wait and take the next dose as normal. Do not
take a dose to make up for the forgotten one but
tell your doctor or pharmacist what had happened.
Stopping/reducing the dose of your Medrone
Your doctor will decide when it is time to stop your
dose.
You must not stop taking Medrone suddenly,
especially if you :
• have had more than 6 mg Medrone daily for
more than 3 weeks
• have been given high doses of Medrone (more
than 32 mg daily) even if it was only for 3 weeks
or less
• have already had a course of corticosteroid
tablets or injections in the last year
• already had problems with your adrenal glands
(adrenocortical insufficiency) before you started
this treatment
• take repeat doses in the evening.
You will need to come off Medrone slowly to avoid
withdrawal symptoms. These symptoms may
include itchy skin, fever, muscle and joint pains,
runny nose, sticky eyes, loss of appetite, nausea,
vomiting, headache, feeling tired, peeling
skin and weight loss.
If your symptoms seem to return or get worse as
your dose of Medrone is reduced tell your doctor
immediately.
Mental problems while taking Medrone
Mental health problems can happen while taking
steroids like Medrone (see section 4).
• These illnesses can be serious.
• Usually they start within a few days or weeks of
starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However if
the problems do happen they might need
treatment.

Talk to a doctor if you (or someone using this
medicine) shows any signs of mental problems.
This is particularly important if you are depressed,
or might be thinking about suicide. In a few cases
mental problems have happened when doses are
being lowered or stopped.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Your
doctor will have given you this medicine for a
condition which if not treated properly could
become serious.
These side effects may occur with certain
frequencies,which are defined as follows:
• common: may affect up to 1 in 10 people.
• not known: frequency cannot be estimated from
the available data.
In certain medical conditions medicines like
Medrone (steroids) should not be stopped
abruptly. If you suffer from any of the following
symptoms, seek IMMEDIATE medical attention.
Your doctor will then decide whether you
should continue taking your medicine:
common
• Burst or bleeding ulcers, symptoms of which
are stomach pain (especially if it seems to
spread to your back), bleeding from the back
passage, black or bloodstained stools and/or
vomiting blood.
• Infections. This medicine can hide or change
the signs and symptoms of some infections, or
reduce your resistance to the infection, so that
they are hard to diagnose at an early stage.
Symptoms might include a raised temperature
and feeling unwell. Symptoms of a flare up of a
previous TB infection could be coughing blood
or pain in the chest. Medrone may also make
you more likely to develop a severe infection.
not known
• Allergic reactions, such as skin rash, swelling
of the face or wheezing and difficulty breathing.
This type of side effect is rare, but can be
serious.
• Pancreatitis, stomach pain spreading to your
back, possibly accompanied by vomiting, shock
and loss of consciousness.
• Pulmonary embolus (blood clots in the lung),
symptoms of include sudden sharp chest pain,
breathlessness and coughing up blood.
• Raised pressure within the skull of children
(pseudotumour cerebri) symptoms of which are
headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after
treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in
a leg vein), symptoms of which include painful
swollen, red and tender veins.
If you experience any of the following side
effects, or notice any other unusual effects not
mentioned in this leaflet, tell your doctor
straight away:
Blood, heart and circulation
common
• High blood pressure, symptoms of which are
headaches, or generally feeling unwell.
not known
• Problems with the pumping of your heart (heart
failure) symptoms of which are swollen ankles,
difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of
the heart, irregular or very fast or slow pulse.
• Increased numbers of white blood cells
(leukocytosis).
• Low blood pressure.
Body water and salts
common
• Swelling and high blood pressure, caused by
increased levels of water and salt content.

• Cramps and spasms, due to the loss of

potassium from your body. In rare cases this can
lead to congestive heart failure (when the heart
cannot pump properly).
Digestive system
not known
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers, inflammation or thrush in the
oesophagus (the tube that connects your mouth
with your stomach), which can cause discomfort
on swallowing.
• Indigestion.
• Bloated stomach.
• Abdominal pain.
• Diarrhoea.
• Persistent hiccups, especially when high doses
are taken.
Eyes
common
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
not known
• Glaucoma (raised pressure within the eye,
causing pain in the eyes and headaches).
• Swollen optic nerve (papilloedema, indicated by
sight disturbance).
• Thinning of the clear part at the front of the eye
(cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or distorted vision (due to a disease
called chorioretinopathy).
Hepatobiliary disorders
not known
• Increase of liver enzymes.
Hormone and metabolic system
common
• Slowing of normal growth in infants, children and
adolescents which may be permanent.
• Round or moon-shaped face (Cushingoid
facies).
not known
• Irregular or no periods in women.
• Increased hair on the body and face in women
(hirsutism).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of
some hormones which in turn can cause low
blood pressure and dizziness. This effect may
persist for months.
• The amount of certain chemicals (enzymes)
called alanine transaminase, aspartate
transaminase and alkaline phosphatase that
help the body digest drugs and other
substances in your body may be raised after
treatment with a corticosteroid. The change is
usually small and the enzyme levels return to
normal after your medicine has cleared naturally
from your system. You will not notice any
symptoms if this happens, but it will show up if
you have a blood test.
• Accumulation of fat tissue on localised parts of
the body, manifesting as different presentations
for example back pain or weakness (due to
epidural lipomatosis).
Immune system
not known
• Increased susceptibility to infections which can
hide or change normal reactions to skin tests,
such as that for tuberculosis.
Muscles and bones
common
• Muscle weakness or wasting.
not known
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of
blood, this causes pain in the hip.
• Joint pain or joint problems.
• Torn muscle tendons causing pain and/or
swelling.
• Muscle pain, cramps or spasms.

Ref: LTT0012/070416/1/B

Nervous system
Steroids including methylprednisolone can cause
serious mental health problems.
These are common in both adults and children.
They can affect about 5 in every 100 people taking
medicines like methylprednisolone.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up and
down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and losing
your memory.
• Feeling, seeing or hearing things which do not
exist. Having strange and frightening thoughts,
changing how you act or having feelings of
being alone.
not known
• Irritability.
• Fits.
• Dizziness, a feeling of dizziness or ‘spinning’.
• Headache.
Skin
common
• Acne.
• Poor wound healing.
• Thinning of skin.
not known
• Stretch marks.
• Bruising.
• Sweating.
• Itchy skin.
• Rash or redness of skin.
• Hives (red itchy swellings).
• Dilation of small blood vessels on the surface of
the skin (red spider veins).
• Red, brown or purple, pin point, round spots.
• Brown/purple/red raised patches on the skin or
inside the mouth (Kaposi’s sarcoma).
Vascular disorders
not known
• Increased clotting of the blood
Other side effects
not known
• Feeling unwell.
• Feeling tired.
It is important if you are to have a blood test that
you tell the doctor or nurse that you have been
given treatment with Medrol.
If you experience any of the side effects listed
above tell your doctor straight away.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting effects
you can help provide more information on the
safety of this medicine.

5. HOW TO STORE MEDROL

PATIENT INFORMATION LEAFLET

Ref: LTT0012/070416/2/F

®

Medrol tablets should not be used after the expiry
date ‘EXP’ shown on the carton and blister strip. If
your medicine is out of date take it to your
pharmacist who will dispose of it safely.
Do not store above 25°C.
Store in the original package.
Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Medrol contains
• The active substance is 100 mg
methylprednisolone.
• The other ingredients are methylcellulose,
magnesium stearate, microcrystalline cellulose,
Aluminium lakes indigo (E132) and sodium
starch glycolate.
What Medrol looks like and contents of the
pack
• Medrol is a blue, round tablet with ‘UPJOHN’
on one side and ‘X’ score mark on the other
side.
• The tablets are packed in blisters containing 10
tablets and comes in boxes of 20’s & 30’s.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer Italia
SRL, Via del Commercio, Marino del Tronto, Ascoli
Piceno I-63046, Italy and is procured from within
the EU. Product Licence Holder: LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, Redditch,
B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
PL 33723/0012 - Medrol 100mg Tablets
Medrol is a registered trademark of Pfizer
Enterprises Sarl.
Leaflet revision date: 07/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

MEDROL 100MG TABLETS
(methylprednisolone)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Medrol 100mg Tablets and
will be referred to as Medrol throughout the rest of
this leaflet.
What is in this leaflet
1. What Medrol is and what it is used for
2. What you need to know before you take
Medrol
3. How to take Medrol
4. Possible side effects
5. How to store Medrol
6. Contents of the pack and other information
1. WHAT MEDROL IS AND WHAT IT IS USED
FOR
This medicine contains methylprednisolone, which
belongs to a group of medicines called steroids.
Their full name is corticosteroids. Corticosteroids
are produced naturally in your body and are
important for many body functions. Boosting your
body with extra corticosteroid such as Medrol
can help following surgery (e.g. organ transplants),
injuries or other stressful conditions. These include
inflammatory or allergic conditions affecting the:
• brain (e.g. tuberculous meningitis)
• bowel and gut (e.g. Crohn’s disease and
ulcerative colitis)
• blood or blood vessels (e.g. leukaemia or
arteritis, inflammation of the arteries)
• joints (e.g. rheumatic fever)
• lungs (e.g. asthma, tuberculosis)
• muscle (e.g. dermatomyositis and polymyositis)
• skin (e.g. pemphigus vulgaris, an auto-immune
disorder in which the body’s immune system is
overactive causing the skin to blister)
Medrol may be prescribed to treat conditions other
than those listed above.
You must talk to a doctor if you are unsure why
you have been given this medicine, if you do not
feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MEDROL
Do not take Medrol:
• If you think you have ever suffered an allergic
reaction, or any other type of reaction after
being given Medrol or any of the other
ingredients of this medicine (listed in section 6).
An allergic reaction may cause a skin rash or
reddening, swollen face or lips or shortness of
breath.
• If you have any serious fungal infection such
as a serious fungal infection in your lungs or
oesophagus (the tube that connects your mouth
with your stomach) or any other infection which
is not being treated with an antibiotic or antiviral
medicine.
• If you have recently had, or are about to have
any vaccination.
If you get a rash or another symptom of an
infection tell your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine if you have any of the following
conditions.
Your doctor may have to monitor your treatment
more closely, alter your dose or give you another
medicine.
• Chickenpox, measles or shingles. If you think
you have been in contact with someone with
chickenpox, measles or shingles and you have
not already had these illnesses, or if you are
unsure if you have had them.
• Worm infestation (e.g. threadworm).
• Severe depression or manic depression
(bipolar disorder). This includes having had
depression before while taking steroid
medicines like Medrol, or having a family
history of these illnesses.
• Diabetes (or if there is a family history of
diabetes).
• Fits or seizures.
• Glaucoma (increased pressure in the eye) or if
there is a family history of glaucoma, or if you
have cataracts.
• Viral (e.g. herpes) or fungal eye infection.
• You recently suffered a heart attack.
• Heart problems, including heart failure.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kidney or liver disease.
• Kaposi’s sarcoma (a type of skin cancer).
• Muscle problems (pain or weakness) have
happened while taking steroid medicines like
Medrol in the past.
• Myasthenia gravis (a condition causing tired
and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal
gland tissue. The adrenal glands are located
above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach or
intestinal problems.
• Thrombophlebitis - vein problems due to
thrombosis (clots in the veins) resulting in
phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered
tuberculosis in the past.
• Cushing’s disease (condition caused by an
excess of cortisol hormone in your body).
• Brain injury due to trauma (injury).
• Unusual stress.
Other medicines and Medrol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, (including medicines you have
obtained without a prescription).This
could be harmful or affect the way Medrol or the
other medicine works:
• Acetazolamide - used to treat glaucoma and
epilepsy.
• Aminoglutethimide or Cyclophosphamide –
used for treating cancer.
• Anticoagulants - used to ‘thin’ the blood such
as acenocoumarol, phenindione and warfarin.
• Anticholinesterases - used to treat myasthenia
gravis (a muscle condition) such as distigmine
and neostigmine.
• Antibacterials (such as isoniazid,
erythromycin, clarithromycin and
troleandomycin).
• Antidiabetics – medicines used to treat high
blood sugar.
• Aprepitant or fosaprepitant – used to prevent
nausea and vomiting.
• Aspirin and non-steroidal anti-inflammatory
medicines (also called NSAIDs) such as
ibuprofen used to treat mild to moderate pain.
• Barbiturates, carbamezipine, phenytoin and
primidone – used to treat epilepsy.
• Carbenoxolone and cimetidine - used for
heartburn and acid indigestion.

• Ciclosporin - used to treat conditions such as
severe rheumatoid arthritis, severe psoriasis or
following an organ or bone marrow transplant.
• Digoxin - used for heart failure and/or an
irregular heartbeat.
• Diltiazem or mibefradil – used for heart
problems or high blood pressure.
• Ethinylestridiol and norethisterone – an oral
contraceptive.
• Indinavir or ritonavir – used to treat HIV
infections.
• Ketoconazole or itraconazole – used to treat
fungal infections.
• Pancuronium or vecuronium – or other
medicines called neuromuscular blocking agents
which are used in some surgical procedures.
• Potassium depleting agents – such as
diuretics (sometimes called water tablets),
amphotericin B, xanthenes or beta2 agonists
(e.g. medicines used to treat asthma).
• Rifampicin and rifabutin – antibiotics used to
treat tuberculosis (TB).
• Tacrolimus – used following an organ transplant
to prevent rejection of the organ.
• Vaccines - tell your doctor or nurse if you have
recently had, or are about to have any
vaccination. You must not have ‘live’ vaccines
while using this medicine. Other vaccines may
be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood
pressure or water retention (oedema) tell your
doctor as he/she may need to adjust the dose of
the medicines used to treat these conditions.
Before you have any operation tell your doctor,
dentist or anesthetist that you are taking Medrol.
If you require a test to be carried out by your
doctor or in hospital it is important that you tell
the doctor or nurse that you are taking Medrol.
This medicine can affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine,
as it could slow the baby’s growth.
Cataracts have been observed in infants born to
mothers treated with long-term corticosteroids during pregnancy. If you are breast-feeding, ask your
doctor or pharmacist for advice, as small amounts
of corticosteroid medicines may get into breast
milk.
Driving and using machines
Undesirable effects, such as dizziness, vertigo,
visual disturbances and fatigue are possible after
treatment with corticosteroids. If you are affected
do not drive or operate machinery.
3. HOW TO TAKE MEDROL
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Steroid Cards
Remember to always carry a Steroid Treatment
Card. Make sure your doctor or pharmacist has
filled out the details of your medicine,
including the dose and how long you will
require steroid treatment.
You should show your steroid card to anyone who
gives you treatment (such as a doctor, nurse or
dentist) while you are taking Medrol, and for 3
months after you stop taking the tablets.
If you are admitted to hospital for any reason
always tell your doctor or nurse that you are taking
Medrol. You can also wear a medic-alert bracelet
or pendant to let medical staff know that you are
taking a steroid if you have an accident or become
unconscious.

Adults
The normal daily dose is between 4 mg and 360
mg per day, depending on your condition and how
severe it is. Your doctor will prescribe the lowest
dose possible.
Your doctor may tell you to take your daily dose all
in one go, split your daily dose throughout the day,
or take it every other day at 8.00 am.
Swallow the tablets whole with a drink of water.
The score line is not intended for breaking the
tablet.
Do not eat grapefruit or drink grapefruit juice while
taking Medrol.
If you are being given Medrol because your body
cannot make its own corticosteroids, your doctor
may also want you to take a second type of
steroid to help your salt balance. Your doctor may
prescribe a higher dose at the start of your
treatment to bring your condition under control.
When your doctor is happy that your condition has
improved your dose will be reduced gradually.
Normally the dose will be reduced by not more
than 2 mg every 7 to 10 days.
Elderly:
Your doctor may want to see you more regularly to
check how you are getting on with your tablets.
Children and adolescents:
Corticosteroids can affect growth in children so
your doctor will prescribe the lowest dose that will
be effective for your child. Your doctor may tell you
to give your child this medicine on every other day.
If you take more Medrol than you should
It is important that you do not take more tablets
than you are told to take. If you accidentally take
too many tablets, seek medical attention straight
away.
If you forget to take your Medrol
Wait and take the next dose as normal. Do not
take a dose to make up for the forgotten one but
tell your doctor or pharmacist what had happened.
Stopping/reducing the dose of your Medrol
Your doctor will decide when it is time to stop your
dose.
You must not stop taking Medrol suddenly,
especially if you :
• have had more than 6 mg Medrol daily for
more than 3 weeks
• have been given high doses of Medrol (more
than 32 mg daily) even if it was only for 3 weeks
or less
• have already had a course of corticosteroid
tablets or injections in the last year
• already had problems with your adrenal glands
(adrenocortical insufficiency) before you started
this treatment
• take repeat doses in the evening.
You will need to come off Medrol slowly to avoid
withdrawal symptoms. These symptoms may
include itchy skin, fever, muscle and joint pains,
runny nose, sticky eyes, loss of appetite, nausea,
vomiting, headache, feeling tired, peeling
skin and weight loss.
If your symptoms seem to return or get worse as
your dose of Medrol is reduced tell your doctor
immediately.
Mental problems while taking Medrol
Mental health problems can happen while taking
steroids like Medrol (see section 4).
• These illnesses can be serious.
• Usually they start within a few days or weeks of
starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However if
the problems do happen they might need
treatment.

Talk to a doctor if you (or someone using this
medicine) shows any signs of mental problems.
This is particularly important if you are depressed,
or might be thinking about suicide. In a few cases
mental problems have happened when doses are
being lowered or stopped.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Your
doctor will have given you this medicine for a
condition which if not treated properly could
become serious.
These side effects may occur with certain
frequencies,which are defined as follows:
• common: may affect up to 1 in 10 people.
• not known: frequency cannot be estimated from
the available data.
In certain medical conditions medicines like
Medrol (steroids) should not be stopped
abruptly. If you suffer from any of the following
symptoms, seek IMMEDIATE medical attention.
Your doctor will then decide whether you
should continue taking your medicine:
common
• Burst or bleeding ulcers, symptoms of which
are stomach pain (especially if it seems to
spread to your back), bleeding from the back
passage, black or bloodstained stools and/or
vomiting blood.
• Infections. This medicine can hide or change
the signs and symptoms of some infections, or
reduce your resistance to the infection, so that
they are hard to diagnose at an early stage.
Symptoms might include a raised temperature
and feeling unwell. Symptoms of a flare up of a
previous TB infection could be coughing blood
or pain in the chest. Medrone may also make
you more likely to develop a severe infection.
not known
• Allergic reactions, such as skin rash, swelling
of the face or wheezing and difficulty breathing.
This type of side effect is rare, but can be
serious.
• Pancreatitis, stomach pain spreading to your
back, possibly accompanied by vomiting, shock
and loss of consciousness.
• Pulmonary embolus (blood clots in the lung),
symptoms of include sudden sharp chest pain,
breathlessness and coughing up blood.
• Raised pressure within the skull of children
(pseudotumour cerebri) symptoms of which are
headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after
treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in
a leg vein), symptoms of which include painful
swollen, red and tender veins.
If you experience any of the following side
effects, or notice any other unusual effects not
mentioned in this leaflet, tell your doctor
straight away:
Blood, heart and circulation
common
• High blood pressure, symptoms of which are
headaches, or generally feeling unwell.
not known
• Problems with the pumping of your heart (heart
failure) symptoms of which are swollen ankles,
difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of
the heart, irregular or very fast or slow pulse.
• Increased numbers of white blood cells
(leukocytosis).
• Low blood pressure.
Body water and salts
common
• Swelling and high blood pressure, caused by
increased levels of water and salt content.

• Cramps and spasms, due to the loss of

potassium from your body. In rare cases this can
lead to congestive heart failure (when the heart
cannot pump properly).
Digestive system
not known
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers, inflammation or thrush in the
oesophagus (the tube that connects your mouth
with your stomach), which can cause discomfort
on swallowing.
• Indigestion.
• Bloated stomach.
• Abdominal pain.
• Diarrhoea.
• Persistent hiccups, especially when high doses
are taken.
Eyes
common
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
not known
• Glaucoma (raised pressure within the eye,
causing pain in the eyes and headaches).
• Swollen optic nerve (papilloedema, indicated by
sight disturbance).
• Thinning of the clear part at the front of the eye
(cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or distorted vision (due to a disease
called chorioretinopathy).
Hepatobiliary disorders
not known
• Increase of liver enzymes.
Hormone and metabolic system
common
• Slowing of normal growth in infants, children and
adolescents which may be permanent.
• Round or moon-shaped face (Cushingoid
facies).
not known
• Irregular or no periods in women.
• Increased hair on the body and face in women
(hirsutism).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of
some hormones which in turn can cause low
blood pressure and dizziness. This effect may
persist for months.
• The amount of certain chemicals (enzymes)
called alanine transaminase, aspartate
transaminase and alkaline phosphatase that
help the body digest drugs and other
substances in your body may be raised after
treatment with a corticosteroid. The change is
usually small and the enzyme levels return to
normal after your medicine has cleared naturally
from your system. You will not notice any
symptoms if this happens, but it will show up if
you have a blood test.
• Accumulation of fat tissue on localised parts of
the body, manifesting as different presentations
for example back pain or weakness (due to
epidural lipomatosis).
Immune system
not known
• Increased susceptibility to infections which can
hide or change normal reactions to skin tests,
such as that for tuberculosis.
Muscles and bones
common
• Muscle weakness or wasting.
not known
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of
blood, this causes pain in the hip.
• Joint pain or joint problems.
• Torn muscle tendons causing pain and/or
swelling.
• Muscle pain, cramps or spasms.

Ref: LTT0012/070416/2/B

Nervous system
Steroids including methylprednisolone can cause
serious mental health problems.
These are common in both adults and children.
They can affect about 5 in every 100 people taking
medicines like methylprednisolone.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up and
down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and losing
your memory.
• Feeling, seeing or hearing things which do not
exist. Having strange and frightening thoughts,
changing how you act or having feelings of
being alone.
not known
• Irritability.
• Fits.
• Dizziness, a feeling of dizziness or ‘spinning’.
• Headache.
Skin
common
• Acne.
• Poor wound healing.
• Thinning of skin.
not known
• Stretch marks.
• Bruising.
• Sweating.
• Itchy skin.
• Rash or redness of skin.
• Hives (red itchy swellings).
• Dilation of small blood vessels on the surface of
the skin (red spider veins).
• Red, brown or purple, pin point, round spots.
• Brown/purple/red raised patches on the skin or
inside the mouth (Kaposi’s sarcoma).
Vascular disorders
not known
• Increased clotting of the blood
Other side effects
not known
• Feeling unwell.
• Feeling tired.
It is important if you are to have a blood test that
you tell the doctor or nurse that you have been
given treatment with Methylprednisolone.
If you experience any of the side effects listed
above tell your doctor straight away.

5. HOW TO STORE METHYLPREDNISOLONE
Methylprednisolone tablets should not be used
after the expiry date ‘EXP’ shown on the carton
and blister strip. If your medicine is out of date
take it to your
pharmacist who will dispose of it safely.
Do not store above 25°C.
Store in the original package.
Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Methylprednisolone contains
• The active substance is 100 mg
methylprednisolone.
• The other ingredients are methylcellulose,
magnesium stearate, microcrystalline cellulose,
Aluminium lakes indigo (E132) and sodium
starch glycolate.
What Methylprednisolone looks like and contents of the pack
• Methylprednisolone is a blue, round tablet with
‘UPJOHN’
on one side and ‘X’ score mark on the other
side.
• The tablets are packed in blisters containing 10
tablets and comes in boxes of 20’s & 30’s.
Manufacturer and Licence Holder
This medicine is manufactured by Pfizer Italia
SRL, Via del Commercio, Marino del Tronto, Ascoli
Piceno I-63046, Italy and is procured from within
the EU. Product Licence Holder: LTT Pharma
Limited, Unit 18, Oxleasow Road, East Moons
Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, Redditch,
B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting effects
you can help provide more information on the
safety of this medicine.

PL 33723/0012 - Methylprednisolone 100mg
Tablets

Leaflet revision date: 07/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Ref: LTT0012/070416/3/F

METHYLPREDNISOLONE 100MG TABLETS
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Methylprednisolone 100mg
Tablets and will be referred to as
Methylprednisolone throughout the rest of this
leaflet.
What is in this leaflet
1. What Methylprednisolone is and what it is used
for
2. What you need to know before you take
Methylprednisolone
3. How to take Methylprednisolone
4. Possible side effects
5. How to store Methylprednisolone
6. Contents of the pack and other information
1. WHAT METHYLPREDNISOLONE IS AND
WHAT IT IS USED FOR
This medicine contains methylprednisolone, which
belongs to a group of medicines called steroids.
Their full name is corticosteroids. Corticosteroids
are produced naturally in your body and are
important for many body functions. Boosting your
body with extra corticosteroid such as
Methylprednisolone can help following surgery
(e.g. organ transplants), injuries or other stressful
conditions. These include inflammatory or allergic
conditions affecting the:
• brain (e.g. tuberculous meningitis)
• bowel and gut (e.g. Crohn’s disease and
ulcerative colitis)
• blood or blood vessels (e.g. leukaemia or
arteritis, inflammation of the arteries)
• joints (e.g. rheumatic fever)
• lungs (e.g. asthma, tuberculosis)
• muscle (e.g. dermatomyositis and polymyositis)
• skin (e.g. pemphigus vulgaris, an auto-immune
disorder in which the body’s immune system is
overactive causing the skin to blister)
Methylprednisolone may be prescribed to treat
conditions other than those listed above.
You must talk to a doctor if you are unsure why
you have been given this medicine, if you do not
feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE METHYLPREDNISOLONE
Do not take Methylprednisolone:
• If you think you have ever suffered an allergic
reaction, or any other type of reaction after
being given Methylprednisolone or any of the
other ingredients of this medicine (listed in
section 6). An allergic reaction may cause a skin
rash or reddening, swollen face or lips or
shortness of breath.
• If you have any serious fungal infection such
as a serious fungal infection in your lungs or
oesophagus (the tube that connects your mouth
with your stomach) or any other infection which
is not being treated with an antibiotic or antiviral
medicine.
• If you have recently had, or are about to have
any vaccination.
If you get a rash or another symptom of an
infection tell your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine if you have any of the following
conditions.
Your doctor may have to monitor your treatment
more closely, alter your dose or give you another
medicine.
• Chickenpox, measles or shingles. If you think
you have been in contact with someone with
chickenpox, measles or shingles and you have
not already had these illnesses, or if you are
unsure if you have had them.
• Worm infestation (e.g. threadworm).
• Severe depression or manic depression
(bipolar disorder). This includes having had
depression before while taking steroid
medicines like Methylprednisolone, or having a
family
history of these illnesses.
• Diabetes (or if there is a family history of
diabetes).
• Fits or seizures.
• Glaucoma (increased pressure in the eye) or if
there is a family history of glaucoma, or if you
have cataracts.
• Viral (e.g. herpes) or fungal eye infection.
• You recently suffered a heart attack.
• Heart problems, including heart failure.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kidney or liver disease.
• Kaposi’s sarcoma (a type of skin cancer).
• Muscle problems (pain or weakness) have
happened while taking steroid medicines like
Methylprednisolone in the past.
• Myasthenia gravis (a condition causing tired
and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal
gland tissue. The adrenal glands are located
above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach or
intestinal problems.
• Thrombophlebitis - vein problems due to
thrombosis (clots in the veins) resulting in
phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered
tuberculosis in the past.
• Cushing’s disease (condition caused by an
excess of cortisol hormone in your body).
• Brain injury due to trauma (injury).
• Unusual stress.
Other medicines and Methylprednisolone
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, (including medicines you have
obtained without a prescription).This
could be harmful or affect the way
Methylprednisolone or the other medicine works:
• Acetazolamide - used to treat glaucoma and
epilepsy.
• Aminoglutethimide or Cyclophosphamide –
used for treating cancer.
• Anticoagulants - used to ‘thin’ the blood such
as acenocoumarol, phenindione and warfarin.
• Anticholinesterases - used to treat myasthenia
gravis (a muscle condition) such as distigmine
and neostigmine.
• Antibacterials (such as isoniazid,
erythromycin, clarithromycin and
troleandomycin).
• Antidiabetics – medicines used to treat high
blood sugar.
• Aprepitant or fosaprepitant – used to prevent
nausea and vomiting.
• Aspirin and non-steroidal anti-inflammatory
medicines (also called NSAIDs) such as
ibuprofen used to treat mild to moderate pain.
• Barbiturates, carbamezipine, phenytoin and
primidone – used to treat epilepsy.
• Carbenoxolone and cimetidine - used for
heartburn and acid indigestion.

• Ciclosporin - used to treat conditions such as
severe rheumatoid arthritis, severe psoriasis or
following an organ or bone marrow transplant.
• Digoxin - used for heart failure and/or an
irregular heartbeat.
• Diltiazem or mibefradil – used for heart
problems or high blood pressure.
• Ethinylestridiol and norethisterone – an oral
contraceptive.
• Indinavir or ritonavir – used to treat HIV
infections.
• Ketoconazole or itraconazole – used to treat
fungal infections.
• Pancuronium or vecuronium – or other
medicines called neuromuscular blocking agents
which are used in some surgical procedures.
• Potassium depleting agents – such as
diuretics (sometimes called water tablets),
amphotericin B, xanthenes or beta2 agonists
(e.g. medicines used to treat asthma).
• Rifampicin and rifabutin – antibiotics used to
treat tuberculosis (TB).
• Tacrolimus – used following an organ transplant
to prevent rejection of the organ.
• Vaccines - tell your doctor or nurse if you have
recently had, or are about to have any
vaccination. You must not have ‘live’ vaccines
while using this medicine. Other vaccines may
be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood
pressure or water retention (oedema) tell your
doctor as he/she may need to adjust the dose of
the medicines used to treat these conditions.
Before you have any operation tell your doctor,
dentist or anesthetist that you are taking
Methylprednisolone.
If you require a test to be carried out by your
doctor or in hospital it is important that you tell
the doctor or nurse that you are taking
Methylprednisolone. This medicine can affect the
results of some tests.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine,
as it could slow the baby’s growth.
Cataracts have been observed in infants born to
mothers treated with long-term corticosteroids during pregnancy. If you are breast-feeding, ask your
doctor or pharmacist for advice, as small amounts
of corticosteroid medicines may get into breast
milk.
Driving and using machines
Undesirable effects, such as dizziness, vertigo,
visual disturbances and fatigue are possible after
treatment with corticosteroids. If you are affected
do not drive or operate machinery.
3. HOW TO TAKE METHYLPREDNISOLONE
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Steroid Cards
Remember to always carry a Steroid Treatment
Card. Make sure your doctor or pharmacist has
filled out the details of your medicine,
including the dose and how long you will
require steroid treatment.
You should show your steroid card to anyone who
gives you treatment (such as a doctor, nurse or
dentist) while you are taking Methylprednisolone,
and for 3 months after you stop taking the tablets.
If you are admitted to hospital for any reason
always tell your doctor or nurse that you are taking
Methylprednisolone. You can also wear a
medic-alert bracelet or pendant to let medical staff
know that you are taking a steroid if you have an
accident or become unconscious.

Adults
The normal daily dose is between 4 mg and 360
mg per day, depending on your condition and how
severe it is. Your doctor will prescribe the lowest
dose possible.
Your doctor may tell you to take your daily dose all
in one go, split your daily dose throughout the day,
or take it every other day at 8.00 am.
Swallow the tablets whole with a drink of water.
The score line is not intended for breaking the
tablet.
Do not eat grapefruit or drink grapefruit juice while
taking Methylprednisolone.
If you are being given Methylprednisolone
because your body cannot make its own
corticosteroids, your doctor may also want you to
take a second type of steroid to help your salt balance. Your doctor may prescribe a higher dose at
the start of your treatment to bring your condition
under control.
When your doctor is happy that your condition has
improved your dose will be reduced gradually.
Normally the dose will be reduced by not more
than 2 mg every 7 to 10 days.
Elderly:
Your doctor may want to see you more regularly to
check how you are getting on with your tablets.
Children and adolescents:
Corticosteroids can affect growth in children so
your doctor will prescribe the lowest dose that will
be effective for your child. Your doctor may tell you
to give your child this medicine on every other day.
If you take more Methylprednisolone than you
should
It is important that you do not take more tablets
than you are told to take. If you accidentally take
too many tablets, seek medical attention straight
away.
If you forget to take your Methylprednisolone
Wait and take the next dose as normal. Do not
take a dose to make up for the forgotten one but
tell your doctor or pharmacist what had happened.
Stopping/reducing the dose of your
Methylprednisolone
Your doctor will decide when it is time to stop your
dose.
You must not stop taking Methylprednisolone
suddenly, especially if you :
• have had more than 6 mg Methylprednisolone
daily for more than 3 weeks
• have been given high doses of
Methylprednisolone (more than 32 mg daily)
even if it was only for 3 weeks or less
• have already had a course of corticosteroid
tablets or injections in the last year
• already had problems with your adrenal glands
(adrenocortical insufficiency) before you started
this treatment
• take repeat doses in the evening.
You will need to come off Methylprednisolone
slowly to avoid withdrawal symptoms. These
symptoms may include itchy skin, fever, muscle
and joint pains, runny nose, sticky eyes, loss of
appetite, nausea, vomiting, headache, feeling
tired, peeling skin and weight loss.
If your symptoms seem to return or get worse as
your dose of Methylprednisolone is reduced tell
your doctor immediately.
Mental problems while taking
Methylprednisolone
Mental health problems can happen while taking
steroids like Methylprednisolone (see section 4).
• These illnesses can be serious.
• Usually they start within a few days or weeks of
starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However if
the problems do happen they might need
treatment.

Talk to a doctor if you (or someone using this
medicine) shows any signs of mental problems.
This is particularly important if you are depressed,
or might be thinking about suicide. In a few cases
mental problems have happened when doses are
being lowered or stopped.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Your
doctor will have given you this medicine for a
condition which if not treated properly could
become serious.
These side effects may occur with certain
frequencies,which are defined as follows:
• common: may affect up to 1 in 10 people.
• not known: frequency cannot be estimated from
the available data.
In certain medical conditions medicines like
Medrone (steroids) should not be stopped
abruptly. If you suffer from any of the following
symptoms, seek IMMEDIATE medical attention.
Your doctor will then decide whether you
should continue taking your medicine:
common
• Burst or bleeding ulcers, symptoms of which
are stomach pain (especially if it seems to
spread to your back), bleeding from the back
passage, black or bloodstained stools and/or
vomiting blood.
• Infections. This medicine can hide or change
the signs and symptoms of some infections, or
reduce your resistance to the infection, so that
they are hard to diagnose at an early stage.
Symptoms might include a raised temperature
and feeling unwell. Symptoms of a flare up of a
previous TB infection could be coughing blood
or pain in the chest. Medrone may also make
you more likely to develop a severe infection.
not known
• Allergic reactions, such as skin rash, swelling
of the face or wheezing and difficulty breathing.
This type of side effect is rare, but can be
serious.
• Pancreatitis, stomach pain spreading to your
back, possibly accompanied by vomiting, shock
and loss of consciousness.
• Pulmonary embolus (blood clots in the lung),
symptoms of include sudden sharp chest pain,
breathlessness and coughing up blood.
• Raised pressure within the skull of children
(pseudotumour cerebri) symptoms of which are
headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after
treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in
a leg vein), symptoms of which include painful
swollen, red and tender veins.
If you experience any of the following side
effects, or notice any other unusual effects not
mentioned in this leaflet, tell your doctor
straight away:
Blood, heart and circulation
common
• High blood pressure, symptoms of which are
headaches, or generally feeling unwell.
not known
• Problems with the pumping of your heart (heart
failure) symptoms of which are swollen ankles,
difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of
the heart, irregular or very fast or slow pulse.
• Increased numbers of white blood cells
(leukocytosis).
• Low blood pressure.
Body water and salts
common
• Swelling and high blood pressure, caused by
increased levels of water and salt content.

• Cramps and spasms, due to the loss of

potassium from your body. In rare cases this can
lead to congestive heart failure (when the heart
cannot pump properly).
Digestive system
not known
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers, inflammation or thrush in the
oesophagus (the tube that connects your mouth
with your stomach), which can cause discomfort
on swallowing.
• Indigestion.
• Bloated stomach.
• Abdominal pain.
• Diarrhoea.
• Persistent hiccups, especially when high doses
are taken.
Eyes
common
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
not known
• Glaucoma (raised pressure within the eye,
causing pain in the eyes and headaches).
• Swollen optic nerve (papilloedema, indicated by
sight disturbance).
• Thinning of the clear part at the front of the eye
(cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or distorted vision (due to a disease
called chorioretinopathy).
Hepatobiliary disorders
not known
• Increase of liver enzymes.
Hormone and metabolic system
common
• Slowing of normal growth in infants, children and
adolescents which may be permanent.
• Round or moon-shaped face (Cushingoid
facies).
not known
• Irregular or no periods in women.
• Increased hair on the body and face in women
(hirsutism).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of
some hormones which in turn can cause low
blood pressure and dizziness. This effect may
persist for months.
• The amount of certain chemicals (enzymes)
called alanine transaminase, aspartate
transaminase and alkaline phosphatase that
help the body digest drugs and other
substances in your body may be raised after
treatment with a corticosteroid. The change is
usually small and the enzyme levels return to
normal after your medicine has cleared naturally
from your system. You will not notice any
symptoms if this happens, but it will show up if
you have a blood test.
• Accumulation of fat tissue on localised parts of
the body, manifesting as different presentations
for example back pain or weakness (due to
epidural lipomatosis).
Immune system
not known
• Increased susceptibility to infections which can
hide or change normal reactions to skin tests,
such as that for tuberculosis.
Muscles and bones
common
• Muscle weakness or wasting.
not known
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of
blood, this causes pain in the hip.
• Joint pain or joint problems.
• Torn muscle tendons causing pain and/or
swelling.
• Muscle pain, cramps or spasms.

Ref: LTT0012/070416/3/B

Nervous system
Steroids including methylprednisolone can cause
serious mental health problems.
These are common in both adults and children.
They can affect about 5 in every 100 people taking
medicines like methylprednisolone.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up and
down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and losing
your memory.
• Feeling, seeing or hearing things which do not
exist. Having strange and frightening thoughts,
changing how you act or having feelings of
being alone.
not known
• Irritability.
• Fits.
• Dizziness, a feeling of dizziness or ‘spinning’.
• Headache.
Skin
common
• Acne.
• Poor wound healing.
• Thinning of skin.
not known
• Stretch marks.
• Bruising.
• Sweating.
• Itchy skin.
• Rash or redness of skin.
• Hives (red itchy swellings).
• Dilation of small blood vessels on the surface of
the skin (red spider veins).
• Red, brown or purple, pin point, round spots.
• Brown/purple/red raised patches on the skin or
inside the mouth (Kaposi’s sarcoma).
Vascular disorders
not known
• Increased clotting of the blood
Other side effects
not known
• Feeling unwell.
• Feeling tired.
It is important if you are to have a blood test that
you tell the doctor or nurse that you have been
given treatment with Medrone.
If you experience any of the side effects listed
above tell your doctor straight away.

5. HOW TO STORE MEDRONE

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting effects
you can help provide more information on the
safety of this medicine.

Medrone is a registered trademark of Pfizer
Enterprises Sarl.

PATIENT INFORMATION LEAFLET

Ref: LTT0012/070416/1/F

®

Medrone tablets should not be used after the
expiry date ‘EXP’ shown on the carton and blister
strip. If your medicine is out of date take it to your
pharmacist who will dispose of it safely.
Do not store above 25°C.
Store in the original package.
Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Medrone contains
• The active substance is 100 mg
methylprednisolone.
• The other ingredients are methylcellulose,
magnesium stearate, microcrystalline cellulose,
Aluminium lakes indigo (E132) and sodium
starch glycolate.
What Medrone looks like and contents of the
pack
• Medrone is a blue, round tablet with ‘UPJOHN’
on one side and ‘X’ score mark on the other
side.
• The tablets are packed in blisters containing 10
tablets and comes in boxes of 20’s & 30’s.
Manufacturer and Licence Holder
This medicine is manufactured by Valdepharm,
27100 Val-de-Reuil, France and is procured from
within the EU. Product Licence Holder: LTT
Pharma Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, Redditch,
B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
PL 33723/0012 - Medrone 100mg Tablets

Leaflet revision date: 07/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

MEDRONE 100MG TABLETS
(methylprednisolone)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Medrone 100mg Tablets
and will be referred to as Medrone throughout the
rest of this leaflet.
What is in this leaflet
1. What Medrone is and what it is used for
2. What you need to know before you take
Medrone
3. How to take Medrone
4. Possible side effects
5. How to store Medrone
6. Contents of the pack and other information
1. WHAT MEDRONE IS AND WHAT IT IS USED
FOR
This medicine contains methylprednisolone, which
belongs to a group of medicines called steroids.
Their full name is corticosteroids. Corticosteroids
are produced naturally in your body and are
important for many body functions. Boosting your
body with extra corticosteroid such as Medrone
can help following surgery (e.g. organ transplants),
injuries or other stressful conditions. These include
inflammatory or allergic conditions affecting the:
• brain (e.g. tuberculous meningitis)
• bowel and gut (e.g. Crohn’s disease and
ulcerative colitis)
• blood or blood vessels (e.g. leukaemia or
arteritis, inflammation of the arteries)
• joints (e.g. rheumatic fever)
• lungs (e.g. asthma, tuberculosis)
• muscle (e.g. dermatomyositis and polymyositis)
• skin (e.g. pemphigus vulgaris, an auto-immune
disorder in which the body’s immune system is
overactive causing the skin to blister)
Medrone may be prescribed to treat conditions
other than those listed above.
You must talk to a doctor if you are unsure why
you have been given this medicine, if you do not
feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MEDRONE
Do not take Medrone:
• If you think you have ever suffered an allergic
reaction, or any other type of reaction after
being given Medrone or any of the other
ingredients of this medicine (listed in section 6).
An allergic reaction may cause a skin rash or
reddening, swollen face or lips or shortness of
breath.
• If you have any serious fungal infection such
as a serious fungal infection in your lungs or
oesophagus (the tube that connects your mouth
with your stomach) or any other infection which
is not being treated with an antibiotic or antiviral
medicine.
• If you have recently had, or are about to have
any vaccination.
If you get a rash or another symptom of an
infection tell your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine if you have any of the following
conditions.
Your doctor may have to monitor your treatment
more closely, alter your dose or give you another
medicine.
• Chickenpox, measles or shingles. If you think
you have been in contact with someone with
chickenpox, measles or shingles and you have
not already had these illnesses, or if you are
unsure if you have had them.
• Worm infestation (e.g. threadworm).
• Severe depression or manic depression
(bipolar disorder). This includes having had
depression before while taking steroid
medicines like Medrone, or having a family
history of these illnesses.
• Diabetes (or if there is a family history of
diabetes).
• Fits or seizures.
• Glaucoma (increased pressure in the eye) or if
there is a family history of glaucoma, or if you
have cataracts.
• Viral (e.g. herpes) or fungal eye infection.
• You recently suffered a heart attack.
• Heart problems, including heart failure.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kidney or liver disease.
• Kaposi’s sarcoma (a type of skin cancer).
• Muscle problems (pain or weakness) have
happened while taking steroid medicines like
Medrone in the past.
• Myasthenia gravis (a condition causing tired
and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal
gland tissue. The adrenal glands are located
above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach or
intestinal problems.
• Thrombophlebitis - vein problems due to
thrombosis (clots in the veins) resulting in
phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered
tuberculosis in the past.
• Cushing’s disease (condition caused by an
excess of cortisol hormone in your body).
• Brain injury due to trauma (injury).
• Unusual stress.
Other medicines and Medrone
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, (including medicines you have
obtained without a prescription).This
could be harmful or affect the way Medrone or the
other medicine works:
• Acetazolamide - used to treat glaucoma and
epilepsy.
• Aminoglutethimide or Cyclophosphamide –
used for treating cancer.
• Anticoagulants - used to ‘thin’ the blood such
as acenocoumarol, phenindione and warfarin.
• Anticholinesterases - used to treat myasthenia
gravis (a muscle condition) such as distigmine
and neostigmine.
• Antibacterials (such as isoniazid,
erythromycin, clarithromycin and
troleandomycin).
• Antidiabetics – medicines used to treat high
blood sugar.
• Aprepitant or fosaprepitant – used to prevent
nausea and vomiting.
• Aspirin and non-steroidal anti-inflammatory
medicines (also called NSAIDs) such as
ibuprofen used to treat mild to moderate pain.
• Barbiturates, carbamezipine, phenytoin and
primidone – used to treat epilepsy.
• Carbenoxolone and cimetidine - used for
heartburn and acid indigestion.

• Ciclosporin - used to treat conditions such as
severe rheumatoid arthritis, severe psoriasis or
following an organ or bone marrow transplant.
• Digoxin - used for heart failure and/or an
irregular heartbeat.
• Diltiazem or mibefradil – used for heart
problems or high blood pressure.
• Ethinylestridiol and norethisterone – an oral
contraceptive.
• Indinavir or ritonavir – used to treat HIV
infections.
• Ketoconazole or itraconazole – used to treat
fungal infections.
• Pancuronium or vecuronium – or other
medicines called neuromuscular blocking agents
which are used in some surgical procedures.
• Potassium depleting agents – such as
diuretics (sometimes called water tablets),
amphotericin B, xanthenes or beta2 agonists
(e.g. medicines used to treat asthma).
• Rifampicin and rifabutin – antibiotics used to
treat tuberculosis (TB).
• Tacrolimus – used following an organ transplant
to prevent rejection of the organ.
• Vaccines - tell your doctor or nurse if you have
recently had, or are about to have any
vaccination. You must not have ‘live’ vaccines
while using this medicine. Other vaccines may
be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood
pressure or water retention (oedema) tell your
doctor as he/she may need to adjust the dose of
the medicines used to treat these conditions.
Before you have any operation tell your doctor,
dentist or anesthetist that you are taking Medrone.
If you require a test to be carried out by your
doctor or in hospital it is important that you tell
the doctor or nurse that you are taking Medrone.
This medicine can affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine,
as it could slow the baby’s growth.
Cataracts have been observed in infants born to
mothers treated with long-term corticosteroids during pregnancy. If you are breast-feeding, ask your
doctor or pharmacist for advice, as small amounts
of corticosteroid medicines may get into breast
milk.
Driving and using machines
Undesirable effects, such as dizziness, vertigo,
visual disturbances and fatigue are possible after
treatment with corticosteroids. If you are affected
do not drive or operate machinery.
3. HOW TO TAKE MEDRONE
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Steroid Cards
Remember to always carry a Steroid Treatment
Card. Make sure your doctor or pharmacist has
filled out the details of your medicine,
including the dose and how long you will
require steroid treatment.
You should show your steroid card to anyone who
gives you treatment (such as a doctor, nurse or
dentist) while you are taking Medrone, and for 3
months after you stop taking the tablets.
If you are admitted to hospital for any reason
always tell your doctor or nurse that you are taking
Medrone. You can also wear a medic-alert
bracelet or pendant to let medical staff know that
you are taking a steroid if you have an accident or
become unconscious.

Adults
The normal daily dose is between 4 mg and 360
mg per day, depending on your condition and how
severe it is. Your doctor will prescribe the lowest
dose possible.
Your doctor may tell you to take your daily dose all
in one go, split your daily dose throughout the day,
or take it every other day at 8.00 am.
Swallow the tablets whole with a drink of water.
The score line is not intended for breaking the
tablet.
Do not eat grapefruit or drink grapefruit juice while
taking Medrone.
If you are being given Medrone because your
body cannot make its own corticosteroids, your
doctor may also want you to take a second type of
steroid to help your salt balance. Your doctor may
prescribe a higher dose at the start of your
treatment to bring your condition under control.
When your doctor is happy that your condition has
improved your dose will be reduced gradually.
Normally the dose will be reduced by not more
than 2 mg every 7 to 10 days.
Elderly:
Your doctor may want to see you more regularly to
check how you are getting on with your tablets.
Children and adolescents:
Corticosteroids can affect growth in children so
your doctor will prescribe the lowest dose that will
be effective for your child. Your doctor may tell you
to give your child this medicine on every other day.
If you take more Medrone than you should
It is important that you do not take more tablets
than you are told to take. If you accidentally take
too many tablets, seek medical attention straight
away.
If you forget to take your Medrone
Wait and take the next dose as normal. Do not
take a dose to make up for the forgotten one but
tell your doctor or pharmacist what had happened.
Stopping/reducing the dose of your Medrone
Your doctor will decide when it is time to stop your
dose.
You must not stop taking Medrone suddenly,
especially if you :
• have had more than 6 mg Medrone daily for
more than 3 weeks
• have been given high doses of Medrone (more
than 32 mg daily) even if it was only for 3 weeks
or less
• have already had a course of corticosteroid
tablets or injections in the last year
• already had problems with your adrenal glands
(adrenocortical insufficiency) before you started
this treatment
• take repeat doses in the evening.
You will need to come off Medrone slowly to avoid
withdrawal symptoms. These symptoms may
include itchy skin, fever, muscle and joint pains,
runny nose, sticky eyes, loss of appetite, nausea,
vomiting, headache, feeling tired, peeling
skin and weight loss.
If your symptoms seem to return or get worse as
your dose of Medrone is reduced tell your doctor
immediately.
Mental problems while taking Medrone
Mental health problems can happen while taking
steroids like Medrone (see section 4).
• These illnesses can be serious.
• Usually they start within a few days or weeks of
starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However if
the problems do happen they might need
treatment.

Talk to a doctor if you (or someone using this
medicine) shows any signs of mental problems.
This is particularly important if you are depressed,
or might be thinking about suicide. In a few cases
mental problems have happened when doses are
being lowered or stopped.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Your
doctor will have given you this medicine for a
condition which if not treated properly could
become serious.
These side effects may occur with certain
frequencies,which are defined as follows:
• common: may affect up to 1 in 10 people.
• not known: frequency cannot be estimated from
the available data.
In certain medical conditions medicines like
Medrone (steroids) should not be stopped
abruptly. If you suffer from any of the following
symptoms, seek IMMEDIATE medical attention.
Your doctor will then decide whether you
should continue taking your medicine:
common
• Burst or bleeding ulcers, symptoms of which
are stomach pain (especially if it seems to
spread to your back), bleeding from the back
passage, black or bloodstained stools and/or
vomiting blood.
• Infections. This medicine can hide or change
the signs and symptoms of some infections, or
reduce your resistance to the infection, so that
they are hard to diagnose at an early stage.
Symptoms might include a raised temperature
and feeling unwell. Symptoms of a flare up of a
previous TB infection could be coughing blood
or pain in the chest. Medrone may also make
you more likely to develop a severe infection.
not known
• Allergic reactions, such as skin rash, swelling
of the face or wheezing and difficulty breathing.
This type of side effect is rare, but can be
serious.
• Pancreatitis, stomach pain spreading to your
back, possibly accompanied by vomiting, shock
and loss of consciousness.
• Pulmonary embolus (blood clots in the lung),
symptoms of include sudden sharp chest pain,
breathlessness and coughing up blood.
• Raised pressure within the skull of children
(pseudotumour cerebri) symptoms of which are
headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after
treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in
a leg vein), symptoms of which include painful
swollen, red and tender veins.
If you experience any of the following side
effects, or notice any other unusual effects not
mentioned in this leaflet, tell your doctor
straight away:
Blood, heart and circulation
common
• High blood pressure, symptoms of which are
headaches, or generally feeling unwell.
not known
• Problems with the pumping of your heart (heart
failure) symptoms of which are swollen ankles,
difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of
the heart, irregular or very fast or slow pulse.
• Increased numbers of white blood cells
(leukocytosis).
• Low blood pressure.
Body water and salts
common
• Swelling and high blood pressure, caused by
increased levels of water and salt content.

• Cramps and spasms, due to the loss of

potassium from your body. In rare cases this can
lead to congestive heart failure (when the heart
cannot pump properly).
Digestive system
not known
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers, inflammation or thrush in the
oesophagus (the tube that connects your mouth
with your stomach), which can cause discomfort
on swallowing.
• Indigestion.
• Bloated stomach.
• Abdominal pain.
• Diarrhoea.
• Persistent hiccups, especially when high doses
are taken.
Eyes
common
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
not known
• Glaucoma (raised pressure within the eye,
causing pain in the eyes and headaches).
• Swollen optic nerve (papilloedema, indicated by
sight disturbance).
• Thinning of the clear part at the front of the eye
(cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or distorted vision (due to a disease
called chorioretinopathy).
Hepatobiliary disorders
not known
• Increase of liver enzymes.
Hormone and metabolic system
common
• Slowing of normal growth in infants, children and
adolescents which may be permanent.
• Round or moon-shaped face (Cushingoid
facies).
not known
• Irregular or no periods in women.
• Increased hair on the body and face in women
(hirsutism).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of
some hormones which in turn can cause low
blood pressure and dizziness. This effect may
persist for months.
• The amount of certain chemicals (enzymes)
called alanine transaminase, aspartate
transaminase and alkaline phosphatase that
help the body digest drugs and other
substances in your body may be raised after
treatment with a corticosteroid. The change is
usually small and the enzyme levels return to
normal after your medicine has cleared naturally
from your system. You will not notice any
symptoms if this happens, but it will show up if
you have a blood test.
• Accumulation of fat tissue on localised parts of
the body, manifesting as different presentations
for example back pain or weakness (due to
epidural lipomatosis).
Immune system
not known
• Increased susceptibility to infections which can
hide or change normal reactions to skin tests,
such as that for tuberculosis.
Muscles and bones
common
• Muscle weakness or wasting.
not known
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of
blood, this causes pain in the hip.
• Joint pain or joint problems.
• Torn muscle tendons causing pain and/or
swelling.
• Muscle pain, cramps or spasms.

Ref: LTT0012/070416/1/B

Nervous system
Steroids including methylprednisolone can cause
serious mental health problems.
These are common in both adults and children.
They can affect about 5 in every 100 people taking
medicines like methylprednisolone.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up and
down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and losing
your memory.
• Feeling, seeing or hearing things which do not
exist. Having strange and frightening thoughts,
changing how you act or having feelings of
being alone.
not known
• Irritability.
• Fits.
• Dizziness, a feeling of dizziness or ‘spinning’.
• Headache.
Skin
common
• Acne.
• Poor wound healing.
• Thinning of skin.
not known
• Stretch marks.
• Bruising.
• Sweating.
• Itchy skin.
• Rash or redness of skin.
• Hives (red itchy swellings).
• Dilation of small blood vessels on the surface of
the skin (red spider veins).
• Red, brown or purple, pin point, round spots.
• Brown/purple/red raised patches on the skin or
inside the mouth (Kaposi’s sarcoma).
Vascular disorders
not known
• Increased clotting of the blood
Other side effects
not known
• Feeling unwell.
• Feeling tired.
It is important if you are to have a blood test that
you tell the doctor or nurse that you have been
given treatment with Medrol.
If you experience any of the side effects listed
above tell your doctor straight away.

5. HOW TO STORE MEDROL

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting effects
you can help provide more information on the
safety of this medicine.

Medrol is a registered trademark of Pfizer
Enterprises Sarl.

PATIENT INFORMATION LEAFLET

Ref: LTT0012/070416/2/F

®

Medrol tablets should not be used after the expiry
date ‘EXP’ shown on the carton and blister strip. If
your medicine is out of date take it to your
pharmacist who will dispose of it safely.
Do not store above 25°C.
Store in the original package.
Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Medrol contains
• The active substance is 100 mg
methylprednisolone.
• The other ingredients are methylcellulose,
magnesium stearate, microcrystalline cellulose,
Aluminium lakes indigo (E132) and sodium
starch glycolate.
What Medrol looks like and contents of the
pack
• Medrol is a blue, round tablet with ‘UPJOHN’
on one side and ‘X’ score mark on the other
side.
• The tablets are packed in blisters containing 10
tablets and comes in boxes of 20’s & 30’s.
Manufacturer and Licence Holder
This medicine is manufactured by Valdepharm,
27100 Val-de-Reuil, France and is procured from
within the EU. Product Licence Holder: LTT
Pharma Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, Redditch,
B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM
PL 33723/0012 - Medrol 100mg Tablets

Leaflet revision date: 07/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

MEDROL 100MG TABLETS
(methylprednisolone)
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Medrol 100mg Tablets and
will be referred to as Medrol throughout the rest of
this leaflet.
What is in this leaflet
1. What Medrol is and what it is used for
2. What you need to know before you take
Medrol
3. How to take Medrol
4. Possible side effects
5. How to store Medrol
6. Contents of the pack and other information
1. WHAT MEDROL IS AND WHAT IT IS USED
FOR
This medicine contains methylprednisolone, which
belongs to a group of medicines called steroids.
Their full name is corticosteroids. Corticosteroids
are produced naturally in your body and are
important for many body functions. Boosting your
body with extra corticosteroid such as Medrol
can help following surgery (e.g. organ transplants),
injuries or other stressful conditions. These include
inflammatory or allergic conditions affecting the:
• brain (e.g. tuberculous meningitis)
• bowel and gut (e.g. Crohn’s disease and
ulcerative colitis)
• blood or blood vessels (e.g. leukaemia or
arteritis, inflammation of the arteries)
• joints (e.g. rheumatic fever)
• lungs (e.g. asthma, tuberculosis)
• muscle (e.g. dermatomyositis and polymyositis)
• skin (e.g. pemphigus vulgaris, an auto-immune
disorder in which the body’s immune system is
overactive causing the skin to blister)
Medrol may be prescribed to treat conditions other
than those listed above.
You must talk to a doctor if you are unsure why
you have been given this medicine, if you do not
feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE MEDROL
Do not take Medrol:
• If you think you have ever suffered an allergic
reaction, or any other type of reaction after
being given Medrol or any of the other
ingredients of this medicine (listed in section 6).
An allergic reaction may cause a skin rash or
reddening, swollen face or lips or shortness of
breath.
• If you have any serious fungal infection such
as a serious fungal infection in your lungs or
oesophagus (the tube that connects your mouth
with your stomach) or any other infection which
is not being treated with an antibiotic or antiviral
medicine.
• If you have recently had, or are about to have
any vaccination.
If you get a rash or another symptom of an
infection tell your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine if you have any of the following
conditions.
Your doctor may have to monitor your treatment
more closely, alter your dose or give you another
medicine.
• Chickenpox, measles or shingles. If you think
you have been in contact with someone with
chickenpox, measles or shingles and you have
not already had these illnesses, or if you are
unsure if you have had them.
• Worm infestation (e.g. threadworm).
• Severe depression or manic depression
(bipolar disorder). This includes having had
depression before while taking steroid
medicines like Medrol, or having a family
history of these illnesses.
• Diabetes (or if there is a family history of
diabetes).
• Fits or seizures.
• Glaucoma (increased pressure in the eye) or if
there is a family history of glaucoma, or if you
have cataracts.
• Viral (e.g. herpes) or fungal eye infection.
• You recently suffered a heart attack.
• Heart problems, including heart failure.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kidney or liver disease.
• Kaposi’s sarcoma (a type of skin cancer).
• Muscle problems (pain or weakness) have
happened while taking steroid medicines like
Medrol in the past.
• Myasthenia gravis (a condition causing tired
and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal
gland tissue. The adrenal glands are located
above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach or
intestinal problems.
• Thrombophlebitis - vein problems due to
thrombosis (clots in the veins) resulting in
phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered
tuberculosis in the past.
• Cushing’s disease (condition caused by an
excess of cortisol hormone in your body).
• Brain injury due to trauma (injury).
• Unusual stress.
Other medicines and Medrol
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, (including medicines you have
obtained without a prescription).This
could be harmful or affect the way Medrol or the
other medicine works:
• Acetazolamide - used to treat glaucoma and
epilepsy.
• Aminoglutethimide or Cyclophosphamide –
used for treating cancer.
• Anticoagulants - used to ‘thin’ the blood such
as acenocoumarol, phenindione and warfarin.
• Anticholinesterases - used to treat myasthenia
gravis (a muscle condition) such as distigmine
and neostigmine.
• Antibacterials (such as isoniazid,
erythromycin, clarithromycin and
troleandomycin).
• Antidiabetics – medicines used to treat high
blood sugar.
• Aprepitant or fosaprepitant – used to prevent
nausea and vomiting.
• Aspirin and non-steroidal anti-inflammatory
medicines (also called NSAIDs) such as
ibuprofen used to treat mild to moderate pain.
• Barbiturates, carbamezipine, phenytoin and
primidone – used to treat epilepsy.
• Carbenoxolone and cimetidine - used for
heartburn and acid indigestion.

• Ciclosporin - used to treat conditions such as
severe rheumatoid arthritis, severe psoriasis or
following an organ or bone marrow transplant.
• Digoxin - used for heart failure and/or an
irregular heartbeat.
• Diltiazem or mibefradil – used for heart
problems or high blood pressure.
• Ethinylestridiol and norethisterone – an oral
contraceptive.
• Indinavir or ritonavir – used to treat HIV
infections.
• Ketoconazole or itraconazole – used to treat
fungal infections.
• Pancuronium or vecuronium – or other
medicines called neuromuscular blocking agents
which are used in some surgical procedures.
• Potassium depleting agents – such as
diuretics (sometimes called water tablets),
amphotericin B, xanthenes or beta2 agonists
(e.g. medicines used to treat asthma).
• Rifampicin and rifabutin – antibiotics used to
treat tuberculosis (TB).
• Tacrolimus – used following an organ transplant
to prevent rejection of the organ.
• Vaccines - tell your doctor or nurse if you have
recently had, or are about to have any
vaccination. You must not have ‘live’ vaccines
while using this medicine. Other vaccines may
be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood
pressure or water retention (oedema) tell your
doctor as he/she may need to adjust the dose of
the medicines used to treat these conditions.
Before you have any operation tell your doctor,
dentist or anesthetist that you are taking Medrol.
If you require a test to be carried out by your
doctor or in hospital it is important that you tell
the doctor or nurse that you are taking Medrol.
This medicine can affect the results of some tests.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine,
as it could slow the baby’s growth.
Cataracts have been observed in infants born to
mothers treated with long-term corticosteroids during pregnancy. If you are breast-feeding, ask your
doctor or pharmacist for advice, as small amounts
of corticosteroid medicines may get into breast
milk.
Driving and using machines
Undesirable effects, such as dizziness, vertigo,
visual disturbances and fatigue are possible after
treatment with corticosteroids. If you are affected
do not drive or operate machinery.
3. HOW TO TAKE MEDROL
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Steroid Cards
Remember to always carry a Steroid Treatment
Card. Make sure your doctor or pharmacist has
filled out the details of your medicine,
including the dose and how long you will
require steroid treatment.
You should show your steroid card to anyone who
gives you treatment (such as a doctor, nurse or
dentist) while you are taking Medrol, and for 3
months after you stop taking the tablets.
If you are admitted to hospital for any reason
always tell your doctor or nurse that you are taking
Medrol. You can also wear a medic-alert bracelet
or pendant to let medical staff know that you are
taking a steroid if you have an accident or become
unconscious.

Adults
The normal daily dose is between 4 mg and 360
mg per day, depending on your condition and how
severe it is. Your doctor will prescribe the lowest
dose possible.
Your doctor may tell you to take your daily dose all
in one go, split your daily dose throughout the day,
or take it every other day at 8.00 am.
Swallow the tablets whole with a drink of water.
The score line is not intended for breaking the
tablet.
Do not eat grapefruit or drink grapefruit juice while
taking Medrol.
If you are being given Medrol because your body
cannot make its own corticosteroids, your doctor
may also want you to take a second type of
steroid to help your salt balance. Your doctor may
prescribe a higher dose at the start of your
treatment to bring your condition under control.
When your doctor is happy that your condition has
improved your dose will be reduced gradually.
Normally the dose will be reduced by not more
than 2 mg every 7 to 10 days.
Elderly:
Your doctor may want to see you more regularly to
check how you are getting on with your tablets.
Children and adolescents:
Corticosteroids can affect growth in children so
your doctor will prescribe the lowest dose that will
be effective for your child. Your doctor may tell you
to give your child this medicine on every other day.
If you take more Medrol than you should
It is important that you do not take more tablets
than you are told to take. If you accidentally take
too many tablets, seek medical attention straight
away.
If you forget to take your Medrol
Wait and take the next dose as normal. Do not
take a dose to make up for the forgotten one but
tell your doctor or pharmacist what had happened.
Stopping/reducing the dose of your Medrol
Your doctor will decide when it is time to stop your
dose.
You must not stop taking Medrol suddenly,
especially if you :
• have had more than 6 mg Medrol daily for
more than 3 weeks
• have been given high doses of Medrol (more
than 32 mg daily) even if it was only for 3 weeks
or less
• have already had a course of corticosteroid
tablets or injections in the last year
• already had problems with your adrenal glands
(adrenocortical insufficiency) before you started
this treatment
• take repeat doses in the evening.
You will need to come off Medrol slowly to avoid
withdrawal symptoms. These symptoms may
include itchy skin, fever, muscle and joint pains,
runny nose, sticky eyes, loss of appetite, nausea,
vomiting, headache, feeling tired, peeling
skin and weight loss.
If your symptoms seem to return or get worse as
your dose of Medrol is reduced tell your doctor
immediately.
Mental problems while taking Medrol
Mental health problems can happen while taking
steroids like Medrol (see section 4).
• These illnesses can be serious.
• Usually they start within a few days or weeks of
starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However if
the problems do happen they might need
treatment.

Talk to a doctor if you (or someone using this
medicine) shows any signs of mental problems.
This is particularly important if you are depressed,
or might be thinking about suicide. In a few cases
mental problems have happened when doses are
being lowered or stopped.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Your
doctor will have given you this medicine for a
condition which if not treated properly could
become serious.
These side effects may occur with certain
frequencies,which are defined as follows:
• common: may affect up to 1 in 10 people.
• not known: frequency cannot be estimated from
the available data.
In certain medical conditions medicines like
Medrol (steroids) should not be stopped
abruptly. If you suffer from any of the following
symptoms, seek IMMEDIATE medical attention.
Your doctor will then decide whether you
should continue taking your medicine:
common
• Burst or bleeding ulcers, symptoms of which
are stomach pain (especially if it seems to
spread to your back), bleeding from the back
passage, black or bloodstained stools and/or
vomiting blood.
• Infections. This medicine can hide or change
the signs and symptoms of some infections, or
reduce your resistance to the infection, so that
they are hard to diagnose at an early stage.
Symptoms might include a raised temperature
and feeling unwell. Symptoms of a flare up of a
previous TB infection could be coughing blood
or pain in the chest. Medrone may also make
you more likely to develop a severe infection.
not known
• Allergic reactions, such as skin rash, swelling
of the face or wheezing and difficulty breathing.
This type of side effect is rare, but can be
serious.
• Pancreatitis, stomach pain spreading to your
back, possibly accompanied by vomiting, shock
and loss of consciousness.
• Pulmonary embolus (blood clots in the lung),
symptoms of include sudden sharp chest pain,
breathlessness and coughing up blood.
• Raised pressure within the skull of children
(pseudotumour cerebri) symptoms of which are
headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after
treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in
a leg vein), symptoms of which include painful
swollen, red and tender veins.
If you experience any of the following side
effects, or notice any other unusual effects not
mentioned in this leaflet, tell your doctor
straight away:
Blood, heart and circulation
common
• High blood pressure, symptoms of which are
headaches, or generally feeling unwell.
not known
• Problems with the pumping of your heart (heart
failure) symptoms of which are swollen ankles,
difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of
the heart, irregular or very fast or slow pulse.
• Increased numbers of white blood cells
(leukocytosis).
• Low blood pressure.
Body water and salts
common
• Swelling and high blood pressure, caused by
increased levels of water and salt content.

• Cramps and spasms, due to the loss of

potassium from your body. In rare cases this can
lead to congestive heart failure (when the heart
cannot pump properly).
Digestive system
not known
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers, inflammation or thrush in the
oesophagus (the tube that connects your mouth
with your stomach), which can cause discomfort
on swallowing.
• Indigestion.
• Bloated stomach.
• Abdominal pain.
• Diarrhoea.
• Persistent hiccups, especially when high doses
are taken.
Eyes
common
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
not known
• Glaucoma (raised pressure within the eye,
causing pain in the eyes and headaches).
• Swollen optic nerve (papilloedema, indicated by
sight disturbance).
• Thinning of the clear part at the front of the eye
(cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or distorted vision (due to a disease
called chorioretinopathy).
Hepatobiliary disorders
not known
• Increase of liver enzymes.
Hormone and metabolic system
common
• Slowing of normal growth in infants, children and
adolescents which may be permanent.
• Round or moon-shaped face (Cushingoid
facies).
not known
• Irregular or no periods in women.
• Increased hair on the body and face in women
(hirsutism).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of
some hormones which in turn can cause low
blood pressure and dizziness. This effect may
persist for months.
• The amount of certain chemicals (enzymes)
called alanine transaminase, aspartate
transaminase and alkaline phosphatase that
help the body digest drugs and other
substances in your body may be raised after
treatment with a corticosteroid. The change is
usually small and the enzyme levels return to
normal after your medicine has cleared naturally
from your system. You will not notice any
symptoms if this happens, but it will show up if
you have a blood test.
• Accumulation of fat tissue on localised parts of
the body, manifesting as different presentations
for example back pain or weakness (due to
epidural lipomatosis).
Immune system
not known
• Increased susceptibility to infections which can
hide or change normal reactions to skin tests,
such as that for tuberculosis.
Muscles and bones
common
• Muscle weakness or wasting.
not known
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of
blood, this causes pain in the hip.
• Joint pain or joint problems.
• Torn muscle tendons causing pain and/or
swelling.
• Muscle pain, cramps or spasms.

Ref: LTT0012/070416/2/B

Nervous system
Steroids including methylprednisolone can cause
serious mental health problems.
These are common in both adults and children.
They can affect about 5 in every 100 people taking
medicines like methylprednisolone.
• Feeling depressed, including thinking about
suicide.
• Feeling high (mania) or moods that go up and
down.
• Feeling anxious, having problems sleeping,
difficulty in thinking or being confused and losing
your memory.
• Feeling, seeing or hearing things which do not
exist. Having strange and frightening thoughts,
changing how you act or having feelings of
being alone.
not known
• Irritability.
• Fits.
• Dizziness, a feeling of dizziness or ‘spinning’.
• Headache.
Skin
common
• Acne.
• Poor wound healing.
• Thinning of skin.
not known
• Stretch marks.
• Bruising.
• Sweating.
• Itchy skin.
• Rash or redness of skin.
• Hives (red itchy swellings).
• Dilation of small blood vessels on the surface of
the skin (red spider veins).
• Red, brown or purple, pin point, round spots.
• Brown/purple/red raised patches on the skin or
inside the mouth (Kaposi’s sarcoma).
Vascular disorders
not known
• Increased clotting of the blood
Other side effects
not known
• Feeling unwell.
• Feeling tired.
It is important if you are to have a blood test that
you tell the doctor or nurse that you have been
given treatment with Methylprednisolone.
If you experience any of the side effects listed
above tell your doctor straight away.

5. HOW TO STORE METHYLPREDNISOLONE

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard. By reporting effects
you can help provide more information on the
safety of this medicine.

PL 33723/0012 - Methylprednisolone 100mg
Tablets

Methylprednisolone tablets should not be used
after the expiry date ‘EXP’ shown on the carton
and blister strip. If your medicine is out of date
take it to your
pharmacist who will dispose of it safely.
Do not store above 25°C.
Store in the original package.
Keep out of the sight and reach of children.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer
required. These measures will help to protect the
environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What Methylprednisolone contains
• The active substance is 100 mg
methylprednisolone.
• The other ingredients are methylcellulose,
magnesium stearate, microcrystalline cellulose,
Aluminium lakes indigo (E132) and sodium
starch glycolate.
What Methylprednisolone looks like and contents of the pack
• Methylprednisolone is a blue, round tablet with
‘UPJOHN’
on one side and ‘X’ score mark on the other
side.
• The tablets are packed in blisters containing 10
tablets and comes in boxes of 20’s & 30’s.
Manufacturer and Licence Holder
This medicine is manufactured by Valdepharm,
27100 Val-de-Reuil, France and is procured from
within the EU. Product Licence Holder: LTT
Pharma Limited, Unit 18, Oxleasow Road, East
Moons Moat, Redditch, Worcestershire, B98 0RE.
Repackaged by Lexon (UK) Limited, Redditch,
B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine
and will be able to advise you.

POM

Leaflet revision date: 07/04/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited,
Tel: 01527 505414 for help.

PATIENT INFORMATION LEAFLET

Ref: LTT0012/070416/3/F

METHYLPREDNISOLONE 100MG TABLETS
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor or pharmacist.
• This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them
even if their signs of illness are the same as
yours.
• If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
Your medicine is called Methylprednisolone 100mg
Tablets and will be referred to as
Methylprednisolone throughout the rest of this
leaflet.
What is in this leaflet
1. What Methylprednisolone is and what it is used
for
2. What you need to know before you take
Methylprednisolone
3. How to take Methylprednisolone
4. Possible side effects
5. How to store Methylprednisolone
6. Contents of the pack and other information
1. WHAT METHYLPREDNISOLONE IS AND
WHAT IT IS USED FOR
This medicine contains methylprednisolone, which
belongs to a group of medicines called steroids.
Their full name is corticosteroids. Corticosteroids
are produced naturally in your body and are
important for many body functions. Boosting your
body with extra corticosteroid such as
Methylprednisolone can help following surgery
(e.g. organ transplants), injuries or other stressful
conditions. These include inflammatory or allergic
conditions affecting the:
• brain (e.g. tuberculous meningitis)
• bowel and gut (e.g. Crohn’s disease and
ulcerative colitis)
• blood or blood vessels (e.g. leukaemia or
arteritis, inflammation of the arteries)
• joints (e.g. rheumatic fever)
• lungs (e.g. asthma, tuberculosis)
• muscle (e.g. dermatomyositis and polymyositis)
• skin (e.g. pemphigus vulgaris, an auto-immune
disorder in which the body’s immune system is
overactive causing the skin to blister)
Methylprednisolone may be prescribed to treat
conditions other than those listed above.
You must talk to a doctor if you are unsure why
you have been given this medicine, if you do not
feel better or if you feel worse.
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE METHYLPREDNISOLONE
Do not take Methylprednisolone:
• If you think you have ever suffered an allergic
reaction, or any other type of reaction after
being given Methylprednisolone or any of the
other ingredients of this medicine (listed in
section 6). An allergic reaction may cause a skin
rash or reddening, swollen face or lips or
shortness of breath.
• If you have any serious fungal infection such
as a serious fungal infection in your lungs or
oesophagus (the tube that connects your mouth
with your stomach) or any other infection which
is not being treated with an antibiotic or antiviral
medicine.
• If you have recently had, or are about to have
any vaccination.
If you get a rash or another symptom of an
infection tell your doctor immediately.

Warnings and precautions
Talk to your doctor or pharmacist before taking this
medicine if you have any of the following
conditions.
Your doctor may have to monitor your treatment
more closely, alter your dose or give you another
medicine.
• Chickenpox, measles or shingles. If you think
you have been in contact with someone with
chickenpox, measles or shingles and you have
not already had these illnesses, or if you are
unsure if you have had them.
• Worm infestation (e.g. threadworm).
• Severe depression or manic depression
(bipolar disorder). This includes having had
depression before while taking steroid
medicines like Methylprednisolone, or having a
family
history of these illnesses.
• Diabetes (or if there is a family history of
diabetes).
• Fits or seizures.
• Glaucoma (increased pressure in the eye) or if
there is a family history of glaucoma, or if you
have cataracts.
• Viral (e.g. herpes) or fungal eye infection.
• You recently suffered a heart attack.
• Heart problems, including heart failure.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Kidney or liver disease.
• Kaposi’s sarcoma (a type of skin cancer).
• Muscle problems (pain or weakness) have
happened while taking steroid medicines like
Methylprednisolone in the past.
• Myasthenia gravis (a condition causing tired
and weak muscles).
• Osteoporosis (brittle bones).
• Pheochromocytoma (a rare tumour of adrenal
gland tissue. The adrenal glands are located
above the kidneys).
• Skin abscess.
• Stomach ulcer or other serious stomach or
intestinal problems.
• Thrombophlebitis - vein problems due to
thrombosis (clots in the veins) resulting in
phlebitis (red, swollen and tender veins).
• Tuberculosis (TB) or if you have suffered
tuberculosis in the past.
• Cushing’s disease (condition caused by an
excess of cortisol hormone in your body).
• Brain injury due to trauma (injury).
• Unusual stress.
Other medicines and Methylprednisolone
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, (including medicines you have
obtained without a prescription).This
could be harmful or affect the way
Methylprednisolone or the other medicine works:
• Acetazolamide - used to treat glaucoma and
epilepsy.
• Aminoglutethimide or Cyclophosphamide –
used for treating cancer.
• Anticoagulants - used to ‘thin’ the blood such
as acenocoumarol, phenindione and warfarin.
• Anticholinesterases - used to treat myasthenia
gravis (a muscle condition) such as distigmine
and neostigmine.
• Antibacterials (such as isoniazid,
erythromycin, clarithromycin and
troleandomycin).
• Antidiabetics – medicines used to treat high
blood sugar.
• Aprepitant or fosaprepitant – used to prevent
nausea and vomiting.
• Aspirin and non-steroidal anti-inflammatory
medicines (also called NSAIDs) such as
ibuprofen used to treat mild to moderate pain.
• Barbiturates, carbamezipine, phenytoin and
primidone – used to treat epilepsy.
• Carbenoxolone and cimetidine - used for
heartburn and acid indigestion.

• Ciclosporin - used to treat conditions such as
severe rheumatoid arthritis, severe psoriasis or
following an organ or bone marrow transplant.
• Digoxin - used for heart failure and/or an
irregular heartbeat.
• Diltiazem or mibefradil – used for heart
problems or high blood pressure.
• Ethinylestridiol and norethisterone – an oral
contraceptive.
• Indinavir or ritonavir – used to treat HIV
infections.
• Ketoconazole or itraconazole – used to treat
fungal infections.
• Pancuronium or vecuronium – or other
medicines called neuromuscular blocking agents
which are used in some surgical procedures.
• Potassium depleting agents – such as
diuretics (sometimes called water tablets),
amphotericin B, xanthenes or beta2 agonists
(e.g. medicines used to treat asthma).
• Rifampicin and rifabutin – antibiotics used to
treat tuberculosis (TB).
• Tacrolimus – used following an organ transplant
to prevent rejection of the organ.
• Vaccines - tell your doctor or nurse if you have
recently had, or are about to have any
vaccination. You must not have ‘live’ vaccines
while using this medicine. Other vaccines may
be less effective.
If you are taking long term medication(s)
If you are being treated for diabetes, high blood
pressure or water retention (oedema) tell your
doctor as he/she may need to adjust the dose of
the medicines used to treat these conditions.
Before you have any operation tell your doctor,
dentist or anesthetist that you are taking
Methylprednisolone.
If you require a test to be carried out by your
doctor or in hospital it is important that you tell
the doctor or nurse that you are taking
Methylprednisolone. This medicine can affect the
results of some tests.
Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine,
as it could slow the baby’s growth.
Cataracts have been observed in infants born to
mothers treated with long-term corticosteroids during pregnancy. If you are breast-feeding, ask your
doctor or pharmacist for advice, as small amounts
of corticosteroid medicines may get into breast
milk.
Driving and using machines
Undesirable effects, such as dizziness, vertigo,
visual disturbances and fatigue are possible after
treatment with corticosteroids. If you are affected
do not drive or operate machinery.
3. HOW TO TAKE METHYLPREDNISOLONE
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Steroid Cards
Remember to always carry a Steroid Treatment
Card. Make sure your doctor or pharmacist has
filled out the details of your medicine,
including the dose and how long you will
require steroid treatment.
You should show your steroid card to anyone who
gives you treatment (such as a doctor, nurse or
dentist) while you are taking Methylprednisolone,
and for 3 months after you stop taking the tablets.
If you are admitted to hospital for any reason
always tell your doctor or nurse that you are taking
Methylprednisolone. You can also wear a
medic-alert bracelet or pendant to let medical staff
know that you are taking a steroid if you have an
accident or become unconscious.

Adults
The normal daily dose is between 4 mg and 360
mg per day, depending on your condition and how
severe it is. Your doctor will prescribe the lowest
dose possible.
Your doctor may tell you to take your daily dose all
in one go, split your daily dose throughout the day,
or take it every other day at 8.00 am.
Swallow the tablets whole with a drink of water.
The score line is not intended for breaking the
tablet.
Do not eat grapefruit or drink grapefruit juice while
taking Methylprednisolone.
If you are being given Methylprednisolone
because your body cannot make its own
corticosteroids, your doctor may also want you to
take a second type of steroid to help your salt balance. Your doctor may prescribe a higher dose at
the start of your treatment to bring your condition
under control.
When your doctor is happy that your condition has
improved your dose will be reduced gradually.
Normally the dose will be reduced by not more
than 2 mg every 7 to 10 days.
Elderly:
Your doctor may want to see you more regularly to
check how you are getting on with your tablets.
Children and adolescents:
Corticosteroids can affect growth in children so
your doctor will prescribe the lowest dose that will
be effective for your child. Your doctor may tell you
to give your child this medicine on every other day.
If you take more Methylprednisolone than you
should
It is important that you do not take more tablets
than you are told to take. If you accidentally take
too many tablets, seek medical attention straight
away.
If you forget to take your Methylprednisolone
Wait and take the next dose as normal. Do not
take a dose to make up for the forgotten one but
tell your doctor or pharmacist what had happened.
Stopping/reducing the dose of your
Methylprednisolone
Your doctor will decide when it is time to stop your
dose.
You must not stop taking Methylprednisolone
suddenly, especially if you :
• have had more than 6 mg Methylprednisolone
daily for more than 3 weeks
• have been given high doses of
Methylprednisolone (more than 32 mg daily)
even if it was only for 3 weeks or less
• have already had a course of corticosteroid
tablets or injections in the last year
• already had problems with your adrenal glands
(adrenocortical insufficiency) before you started
this treatment
• take repeat doses in the evening.
You will need to come off Methylprednisolone
slowly to avoid withdrawal symptoms. These
symptoms may include itchy skin, fever, muscle
and joint pains, runny nose, sticky eyes, loss of
appetite, nausea, vomiting, headache, feeling
tired, peeling skin and weight loss.
If your symptoms seem to return or get worse as
your dose of Methylprednisolone is reduced tell
your doctor immediately.
Mental problems while taking
Methylprednisolone
Mental health problems can happen while taking
steroids like Methylprednisolone (see section 4).
• These illnesses can be serious.
• Usually they start within a few days or weeks of
starting the medicine.
• They are more likely to happen at high doses.
• Most of these problems go away if the dose is
lowered or the medicine is stopped. However if
the problems do happen they might need
treatment.

Talk to a doctor if you (or someone using this
medicine) shows any signs of mental problems.
This is particularly important if you are depressed,
or might be thinking about suicide. In a few cases
mental problems have happened when doses are
being lowered or stopped.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side
effects, although not everybody gets them. Your
doctor will have given you this medicine for a
condition which if not treated properly could
become serious.
These side effects may occur with certain
frequencies,which are defined as follows:
• common: may affect up to 1 in 10 people.
• not known: frequency cannot be estimated from
the available data.
In certain medical conditions medicines like
Medrone (steroids) should not be stopped
abruptly. If you suffer from any of the following
symptoms, seek IMMEDIATE medical attention.
Your doctor will then decide whether you
should continue taking your medicine:
common
• Burst or bleeding ulcers, symptoms of which
are stomach pain (especially if it seems to
spread to your back), bleeding from the back
passage, black or bloodstained stools and/or
vomiting blood.
• Infections. This medicine can hide or change
the signs and symptoms of some infections, or
reduce your resistance to the infection, so that
they are hard to diagnose at an early stage.
Symptoms might include a raised temperature
and feeling unwell. Symptoms of a flare up of a
previous TB infection could be coughing blood
or pain in the chest. Medrone may also make
you more likely to develop a severe infection.
not known
• Allergic reactions, such as skin rash, swelling
of the face or wheezing and difficulty breathing.
This type of side effect is rare, but can be
serious.
• Pancreatitis, stomach pain spreading to your
back, possibly accompanied by vomiting, shock
and loss of consciousness.
• Pulmonary embolus (blood clots in the lung),
symptoms of include sudden sharp chest pain,
breathlessness and coughing up blood.
• Raised pressure within the skull of children
(pseudotumour cerebri) symptoms of which are
headaches with vomiting, lack of energy and
drowsiness. This side-effect usually occurs after
treatment is stopped.
• Thrombophlebitis (blood clots or thrombosis in
a leg vein), symptoms of which include painful
swollen, red and tender veins.
If you experience any of the following side
effects, or notice any other unusual effects not
mentioned in this leaflet, tell your doctor
straight away:
Blood, heart and circulation
common
• High blood pressure, symptoms of which are
headaches, or generally feeling unwell.
not known
• Problems with the pumping of your heart (heart
failure) symptoms of which are swollen ankles,
difficulty in breathing and palpitations
(awareness of heart beat) or irregular beating of
the heart, irregular or very fast or slow pulse.
• Increased numbers of white blood cells
(leukocytosis).
• Low blood pressure.
Body water and salts
common
• Swelling and high blood pressure, caused by
increased levels of water and salt content.

• Cramps and spasms, due to the loss of

potassium from your body. In rare cases this can
lead to congestive heart failure (when the heart
cannot pump properly).
Digestive system
not known
• Nausea (feeling sick) or vomiting (being sick).
• Ulcers, inflammation or thrush in the
oesophagus (the tube that connects your mouth
with your stomach), which can cause discomfort
on swallowing.
• Indigestion.
• Bloated stomach.
• Abdominal pain.
• Diarrhoea.
• Persistent hiccups, especially when high doses
are taken.
Eyes
common
• Damage to the optic nerve or cataracts
(indicated by failing eyesight).
not known
• Glaucoma (raised pressure within the eye,
causing pain in the eyes and headaches).
• Swollen optic nerve (papilloedema, indicated by
sight disturbance).
• Thinning of the clear part at the front of the eye
(cornea) or of the white part of the eye (sclera).
• Worsening of viral or fungal eye infections.
• Protruding of the eyeballs (exophthalmos).
• Blurred or distorted vision (due to a disease
called chorioretinopathy).
Hepatobiliary disorders
not known
• Increase of liver enzymes.
Hormone and metabolic system
common
• Slowing of normal growth in infants, children and
adolescents which may be permanent.
• Round or moon-shaped face (Cushingoid
facies).
not known
• Irregular or no periods in women.
• Increased hair on the body and face in women
(hirsutism).
• Increased appetite and weight gain.
• Diabetes or worsening of existing diabetes.
• Prolonged therapy can lead to lower levels of
some hormones which in turn can cause low
blood pressure and dizziness. This effect may
persist for months.
• The amount of certain chemicals (enzymes)
called alanine transaminase, aspartate
transaminase and alkaline phosphatase that
help the body digest drugs and other
substances in your body may be raised after
treatment with a corticosteroid. The change is
usually small and the enzyme levels return to
normal after your medicine has cleared naturally
from your system. You will not notice any
symptoms if this happens, but it will show up if
you have a blood test.
• Accumulation of fat tissue on localised parts of
the body, manifesting as different presentations
for example back pain or weakness (due to
epidural lipomatosis).
Immune system
not known
• Increased susceptibility to infections which can
hide or change normal reactions to skin tests,
such as that for tuberculosis.
Muscles and bones
common
• Muscle weakness or wasting.
not known
• Brittle bones (bones that break easily).
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of
blood, this causes pain in the hip.
• Joint pain or joint problems.
• Torn muscle tendons causing pain and/or
swelling.
• Muscle pain, cramps or spasms.

Ref: LTT0012/070416/3/B

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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