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MEDRONE 100MG TABLETS

Active substance(s): METHYLPREDNISOLONE

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Package leaflet: Information for the patient

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.
The name of your medicine is Medrone 100mg tablets but
will be referred to as Medrone throughout 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 heart
beat.
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 vercuronium - 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 4mg and 360mg 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 2mg 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 6mg Medrone daily for more than 3
weeks
have been given high doses of Medrone (more than
32mg 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 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.
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, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Medrone
Keep out of the sight and reach of children.
This medicine does not require any special storage
conditions.
Do not take the tablets after the expiry date which is stated
on the carton and blister label after ‘Exp’. The date refers to
the last day of that month.

If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
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 in Medrone is methylprednisolone.
Each tablet contains 100mg methylprednisolone.
The other ingredients are sodium starch glycollate,
microcrystalline cellulose, magnesium stearate,
methylcellulose and indigo carmine aluminium lake.
What Medrone looks like and contents of the pack
Medrone are light blue, round tablets scored with a cross on
one side and marked ‘UPJOHN 3379’ on the other.
Medrone is available in blister packs containing 30 tablets.
Manufactured by: Pfizer Italia S.R.L., Ascoli Piceno, Italy.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
®

Medrone 100mg tablets
PL 18799/2293
Leaflet date: 27.06.2016

POM

Medrone is a registered trademark of Pfizer group of
companies.

Package leaflet: Information for the patient

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.
The name of your medicine is Methylprednisolone 100mg
tablets but will be referred to as Methylprednisolone
throughout 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 heart
beat.
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 vercuronium - 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 4mg and 360mg 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 8.00am.
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 2mg 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 6mg Methylprednisolone daily for
more than 3 weeks
have been given high doses of Methylprednisolone
(more than 32mg 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
Methylprednisolone (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. Methylprednisolone 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 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.
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. You can also report side effects directly via at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Methylprednisolone
Keep out of the sight and reach of children.
This medicine does not require any special storage
conditions.
Do not take the tablets after the expiry date which is stated
on the carton and blister label after ‘Exp’. The date refers to
the last day of that month.
If the tablets become discoloured or show any signs of
deterioration, seek the advice of your pharmacist.
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
The active substance is methylprednisolone.
Each tablet contains 100mg methylprednisolone.
The other ingredients are sodium starch glycollate,
microcrystalline cellulose, magnesium stearate,
methylcellulose and indigo caramine aluminium lake.
What Methylprednisolone looks like and contents of the
pack
Methylprednisolone are light blue, round tablets scored with
a cross on one side and marked ‘UPJOHN 3379’ on the
other.
Methylprednisolone is available in blister packs containing
30 tablets.
Manufactured by: Pfizer Italia S.R.L. Ascoli Piceno, Italy.
Procured from within the EU and repackaged by the
Product Licence holder: B&S Healthcare, Unit 4,
Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Methylprednisolone 100mg tablets
PL 18799/2293
Leaflet date: 27.06.2016

POM

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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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