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Active substance(s): METHYLPREDNISOLONE

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Tablets 16 mg

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
• 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.
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

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

2. What you need to know before you take

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.

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:
• 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

• 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).

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
• 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
• 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

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
• 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
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.
Medrone contains lactose and sucrose
If you have been told by your doctor that you have an intolerance

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.
• 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
• 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
Hepatobiliary disorders
not known
• Increase of liver enzymes.
Hormone and metabolic system
• 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
Muscles and bones
• 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
• 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.
• Acne.
• Poor wound healing.
• Thinning of skin.
not known
• Stretch marks.
• Bruising.
• Sweating.

• 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
• 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
• 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.

to some sugars, tell your doctor before taking this medicine.

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.
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
If you are being given Medrone because your body cannot

• 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 effects directly via the Yellow
Card Scheme at By reporting
side effects you can help provide more information on the
safety of this medicine.

5. How to store Medrone

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is
stated on the carton and blister strip after ‘EXP’. The expiry

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.
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



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 if your body cannot produce enough corticosteroid
due to problems with your adrenal glands (e.g. adrenal
Corticosteroids can also 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)
• eye (e.g. optic neuritis, uveitis or iritis)
• joints (e.g. rheumatoid arthritis, rheumatic fever)
• lungs (e.g. asthma, tuberculosis)
• muscle (e.g. dermatomyositis and polymyositis)
• skin (e.g. eczema)
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.

date refers to the last day of that month.
Keep your blister strips securely in the outer carton.
Store below 25°C.
Do not throw away any medicines via wastewater or household
Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.


Package leaflet: Information for the patient

6. Contents of the pack and other information

What Medrone tablets contain
The active substance is methylprednisolone. Each tablet
contains 16 mg methylprednisolone.
The other ingredients are lactose, sucrose, maize starch,
mineral oil and calcium stearate.
What Medrone tablets look like and contents of the pack
Medrone Tablets 16 mg are white, oval, cross-scored on one
side and marked “UPJOHN 73” on the other side.
It is available in blister packs of 30 tablets and in plastic
bottles of 14 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ.
Pfizer Italia S.r.l., Località Marino del Tronto,
63100 Ascoli Piceno (AP), Italy.
Company Contact Address:
For further information on your medicine contact Medical
Information at Pfizer Limited, Walton Oaks, Dorking Road
Tadworth, Surrey, KT20 7NS. Tel: 01304 616161.
This leaflet was last revised in 02/2016.
Ref: MD 13_0

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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.