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MEDRONE 4 MG TABLETS

Active substance(s): METHYLPREDNISOLONE

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Medrone® 4 mg Tablets

2280
27.05.15[5]

(methylprednisolone)
PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking this medicine
- Keep this leaflet. You may need to read it again
- If you have any further questions please ask your doctor or pharmacist
- This medicine has been prescribed for you. Do not pass it to others. It
may harm them even if their symptoms are the same as yours
- If any of the side effects gets serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist
This medicine is available using the above name but will be referred to as
Medrone through out the leaflet
Medrone Tablets are also available in other strengths of 2 mg, 16 mg and
100 mg.
In this leaflet:
1. What Medrone is and what it is used for
2. Before you take Medrone
3. How to take Medrone
4. Possible side effects
5. How to store Medrone
6. Further information
1. WHAT MEDRONE IS AND WHAT IT IS USED FOR
Medrone contain methylprednisolone. Methylprednisolone 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 if
your body cannot produce enough corticosteroid due to problems with your
adrenal glands (e.g. adrenal insufficiency).
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. 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.
Ask your doctor if you are unsure why you have been given this medicine.
2. 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, any other steroid medicine or any
of the ingredients in Medrone tablets (Section 6 contains a list of the
ingredients). An allergic reaction may cause a skin rash or reddening,
swollen face or lips or shortness of breath.
- 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 get a rash or another symptom of an infection tell your doctor
immediately.
Take special care before taking Medrone:
You must tell your doctor before you take 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.
- Herpes 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.
- Karposi’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).
- 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).
Taking other medicines
Always tell your doctor or pharmacist if you are taking any medicines
(including any you have bought without a prescription) as taking Medrone
with other medicines could be harmful.
You should tell your doctor if you are taking any of the following medicines
which can 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
- Antibiotics (such as erythromycin, clarithromycin and troleandomycin)
- 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
- Diuretics – sometimes called water tablets.
- 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
- 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 should 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
You must tell your doctor if you are pregnant, think you might be pregnant
or are trying to become pregnant as this medicine could slow the baby’s
growth.
Tell your doctor if you are breast feeding as small amounts of corticosteroid
medicines may get into breast milk.
Important information about the ingredients of Medrone
Sugar intolerance - these tablets contain two sugars called lactose and
sucrose. If you have been told by your doctor that you have an intolerance
to some sugars, tell your doctor before taking this medicine.
3. HOW TO TAKE MEDRONE
Your doctor will tell you how many tablets to take and when to take them.
This information can also be found on the pharmacy label placed on the
tablet container.
If you are not sure how to take this medicine ask your doctor or pharmacist.
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 8.00am.
Swallow the tablets whole with a drink of water.
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:
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
also section 4, Possible Side Effects).
- 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.
4. POSSIBLE SIDE EFFECTS
Like all steroids these tablets can cause side-effects, although not
everybody gets them. Your doctor will have given you Medrone 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: affects 1 to 10 users in 100
- 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 (leucocytosis).
- 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 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).
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.
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).
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.
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 the Yellow Card Scheme 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
Medrone should not be used after the expiry date ‘EXP’ shown on the
carton and blister strip.
Keep your blister strips securely in the outer carton. If your medicine is out
of date take it to your pharmacist who will dispose of it safely.
Keep your medicine in a safe place where children cannot see or reach it.
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 protect the environment.
6. FURTHER INFORMATION
What Medrone contain
Medrone contain 4 mg methylprednisolone.
The tablets also contain lactose, sucrose, maize starch and calcium
stearate.
What Medrone look like and contents of the pack
Medrone is white elliptical, convex tablet, cross-scored on one side and
marked “UPJOHN” on the other.
Available in packs of 30 tablets.
MARKETING AUTHORISATION HOLDER AND MANUFACTURER
Medrone is manufactured by Valdepharm, 27100 Val De Reuil, France and
procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1
1XD. Repackaged by Servipharm Ltd
POM

PL 20636/2280 – Medrone 4 mg Tablets

Leaflet issue and revision date (Ref): 27.05.15[5]
Medrone is trademark of Pfizer Enterprises Sarl.

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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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