Medrolone contains methylprednisolone sodium succinate. Methylprednisolone belongs to a group of medicines called corticosteroids (steroids). Corticosteroids are produced naturally in your body and are important for many body functions.

Boosting your body with extra corticosteroid such as Medrolone can help following surgery (e.g. organ transplants), flare-ups of the symptoms of multiple sclerosis or other stressful conditions.

These include inflammatory or allergic conditions affecting the:

• Brain caused by a tumour or tuberculosis meningitis
• Bowel and gut e.g. ‘Crohn’s disease’ and ‘ulcerative colitis’
• Lungs caused by asthma, severe allergy or hypersensitivity, tuberculosis or breathing in (aspirating) vomit or stomach contents
• Skin e.g. Stevens-Johnson Syndrome.

Medrolone may be prescribed to treat conditions other than those listed above.

Talk to your doctor if you are unsure why you have been given this medicine.

You must talk to a doctor if you do not feel better or if you feel worse.

Do not use Medrolone:

• If you are allergic to Medrolone or any medicine containing corticosteroid 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 a widespread fungal infection (such as thrush) which is not being treated.
• If you have recently had, or are about to have any vaccination.
• If you are suffering from, or receiving treatment for, swelling of the brain, due to malaria.
• If you are suffering from a traumatic brain injury or stroke.

See your doctor immediately if any of the above applies to you.

Warnings and precautions
Talk to your doctor or pharmacist before using Medrolone 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, shingles or a herpes eye infection. 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).
• Epilepsy, fits or seizures.
• Glaucoma (increased pressure in the eye) or if there is a family history of glaucoma.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• You have recently suffered a heart attack.
• Heart problems, including heart failure or infections.
• Hypertension (high blood pressure).
• Hypothyroidism (an under-active thyroid).
• Joint infection.
• Kaposi’s sarcoma (a type of skin cancer).
• Kidney or liver disease.
• Scleroderma (also known as systemic sclerosis, an autoimmune disorder), because the risk of a serious complication called scleroderma renal crisis may be increased.
• Muscle problems (pain or weakness) have happened while taking steroid medicines 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, diverticulitis (inflammation of the bowel wall) 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.
• Unusual stress.
• Cushing’s disease (condition caused by an excess of cortisol hormone in your body).
• Acute pancreatitis (inflammation of the pancreas).

Medrolone should not be used in the treatment of septic shock.

If methylprednisolone is given to a prematurely born baby, monitoring of heart function and structure may be needed.

Tumour lysis syndrome can occur after treatment of a fast-growing cancer, especially certain leukemias and lymphomas (cancers of the blood) or solid tumours. As the tumour cells die, they break apart and release their contents into the blood. This causes a change in certain chemicals in the blood, which may cause damage to organs, including the kidneys, heart and liver that may lead to muscle cramping, muscle weakness, confusion, irregular heartbeat, visual loss or visual disturbances, and shortness of breath. Your doctor will monitor you closely, especially if you are at high risk of developing tumour lysis syndrome.

Other medicines and Medrolone
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

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
• Antibiotics (such as erythromycin, clarithromycin or troleandomycin)
• Antidiabetics – medicines used to treat high blood sugar
• Antihypertensives – medicines used to lower blood pressure
• Aprepitant and 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, carbamazepine, 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
• Ethinylestradiol and norethisterone – an oral contraceptive
• Antivirals (such as ritonavir, indinavir) and pharmacokinetic enhancers (such as cobicistat) used to treat HIV infections
• Isoniazid - used to treat bacterial infections
• Ketoconazole or itraconazole – used to treat fungal infections
• Mifepristone – used for the medical termination of a pregnancy
• 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 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 anaesthetist that you are taking Medrolone.

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 Medrolone. This medicine can affect the results of some tests.

Medrolone with drink
Do not drink grapefruit juice while taking this medicine.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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. There is a risk of low birth weight of a baby; this risk can be minimised by taking the lowest effective dose of the corticosteroids.

Cataracts have been observed in infants born to mothers undergoing long-term treatment with 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.

Medrolone contains sodium
Medrolone 40 mg contains sodium. Each vial of Medrolone 40 mg Powder for Solution for Injection/Infusion contains 8.418 mg sodium. This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’. If more than one vial is required, this should be taken into consideration if you are on a controlled sodium diet.

Medrolone 500 mg contains sodium. Each vial of Medrolone 500 mg Powder for Solution for Injection/Infusion contains 54.51 mg sodium (main component of cooking/table salt). This is equivalent to 2.73% of the recommended maximum daily dietary intake of sodium for an adult.

If you are admitted to hospital for any reason always tell your doctor or nurse that you are taking Medrolone.

Dosage information
Your doctor will decide on the site of injection, how much of the medicine and how many injections you will receive depending on the condition being treated and its severity. Your doctor will inject you with the lowest dose for the shortest possible time to get effective relief of your symptoms.

Your doctor will decide when you should be switched to oral therapy.

Adults
Medrolone will be given as an injection by your doctor or nurse, either into a vein (intravenous) or into a muscle (intramuscular). Usually the first dose is given into a vein, especially in an emergency.

It will be given slowly over at least 5 minutes. For larger doses this may take 30 minutes or more. Large doses should normally be used for only two to three days.

The medicine is first dissolved in bacteriostatic water for injection. If the medicine is to be given by infusion (using a pump or drip) it is then mixed with another suitable fluid. No other medicines should be mixed with it.

Elderly
Treatment will normally be the same as for younger adults. However your doctor may want to see you more regularly to check how you are getting on with this medicine.

Use in children and adolescents
Corticosteroids can affect growth in children so your doctor will prescribe the lowest dose that will be effective for your child.

If you are given more Medrolone than you should
If you think you have been given too many injections of Medrolone please speak to your doctor immediately.

Stopping/reducing the dose of your Medrolone
Your doctor will decide when it is time to stop your treatment.

You will need to come off this treatment slowly if you:

• Have had repeated doses of corticosteroids for more than 3 weeks.
• Have been given high doses of Medrolone, over 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.

You will need to come off this medicine slowly to avoid withdrawal symptoms. These symptoms may include itchy skin, fever, muscle and joint pains, runny nose, sticky eyes, sweating and weight loss.

If your symptoms seem to return or get worse as your dose of this medicine 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.

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.

In certain medical conditions medicines like methylprednisolone sodium succinate (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:

• 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.
• 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. Symptoms of a previous malaria infection could involve chills and fever. Methylprednisolone may also make you more likely to develop a severe infection.
• 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.

The side effects may occur with certain frequencies, which are defined as follows:

• Rare: may affect up to 1 in 1,000 people.
• Not known: frequency cannot be estimated from the available data.

Blood, heart and circulation
Not known

• High blood pressure, symptoms of which are headaches, or generally feeling unwell.
• 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.
• Low blood pressure symptoms may include dizziness, fainting, lightheadedness, blurred vision, a rapid, or irregular heartbeat (palpitations), general weakness.
• Increased numbers of white blood cells (leukocytosis).

Body water and salts
Not known

• 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

• Ulcers.
• Nausea (feeling sick) or vomiting (being sick).
• Diarrhoea.
• Thrush in the gullet (discomfort on swallowing).
• Indigestion.
• Bloated stomach.
• Abdominal pain.
• Hiccups.

 Ears
Not known

• A feeling of dizziness or spinning (vertigo).

Eyes
Rare

• Blurred vision.

Not known

• Cataracts (indicated by failing eyesight).
• Glaucoma (raised pressure within the eye, causing pain in the eyes and headaches).
• Swollen optic nerve (papilledema, 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 vision (chorioretinopathy).

General disorders
Not known

• Poor wound healing.
• Feeling tired or unwell.
• Skin reactions at the site of injection.

Hormones and metabolic system
Not known

• Slowing of normal growth in infants, children and adolescents which may be permanent.
• Round or moon-shaped face (Cushingoid facies).
• Irregular or no periods in women.
• 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.
• Suppression of reactions to skin tests, such as that for tuberculosis.

Muscles and bones
Not known

• Brittle bones (bones that break easily).
• Muscle weakness.
• Muscle wasting.
• Broken bones or fractures.
• Breakdown of bone due to poor circulation of blood, this causes pain in the hip.
• Torn muscle tendons causing pain and/or swelling.
• Muscle cramps or spasms.

Nerves and mood issues
Not known

• Steroids including methylprednisolone can cause serious mental health problems.
• 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.
• Fits.

Skin
Not known

• Acne.
• Bruising.
• Thinning of skin (skin atrophy).
• Stretch marks (skin striae).
• Small purple/red patches on the skin.
• Pale or darker patches on your skin, or raised patches which are an unusual colour.
• Excessive growth of bodily and facial hair.
• Rash, itching, hives.
• Increased sweating.

Liver disorder
Not known

• Methylprednisolone can damage your liver; hepatitis and increase of liver enzymes have been reported.

Vascular disorders
Not known

• Increased clotting of the blood.
• Warmth and reddening of the skin (Flushing).

If you experience any of the side effects listed above tell your doctor straight away.

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Store in the original package.

After reconstitution with solvent:
Chemical and physical in-use stability of the reconstituted solution has been demonstrated for 48 hours at room temperature.

After reconstitution with solvent and further dilution with other solutions for infusion:
Chemical and physical in-use stability of the reconstituted and further diluted solution has been demonstrated for 48 hours at room temperature.

From microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of the user.

Any unused liquid should be disposed of safely.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice that the solution contains particles or discoloured.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.