Methylprednisolone 40, 125, 500, 1g powder for solution for injection HU/H/0317/001-004/MR

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PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

Methylprednisolone 40 mg, 125 mg, 500 mg and 1000 mg powder for solution for injection

Read all of this leaflet carefully before you are given this medicine.

•    This patient information leaflet contains all information you should know about the product.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1.    What Methylprednisolone is and what it is used for

2.    Before you are given Methylprednisolone

3.    How Methylprednisolone is used

4.    Possible side effects

5.    How to store Methylprednisolone

6.    Further information

1. WHAT METHYLPREDNISOLONE IS AND WHAT IT IS USED FOR

Methylprednisolone is the active substance of Methylprednisolone powder for solution for injection.

Methylprednisolone 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 Methylprednisolone can help following surgery (e.g. organ transplants), flare-ups of the symptoms of multiple sclerosis or other stressful conditions.

Methylprednisolone may be used to treat the following diseases:

Skin disorders:

Severe inflammatory diseases of the skin.

Allergic conditions:

Bronchial, asthma.

Acute throat oedema of non-infectious origin.

Severe perennial allergic rhinitis.

Swelling of the mouth, the tongue and the trachea, which can cause difficulty in breathing (angioneurotic oedema).

Very serious allergic reaction (anaphylaxis).

Critical phases of gastro-intestinal diseases:

Inflammation of the large bowel and inflammation of the small bowel (Crohn’s disease).

Respiratory diseases:

Aspiration of gastric contents.

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Severe inflammatory diseases affecting the lung.

Neurological disorders:

In certain cases of brain swelling, acute spinal cord injuries, worsening or flare-up of sclerosis multiplex. Other diseases:

In certain cases of meningitis caused by the pathogen responsible for tuberculosis.

To reduce the reactions of the immune system in case of organ transplantation.

2. BEFORE YOU ARE GIVEN METHYLPREDNISOLONE

You should not be given Methylprednisolone if:

•    You are allergic to methylprednisolone, other corticosteroids or to any of the other ingredients of the medicinal product.

•    You have an infection that is not being treated.

•    You have a severe infection and blood poisoning.

•    You have headaches associated with malaria.

•    You have any fungal infections.

Take special care with Methylprednisolone

Tell your doctor if you have any of the following conditions:

•    Stomach ulcer

•    Renal insufficiency

•    Hypertension (high blood pressure)

•    Herpes eye infection (blistery skin rash of viral origin)

•    Intense osteoporosis

•    Myasthenia gravis (a condition causing tired and weak muscles).

If your doctor gives you a high dose of methylprednisolone, they may also give you an antacid (medicine to neutralise the acid in your stomach). This is to prevent a peptic ulcer.

Corticosteroids may mask the signs of infection. New infections may appear while you are being given methylprednisolone and the body may have reduced ability to fight the infection. You should not be given chicken-pox vaccine (Varicella)whilst given corticosteroids. If your doctor gives you a large dose of corticosteroid then other vaccines should not be given.

Personal contact with chicken-pox or measles patients should be avoided. If exposure occurs, patients should seek urgent medical attention.

If corticosteroids are used in patients with tuberculosis, close observation is necessary as reactivation of the disease may occur.

Within a few days or weeks patients and/or carers may notice severe psychiatric reactions. These may appear as depressed mood or suicidal thoughts. If this happens, please contact your doctor/nurse. This reaction should be improved with dose reduction or withdrawal.

Taking other medicines

Always tell your doctor or pharmacist if you are currently taking or have recently taken any other medicines, including medicines obtained without a prescription.

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Interaction with the below listed medicinal products has been reported, therefore use in combination with these medicines needs special care. Speak to your doctor if you are taking:

•    certain antibiotics: oleandomycin, troleandomycin, erythromycin, rifampicin

•    azole-type antifungal products: ketoconazole

•    neostigmin, pyridostigmin

•    phenobarbital, phenytoin

•    anxiolitics

•    antipsychotics

•    insulin, oral antidiabetic agents (glibenclamide, metformin)

•    oral anticoagulants and heparin

•    all high blood pressure decreasing agents

•    digoxin and similar heart glycosides

•    all potassium discharging diuretics

•    vaccines containing live or inactivated pathogens (epidemic poliomyelitis, BCG, mumps, measles, rubella vaccines).

•    methotrexate, cyclosporine

•    pancuronium

•    salbutamol.

Using this medicine in combination with non-steroidal anti-inflammatory medicines may result in stomach ulcers or increase their severity.

During prolonged use of methylprednisolone and medicines known as salicylates (such as aspirin), the dose of methylprednisolone should be decreased gradually, because abrupt lowering the dose of methylprednisolone may result in salicylate toxicity. If you have salicylate toxicity, you may feel sick (nausea), be sick (vomiting), have ringing in your ears (tinnitus), feel tired (lethargic) or feel dizzy.

The above list contains the medicinal products grouped according to their active ingredient and medical use and not according to the brand name. Consult your doctor in case you are unsure whether the other medicines you take may be used in combination with Methylprednisolone powder for solution for injection.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking any medicine.

3. HOW TO USE METHYLPREDNISOLONE

The preparations may only be administered by a doctor or skilled hospital staff.

The powder is first dissolved in sterile water for injections and resulting solution is administered as an injection into the muscle (intramuscular) or vein (intravenous); although it is usually injected into the vein in an emergency.

The method, quantity and rate of administration of the injection is determined by your doctor based on how ill you are and your age.

Adults:

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The initial dose is usually 10-500 mg depending on the disease treated. Larger doses may be required for short-term management of severe, acute conditions. The initial dose, up to 250 mg, should be given intravenously as a bolus injection over a period of at least 5 minutes, doses exceeding 250 mg should be given as an infusion over a period of at least 30 minutes.

Infants and children:

•    In infancy, childhood and adolescence, corticosteroids may cause growth to be slowed down. This may be irreversible. Your doctor should limit treatment to the minimum dose for the shortest period of time.

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.

If you are given more Methylprednisolone than you should:

If you think you have been given too many injections of Methylprednisolone please speak to your doctor immediately

If you forget to use Methylyprednisolone:

Your doctor or nurse will have instructions about when to give you your medicine. It is unlikely that you will not be given the medicine as it has been prescribed. If you are concerned that you have missed a dose talk to your doctor or other medical staff immediately.

If you stop taking Methylprednisolone:

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 Methylprednisolone, 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.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Methylprednisolone can cause side effects, although not everybody gets them. Frequencies of the observed side effects are defined as:

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Metabolism and nutrition disorders:

Uncommon: Sodium and fluid retention, potassium loss, possibility of deterioration of glucose control, therefore a possible increase in medication for diabetes may be required.

Rare: decreased blood potassium level (hypokalaemic alkalosis)

Cardiac disorders:

Heart rupture followed by heart attack

Vascular disorders:

Uncommon: high blood pressure, increased clotting of the blood

Musculoskeletal and connective tissue disorders:

Common: muscle weakness, brittle bones (osteoporosis)

Rare: death of bone cells particularly of the upper arm and upper leg (bone necrosis)

Gastrointestinal disorders:

Rare: peptic ulcer

Indigestion, abdominal pain, ulcers in the gullet, fungal infection of the gullet, inflammation of the pancreas, perforation of the bowel, feeling sick (nausea), being sick (vomiting), bad taste in the mouth

General disorders and administration site conditions:

Common: delayed wound healing

Uncommon: wasting away of skin and soft tissue at the injection site Rare: allergic dermatitis, contact dermatitis, rapid swelling of the skin

Nervous system disorders:

Common: convulsions

Rare: increased pressure in the head, high blood pressure (hypertension)

Endocrine disorders:

Common: decreased hormone secretion, Cushing-like symptoms, growth suppression in children, brittle bones (osteoporosis)

Irregular periods, periods stopping

Eye disorders:

Uncommon: loss of vision due to abnormally high pressure in the eye (glaucoma), blurred vision Swollen eyes, corneal thinning, irritation of any viral and fungal diseases of the eye Immune system disorders:

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Common: increased likelihood and severity of infections, although there may be no symptoms, reduced reaction to skin tests, if you have previously had tuberculosis it may re-occur Rare: hypersensitivity, allergic reactions, sometimes serious which can cause difficulty breathing, dizziness or wheezing

Psychiatric disorders:

Very common: psychotic disturbance

You may experience psychological effects when you stop taking methylprednisolone

Respiratory and thoracic and mediastinal disorders:

Rare: difficulty in breathing or wheezing

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE METHYLPREDNISOLONE

Keep out of reach and sight of children

Store in the original package in order to protect from light.

Chemical and physical in use stability has been demonstrated for 8 hours at 25°C and for 24 hours in a refrigerator at 2-8°C.

From a microbiological point of view once opened, the product may be stored for a maximum of 24 hours at 2-8°C. Other in-use storage times and conditions are the responsibility of the user.

Do not use Methylprednisolone after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Methylprednisolone contains

The active substance in Methylprednisolone Powder for Solution for Injection is methylprednisolone.

Each vial of powder contains 40 mg, 125 mg, 500 mg and 1000 mg methylprednisolone (as methylprednisolone sodium succinate).

The other ingredients are:

Sodium hydroxide, sodium dihydrogen phosphate-dihydrate, disodium hydrogen phosphate anhydrous. Methylprednisolone 40 mg powder for solution for injection also contains lactose monohydrate.

What Methylprednisolone looks like and contents of the pack

Appearance: white or almost white, sterile, lyophilized powder.

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Methylprednisolone powder for solution for injection is presented in the following packaging:

Nature and content of container:

Methylprednisolone 40 mg powder for injection: Transparent glass vial, which is sealed with a rubber stopper, aluminium cap and a dark green coloured plastic disc, placed into a carton box.

Available in packs of 1, 3, 5, 10, 50 and 100 vials

Not all pack sizes may be marketed.

Methylprednisolone 125 mg powder for injection: Transparent glass vial, which is sealed with a rubber stopper, aluminium cap and an orange coloured plastic disc, placed into a carton box.

Available in packs of 1, 3, 10 and 50 vials.

Not all pack sizes may be marketed.

Methylprednisolone 500 mg powder for injection: Transparent glass vial, which is sealed with a rubber stopper, aluminium cap and a pink coloured plastic disc, placed into a carton box.

Available in packs of 1, 3 and 10 vials.

Not all pack sizes may be marketed.

Methylprednisolone 1000 mg powder for injection: Transparent glass vial, which is sealed with a rubber stopper, aluminium cap and a white coloured plastic disc, placed into a carton box.

Available in packs of 1, 3 and 10 vials.

Not all pack sizes may be marketed.

Not all pack sizes may be marketed.

Marketing authorisation holder:

Teva UK Limited, Eastbourne, BN22 9AG, United Kingdom Manufacturer:

TEVA Pharmaceutical Works Private Limited Company H-2100 Godollo, Tancsics Mihaly ut 82,

Hungary

The leaflet was revised in June 2012

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The following information is intended for medical or healthcare professionals only:

Method of administration:

Methylprednisolone may be administered intravenously or intramuscularly, the preferred method for emergency use being intravenous injection given over a suitable time interval.

The injectable solution should be prepared according to the following prescriptions:

Parenteral drug products should wherever possible be visually inspected for particulate matter and discoloration prior to administration.

Dilution should be made using sterile water for injection.

a.) Preparation of the injection: The diluent should be added to the sterile powder under aseptic conditions.

Reconstitution table

Presentation	Solvent quantity (ml)	Quantity of dissolved product (ml)	Nominal conc. (mg/ml)
40 mg/vial	1	1	40
125 mg/vial	2	2	62.5
500 mg/vial	7.8	8	62.5
1000 mg/vial	15.6	16	62.5

b.) Preparation of infusion solution: Sterile powder should be diluted as described above. The initially prepared solution may be diluted with 5% dextrose in water, isotonic saline solution, or 5% dextrose in 0,9% saline solution. To avoid compatibility problems with other drugs Methylprednisolone should be administered separately, and only with the solutions mentioned above.

When Methylprednisolone is administered in high doses intravenously, it should be given over a period of at least 30 minutes. Doses up to 250 mg should be given intravenously over a period of at least five minutes.

Undesirable effects may be minimized by using the lowest effective dose for the minimum period.

Storage condition

See section 5 “How to store Methylprednisolone ”

Chemical and physical in use stability has been demonstrated for 8 hours at 25°C and for 24 hours in a refrigerator at 2-8°C.

From a microbiological point of view once opened, the product may be stored for a maximum of 24 hours at 2-8°C. Other in-use storage times and conditions are the responsibility of the user.

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