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Home , Carbenoxolone, Methylprednisolone

Package Leaflet: Information for the patient

METHYLPREDNISOLONE 500 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION 1000 MG POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION

Methylprednisolone sodium succinate

Read all of this leaflet carefully • Heart problems, including heart before you start taking this medicine failure or infections Other vaccines may be less effective. because it contains important • Hypertension (high blood pressure) If you are taking long term information for you • Hypothyroidism (an under-active medication(s) • Keep this leaflet. You may need to thyroid) If you are being treated for diabetes, read it again • Joint infection high blood pressure or water retention • If you have any further questions • Kaposi’s sarcoma (a type of skin (oedema) tell your doctor as he/she please ask your doctor or pharmacist cancer) may need to adjust the dose of the • This medicine has been prescribed • or disease medicine used to treat these for you. Do not pass it on to others. It • conditions. Muscle problems (pain or may harm them even if their signs of weakness) have happened while Before you have any operation tell illness are the same as yours taking your doctor, dentist or anaesthetist that • If you get any side effects, talk to • Myasthenia gravis (a condition you are being treated with your doctor or pharmacist. This causing tired and weak muscles) Methylprednisolone. includes any side effects not listed in • Osteoporosis (brittle bones) or if If you require a test to be carried out this leaflet. you are a women who has gone by your doctor or in hospital it is What is in this leaflet: through the menopause important that you tell the doctor or 1. What Methylprednisolone is and • Skin abscess nurse that you are taking what it is used for • Stomach ulcer, diverticulitis Methylprednisolone as this medicine 2. What you need to know before you (inflammation of the bowel wall) or could affect the test results. are given Methylprednisolone other serious stomach or intestinal Pregnancy and breast-feeding 3. How Methylprednisolone is given to problems You must tell your doctor if you are you • Thrombophlebitis – vein problems pregnant, think you might be pregnant 4. Possible side effects due to thrombosis (clots in the veins) or are trying to become pregnant as 5. How to store Methylprednisolone resulting in phlebitis (red, swollen this medicine could slow the baby’s 6. Contents of the pack and other and tender veins) growth. information. • (TB) or if you have Cataracts have been observed in 1. WHAT METHYLPREDNISOLONE IS AND suffered tuberculosis in the past. infants born to mothers undergoing WHAT IT IS USED FOR • Unusual stress • Cushing’s disease (condition long-term treatment with Methylprednisolone contains caused by an excess of during pregnancy. methylprednisolone sodium succinate. hormone in your body) Tell your doctor if you are breast- Methylprednisolone belongs to a group feeding as small amounts of • Acute pancreatitis (inflammation of of medicines called corticosteroids medicines may get into the pancreas). (steroids). Corticosteroids are produced breast milk. naturally in your body and are You must tell your doctor before you Methylprednisolone contains important for many body functions. take this medicine if you have any of sodium the conditions listed above. Boosting your body with extra This medicine contains 1.6 mmol (37.2 corticosteroid such as Other medicines and mg) of sodium in each 500mg vial of Methylprednisolone can help following Methylprednisolone methylprednisolone and 3.2 mmol

surgery (e.g. organ transplants), flare- Always tell your doctor or pharmacist if (74.4mg) of sodium in each 1000mg ups of the symptoms of multiple you are taking any other medicines vial of methylprednisolone. If you are sclerosis or other stressful conditions. on a controlled sodium (salt) diet tell (including any you have bought without These include inflammatory or allergic a prescription) as taking your doctor in case your sodium intake Methylprednisolone with other needs to be adjusted. conditions affecting the: • brain caused by a tumour or medicines could be harmful. 3. HOW METHYLPREDNISOLONE IS GIVEN

meningitis You should tell your doctor if you are TO YOU • bowel and gut e.g. ‘Crohn’s disease’ taking any of the following medicines Cards and ‘’ which can affect the way Remember to always carry a Steroid • lungs caused by , severe Methylprednisolone or other medicines Treatment Card. Make sure your allergy or hypersensitivity, works: doctor or pharmacist has filled out tuberculosis or breathing in • Acetazolamide – used to treat the details of your medicine, (aspirating) vomit or stomach including the dose and how long contents glaucoma, epilepsy and water retention you will require steroid treatment. • skin e.g. Stevens-Johnson • Syndrome. or You should show your steroid card to – used for anyone who gives you treatment (such Methylprednisolone may be prescribed treating cancer as a doctor, nurse or dentist) while you to treat conditions other than those • – used to ‘thin’ the are taking this medicine, and for 3 listed above. Ask your doctor if you are blood such as acenococoumarol, months after your last injection. unsure why you have been given this phenindione and warfarin If you are admitted to hospital for any medicine. • Anticholinesterases – used to treat reason always tell your doctor or nurse 2. WHAT YOU NEED TO KNOW BEFORE myasthenia gravis (a muscle that you are taking Methylprednisolone. YOU ARE GIVEN METHYLPREDNISOLONE condition) such as distigmine and You can also wear a medic-alert Do not use Methylprednisolone if: neostigmine bracelet or pendant to let medical staff • • you think you have ever suffered an Antibiotics (such as , know that you are taking a steroid if allergic reaction, or any other type of clarithromycin or ) you have an accident or become • reaction after being given Antidiabetics – medicines used to unconscious. treat high blood sugar. If you have Methylprednisolone, or any other Dosage information medicine containing a corticosteroid or diabetes, you may need to check your blood sugar more closely when Your doctor will decide on the site of any of the ingredients in this medicine injection, how many injections you will using methylprednisolone (section 6 of this leaflet contains a list receive depending on the condition • Antihypertensives – medicines of ingredients). An allergic reaction may being treated and its severity. Your cause a skin rash or reddening, swollen used to treat high blood pressure • doctor will inject the lowest dose for the face or lips or shortness of breath. Aprepitant and Fosaprepitant – shortest possible time to get effective used to prevent nausea and vomiting • you have any fungal infection (such relief of your symptoms. as thrush), other than on the skin • and non-steroidal anti- which is not being treated inflammatory medicines (also called Adults Methylprednisolone will be given, as an • you have recently had, or are about NSAIDs) such as ibuprofen, injection by your doctor or nurse, either to have any vaccination naproxen and diclofenac used to into a vein (intravenous) or into a • you are suffering from, or receiving treat mild to moderate pain muscle (intramuscular). Usually the first treatment for malaria • Barbiturates, , • and primidone – used to dose is given into a vein, especially in you are suffering from a head injury an emergency. It will be given slowly or stroke. treat epilepsy • and – over at least 5 minutes. For larger See your doctor immediately if any doses may take 30 minutes or more. of the above applies to you. used for heartburn and acid indigestion Large doses should normally be used Warnings and precautions for only 2 to 3 days. The medicine is • Ciclosporin – used to treat You must tell your doctor before you conditions such as severe first dissolved in water for injections. If take this medicine if you have any of , severe the medicine is to be given by infusion the following conditions. or following an organ or bone (using a pump or drip) it is then mixed with another suitable fluid. No other Your doctor may have to monitor your marrow transplant • medicines should be mixed with it. treatment more closely, alter your dose Digoxin – used for heart failure or give you another medicine. and/or irregular heart beat Elderly • Treatment will normally be the same as • Diltiazem or mibefradil – used for Chickenpox, measles, shingles or heart problems or high blood for younger adults. However your a herpes eye infection. If you think pressure doctor may want to see you more you have been in contact with • and regularly to check how you are getting someone with chickenpox, measles norethisterone – an oral on with this medicine. or shingles and you have not already contraceptive had these illnesses, or if you are Children • Isoniazid – used to treat bacterial unsure if you had them. If you are Corticosteroids can affect growth in infections children so your doctor will prescribe not immune or you are a parent of a • child receiving this medicine, avoid or itraconazole – the lowest dose that will be effective for used to treat fungal infections your child. close contact with anyone with these • infections. Seek medical advice if – used for the medical Do not drink grapefruit juice while being you think you have been exposed to termination of pregnancy treated with Methylprednisolone. • Pancuronium or vercuronium – one of these infections or if a If you are given more member of your household develops other medicines called neuromuscular blocking agents Methylprednisolone than you should one of them If you think you have been given too • which are used in some surgical Heart failure for which you are being many injections please speak to your treated with digoxin procedures • doctor immediately. • Worm infestation (e.g. threadworm) Potassium depleting agents – such • as diuretics (sometimes called water Stopping/reducing the dose of your Severe depression or manic Methylprednisolone depression (bipolar disorder). This tablets), amphotericin B, xanthenes or beta2 agonists (e.g. Your doctor will decide a suitable time includes having had depression to stop treatment. before while taking steroid medicines medicines to treat asthma) • and rifabutin – You will need to come off this treatment like Methylprednisolone, or having a slowly if you: family history of these illnesses or antibiotics used to treat tuberculosis • have had repeated doses of problems such as delusions, (TB) • corticosteroid for more than 3 weeks hallucinations or disorganised – used following an • have been given high doses of speech after taking steroids organ transplant to prevent rejection Methylprednisolone, over 32 mg • Diabetes (or if there is a family of the organ • daily, even if it is only for 3 weeks or history of diabetes). If you have Some medicines may increase the less diabetes, you should closely monitor effect of Methylprednisolone and • have already had a course of blood sugar while taking your doctor may wish to monitor you corticosteroid tablets or injections in methylprednisolone. carefully if you are taking these the last year • Epilepsy, fits or seizures medicines (including some • already had problems with your • Glaucoma (increased pressure in medicines for HIV: , cobicistat). adrenal glands (adrenocortical the eye) or if there is a family history • insufficiency) before you started this of glaucoma Vaccines – tell your doctor or nurse treatment. if you have recently had, or about to • have any vaccination. You should You have recently suffered a heart attack not have ‘live’ vaccines while using this medicine. ------

Information for the Healthcare Methylprednisolone may be the condition, up to 1g/day for graft Professional administered i.v. or i.m. For emergency rejection reactions following

Methylprednisolone 500mg & use the preferred method is i.v. transplantation. 1000mg powder and solvent for injection; doses above 250mg should Doses of 500mg to 1000mg should be solution for injection/infusion be given over at least 30 minutes; limited to 48 to 72 hours until the For full prescribing information please doses up to 250mg should be given patient's condition has stabilised, to read the Summary of Product over at least 5 minutes. Subsequent avoid serious side effects. In Characteristics. doses may be given i.v. or i.m. at anaphylactic reactions adrenaline or Presentation: Each vial of powder intervals dictated by the patient's noradrenaline should be administered contains the equivalent of either 500mg response and clinical condition. first for an immediate haemodynamic or 1000mg of methylprednisolone as Corticosteroid therapy is an adjunct to, effect, followed by i.v. injection of the sodium succinate salt. The 500mg and not replacement for, conventional methylprednisolone with other vials come with an ampoule containing therapy. accepted procedures. 7.8ml of water for injections. The Undesirable effects may be minimised In sensitivity reactions 1000mg vials come with a vial by using the lowest effective dose for methylprednisolone provides relief containing 15.6ml of water for injections the minimum period. within one half to two hours. Therapeutic Indications Parenteral drug products should In status asthmaticus, it may be given Treatment of any condition in which wherever possible be visually inspected at a dose of 40mg i.v., repeated as rapid and intense corticosteroid effect for particulate matter and discoloration dictated by patient response. In some is required. prior to administration. asthmatic patients administration by Dosage and Method of Adults: initial dosage will vary from 10 slow i.v. drip over a period of hours is Administration: to 500mg depending on the severity of recommended.

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481384_1216 PIL METILPREDNISOLONA 22/12/16 08:30 página 1 You will need to come off this medicine common • Thinning of skin (skin atrophy). slowly to avoid withdrawal symptoms. • Swelling and high blood pressure, not known These symptoms may include itchy caused by increased levels of water • Stretch marks (skin striae) skin, fever, muscle and joint pains, and salt content. • Small purple/red patches on the skin runny nose, sticky eyes, sweating and not known • Pale or darker patches on your skin, weight loss. • Cramps and spasms, due to the loss or raised patches which are unusual If your symptoms seem to return or get of potassium from your body. In rare colour worse as your dose of this medicine is cases this can lead to congestive • Excessive growth of bodily and facial reduced tell your doctor immediately. heart failure (when the heart cannot hair pump properly). • Mental health problems while taking Rash, itching, Digestive system • Increased sweating. Methylprednisolone common Mental health problems can happen Additionally the tearing of heart • Ulcers. muscles has been observed in patients while taking steroids like not known Methylprednisolone (see also section 4, taking methylprednisolone following a • Nausea (feeling sick) or vomiting Possible Side Effects). heart attack. (being sick) • These illnesses can be serious Withdrawal symptoms • Diarrhoea • Usually they start within a few days A 'withdrawal syndrome' may occur, • Thrush in the gullet (discomfort when or weeks of starting the medicine see Section 3 for more information swallowing) • They are more likely to happen at • Indigestion If you experience any of the side high doses • effects listed above tell your doctor • Bloated stomach Most of these problems go away if • straight away. Abdominal pain the dose is lowered or the medicine • is stopped. However, if the problems Hiccups. Reporting of side effects Ears If you get any side effects, talk to your do happen they might need not known treatment. doctor or nurse. This includes any • A feeling of dizziness or spinning possible side effects not listed in this Talk to a doctor if you (or someone (). leaflet. using this medicine) show any signs of Eyes You can also report side effects directly mental problems. This is particularly common (see details below). By reporting side important if you are depressed, or • Cataracts (indicated by failing effects you can help provide more might be thinking about suicide. In a eyesight). information on the safety of this few cases mental problems have not known medicine. happened when doses are being • Glaucoma (raised pressure within lowered or stopped. United Kingdom the eye, causing pain in the eyes Report any unwanted side-effects via If you have any further questions on the and headaches) the Yellow Card Scheme at: use of this medicine, ask your doctor or • Swollen optic nerve (papillioedema, www.mhra.gov.uk/yellowcard. pharmacist. indicated by sight disturbances). • Ireland 4. POSSIBLE SIDE EFFECTS Thinning of the clear part at the front of the eye (cornea) or of the white Reports may be made to HPRA Like all medicines, this medicine can part of the eye (sclera) Pharmacovigilance, Earlsfort Centre, cause side-effects, although not • Worsening of viral or fungal eye Earlsfort Terrace, IRL - Dublin 2 everybody gets them. Your doctor will infections Tel: +353 1 6764971; Fax: +353 1 have given you this medicine for a • Protruding of the eyeballs 6762517 condition which if not treated properly (exophthalmos) Website: www.hpra.ie; could become serious. E-mail: [email protected]. • Disease of the retina and choroid In certain medical conditions membrane. 5. HOW TO STORE medicines like Methylprednisolone General disorders METHYLPREDNISOLONE (steroids) should not be stopped common This medicine must not be used after abruptly. If you suffer from any of • Poor wound healing. the expiry date shown on the the following symptoms seek not known packaging. The expiry date refers to IMMEDIATE medical attention. Your • Feeling tired or unwell the last day of the month. doctor will then decide whether you • Skin reactions at the site of injection. Keep vials/ampoules in the outer carton should continue taking your Hormones and metabolic system to protect from light. medicine: common The doctor or pharmacist will keep the • Allergic reactions such as skin • Slowing of normal growth in infants, medicine in a safe place where children rash, swelling of the face or children and adolescents which may cannot reach or see it. wheezing and difficulty breathing. be permanent The reconstituted methylprednisolone This type of side effect is rare, but • Round or moon-shaped face solution and water for injections should can be serious (Cushingoid facies). be used immediately and any • Pancreatitis, stomach pain not known remainder discarded. spreading to your back, possibly • Irregular or no periods in women Your doctor or nurse will ensure that accompanied by vomiting, shock and • Increased appetite and weight gain your medicine is used and disposed of loss of consciousness • Diabetes or worsening of existing correctly. • Burst or bleeding ulcers, diabetes 6. CONTENTS OF THE PACK AND OTHER symptoms of which are stomach pain • Prolonged therapy can lead to lower INFORMATION (especially if it seems to spread to levels of some hormones which in your back), bleeding from the back turn can cause low blood pressure What Methylprednisolone powder for solution for injection/infusion passage, black or bloodstained and dizziness. This effect may stools and/or vomiting blood persist for months contains This medicine contains • Infections. This medicine can hide • The amount of certain chemicals methylprednisolone sodium succinate or change the signs and symptoms (enzymes) called transaminase, as the active ingredient: of some infections, or reduce your aspartate transaminase and alkaline resistance to the infection, so that phosphatase that help the body Methylprednisolone 500mg powder and they are hard to diagnose at an early digest drugs and other substances in solvent for solution for stage. Symptoms might include a your body may be raised after injection/infusion: raised temperature and feeling treatment with a corticosteroid. The Each vial of powder contains 663mg unwell. Symptoms of a flare up of a change is usually small and the methylprednisolone sodium succinate previous TB infection could be enzyme levels return to normal after (equivalent to 500mg coughing blood or pain in the chest. your medicine has cleared naturally methylprednisolone). Symptoms of a previous malaria from your system. You will not notice Each ampoule of solvent contains infection could involve chills and any symptoms if this happens, but it 7.8ml of water for injections.

fever. Methylprednisolone may also will show up if you have a blood test. Methylprednisolone 1000mg powder make you more likely to develop a • A disorder causing accumulation of and solvent for solution for severe infection fat tissue on local parts of the body injection/infusion: • Pulmonary embolus (blood clots in (lipomatosis). Each vial of powder contains 1326mg the lung), symptoms include sudden Immune system methylprednisolone sodium succinate sharp chest pain, breathlessness common (equivalent to 1000mg and coughing up blood • Increased susceptibility to infections. methylprednisolone). • Raised pressure within the skull of not known Each vial of solvent contains 15.6ml of children (pseudotumor cerebri) • Suppression of reactions to skin water for injections. symptoms of which are headaches tests, such as that for tuberculosis. Methylprednisolone powder for solution with vomiting, lack of energy and Liver for injection/infusion also contains the drowsiness. This side-effect usually not known inactive ingredient sodium phosphate. occurs after treatment is stopped • Methylprednisolone can damage What Methylprednisolone looks like • Thrombophlebitis (blood clots or your liver, hepatitis and increase of and contents of the pack: thrombosis in a leg vein), symptoms liver enzymes have been reported. Methylprednisolone 500mg/1000mg of which include painful swollen, red Muscle and bone issues powder for solution for injection/infusion and tender veins. common is a white powder which comes in a • If you experience any of the Brittle bones (bones break easily) clear glass vial. Each pack contains • following side effects, or notice any Muscle weakness. one vial of methylprednisolone not known other unusual effects not mentioned 500mg/1000mg powder and one vial or in this leaflet, tell your doctor • Muscle wasting ampoule of Sterilised Water for straight away. • Broken bones or fractures Injections. • Breakdown of bone due to poor The side effects may occur with certain Marketing Authorisation Holder circulation of blood, this causes pain frequencies, which are defined as Beacon Pharmaceuticals Limited, DCC follows: in the hip • Vital, Westminster Industrial Estate, • common: affects 1 to 10 users in 100 Torn muscle tendons causing pain Repton Road, Measham, DE 12 7 DT, • not known: frequency cannot be and/or swelling England • estimated from the available data. Muscle cramps or spasms. Manufacturer Nerves and mood issues Biomendi, S.A., Polígono Industrial de Blood, heart and circulation common common Bernedo s/n - 01118 Bernedo, Álava, Steroids including methylprednisolone Spain. • High blood pressure, symptoms of can cause serious health problems. This leaflet was last revised in which are headaches, or generally These are common in both adults and November 2016 feeling unwell. children. They can affect about 5 in not known every 100 people taking medicines like • Problems with the pumping of your methylprednisolone. heart (heart failure) symptoms of • Feeling depressed which are swollen ankles, difficulty in • Feeling high (mania), or moods that breathing and palpitations go up and down BMXP227BNC (awareness of heart beat) or • Feeling anxious, having problems irregular or very fast or slow pulse sleeping, difficulty in thinking or HARD TO READ? CALL • Low blood pressure symptoms may being confused and losing your include dizziness, fainting, light- memory +44 (0)1892-600930 FOR headedness, blurred vision, a rapid, • Feeling, seeing or hearing things HELP or irregular heartbeat (palpitations), which do not exist. Having strange general weakness and frightening thoughts, changing • Increased numbers of white blood how you act or having feelings of cells (leucocytisis) being alone. • Increased clotting of the blood. Skin common • Acne • Bruising Body water and salts 481384/1216

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In graft rejection reactions following For graft rejection reactions following with 5% dextrose in water, isotonic transplantation doses of up to 1000mg transplantation, 10 to 20mg/kg/day for saline solution, or 5% dextrose in per day have been used to suppress up to 3 days, to a maximum of 1 g/day, isotonic saline solution. To avoid rejection crises, with 500mg to 1000mg is recommended. compatibility problems with other drugs most commonly used for acute In the treatment of status asthmaticus, the reconstituted solution should be rejection. 1 to 4mg/kg/day for 1 to 3 days is administered separately, only in the Refer to the Summary of Product recommended. diluents mentioned. Characteristics for the suggested Elderly: Methylprednisolone is Storage Precautions: Keep dosage schedules for oedemas due to primarily used in acute short term vials/ampoules in the outer carton to brain tumour. conditions. Treatment should consider protect from light. Nature of In the treatment of acute exacerbations the more serious consequences of the Container: Type I glass vials with butyl of in adults, the common side-effects and close clinical rubber stopper and aluminium flip-cap. recommended dose is 1000mg daily for supervision is required. Type I glass ampoules. Instructions 3 days, given as an i.v. infusion over at Pharmaceutical Information: for Use and Handling: Please refer to least 30 minutes. Contains sodium phosphate as buffer. Dosing instructions. For single use Children: In the treatment of The powder should be reconstituted in only. Unused solution must be haematological, rheumatic, renal and the water for injections supplied. After discarded immediately. dermatological conditions, 30mg/kg/day reconstitution in water for injections, to a maximum of 1 g/day is each ml of solution contains the recommended. This may be repeated equivalent of 59.6 mg of for three pulses either daily or on Methylprednisolone. The alternate days. reconstituted solution may be diluted

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