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1.3.1.3 Patient Information Leaflet

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1.3.1.3 Patient Information Leaflet Sandoz Business use only Page 1 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE PATIENT [Nationally completed name, 200 mg, retard tablet] Carbamazepine 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 pharmacist. 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 [Nationally completed name] is and what it is used for 2. What you need to know before you take [Nationally completed name] 3. How to take [Nationally completed name] 4. Possible side effects 5. How to store [Nationally completed name] 6. Contents of the pack and other information 1. What [Nationally completed name] is and what it is used for Carbamazepine, the active ingredient in [nationally completed name], can affect the body in several different ways. It is an anti-convulsant medicine (prevents fits), it can also modify some types of pain and can control mood disorders. This medicine is used: To treat some forms of epilepsy 2. What you need to know before you take [Nationally completed name] You may only take [Nationally completed name] after a full medical examination. Do not take [Nationally completed name] If you are allergic (hypersensitive) to carbamazepine, to any of a related group of drugs known as tricyclic antidepressants (such as amitriptyline or imipramine), or to any of the other ingredients of [Nationally completed name] (listed in section 6). If you have severe heart disease. If you have had serious blood illnesses in the past. Sandoz Business use only Page 2 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00 If you have a disturbance in the production of porphyrin, a pigment important for liver function and blood formation (also called ‘hepatic porphyria’). If you are also taking drugs belonging to a special group of antidepressants called monoamine- oxidase inhibitors (MAOIs). If this applies to you, tell your doctor before taking [Nationally completed name]. If you think you may be allergic, ask your doctor for advice. Warnings and precautions Talk to your doctor or pharmacist before taking [Nationally completed name] If you have blood illnesses (including those caused by other drugs). If you have ever shown unusual sensitivity (rash or any other signs of allergy) to oxcarbazepine or to any other medicines. It is important to note that if you are allergic to carbamazepine, the chances are approximately 1 in 4 (25 %) that you could also have an allergic reaction to oxcarbazepine. If you have or have had heart, liver or kidney disease in the past. If you have increased pressure in the eye (glaucoma). If you were told by your physician that you suffer from a mental disorder called psychosis that may be accompanied by confusion or agitation. If you are a woman taking a hormonal contraceptive (birth control medicine). [Nationally completed name] may render this contraceptive ineffective. Therefore, you should use a different or additional non-hormonal method of contraception while you are taking [Nationally completed name]. This should help to prevent an unwanted pregnancy. Tell your doctor at once if you get irregular vaginal bleeding or spotting. If you have any questions about this, ask your doctor or health professional. If any of the following apply to you, tell your doctor immediately. If an allergic reaction happens such as fever with lymph nodes swelling, rash or skin blistering, tell your doctor immediately or go to the emergency department at your nearest hospital (see Possible side effects). If you develop serious skin reactions such as rash, red skin, blistering of the lips, eyes or mouth, skin peeling and accompanied by fever, tell your doctor immediately or go to the emergency department at your nearest hospital (see Possible side effects). These reactions may be more frequent in patients in some Asian countries (e.g. Taiwan, Malaysia and The Philippines) and in patients with Chinese ancestry. If you experience an increase in the number of seizures, tell your doctor immediately. If you notice symptoms suggestive of hepatitis, such as jaundice (yellowing of skin and eyes), tell your doctor immediately. If at any time you have thoughts of harming or killing yourself. A small number of people being treated with antiepileptics such as carbamazepine have had such thoughts or behaviour. Serious skin rashes (Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of carbamazepine. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza- like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread Sandoz Business use only Page 3 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00 blistering and peeling of the skin. The highest risk for occurrence of serious skin reactions is within the first months of treatment. These serious skin reactions can be more common in people from some Asian countries. The risk of these reactions in patients of Han Chinese or Thai origin may be predicted by testing a blood sample of these patients. Your doctor should be able to advise if a blood test is necessary before taking carbamazepine. If you develop a rash or these skin symptoms, stop taking carbamazepine and contact your doctor immediately. Carbamazepine may cause a multi organ hypersensitivity disorder known as DRESS; it can affect several organs such as lungs, kidneys, pancreas, heart, intestine. If you have kidney problems or are treated with medicines that lower the sodium in your blood (e.g. diuretics) or if you are elderly, your doctor may have to measure your sodium blood levels before giving you carbamazepine. Do not stop your treatment with [Nationally completed name] without first checking with your doctor. To prevent sudden worsening of your seizure, do not discontinue your medicine abruptly. Other medicines and [Nationally completed name] Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Remember also those not prescribed by a doctor. It is particularly important for [nationally completed name] since many other medicines interact with it. You may need a change in your dose or, sometimes, to stop one of the medicines. If you are taking any of the following medicines, tell your doctor or pharmacist: Lithium, fluoxetine, fluvoxamine, nefazodone, paroxetine, trazodone, viloxazine, bupropion (used to help stop smoking), citalopram, mianserin, sertraline, tricyclic antidepressants (e.g. imipramine, desipramine, amitriptyline, nortriptyline, clomipramine), monoamine-oxidase inhibitors (MAOIs) (medicines used to treat depression) Alprazolam, midazolam (medicines used to treat anxiety) Corticosteroids, e.g. prednisolone, dexamethasone (used for inflammatory conditions such as asthma, inflammatory bowel disease, muscle and joint pains) Anticoagulants, such as warfarin, phenprocoumon, dicoumarol and acenocoumarol (to stop your blood clotting) Antibiotics, such as erythromycin, troleandomycin, josamycin, clarithromycin, ciprofloxacin, doxycycline (used to treat bacterial infections) Clozapine, haloperidol, bromperidol, olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, paliperidone, thioridazine, loxapine (antipsychotics, used to treat mental disorder) Painkillers, containing dextropropoxyphene, ibuprofen, buprenorphine, methadone, paracetamol, phenazone (antipyrine), tramadol. Long term use of carbamazepine and paracetamol may be associated with liver toxicity. Stiripentol, vigabatrin, felbamate, methsuximide, oxcarbazepine, phenobarbitone, phensuximide, phenytoin, fosphenytoin, primidone, clobazam, clonazepam, ethosuximide, lamotrigine, tiagabine, topiramate, valproic acid, valnoctamide and valpromide, zonisamide, mephenytoin, progabide, levetiracetam (medicines used to treat epilepsy) Sandoz Business use only Page 4 of 9 1.3.1 spc-label-pl - common-pl - 4,519 20140527 (NL/H/0238/002/IB/040) CARBAMAZEPINE 200 MG PROLONGED RELEASE TABLET 551-031D.00 Antifungals, such as itraconazole, ketoconazole, fluconazole, voriconazole (medicines used to treat fungal infections) Verapamil, diltiazem, felodipine or digoxin (medicines for high blood pressure or heart problems) Simvastatin, atorvastatin, lovastatin, cerivastatin, ivabradine (medicines for high cholesterol) Diuretics (water tablets), such as furosemide or hydrochlorothiazide Cimetidine or omeprazole (medicines used to treat gastric ulcers) Isotretinoin (medicine for the treatment of acne) Metoclopramide (an anti-sickness medication) Acetazolamide (a medicine to treat glaucoma – increased pressure in the eye) Danazol (treatment for endometriosis) Theophylline or aminophylline (used in the treatment of asthma) Ciclosporin (an immunosuppressant, used after transplant
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