Package leaflet: Information for the patient Migräne-Kranit 500 mg Tablets Active substance: phenazone Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. - Keep this leaflet. You may need to read it again. - Ask your pharmacist if you need more information or advice. - 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. - You must talk to a doctor if you do not feel better or if you feel worse. What is in this leaflet 1. What Migräne-Kranit 500 mg Tablets are and what they are used for 2. What you need to know before you take Migräne-Kranit 500 mg Tablets 3. How to take Migräne-Kranit 500 mg Tablets 4. Possible side effects 5. How to store Migräne-Kranit 500 mg Tablets 6. Contents of the pack and other information 1. WHAT MIGRÄNE-KRANIT 500 MG TABLETS ARE AND WHAT THEY ARE USED FOR Migräne-Kranit 500 mg Tablets relieve migraine headaches and other pain. Migräne-Kranit 500 mg Tablets are used: - for the acute treatment of headaches from migraine attacks with or without aura, - for mild to moderate pain. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIGRÄNE-KRANIT 500 MG TABLETS Do not take Migräne-Kranit 500 mg Tablets: - if you are allergic to phenazone, pyrazolones and phenylbutazone or any of the other ingredients of this medicine (listed in section 6). - if you suffer from hereditary glucose-6-phosphate dehydrogenase deficiency (hereditary disease associated with the risk of spontaneous destruction of red blood cells), - if you suffer from acute hepatic porphyria (hereditary disease associated with a dysfunction of the production of the substance which gives blood its red colour), - during pregnancy and breast-feeding. 1
Migräne-Kranit 500 mg Tablets are not suited for nursing infants and children under 12 years of age. Furthermore, no findings are available for this age group, which is why Migräne-Kranit 500 mg Tablets must not be used in those children. Warnings and precautions Talk to your doctor or pharmacist before taking Migräne-Kranit 500 mg Tablets. Patients in whom blood count abnormalities have already been documented should only take Migräne-Kranit 500 mg Tablets if their blood count is monitored by a doctor. Patients with known allergies or (a history of) specific diseases that may be caused by allergies are more likely to experience a shock reaction (sudden circulatory collapse). This in particular applies to patients with: - bronchial asthma (attacks of shortness of breath caused by a narrowing of the smallest airways) and chronic (persisting) inflammations of the airways, - allergies to painkillers and antirheumatic medicines (intolerance to analgesics) or allergies to other medicines, - allergies to certain foods, preservatives, alcoholic drinks or - allergies to fur or hair dyes. Patients with those diseases may only use Migräne-Kranit 500 mg Tablets under medical supervision. The dose for elderly people and patients with acute liver disease should be based on the lower end of the recommended dose range since the effect of Migräne-Kranit 500 mg Tablets is stronger and longer in those patients. Other medicines and Migräne-Kranit 500 mg Tablets Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. Taking Migräne-Kranit 500 mg Tablets at the same time as warfarin decreases the effect of warfarin, shortening the coagulation time. If Migräne-Kranit 500 mg Tablets are taken over a long period of time together with enzyme inducers such as phenytoin, carbamazepine, barbiturates, spironolactone or rifampicin, the duration of effect of phenazone may be shortened. Taking Migräne-Kranit 500 mg Tablets at the same time as cimetidine and/or disulfiram or beta receptor blockers such as propranolol, calcium antagonists such as verapamil or diltiazem, antiarrhythmic agents such as amiodarone, oral contraceptives or ketoconazole slows down the breakdown and/or excretion of phenazone. Just like with fever, there is the possibility of an accumulation (elevated levels of phenazone in the blood). Migräne-Kranit 500 mg Tablets with food, drink and alcohol No special precautions need to be taken. 2
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. Since no experience with the use of Migräne-Kranit 500 mg Tablets during pregnancy is available and the active substance is excreted in human milk, Migräne-Kranit 500 mg Tablets must not be used during pregnancy and breast-feeding. Driving and using machines No special precautions need to be taken. 3. HOW TO TAKE MIGRÄNE-KRANIT 500 MG TABLETS Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Unless prescribed otherwise by your doctor, the recommended dose is: Acute treatment of headaches from migraine attacks with or without aura For the acute treatment of headaches from migraine attacks with or without aura, adults and adolescents over 15 years of age take 2 tablets (equivalent to 1000 mg phenazone), if required several times daily with 4 to 8 hours between doses. The maximum total daily dose should not exceed 8 tablets. For use in children and adolescents up to 15 years of age, no sufficient findings for giving a general dosage recommendation for the acute treatment of headaches from migraine attacks are available. Mild to moderate pain Adults and adolescents over 15 years of age take 1-2 tablets (equivalent to 500 mg - 1000 mg phenazone), if required several times daily with 4 to 8 hours between doses. The maximum total daily dose should not exceed 8 tablets. Children between 12 and 15 years take one tablet (equivalent to 500 mg phenazone) 1-2 times daily with 6 to 8 hours between doses. The total daily dose should not exceed 2 tablets. In elderly patients as well as patients with reduced general condition and impaired creatinine clearance or liver function, the dose should be decreased since the excretion of the metabolic products of Migräne-Kranit 500 mg Tablets may be slowed down. In those cases, the total daily dose should not exceed 3 tablets of Migräne-Kranit 500 mg Tablets (equivalent to 1500 mg phenazone). Method of administration: Oral use. Migräne-Kranit 500 mg Tablets are taken with plenty of liquid (e.g. a glass of water) with or without meals. 3
Duration of use: Without the advice of a physician or dentist, medicines containing phenazone should not be taken for longer than 3-4 days. If you take more Migräne-Kranit 500 mg Tablets than you should Signs of an overdose are trembling, seizures, visual disturbances, skin rashes and fainting. If any of those signs occur, contact a doctor immediately. If required, first aid may need to be initiated. In case of fainting, it must be ensured that the airways remain unobstructed. If you forget to take Migräne-Kranit 500 mg Tablets Do not take a double dose to make up for a forgotten dose. If you stop taking Migräne-Kranit 500 mg Tablets If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, this medicine can cause side effects, although not everybody gets them. The stated frequencies of the side effects are based on the following categories: Very common: may affect more than 1 in 10 treated Common: may affect 1 to 10 in 100 treated Uncommon: may affect 1 to 10 in 1,000 treated Rare: may affect 1 to 10 in 10,000 treated Very rare: may affect less than 1 in 10,000 treated Not known: cannot be estimated from the available data Possible side effects: Skin and subcutaneous tissue disorders: Uncommon: skin changes with reddening and itching, inflammations, skin rashes in various forms, skin nodules, blisters and hives. Rare: swelling with dropsy, mucosal inflammation and swelling, in particular in the throat, skin rashes to the point of peeling and detachment of skin (fixed eruptions, urticaria, in particularly rare cases: maculopapular rash, erythema multiforme, erythema nodosum, angiooedema as well as toxic epidermal necrolysis). General disorders and administration site conditions: Rare: immediate severe allergic reaction with signs of shock. 4
NB: A shock is a very rare event. It may manifest in different severities with the following warning signs: cold sweat, breathing problems, dizziness, feeling sick, lightheadedness. There may also be a sense of constriction around the heart, racing pulse and a drop in blood pressure. Those signs may occur immediately or up to one hour after taking Migräne-Kranit 500 mg Tablets. When the first signs of a shock occur, immediately call the nearest doctor that can be contacted! During the time until the doctor arrives, the patient's upper body should be kept flat and the patient should put their legs up. The patient should be kept warm with a cover to prevent cooling. In individual cases, blood count changes after use of Migräne-Kranit 500 mg Tablets cannot be ruled out. Countermeasures for side effects: If severe side effects occur, stop taking Migräne-Kranit 500 mg Tablets; in that case, please promptly contact your doctor. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Bundesinstitut für Arzneimittel und Medizinprodukte, Abt. Pharmakovigilanz, Kurt- Georg-Kiesinger-Allee 3, D-53175 Bonn, Website: www.bfarm.de. By reporting side effects you can help provide more information on the safety of this medicine. 5. HOW TO STORE MIGRÄNE-KRANIT 500 MG TABLETS Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and strip after "EXP:". The expiry date refers to the last day of that month. Storage conditions: Store Migräne-Kranit 500 mg Tablets out of light. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Migräne-Kranit 500 mg Tablets contain The active substance is phenazone. One tablet contains 500 mg phenazone. 5
The other ingredients are: crospovidone Ph. Eur., microcrystalline cellulose, colloidal silica Ph. Eur., magnesium stearate [herbal] Ph. Eur. What Migräne-Kranit 500 mg Tablets look like and contents of the pack Migräne-Kranit 500 mg Tablets are white, round tablets with one-sided score line. Migräne-Kranit 500 mg Tablets are available in packs with 10 tablets, 20 tablets (N1), 50 tablets (N2) and 100 tablets (N3). Marketing Authorisation Holder and Manufacturer Krewel Meuselbach GmbH Krewelstr. 2 53783 Eitorf tel: +49 (0)2243 / 87-0 fax: +49 (0)2243 / 87-175 e-mail: info@krewelmeuselbach.de This leaflet was last revised in July 2013. 6