Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
tolcapone
Viatris Healthcare Limited
N04BX01
tolcapone
Anti-Parkinson drugs, Other dopaminergic agents
Parkinson Disease
Tasmar is indicated in combination with levodopa / benserazide or levodopa / carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol-O-methyltransferase (COMT) inhibitors.Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first-line adjunct therapy to levodopa / benserazide or levodopa / carbidopa.Since Tasmar should be used only in combination with levodopa / benserazide and levodopa / carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar.
Revision: 24
Authorised
1997-08-27
40 B. PACKAGE LEAFLET 41 PACKAGE LEAFLET: INFORMATION FOR THE USER Tasmar 100 mg film-coated tablets tolcapone 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 further questions, please ask your doctor or your pharmacist. - This medicine has been prescribed for you. 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 Tasmar is and what it is used for 2. What do you need to know before you take Tasmar 3. How to take Tasmar 4. Possible side effects 5. How to store Tasmar 6. Contents of the pack and other information 1. WHAT TASMAR IS AND WHAT IT IS USED FOR For the treatment of Parkinson’s disease, Tasmar is used together with the medicinal product levodopa (as levodopa/benserazide or levodopa/carbidopa). Tasmar is used when all other alternative medicines cannot stabilise your Parkinson’s disease. For the treatment of your Parkinson’s disease you already take levodopa. A natural protein (enzyme) in your body, the (COMT) Catechol- _O_ -methyltransferase breaks down the levodopa. Tasmar blocks this enzyme and thus slows the breakdown of levodopa. This means when it is taken together with levodopa (as levodopa/benserazide or levodopa/carbidopa) you should have an improvement in the symptoms of your Parkinson’s disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TASMAR DO NOT TAKE TASMAR: - if you have liver disease or increased liver enzymes - if you have severe involuntary movement (dyskinesia) - if you have a previous history of severe symptoms of muscle stiffening, fever or mental confusion (Neuroleptic Malignant Syndrome (NMS) Symptom Complex) and/or if you have damage of skeletal muscle tissue (non-traumatic rhabdomyolysis) or fever (hyperthe Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tasmar 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 100 mg tolcapone. Excipients with known effect Each film-coated tablet contains 7.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Pale to light yellow, hexagonal, biconvex, film-coated tablet. “TASMAR” and “100” are engraved on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tasmar is indicated in combination with levodopa/benserazide or levodopa/carbidopa for use in patients with levodopa-responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of other catechol- _O_ -methyltransferase (COMT) inhibitors (see section 5.1). Because of the risk of potentially fatal, acute liver injury, Tasmar should not be considered as a first- line adjunct therapy to levodopa/benserazide or levodopa/carbidopa (see sections 4.4 and 4.8). Since Tasmar should be used only in combination with levodopa/benserazide and levodopa/carbidopa, the prescribing information for these levodopa preparations is also applicable to their concomitant use with Tasmar. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Paediatric population _ Tasmar is not recommended for use in children below the age of 18 due to insufficient data on safety or efficacy. There is no relevant indication for use in children and adolescents. _Elderly _ No dose adjustment of Tasmar is recommended for elderly patients. _Hepatic impairment (see section 4.3) _ Tasmar is contraindicated for patients with liver disease or increased liver enzymes. _ _ _Renal impairment (see section 5.2) _ No dose adjustment of Tasmar is recommended for patients with mild or moderate renal impairment (creatinine clearance of 30 ml/min or greater). Patients with severe renal impairment (creatinine clearance <30 ml/min) should be treated with caution. No informatio Đọc toàn bộ tài liệu