Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
entacapone
Orion Corporation
N04BX02
entacapone
Anti-Parkinson drugs
Parkinson Disease
Entacapone is indicated as an adjunct to standard preparations of levodopa / benserazide or levodopa / carbidopa for use in adult patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.
Revision: 26
Authorised
1998-09-22
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: INFORMATION FOR THE USER COMTAN 200 MG FILM-COATED TABLETS entacapone 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 Comtan is and what it is used for 2. What you need to know before you take Comtan 3. How to take Comtan 4. Possible side effects 5. How to store Comtan 6. Contents of the pack and other information 1. WHAT COMTAN IS AND WHAT IT IS USED FOR Comtan tablets contain entacapone and are used together with levodopa to treat Parkinson’s disease. Comtan aids levodopa in relieving the symptoms of Parkinson's disease. Comtan has no effect on relieving the symptoms of Parkinson’s disease unless taken with levodopa. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COMTAN DO NOT TAKE COMTAN if you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6); if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure); if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtan); if you have liver disease; if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS). See Section 4 Possible side effects for the characteristics of NMS; if you have ever suffered from a rare muscle disorder called rhabdomyolysis which was not caused by injury. WARNINGS AND PRECAUTIONS Talk to your doctor or pharm Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Comtan 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg entacapone. Excipients with known effect Each tablet contains 1.82 mg sucrose, and 7.3 mg sodium as a constituent of the excipients. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet Brownish-orange, oval, biconvex film-coated tablet with “Comtan” engraved on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in adult patients with Parkinson’s disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa. The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone. Posology One 200 mg tablet is taken with each levodopa/dopa decarboxylase inhibitor dose. The maximum recommended dose is 200 mg ten times daily, i.e. 2,000 mg of entacapone. Entacapone enhances the effects of levodopa. Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment. The daily dose of levodopa should be reduced by about 10–30% by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient. If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms. Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations slightly Przeczytaj cały dokument