Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
ENTACAPONE
Niche Generics Limited
N04BX02
ENTACAPONE
200 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Other dopaminergic agents
Authorised
2012-12-07
I N THIS LEAFLET: 1. What Entacapone Niche is and what it is used for 2. What you need to know before you take Entacapone Niche 3. How to take Entacapone Niche 4. Possible side effects 5. How to store Entacapone Niche 6. Contents of the pack and other information 1. WHAT ENTACAPONE NICHE IS AND WHAT IT IS USED FOR Entacapone Niche film-coated tablets contain entacapone and are used together with levodopa to treat Parkinson’s disease in adults. Entacapone Niche improves the therapeutic effect of levodopa in relieving the symptoms of Parkinson's disease. Entacapone Niche has no effect on relieving the symptoms of Parkinson’s disease unless taken with levodopa. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTACAPONE NICHE DO NOT TAKE ENTACAPONE NICHE: ■ 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 Entacapone Niche); ■ 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 pharmacist before taking Entacapone Niche: ■ if you have ever had a heart attack or any other diseases of the heart; ■ if you are taking a medicine which may cause dizziness or light-headedness (low blood pressure) when rising Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Entacapone Niche 200 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of entacapone. Excipient with known effect: 4.41 mg lactose monohydrate per film-coated tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Brown, capsule shaped, biconvex film-coated tablets, with debossing “70” on obverse side and plain on reverse. 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 tre Διαβάστε το πλήρες έγγραφο