Страна: Великобритания
Език: английски
Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Entacapone; Carbidopa; Levodopa
Orion Pharma (UK
Entacapone; Carbidopa; Levodopa
200mg ; 31.25mg ; 125mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100; GTIN: 6432100014047 6432100014030
PACKAGE LEAFLET: INFORMATION FOR THE USER STALEVO 125 MG/31.25 MG/200 MG FILM-COATED TABLETS Levodopa/carbidopa/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 Stalevo is and what it is used for 2. What you need to know before you take Stalevo 3. How to take Stalevo 4. Possible side effects 5 How to store Stalevo 6. Contents of the pack and other information 1. WHAT STALEVO IS AND WHAT IT IS USED FOR Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stalevo is used for the treatment of Parkinson’s disease. Parkinson’s disease is caused by low levels of a substance called dopamine in the brain. Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson’s disease. Carbidopa and entacapone improve the antiparkinson effects of levodopa. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE STALEVO DO NOT TAKE STALEVO IF YOU: - are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6) - have narrow-angle glaucoma (an eye disorder) - have a tumour of the adrenal gland - are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO-inhibitors) - have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used to treat severe mental disorders) - have ever had non-traumatic rhabdomyolysis (a rare muscle disorder) - have a severe liver disease. WARNINGS AND PRE Прочетете целия документ
STALEVO 125/31.25/200MG Summary of Product Characteristics Updated 06-Feb-2015 | Orion Pharma (UK) Limited 1. Name of the medicinal product Stalevo 125 mg/31.25 mg/200 mg film-coated tablets 2. Qualitative and quantitative composition Each tablet contains 125 mg of levodopa, 31.25 mg of carbidopa and 200 mg of entacapone. Excipient with known effect: Each tablet contains 1.6 mg of sucrose. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet Light brownish red, oval film-coated tablets marked with 'LCE 125' on one side. 4. Clinical particulars 4.1 Therapeutic indications Stalevo is indicated for the treatment of adult patients with Parkinson's disease and end-of-dose motor fluctuations not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor treatment. 4.2 Posology and method of administration Posology The optimum daily dose must be determined by careful titration of levodopa in each patient. The daily dose should be preferably optimised using one of the seven available tablet strengths (50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg, 150 mg/37.5 mg/200 mg, 175 mg/43.75 mg/200 mg or 200 mg/50 mg/200 mg levodopa/carbidopa/entacapone). Patients should be instructed to take only one Stalevo tablet per dose administration. Patients receiving less than 70-100 mg carbidopa a day are more likely to experience nausea and vomiting. While the experience with total daily dose greater than 200 mg carbidopa is limited, the maximum recommended daily dose of entacapone is 2,000 mg and therefore the maximum dose is 10 tablets per day for the Stalevo strengths of 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg and 150 mg/37.5 mg/200 mg. Ten tablets of Stalevo 150 mg/37.5 mg/200 mg equals 375 mg of carbidopa a day. According to this daily carbidopa dose, the maximum recommended daily Stalevo 175 mg/43.75 mg/200 mg dose is 8 tablets per day and Stalevo 200 mg/50 mg/200 mg dose is 7 tablets per day. Usually Прочетете целия документ