Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cabergoline
Dowelhurst Ltd
N04BC06
Cabergoline
2mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 04090100
CABERGOLINE 2MG TABLETS PATIENT INFORMATION LEAFLET 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. Your medicine is called Cabergoline 2mg Tablets but will be referred to as Cabergoline throughout this Patient Information Leaflet. Please note that the leaflet also contains information about other strength of the medicine, Cabergoline 1mg Tablets WHAT IS IN THIS LEAFLET: What Cabergoline is and what it is used for What you need to know before you take Cabergoline How to take Cabergoline Possible side effects How to store Cabergoline Contents of the pack and other information WHAT CABERGOLINE IS AND WHAT IT IS USED FOR Cabergoline belongs to a group of medicines known as dopamine agonists. Cabergoline acts in a similar way to a chemical present in the nervous system called dopamine. Patients with Parkinson’s disease do not have enough of this important chemical. Cabergoline is used to treat Parkinson’s disease. It can be used either taken alone or in combination with levodopa, as second choice following non-ergot derived therapies. Treatment under a specialist is required. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CABERGOLINE DO NOT TAKE CABERGOLINE IF YOU • are allergic to cabergoline, other ergot alkaloids (e.g. bromocriptine), or to any of the other ingredients of this medicine (listed in section 6) • have swelling of the hands and feet and a high blood pressure during pregnancy (preeclampsia, eclampsia) • have uncontrolled high blood pressure • have ever been diagnosed in the past with problems described as fi Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Cabergoline 2mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2 mg cabergoline. Excipient(s) with known effect: lactose 150.6 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _ _ The tablet can be divided into equal doses. _ _ White, capsule-shaped, biconvex tablets with scores on both sides. One side is debossed with ‘CBG’ and ‘2’ on either side of the score. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _TREATMENT OF PARKINSON’S DISEASE: _ If treatment with a dopamine agonist is being considered, cabergoline is indicated as second line therapy in patients who are intolerant or fail treatment with a non-ergot compound, as monotherapy, or as adjunctive treatment to levodopa plus dopa-decarboxylase inhibitor in the management of the signs and symptoms of Parkinson's disease. Treatment should be initiated under specialist supervision. The benefit of continued treatment should be regularly reassessed, taking into account the risk of fibrotic reactions and valvulopathy (see sections 4.3, 4.4 and 4.8). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults and older people: As expected for dopamine agonists, dose response for both efficacy and undesirable effects appears to be linked to individual sensitivity. Optimization of dose should be obtained through slow initial dose titration, from starting doses of 0.5mg cabergoline (de novo patients) and 1 mg cabergoline (patients on L dopa) daily. The dosage of concurrent levodopa may be gradually decreased, while the dosage of cabergoline is increased, until the optimum balance is determined. In view of the long half-life of the compound, increments of the daily dose of 0.5-1 mg cabergoline should be done at weekly (initial weeks) or bi-weekly intervals, up to optimal doses. The recommended therapeutic dosage is 2 to 3 mg cabergoline /day as adjuvant therapy to levodopa/carbidopa. The maximum dose of 3mg/day of cabergoline must no Lees het volledige document