CABASER 2 MG TABLET
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
04-05-2024
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Virkt innihaldsefni:
CABERGOLINE
Fáanlegur frá:
Pharmacia Ireland
Skammtar:
2 Milligram
Lyfjaform:
Tablets
Leyfisdagur:
1999-10-29
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cabaser 2 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tablet contains 2mg of Cabergoline.
Each tablet also contains 150.8mg of anhydrous lactose.
For full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, oval, both sides concave tablets, one side scored and engraved “7” on the left of the breakline and “02” on the
right of it.
The tablet can be divided into equal halves
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF PARKINSON'S DISEASE
If treatment with a dopamine agonist is being considered, Cabaser 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
Cabaser is for oral administration. Since the tolerability of dopaminergic agents is improved when administered with food,
it is recommended that Cabaser be taken with meals.
Cabaser is intended for chronic, long term treatment.
ADULTS AND ELDERLY PATIENTS
As expected for dopamine agonists, dose response for both efficacy and side effects appears to be linked to individual
sensitivity. Optimization of dose should be obtained through slow initial dose titration, from starting doses of 1 mg daily.
The dosage of concurrent levodopa may be gradually decreased, while the dosage of Cabaser is increased, until the
optimum balan
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