DOSTINEX Tablets

Active ingredients: Cabergoline

Product name and form

Dostinex 0.5 mg Tablets.

Pharmaceutical Form

Tablet.

Flat, capsule-shaped, 4 × 8 mm, scored, white tablets.

Qualitative and quantitative composition

One Dostinex tablet contains 0.5 mg cabergoline.

Excipients with known effect: Each tablet contains 75.90 mg of lactose.

For the full list of excipients, see section 6.1.

Active Ingredient
Description

Cabergoline is a dopaminergic ergoline derivative endowed with a potent and long-lasting PRL-lowering activity.

List of Excipients

Lactose
Leucine

Pack sizes and marketing

Class I amber glass bottles, stoppered with an aluminum tamper-evident screw cap with silica gel insert or high-density polyethylene (HDPE) bottles with child-resistant polypropylene (PP) cap with inner low-density polyethylene (LDPE) desiccant canister containing silica gel.

Each bottle contains 2, 4 or 8 tablets and is enclosed in an outer cardboard carton.

Not all pack sizes may be marketed.

Marketing authorization holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9JN

Marketing authorization dates and numbers

PL 00057/0969

24 June 2002

Drugs

Drug
Countries
Austria, Australia, Brazil, Cyprus, Germany, Spain, Finland, France, Hong Kong, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom