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PARLODEL Capsule (2018)

Active ingredients: Bromocriptine

Product Name and Form

PARLODEL 5mg Capsules.

Pharmaceutical form

Light blue and white opaque hard gelatine capsules imprinted with ‘5 MG’ on the capsule body.

Qualitative and Quantitative Composition

Active substance: Ergotaman-3', 6', 18-trione, 2-bromo-12'-hydroxy-2'-(1-methylethyl-5'-(2-methylpropyl)-, (5’alpha)-mono-methanesulphonate.

Each capsule contains 5.735mg of bromocriptine mesilate (equivalent to 5mg bromocriptine base).

For a full list of excipients see section 6.1

Chemical substance
Description
Bromocriptine

Bromocriptine is an inhibitor of prolactin secretion and a stimulator of dopamine receptors. The areas of application of bromocriptine are divided into endocrinological and neurological indications.

List of excipients

Capsule Content:

Silica, colloidal anhydrous
Magnesium stearate
Maleic acid
Maize starch
Lactose monohydrate

Capsule Shell:

Indigo carmine (E132)
Titanium dioxide (E171)
Gelatin

Printing Ink:

Shellac (E904)
Iron Oxide Black (E172)
Propylene glycol

Pack sizes and Marketing

Opaque white PV/PVDC blister strip containing 30 PARLODEL 5mg capsules.

Amber glass bottle with a tamper resistant closure containing 100 PARLODEL 5mg capsules.

Not all pack sizes will be marketed.

Marketing authorization holder
Authorization dates

Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

09 October 1981 / 27 October 1997

Marketing authorization number:

PL 46302/0138