CATAPRES Tablet Ref.[6730] Active ingredients: Clonidine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2023  Publisher: Glenwood GmbH, Pharmazeutische Erzeugnisse, Arabellastrasse 17, 81925 Munich, Germany

Product name and form

Catapres Tablets 100 micrograms.

Pharmaceutical Form

Tablet.

White, round, flat, bevel-edged tablets impressed with the motif 01C / 01C on one side.

Qualitative and quantitative composition

Each tablet contains clonidine hydrochloride 100 micrograms.

For excipients see 6.1.

Active Ingredient Description
Clonidine

Clonidine has been shown to have both central and peripheral sites of action. With long-term treatment clonidine reduces the responsiveness of peripheral vessels to vasoconstrictor and vasodilator substances and to sympathetic nerve stimulation. Early in treatment, however, blood pressure reduction is associated with a central reduction of sympathetic outflow and increased vagal tone.

List of Excipients

Lactose monohydrate
Calcium hydrogen phosphate (anhydrous)
Maize starch
Colloidal silica (anhydrous)
Povidone
Modified starch (corn starch oxidized)
Stearic acid

Pack sizes and marketing

Opaque PVC 250 μm/PVDC 40g/m² blisters with aluminium lidding foil 20 μm containing 50, 84, 100 or 250 tablets. Not all pack sizes are marketed.

Marketing authorization holder

Glenwood GmbH, Pharmazeutische Erzeugnisse, Arabellastrasse 17, 81925 Munich, Germany

Marketing authorization dates and numbers

PA2256/003/001

Date of first authorisation: 1st April 1979
Date of last renewal: 1st November 2005

Drugs

Drug Countries
CATAPRES Australia, Ireland, Japan, Malta, New Zealand, United Kingdom, United States

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