DIXARIT Coated tablet Ref.[50231] Active ingredients: Clonidine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS, United Kingdom

Product name and form

Dixarit Tablets 25 micrograms.

Pharmaceutical Form

Coated tablet.

Blue, biconvex, sugar-coated tablets.

Qualitative and quantitative composition

Each tablet contains clonidine hydrochloride 25 micrograms.

Excipients with known effect: Each tablet contains 16.85 mg lactose and 20.388 mg sucrose.

For the full list of excipients, see section 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

Tablet core:

Calcium hydrogen phosphate, anhydrous
Lactose monohydrate
Maize starch
Colloidal anhydrous silica
Povidone
Maize starch, soluble
Indigo carmine (E132)
Magnesium stearate

Tablet coating:

Povidone
Sucrose
Talc
Acacia
Titanium dioxide (E171)
Indigo carmine (E132)
Macrogol
Carnauba wax
White beeswax

Pack sizes and marketing

PVC/aluminium blister packs of 84, 100, 112.

Currently the 112 pack is the only marketed pack.

Marketing authorization holder

Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS, United Kingdom

Marketing authorization dates and numbers

PA 0007/032/001

Date of first authorisation: 07 May 1987
Date of last renewal: 01 November 2005

Drugs

Drug Countries
DIXARIT Estonia, United Kingdom, South Africa

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