RAPORSIN XL Prolonged-release tablet Ref.[49967] Active ingredients: Doxazosin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Product name and form

Raporsin XL 4mg Prolonged-release Tablets.

Pharmaceutical Form

Prolonged-release tablet.

White, round, biconvex tablets with bossing “DL”.

Qualitative and quantitative composition

Each prolonged-release tablet contains: 4 mg doxazosin (as mesilate).

For a full list of excipients, see section 6.1.

Active Ingredient Description
Doxazosin

Doxazosin is a potent and selective post-junctional alpha-1-adrenoceptor antagonist. This action results in a decrease in systemic blood pressure.

List of Excipients

Tablet core:

Polyethylene oxide
Cellulose, microcrystalline
Povidone K 29-32
Butylhydroxytoluene (E321)
All-rac-α-Tocopherol
Silica, colloidal anhydrous
Sodium stearyl fumarate

Tablet coat:

Methacrylic acid – ethyl acrylate copolymer (1:1) Dispersion 30 per cent
Silica, colloidal anhydrous
Macrogol 1300-1600
Titanium dioxide (E171)

Pack sizes and marketing

PVC/PVDC/aluminium blister.

Pack sizes: 10, 28, 30, 50, 90, 98 and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord-UK Ltd (Trading style: Accord), Whiddon Valley, Barnstaple, Devon, EX32 8NS

Marketing authorization dates and numbers

PL 0142/1184

12.02.2009

Renewal Approved 06.02.2014

Drugs

Drug Countries
RAPORSIN Ireland, United Kingdom

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