IRPRESTAN Film-coated tablet Ref.[49871] Active ingredients: Irbesartan

Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Accord Healthcare Ireland Ltd., Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland

Product name and form

Irprestan 75 mg film-coated tablets.

Pharmaceutical Form
Film-coated tablet. White, elliptical, biconvex, 5.2 × 10 mm film-coated tablets, market ‘I’ on one side and ‘75’ on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 75 mg irbesartan.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Irbesartan	Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT₁) antagonist. It is expected to block all actions of angiotensin-II mediated by the AT₁ receptor, regardless of the source or route of synthesis of angiotensin-II. The selective antagonism of the angiotensin-II (AT₁) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.

List of Excipients
Tablet core: Croscarmellose sodium (E468) Microcrystalline cellulose (E460) Hypromellose(E464) Mannitol (E421) Magnesium stearate (E572) Silica, colloidal anhydrous (E551) Tablet coating: Hydroxypropyl cellulose (E463) Hypromellose (E464) Macrogol 6000 Titanium dioxide (E171)

Pack sizes and marketing

Blister packs (PVC/PVdC-Alu blisters).

Tablet containers (HDPE) with desiccant and LDPE cap.

Pack sizes:

Blisters: 14, 28, 30, 56, 84, 90, 98 tablets

Tablet containers: 30, 60, 250 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Ireland Ltd., Euro House, Euro Business Park, Little Island, Cork T45 K857, Ireland

Marketing authorization dates and numbers

PA2315/185/001

Date of first authorisation: 3^rd July 2009
Date of last renewal: 14^th May 2014

Drugs

Drug	Countries
IRPRESTAN	Ireland, Poland, Singapore, Turkey

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