EPROSARTAN Film-coated tablet Ref.[8513] Active ingredients: Eprosartan

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Product name and form

Eprosartan Mylan 300 mg Film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

300 mg: A white to off-white, film coated, oval, biconvex, bevelled edge tablet imprinted with ‘M EN1’ in black ink on one side of the tablet and blank on the other side.

Qualitative and quantitative composition

Each film-coated tablet contains 367.90 mg of eprosartan mesilate equivalent to 300 mg of eprosartan.

Excipient with known effect: 21.390 mg of lactose monohydrate per 300 mg tablet.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Eprosartan

Eprosartan is a potent, synthetic, orally active non-biphenyl non-tetrazole angiotensin II receptor antagonist, which binds selectively to the AT1 receptor.

List of Excipients

Tablet core:

Lactose monohydrate
Microcrystalline cellulose (Avicel PH101)
Pregelatinised maize starch
Silica, colloidal anhydrous
Polysorbate 80
Povidone (K-12)
Microcrystalline cellulose (Avicel PH102)
Crospovidone (Type B)
Magnesium Stearate

Film coating:

Hydroxypropyl cellulose (E462)
Hypromellose 6 cP
Titanium dioxide (E171)
Macrogol 400

Imprinting ink:

Shellac
Iron oxide black (E172)
Ammonium hydroxide 28%
Propylene glycol

Pack sizes and marketing

White HDPE bottle with a white opaque polypropylene screw cap with induction sealing liner. Pack size of 500 film-coated tablets

Aluminium foil blisters laminated with PVC on one side and coated with a heat seal lacquer (Aclar/PVC/Al). Pack sizes of 14, 28, 30, 56, 98, 100 or 168 film-coated tablets. Calendar pack sizes of 14, 28, 56, 98 and 168 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Generics [UK] Limited t/a Mylan, Station Close, Potters Bar, Hertfordshire, EN6 1TL

Marketing authorization dates and numbers

PL 04569/1227

14/03/2012

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