FOSINOPRIL SODIUM Tablet Ref.[8410] Active ingredients: Fosinopril

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

Fosinopril Sodium 10mg Tablets.

Pharmaceutical Form

Tablet.

White to off-white, circular, flat, uncoated 8mm tablets marked ‘FL 10’.

Qualitative and quantitative composition

Each tablet contains 10mg of Fosinopril sodium.

Excipient(s) with known effect: Each tablet contains 118mg lactose monohydrate.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fosinopril

Fosinopril is the pro-drug (ester) of the long acting active ACE inhibitor fosinoprilat. After oral administration fosinopril is quickly and fully metabolised to the active fosinoprilat. Fosinopril contains a phosphinic group capable of a specific binding to the active site of the angiotensin converting enzyme, preventing the conversion of angiotensin I in angiotensin II.

List of Excipients

Also contains:

Lactose monohydrate
Pregelatinised starch
Croscarmellose sodium
Microcrystalline cellulose
Glycerol dibehenate
Magnesium stearate

Pack sizes and marketing

Aluminium-aluminium blisters: Each carton will contain either 7, 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100* 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 0142/0582

17.01.2005 / 05.09.2018

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