AMILORIDE ROSEMONT Oral solution Ref.[6161] Active ingredients: Amiloride

Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial park, Braithwaite Street, Leeds, LS11 9XE

Product name and form

Amiloride Rosemont 5mg/5ml Oral Solution.

Pharmaceutical Form
Solution for oral administration.

Qualitative and quantitative composition

Amiloride Hydrochloride BP 5.675mg equivalent to anhydrous Amiloride Hydrochloride 5mg.

Active Ingredient	Description
Amiloride	Amiloride has mild diuretic and anti-hypertensive activity. It acts primarily in the distal tubule and does not require aldosterone for its action. Amiloride is a mild natriuretic which does not initiate a concomitant decrease in potassium levels.

List of Excipients
Citric Acid Monohydrate Ph Eur Methyl Hydroxybenzoate Ph Eur Propyl Hydroxybenzoate Ph Eur Propylene Glycol Ph Eur Vanillin Ph Eur Compound Orange Spirit BP Liquid Maltitol Ph Eur Purified Water Ph Eur

Pack sizes and marketing

Glass (Type III) amber bottle, with capacity of 150ml.

Closures: HDPE EPE wadded, tamper evident, child resistant.

Marketing authorization holder

Rosemont Pharmaceuticals Ltd, Rosemont House, Yorkdale Industrial park, Braithwaite Street, Leeds, LS11 9XE

Marketing authorization dates and numbers

PL 00427/0091

21 November 1995

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