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.

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
Authorization Dates

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

21 November 1995

Marketing authorization number:

PL 00427/0091