FRUSOL Oral solution Ref.[27733] Active ingredients: Furosemide

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Product name and form

Frusol 20mg/5ml Oral Solution.

Pharmaceutical Form

A clear yellow liquid (Oral Solution).

Qualitative and quantitative composition

Each 5ml contains 20 milligrams Furosemide.

Excipient(s) with known effect:

Ethanol 397.28mg/5ml
Quinoline Yellow (E104) 0.075mg/5ml
Liquid Maltitol (E965) 2.5g/5ml
Propylene Glycol (E1520) 0.35mg/5ml

For the full list of excipients, see section 6.1.

Active Ingredient Description
Furosemide

Furosemide inhibits active chloride transport in the thick ascending limb. Re-absorption of sodium, chloride from the nephron is reduced and a hypotonic or isotonic urine produced. The evidence from many experimental studies suggests that furosemide acts along the entire nephron with the exception of the distal exchange site.

List of Excipients

Ethanol
Sodium hydroxide
Quinoline yellow (E104)
Cherry flavour (containing ethanol and propylene glycol (E1520))
Liquid maltitol (E965)
Disodium hydrogen phosphate (E339)
Citric acid monohydrate (E330)
Purified water

Pack sizes and marketing

Bottles: Amber (Type III) glass.

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

Capacity: 150ml.

Marketing authorization holder

Rosemont Pharmaceuticals Ltd, Yorkdale Industrial Park, Braithwaite Street, Leeds, LS11 9XE, UK

Marketing authorization dates and numbers

PL 00427/0109

Date of first authorisation: 06 April 1998
Date of latest renewal: 31 March 2003

Drugs

Drug Countries
FRUSOL Cyprus, Estonia, Malta, United Kingdom

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