METFORMIN Oral Solution Ref.[6977] Active ingredients: Metformin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Product name and form

Metformin 100mg/ml Oral Solution.

Pharmaceutical Form

Oral Solution.

Clear brown solution with characteristic odour.

Qualitative and quantitative composition

Each 1ml of solution contains 100mg of metformin hydrochloride.

Excipient(s) with known effect:

Sodium methyl parahydroxybenzoate (E219): contains 2.07mg sodium methyl parahydroxybenzoate per ml.

Sodium propyl parahydroxybenzoate (E217): contains 0.22mg sodium propyl parahydroxybenzoate per ml.

Liquid maltitol (E965): contains 463.0 mg liquid maltitol per ml.

Sodium: contains 7.0mg sodium per 5ml.

Potassium: contains 14.5mg potassium per 5ml.

It also contains sodium sulphite (E221), ethanol and sucrose.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Metformin

Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose. It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.

List of Excipients

Sodium methyl parahydroxybenzoate (E219)
Sodium propyl parahydroxybenzoate (E217)
Sodium dihydrogen phosphate dihydrate
Di-sodium hydrogen phosphate anhydrous (E339)
Liquid maltitol (75%) (E965)
Acesulfame potassium (E950)
Caramel colour (E150b) (containing sucrose and sodium sulphite (E221))
Peppermint flavour
Peach flavour (containing ethanol)
Purified Water
Hydrochloric acid 2N (for pH adjustment)

Pack sizes and marketing

Amber (Type III) glass bottle, with tamper evident and child resistant screw-cap with either a LDPE or HDPE seal, along with a 10ml oral syringe.

Pack size: 150ml

Marketing authorization holder

Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Marketing authorization dates and numbers

PL 20046/0255

11/07/2013

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