METFORMIN Oral Solution (2018)
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Περιεχόμενα
Name of the medicinal product
Metformin 100mg/ml Oral Solution.
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 ...
Pharmaceutical form
Oral Solution. Clear brown solution with characteristic odour.
Therapeutic indications
Treatment of type 2 diabetes mellitus, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. Adults In adults, metformin hydrochloride ...
Posology and method of administration
Posology Adults (with normal renal function, GFR≥ 90 mL/min) Monotherapy and combination with other oral antidiabetic agents The usual starting dose is 500mg (5ml) or 850mg (8.5ml) metformin hydrochloride ...
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in section 6.1. Diabetic pre-coma. Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis). Severe ...
Special warnings and precautions for use
Lactic acidosis Lactic acidosis, a very rare, but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis. Metformin accumulation occurs ...
Interaction with other medicinal products and other forms of interaction
Concomitant use not recommended Alcohol Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in cases of fasting, malnutrition or hepatic impairment. Consumption of ...
Fertility, pregnancy and lactation
Pregnancy Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased risk of congenital abnormalities and perinatal mortality. A limited amount of data from the use ...
Effects on ability to drive and use machines
Metformin has no influence on the ability to drive and use machines. Metformin monotherapy does not cause hypoglycaemia and therefore has no effect on the ability to drive or to use machines. However, ...
Undesirable effects
During treatment initiation, the most common adverse reactions are nausea, vomiting, diarrhoea, abdominal pain and loss of appetite which resolve spontaneously in most cases. To prevent them, it is recommended ...
Overdose
Symptoms Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85g, although lactic acidosis has occurred in such circumstances. High overdose of metformin or concomitant risks may ...
Pharmacodynamic properties
Pharmacotherapeutic group: Blood glucose lowering drugs, Biguanides ATC Code: A10BA02 Mechanism of action Metformin hydrochloride is a biguanide with antihyperglycaemic effects, lowering both basal and ...
Pharmacokinetic properties
Absorption After an oral dose of metformin hydrochloride, T<sub>max</sub> is reached approximately in 2.5 hours. Absolute bioavailability of a 500mg or 850mg metformin hydrochloride tablet is approximately ...
Preclinical safety data
Non clinical data reveal no special hazard for humans based on conventional studies on safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
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 ...
Incompatibilities
Not applicable.
Shelf life
18 months unopened 28 days opened
Special precautions for storage
Do not store above 25°C. Once opened, use within 28 days.
Nature and contents of container
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
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom
Marketing authorization number(s)
PL 20046/0255
Date of first authorization / renewal of the authorization
11/07/2013
Date of revision of the text
16/08/2018
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