Metformin Hydrochloride Lamda Oral Solution 1000mg/5ml

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

METFORMIN HYDROCHLORIDE

Доступно од:

Lamda Laboratories SA 59, Ioannou Metaxa str, Karellas,Koropi, Attiki, Greece

АТЦ код:

A10BA02

INN (Међународно име):

METFORMIN HYDROCHLORIDE 1000 mg/5ml

Фармацеутски облик:

ORAL SOLUTION

Састав:

METFORMIN HYDROCHLORIDE 1000 mg/5ml

Тип рецептора:

POM

Терапеутска област:

DRUGS USED IN DIABETES

Статус ауторизације:

Withdrawn

Датум одобрења:

2016-05-30

Информативни летак

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PACKAGE LEAFLET: INFORMATION FOR THE USER
1000 MG/5 ML ORAL SOLUTION
For use in adults and children from 10 years of age
Metformin hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1.
WHAT
IS AND WHAT IT IS USED FOR
contains metformin, a medicine to
treat diabetes. It belongs to
a group of medicines called biguanides.
Insulin is a hormone produced by the pancreas that makes your body
take in glucose (sugar) from
the blood. Your body uses glucose to produce energy or stores it for
future use.
If you have diabetes, your pancreas does not make enough insulin or
your body is not able to use
properly the insulin it produces. This leads to a high level of
glucose in your blood. helps to lower your blood glucose to as normal a
level as possible.
If you are an overweight adult, taking over a long period of
time also helps to lower the risk of complications associated with
diabetes. is associated with either a stable body weight
or modest weight loss.
is use

Карактеристике производа

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Metformin Hydrochloride Lamda 1000 mg/5 ml oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml oral solution contain 1000 mg of metformin hydrochloride.
Excipients with known effect:
Sodium propyl parahydroxybenzoate (E 217) 0.55 mg/5 ml
Ethanol (alcohol) 5 mg/5 ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution
Clear, colourless solution with characteristic peach odour
4.
CLINICAL PARTICULARS
4.1
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.
•
In adults, may be used as monotherapy
or in
combination with other oral antidiabetic agents or with insulin.
•
In children from 10 years of age and adolescents,
may be used as monotherapy or in combination with insulin.
A reduction of diabetic complications has been shown in overweight
type 2 diabetic adult
patients treated with metformin as first-line therapy after diet
failure (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults _
_ _
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS
The usual starting dose is 500 mg (2.5 ml) or 850 mg (4.25 ml)
metformin hydrochloride 2
or 3 times daily given during or after meals.
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After 10 to 15 days the dose should be adjusted on the basis of blood
glucose measurements.
A slow increase of dose may improve gastrointestinal tolerability.
The maximum recommended dose of metformin hydrochloride is 3 g (15 ml)
daily, taken as
3 divided doses.
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and
initiate metformin at the dose indicated above.
COMBINATION WITH INSULIN
Metformin and insulin may be used in combination therapy to achieve
better blood glucose
control. Metformin hydrochloride is given at the usual st