Metformin Hydrochloride 500mg/5ml Oral Solution

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

METFORMIN HYDROCHLORIDE

Доступна з:

Rosemont Pharmaceuticals Ltd

Код атс:

A10BA; A10BA02

ІПН (Міжнародна Ім'я):

METFORMIN HYDROCHLORIDE

Дозування:

500 mg/5ml

Фармацевтична форма:

Oral solution

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Biguanides; metformin

Статус Авторизація:

Marketed

Дата Авторизація:

2007-10-12

інформаційний буклет

METFORMIN HYDROCHLORIDE 500MG/5ML ORAL SOLUTION
MODULE 1.3.1
SPC, LABEL AND LEAFLET
VERSION: SEPTEMBER 2017
PAGE 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 further questions, ask your doctor or your pharmacist.

This medicine has been prescribed only for you. Do not pass it on to
others. It may
harm them, even if their symptoms 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 Metformin Hydrochloride Oral Solution is and what it is used
for
2. What you need to know before you take Metformin Hydrochloride Oral
Solution
3. How to take Metformin Hydrochloride Oral Solution
4. Possible side effects
5. How to store Metformin Hydrochloride Oral Solution
6. Contents of the pack and other information
WHAT METFORMIN IS
Metformin is 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.
Metformin helps to lower your blood glucose to as normal a level as
possible.
If you are an overweight adult, taking Metformin over a long period of
time also helps to
lower the risk of complications associated with diabetes.
WHAT METFORMIN IS USED FOR
Metformin is used to treat patients with type 2 diabetes (also called
'non-insulin dependent
diabetes') when diet and exercise alone have not been enough to
control your blood glucose
levels. It is used particularly in overweight patients.
Adults can take metf

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metformin Hydrochloride 500mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml oral solution contains 500mg Metformin Hydrochloride.
1ml of oral solution contains 100mg Metformin Hydrochloride.
Excipients: Sodium methyl parahydroxybenzoate (E219), sodium propyl
parahydroxybenzoate (E217) and maltitol
liquid (E965)
Sodium = 5.3mg/ 5ml
Potassium = 14.5mg/ 5ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear brown liquid.
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, Metformin Hydrochloride Oral Solution may be used as
monotherapy or in combination with other
oral anti-diabetic agents or with insulin.
•
In children from 10 years of age and adolescents, Metformin
Hydrochloride Oral Solution 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 5.1.
Pharmacodynamic properties).
4.2 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 one 5ml spoonful (500mg) 2 or 3 times daily
given during or after meals.
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 3g (six
5ml spoonfuls) daily, taken as 3 divided doses.
If transfer from another oral antidiabetic agent is intended:
discontinue the other agent and initiate metformin
hydrochloride at the dose indicated above.
_Combination with insulin:_
Metformin hydrochloride and insulin may be used