Metformin 1g5ml oral solution sugar free

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Metformin hydrochloride

Beszerezhető a:

Colonis Pharma Ltd

ATC-kód:

A10BA02

INN (nemzetközi neve):

Metformin hydrochloride

Adagolás:

200mg/1ml

Gyógyszerészeti forma:

Oral solution

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: ; GTIN: 5060380960405

Betegtájékoztató

Package leaflet: Information for the user
Metformin hydrochloride
Metformin Colonis 1000mg/5ml
Oral Solution
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 Metformin Oral Solution is and
what it is used for
2. What you need to know before you take
Metformin Oral Solution
3. How to take Metformin Oral Solution
4. Possible side effects
5. How to store Metformin Oral Solution
6. Contents of the pack and other
information
1. What Metformin Oral Solution
is and what it is used for
■
Metformin Colonis 1000mg/5ml Oral
Solution (referred to as Metformin
Oral Solution in this leaflet) contains
metformin hydrochloride, a medicine
to treat diabetes. It belongs to a group
of medicines called biguanides.
■
After you have eaten, your body
converts the carbohydrates and sugar
in your food into glucose, which travels
in your blood to where it is needed.
Insulin is a hormone produced in your
pancreas which moves the glucose
from your blood into your body’s cells
where it is used as energy (fuel)
■
If you have type 2 diabetes, your
pancreas does not make enough insulin
or your body is not able to use properly
the insulin it produces, (known as
insulin resistance). This leads to
high levels of glucose in your blood.
Metformin Oral Solution helps to lower
your blood glucose to as normal a level
as possible.
■
This medicine 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 gluco

Termékjellemzők

OBJECT 1
METFORMIN COLONIS 1000 MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 08-Dec-2017 | Colonis
Pharma Ltd
1. Name of the medicinal product
Metformin Colonis 1000 mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml oral solution contains 1000 mg of metformin hydrochloride.
Each ml contains 200 mg of Metformin hydrochloride.
_Excipients with known effect _:
Sodium propyl parahydroxybenzoate (E217) 0.55 mg/5ml
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, Metformin Colonis Oral Solution 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, Metformin
Colonis 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 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 500mg (2.5 ml) or 850 mg (4.25 ml)
metformin hydrochloride 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 (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 hydrochloride and insulin may be used in combination therapy