Metformin 500mg5ml oral solution sugar free

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Metformin hydrochloride

Disponible depuis:

Colonis Pharma Ltd

Code ATC:

A10BA02

DCI (Dénomination commune internationale):

Metformin hydrochloride

Dosage:

100mg/1ml

forme pharmaceutique:

Oral solution

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: ; GTIN: 5060380960382

Notice patient

Package leaflet: Information for the user
Metformin hydrochloride
Metformin Colonis 500mg/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 500mg/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 glucose

Résumé des caractéristiques du produit

OBJECT 1
METFORMIN COLONIS 500MG/5ML ORAL SOLUTION
Summary of Product Characteristics Updated 08-Dec-2017 | Colonis
Pharma Ltd
1. Name of the medicinal product
Metformin Colonis 500 mg/5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml oral solution contains 500 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
Note: Metformin Colonis Oral Solution 500mg/5ml is intended for the
administration of doses of 500mg
or multiples of 500mg. 850mg/5ml and 1000mg/5ml presentations are also
available.
Posology
_Adults_
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS
The usual starting dose is 500 mg (5 ml) or 850 mg 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. In
patients receiving a high metformin
hydrochloride dose (2 to 3 grams per day), it is possible to replace
the 500mg/5ml presentation with the
1000mg/5ml presentation in order to administer a lower volume.
The maximum recomm