Metformin Pinewood 1000 mg film-coated tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Metformin Hydrochloride

Disponible depuis:

Juta Pharma GmbH

Code ATC:

A10BA02

DCI (Dénomination commune internationale):

Metformin Hydrochloride

Dosage:

1000 milligram(s)

forme pharmaceutique:

Film-coated tablet

Domaine thérapeutique:

metformin

Date de l'autorisation:

2019-07-19

Notice patient

190 mm
Print Free Area
Size : 190 mm x 729 mm (L x H)
(Front & Back)
729 mm
FRONT
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
or nurse.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their sign of illness
are the same as yours.
• If you get any of the side effects, talk to your doctor or
pharmacist or nurse. This includes any side effects not listed in this
leaflet. See section 4.
What is in this leaflet:
1. What Metformin Pinewood tablets are and what they are used for
2. What you need to know before you take Metformin Pinewood tablets
3. How to take Metformin Pinewood tablets
4. Possible side effects
5. How to store Metformin Pinewood tablets
6. Contents of the pack and other information
1. What Metformin Pinewood tablets are and what they are used for
Metformin Pinewood tablets contain the active ingredient metformin
hydrochloride. Metformin hydrochloride belongs to a group
of medicines called biguanides used for the treatment of
non-insulin-dependent diabetes mellitus (type 2 diabetes) in adults
and
children from 10 years of age.
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 Pinewood tablets over
a long period of time also helps to lower the risk of
complications associated with diabetes. Metformin Pinewood tablets are
associated with either a stable body weight or modest
weight loss.
Metformin Pinewood tablets are

Résumé des caractéristiques du produit

Health Products Regulatory Authority
16 October 2019
CRN0098WV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metformin Pinewood 1000 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains metformin hydrochloride 1000 mg
corresponding to metformin base 780 mg.
This medicine contains less than 1 mmol sodium (23 mg) per tablet,
that is to say essentially 'sodium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off white oval shaped, biconvex, film-coated tablets, with a
deep breakline on one side and breakline on other side.
The tablet can be divided into equal halves.
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 Pinewood film-coated tablets 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 Pinewood
film-coated tablets 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 with normal renal function (GFR≥ 90 mL/min)_
_ _
MONOTHERAPY AND COMBINATION WITH OTHER ORAL ANTIDIABETIC AGENTS

The usual starting dose is 500 mg 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.

The maximum recommended dose of metformin hydrochloride is 3 g daily,
taken as 3 divided doses. In patients
receiving a high metformin dose (2 to 3 grams per day), it is possi