Metformin Pinewood 850 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Metformin Hydrochloride

Available from:

Pinewood Laboratories Ltd

ATC code:

A10BA02

INN (International Name):

Metformin Hydrochloride

Dosage:

850 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

metformin

Authorization status:

Marketed

Authorization date:

2019-07-19

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN PINEWOOD 500 MG FILM-COATED TABLETS
METFORMIN PINEWOOD 850 MG FILM-COATED TABLETS
METFORMIN PINEWOOD 1000 MG FILM-COATED TABLETS
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. 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 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 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.
Metformin Pinewood tablets help 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 used to treat patients with type 2
diabetes (

Summary of Product characteristics

Health Products Regulatory Authority
25 September 2023
CRN00DQF8
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Metformin Pinewood 850 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains metformin hydrochloride 850 mg
corresponding to metformin base 663 mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, capsule shaped, biconvex, film coated tablets with
scoreline on one side and plain on other side.
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.

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
be