Siofor SR 1000 mg prolonged-release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METFORMIN HYDROCHLORIDE PH. EUR.

Available from:

A. Menarini Pharmaceuticals Ireland Ltd

ATC code:

A10BA; A10BA02

INN (International Name):

METFORMIN HYDROCHLORIDE PH. EUR.

Dosage:

1000 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Biguanides; metformin

Authorization status:

Not marketed

Authorization date:

2019-05-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SIOFOR SR 500 MG PROLONGED-RELEASE TABLETS
SIOFOR SR 750 MG PROLONGED-RELEASE TABLETS
SIOFOR SR 1000 MG PROLONGED-RELEASE 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 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 Siofor SR is and what it is used for
2.
What you need to know before you take Siofor SR
3.
How to take Siofor SR
4.
Possible side effects
5.
How to store Siofor SR
6.
Contents of the pack and other information
1.
WHAT SIOFOR SR IS AND WHAT IT IS USED FOR
Siofor SR contains the active ingredient metformin hydrochloride and
belongs to a group of
medicines called biguanides, used in the treatment of diabetes.
Siofor SR is used for the treatment of Type 2 (non-insulin dependent)
diabetes mellitus when diet and
exercise changes alone have not been enough to control blood glucose
(sugar). Insulin is a hormone
that enables body tissues to take glucose from the blood and to use it
for energy or for storage for
future use. People with Type 2 diabetes do not make enough insulin in
their pancreas or their body
does not respond properly to the insulin it does make. This causes a
build-up of glucose in the blood
which can cause a number of serious long-term problems so it is
important that you continue to take
your medicine, even though you may not have any obvious symptoms.
Siofor SR makes the body
more sensitive to insulin and helps return to normal the way your body
uses glucose.
Siofor SR is associated with either a stable body weight or modest
weight loss.

Summary of Product characteristics

Health Products Regulatory Authority
09 May 2019
CRN008K4Z
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Siofor SR 1000 mg prolonged-release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 1000 mg metformin hydrochloride
corresponding to 780 mg metformin base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white, oval tablet, debossed on one side with 'SR 1000'
and plain on the other side.
Tablet dimensions: length 22.00 mm, breadth 10.50 mm, thickness 8.90
mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of type 2 diabetes mellitus in adults, particularly in
overweight patients, when dietary management and exercise
alone does not result in adequate glycaemic control. Siofor SR may be
used as monotherapy or in combination with other oral
antidiabetic agents, or with insulin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults with normal renal function (GFR ≥ 90 mL/min)_
MONOTHERAPY IN TYPE 2 DIABETES MELLITUS AND COMBINATION WITH OTHER
ORAL ANTIDIABETIC AGENTS:
-Siofor SR 1000 mg should be taken once daily with the evening meal at
a maximum recommended dose of 2 tablets per day.
-Siofor SR 1000 mg is intended as a maintenance therapy for patients
currently treated with either 1000 mg or 2000 mg of
metformin hydrochloride. On switch, the daily dose of Siofor SR should
be equivalent to the current daily dose of metformin
hydrochloride.
-In patients treated with metformin hydrochloride at a dose above 2000
mg daily, switching to Siofor SR is not recommended.
-If glycaemic control is not achieved on once daily dosing of Siofor
SR at a maximum dose of 2000 mg a day, then a twice daily
dosing schedule should be considered with both doses being given with
food, at the time of the morning and evening meals. If
glycaemic control is still not achieved, patients may be switched to
standard metformin hydrochloride tablets to a maximum
dose of 3000 mg daily.
-In t