Yaltormin SR 1000mg Prolonged Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

Pinewood Laboratories Ltd,

ATC code:

A10BA; A10BA02

INN (International Name):

METFORMIN HYDROCHLORIDE

Dosage:

1000 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

Biguanides; metformin

Authorization status:

Not marketed

Authorization date:

2016-04-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
YALTORMIN SR 500MG PROLONGED RELEASE TABLETS
YALTORMIN SR 750MG PROLONGED RELEASE TABLETS
YALTORMIN SR 1000MG PROLONGED RELEASE TABLETS
METFORMIN HYDROCHLORIDE
This medicine is intended for ADULT
patients only.
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 Yaltormin SR is and what it is used for
2.
What you need to know before you take Yaltormin SR
3.
How to take Yaltormin SR
4.
Possible side effects
5.
How to store Yaltormin SR
6.
Contents of the pack and other information
1. WHAT YALTORMIN SR IS AND WHAT IT IS USED FOR
Yaltormin SR prolonged release tablets contain the active ingredient
metformin
hydrochloride and belong to a group of medicines called biguanides,
used in the treatment of
diabetes. Yaltormin 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. Yaltormin SR makes the body
more sensitive to
insulin and helps return to normal the way your b

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2021
CRN009YYV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Yaltormin SR 1000mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One 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 Tablets
White to off-white, oval tablet debossed with ‘SR 1000’ on one
side and plain on other side. The tablets are approximately
22 mm in length and 10.5 mm in breadth.
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. Yaltormin 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 and combination with other oral antidiabetic agents:_
• Yaltormin SR 1000 mg should be taken once daily with the evening
meal at a maximum recommended dose of 2 tablets per
day.
• Yaltormin 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 Yaltormin 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 Yaltormin SR is not
recommended.
• For patients new to metformin hydrochloride, the usual starting
dose of Yaltormin SR is 500 mg once daily given with the
evening meal. After 10 to 15 days the dose should be adjusted on the
basis of blood glucose measurements. A slow increment
in dose may improve gastro-intestinal tolerability.
• If glycaemic control is not achieved on once daily dosing of
Yaltormin SR at a maximum dose of 2000