Yaltormin SR 500mg Prolonged Release Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

METFORMIN HYDROCHLORIDE

Tilgjengelig fra:

Pinewood Laboratories Ltd,

ATC-kode:

A10BA; A10BA02

INN (International Name):

METFORMIN HYDROCHLORIDE

Dosering :

500 milligram(s)

Legemiddelform:

Prolonged-release tablet

Terapeutisk område:

Biguanides; metformin

Autorisasjon status:

Not marketed

Autorisasjon dato:

2016-04-08

Informasjon til brukeren

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

Preparatomtale

Health Products Regulatory Authority
04 January 2021
CRN009YYV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Yaltormin SR 500mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged release tablet contains 500mg metformin hydrochloride
corresponding to 390 mg metformin base.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged Release Tablets
White to off-white, capsule shaped tablet debossed with ‘SR 500’
on one side and plain on other side. The tablets are
approximately 16.5 mm in length and 8.2 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≥ 90mL/min)
_Monotherapy in Type 2 diabetes mellitus and combination with other
oral antidiabetic agents:_
• The usual starting dose is one tablet of Yaltormin SR 500mg once
daily.
• After 10 to 15 days the dose should be adjusted on the basis of
blood glucose measurements. A slow increase of dose may
improve gastro-intestinal tolerability. The maximum recommended dose
is 4 tablets daily.
• Dosage increases should be made in increments of 500 mg every
10-15 days, up to a maximum of 2000 mg once daily with
the evening meal. If glycaemic control is not achieved on Yaltormin SR
2000 mg once daily, Yaltormin SR 1000 mg twice daily
should be considered, with both doses being given with food. If
glycaemic control is still not achieved, patients may be
switched to standard metformin tablets to a maximum dose of 3000 mg
daily.
• In patients already treated with metformin tablets, the starting
dose of Yaltormin SR should be equivalent to the daily dose
of metformin immediate release tablets.