Yaltormin SR 500mg Prolonged Release Tablets

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

METFORMIN HYDROCHLORIDE

Disponible depuis:

Wockhardt UK Limited

Code ATC:

A10BA; A10BA02

DCI (Dénomination commune internationale):

METFORMIN HYDROCHLORIDE

Dosage:

500 milligram(s)

forme pharmaceutique:

Prolonged-release tablet

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Biguanides; metformin

Statut de autorisation:

Not marketed

Date de l'autorisation:

2016-04-08

Notice patient

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

Résumé des caractéristiques du produit

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. In patients treated
with metformin at a dose above 2000 mg daily,
switching t