Yaltormin SR 750mg Prolonged Release Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

METFORMIN HYDROCHLORIDE

Available from:

Wockhardt UK Limited

ATC code:

A10BA; A10BA02

INN (International Name):

METFORMIN HYDROCHLORIDE

Dosage:

750 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

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

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Yaltormin SR 750mg Prolonged Release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prolonged release tablet contains 750 mg metformin hydrochloride
corresponding to 585 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 750’
on one side and plain on other side. The tablets are
approximately 19.6 mm in length and 9.3 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 and combination with other oral antidiabetic agents:_
Yaltormin SR 750 mg is intended for patients who are already treated
with metformin tablets (prolonged or immediate
release).
The dose of Yaltormin SR 750 mg should be equivalent to the daily dose
of metformin tablets (prolonged or immediate
release), up to a maximum dose of 1500 mg given with the evening meal.
After 10 to 15 days, it is recommended to check that the dose of
Yaltormin SR 750 mg is adequate on the basis of
blood glucose measurements.
_Combination with insulin:_
For patients already treated with metformin and insulin in combination
therapy, the dose of Yaltormin SR 750 mg
should be equivalent to the daily dose of metformin tablets up to a
maximum of 1500 mg given with the evening meal,
while insulin dosage is adjusted on the basis of blood glucose
measurements.
_Elderly_:
Due to the potential for decreased renal function in elderly subjects,
the metformin dosage should be adjusted based on
renal function. Regular assessment of renal function is necessary (see
section 4.4).