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YALTORMIN SR 500MG PROLONGED RELEASE TABLETS

Active substance(s): METFORMIN HYDROCHLORIDE

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for UK submission only

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
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 body uses glucose.
Yaltormin SR is associated with either a stable body weight or modest weight loss.
Yaltormin SR Prolonged Release Tablets are specially made to release the drug slowly in your body
and therefore are different to many other types of tablet containing metformin.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE YALTORMIN SR
Do not take Yaltormin SR if:
• you are allergic to metformin or to any of the other ingredients which are listed later on in the
leaflet (see under ‘6. Further information’). An allergic reaction may cause a rash, itching or
shortness of breath.
• you have ketosis (this is a symptom of uncontrolled diabetes in which substances called ‘ketone
bodies’ accumulate in the blood – you may notice that your breath has an unusual, fruity odour).
• you have long-term kidney or liver problems.
• you have had serious complications with your diabetes or other serious conditions which resulted
in rapid weight loss, nausea, vomiting or dehydration.
• you have a severe infection or have recently suffered a severe injury.
• you have been treated for heart problems or have recently had a heart attack or have severe
circulatory problems or breathing difficulties.
• you are a heavy drinker of alcohol.
• you are under 18 years of age.
Warnings and precautions
After you have started taking your medicine:
If you have diabetes you should have your blood or urine tested for sugar regularly. You should return
to your doctor at least once a year to check the function of your kidneys (more often if you are elderly
or if you have kidney problems).
If you start to lose weight unexpectedly or suffer severe nausea or vomiting, uncontrolled rapid
breathing or abdominal pains, stop taking the medicine and tell your doctor straight away. This
can be a sign of a rare, but serious, complication with your diabetes called ‘lactic acidosis’ which
means there is too much acid in the blood (see also under ‘4. Possible side effects’).
You may see some remains of the tablets in your stools. Do not worry- this is normal for this type of
tablet.
If you need to have an X-ray examination involving the injection of a dye, tell the doctor that you take
Yaltormin SR as you may need to stop taking it for a few days afterwards.
Tell your doctor if you are going to have an operation under general anaesthetic, as you may need to
stop taking Yaltormin SR for a couple of days before and after the procedure.
You should continue to follow any dietary advice that your doctor has given you and you should
make sure that you eat carbohydrates regularly throughout the day.
Do not stop taking this medicine without speaking to your doctor.
Other medicines and Yaltormin SR:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following medicines, your blood sugar levels may need to be checked
more often and your dose adjusted:
• Steroids such as prednisolone, mometasone, beclometasone.
• Diuretics (water tablets) such as furosemide.
• Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and
low blood pressure. Epinephrine is also included in some dental anaesthetics.
You should avoid using alcohol-containing medicines as this will increase the risk of lactic acidosis
(see under ‘4. Possible side effects’).
Yaltormin SR with food, drink and alcohol:
You should take Yaltormin SR with or immediately after food.
You should avoid drinking alcohol as this will increase the risk of lactic acidosis (see under ‘4. Possible
side effects’).
Pregnancy and breast-feeding
Do not take Yaltormin SR if you are pregnant or breast feeding. Ask your doctor or pharmacist for
advice before taking any medicine.
Driving and using machines
Yaltormin SR taken on its own does not cause ‘hypos’ (symptoms of low blood sugar or
hypoglycaemia, such as faintness, confusion and increased sweating) and therefore should not affect
your ability to drive or use machinery.
You should be aware, however, that Yaltormin SR taken with other antidiabetic medicines can cause
hypos, so in this case you should take extra care when driving or operating machinery.
3. HOW TO TAKE YALTORMIN SR
Your doctor may prescribe Yaltormin SR for you to take on its own, or in combination with other oral
antidiabetic medicines or insulin.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
Swallow the tablets whole with a glass of water; do not chew.
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ART WORK CHECK BOX
PRODUCT :

Process
Black

Yaltormin SR (Metformin hydrochloride)
500mg, 750mg, 1000 Tablets - 28 Tablets & 56 Tablets
CUSTOMER :
Wockhardt UK
FP CODE:

PLANT LOCATION :
for UK submission only
DIMENSIONS :
(w)148 x (h)420mm
TEXT FONT SIZE :
9pt.
PHARMACODE No. : DUMMY
SAP CODE No. :

FILE NAME :
Yaltormin tablet_Leaflet.ai
SOFTWARE :
Adobe Illustrator CS5
TYPEFACES :
Myriad Pro Regular / Italic / Bold
ARTWORK (DETAILS) 18th August, 2015
RECEIVED ON :
PROOF REVISION :
R 1st PDF sent on - 24TH AUG. 2015
R 2nd PDF sent on - 23RD FEB. 2016
R 3rd PDF sent on - 26TH FEB. 2016

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Usually you will start treatment with 500 milligrams Yaltormin SR daily. After you have been taking
Yaltormin SR for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The
maximum daily dose is 2000 milligrams of Yaltormin SR.
Normally, you should take the tablets once a day, with your evening meal.
In some cases, your doctor may recommend that you take the tablets twice a day. Always take the
tablets with food.
If you take more Yaltormin SR than you should
If you take extra tablets by mistake you need not worry, but if you have unusual symptoms, contact
your doctor. These symptoms may include weakness, confusion, fast breathing and new onset of
nausea, vomiting or stomach pain. If the overdose is large, lactic acidosis is more likely and this is a
medical emergency requiring treatment in hospital (see also under ‘4. Possible side effects’).
If you forget to take Yaltormin SR
Take it as soon as you remember with some food. Do not take a double dose to make up for a
forgotten dose.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you
notice any of the following, stop taking Yaltormin SR and see your doctor immediately:
• unexpected weight loss
• very severe nausea or vomiting
• very fast breathing which you cannot stop
• stomach pains or feeling cold
These can be signs of serious problems with your diabetes and may mean you have a very rare side
effect called “lactic acidosis” (too much acid in the blood). If this happens, see a doctor as you will
need treatment straight away.
• Abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice.
If you develop yellowing of the eyes and/or skin contact your doctor immediately.
Other possible side effects are listed by frequency as follows:
Very common (affects more than 1 person in 10):
• Diarrhoea, nausea, vomiting, stomach ache or loss of appetite. If you get these, do not stop taking
the tablets as these symptoms will normally go away in about 2 weeks. It helps if you take the
tablets with or immediately after a meal.
Common (affects less than 1 person in 10, but more than 1 person in 100):
• Taste disturbance
Very rare (affects less than 1 person in 10,000):
• Decreased vitamin B12 levels
• Skin rashes including redness, itching and hives.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the national reporting systems
listed below:
United Kingdom:
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland:
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517;
Website: www.hpra.ie; e-mail: medsafety@hpra.ie
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE YALTORMIN SR
Keep this medicine out of the sight and reach of children.
Do not use them after the expiry date which is stated on the carton after “EXP”. The expiry date refers
to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. FURTHER INFORMATION
What Yaltormin SR contains
Yaltormin SR 500mg Prolonged Release Tablets contain 500mg of the active ingredient metformin
hydrochloride, equivalent to 390mg metformin.
Yaltormin SR 750mg Prolonged Release Tablets contain 750mg of the active ingredient metformin
hydrochloride equivalent to 585mg metformin.
Yaltormin SR 1000mg Prolonged Release Tablets contain 1000mg of the active ingredient metformin
hydrochloride equivalent to 780mg metformin.
The other ingredients are magnesium stearate, silica colloidal anhydrous, carmellose sodium and
hypromellose.
What Yaltormin SR looks like and contents of the pack
The 500 milligram tablets are white to off–white, capsule shaped tablets debossed with ‘SR 500’ on
one side and plain on other side. The tablets dimensions are approximately 16.5mm x 8.2mm.
The 750 milligram tablets are white to off-white, capsule shaped tablets debossed with ‘SR 750’ on
one side and plain on other side. The tablets dimensions are approximately 19.6mm x 9.3mm.
The 1000 milligrams tablets are white to off-white, oval tablets debossed with ‘SR 1000’ on one side
and plain on other side. The tablets dimensions are approximately 22mm x 10.5mm.
Yaltormin SR is supplied in packs of 28 and 56 prolonged release tablets. Not all pack sizes may be
marketed.
Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Other sources of information
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give the following information:
Product name
Reference number
Yaltormin SR 500mg Prolonged Release Tablets
29831/0655
Yaltormin SR 750mg Prolonged Release Tablets
29831/0656
Yaltormin SR 1000mg Prolonged Release Tablets
29831/0657
This is a service provided by the Royal National Institute of Blind People.
For the Republic of Ireland please call +44 1978 669272.
Useful tips
• If you smoke, try to stop
• Take regular exercise
• Drink as little alcohol as possible
• Look after your feet. Ask about this at the surgery or hospital
• Carry a card, bracelet or disk saying you are diabetic
• Visit your diabetic clinic regularly
If you want more information about diabetes contact:
Diabetes UK Central Office
Macleod House, 10 Parkway, London NW1 7AA
Tel: 020 7424 1000
This leaflet was last revised in 02/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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