Yaltormin SR 750mg Prolonged Release Tablets

• 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.

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

• you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash, itching or shortness of breath
• you have uncontrolled diabetes with for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see ‘‘ Risk of lactic acidosis’’ below) or ketoacidosis.
  Ketoacidosis is a condition in which substances called ‘ketone bodies’ accumulate in the blood and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell
• you have liver problems
• you have severely reduced kidney function
• you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney.
  Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions)
• you have lost too much water from your body (dehydration). Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘Warnings and precautions’)
• you have been treated for acute heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Warnings and precautions)
• you are a heavy drinker of alcohol
• you are under 18 years of age.

Risk of lactic acidosis

Yaltormin SR may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which part of the body has a reduced supply of oxygen (such as acute severe heart disease).

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Yaltormin SR for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Yaltormin SR and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe tiredness
• difficulty in breathing
• reduced body temperature and heartbeat.

Lactic acidosis is a medical emergency and must be treated in a hospital.

If you need to have major surgery you must stop taking Yaltormin SR during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Yaltormin SR.

During treatment with Yaltormin SR, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.

If you are older than 75 years, treatment with Yaltormin SR should not be started to lower the risk of developing type 2 diabetes

You may see some remains of the tablets in your stools. Do not worry- this is normal for this type of tablet.

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.

If you need to have an injection of contrast medium that contains iodine into your bloodstream, in the context of an X-ray or scan, you must stop taking Yaltormin SR before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Yaltormin SR.

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests or your doctor may need to adjust the dosage of Yaltormin SR. It is especially important to mention the following:

• Medicines which increase urine production (diuretics (water tablets) such as furosemide)
• Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists
• Steroids such as prednisolone, mometasone, beclometasone
• Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthetics
• Medicines that may change the amount of Yaltormin SR in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Avoid excessive alcohol intake while taking Yaltormin SR since this may increase the risk of lactic acidosis (see section ‘Warnings and precautions’).

Do not take Yaltormin SR if you are pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine.

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.

This medicine contains less than 1mmol sodium (23mg) per dosage unit, that is to say it is essentially ‘sodium free’.

If you take extra tablets by mistake you need not worry, but if you have unusual symptoms, contact your doctor. If the overdose is large, lactic acidosis is more likely. Symptoms of lactic acidosis are non-specific, such as vomiting, bellyache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heart beat. If you experience some of these symptoms, you should immediately seek medical attention, as lactic acidosis may lead to coma. Stop taking Yaltormin SR immediately and contact a doctor or the nearest hospital straightaway.

Take it as soon as you remember with some food. Do not take a double dose to make up for a forgotten dose.

Very common (may affect more than 1 in 10 people):

• 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 (may affect up to 1 in 10 people):

• Taste disturbance
• Decreased or low vitamin B12 levels in the blood (symptoms may include extreme tiredness (fatigue), a sore and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems.

Very rare (may affect up to 1 in 10,000 people):

• Skin rashes including redness, itching and hives.

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:

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

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.

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.

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.

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: