Sukkarto SR 500mg prolonged release tablets

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 Sukkarto SR is and what it is used for
2. What you need to know before you take Sukkarto SR
3. How to take Sukkarto SR
4. Possible side effects
5. How to store Sukkarto SR
6. Contents of the pack and other information

Do not take Sukkarto SR

• if 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.
• if you have severely reduced kidney function.
• if 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.
• if 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 section “Warnings and precautions”).
• if you have liver problems.
• if 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 section “Warnings and precautions”).
• if 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 section “Warnings and precautions”).
• if you are a heavy drinker of alcohol.
• if you are under the age of 18 years.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sukkarto SR.

Risk of lactic acidosis

Sukkarto 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 a 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 Sukkarto 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 Sukkarto 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 Sukkarto SR during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Sukkarto SR.

During treatment with Sukkarto 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 Sukkarto SR should not be started to lower the risk of developing type 2 diabetes.

You may see some remains of your 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.

Other medicines and Sukkarto SR

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

Tell your doctor or pharmacist 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 Sukkarto SR. It is especially important to mention the following:

• 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 which increase urine production (diuretics (water tablets) such as furosemide).
• Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
• Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
• Medicines that may change the amount of Sukkarto SR in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Sukkarto SR with food, drink and alcohol

The tablets should be swallowed whole with a glass of water during or immediately after meals.

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

Pregnancy and breast-feeding

Do not take Sukkarto SR if you are pregnant or breast-feeding. If you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Sukkarto 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 Sukkarto SR taken with other antidiabetic medicines can cause hypos, so in this case you should take extra care when driving or operating machinery.

If you take more Sukkarto SR than you should

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 heartbeat. If you experience some of these symptoms, you should immediately seek medical attention, as lactic acidosis may lead to coma. Stop taking Sukkarto SR immediately and contact a doctor or the nearest hospital straightaway.

If you forget to take Sukkarto SR

Take the missed dose as soon as you remember with some food, unless it's nearly time for the next one. Do not take a double dose to make up a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Sukkarto SR

If you stop taking Sukkarto SR, tell your doctor as soon as possible, as your diabetes will not be controlled.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard 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.

What Sukkarto SR contains

The active substance is metformin hydrochloride. Each prolonged release tablet contains 500 mg of metformin hydrochloride.

The other ingredients are stearic acid; shellac (refined bleached); povidone K-30; silica, colloidal anhydrous; magnesium stearate; hypromellose; hydroxy propyl cellulose; titanium dioxide; propylene glycol; macrogol 6000 and talc.

What Sukkarto SR looks like and contents of the pack

Sukkarto SR 500 mg tablets are off-white coloured, oval, biconvex film-coated tablets plain on both sides.

Sukkarto SR is available in blister packs of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100 and 112 tablets.

Not all pack sizes may be marketed.

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