What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20117/0110.


Sukkarto SR 500mg prolonged release tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Sukkarto SR 500 mg 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 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

1. What Sukkarto SR is and what it is used for

Sukkarto SR 500mg prolonged release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of Type 2 (non-insulin dependent) diabetes mellitus.

Sukkarto SR is used together with diet and exercise to lower the risk of developing Type 2 diabetes in overweight adults, when diet and exercise alone for 3 to 6 months have not been enough to control blood glucose (sugar). You are at high risk of developing Type 2 diabetes if you have additional conditions like high blood pressure, age above 40 years, an abnormal amount of lipids (fat) in the blood or a history of diabetes during pregnancy.

The medicine is particularly effective if you are aged below 45 years, are very overweight, have high blood glucose levels after a meal or developed diabetes during pregnancy.

Sukkarto SR is used for the treatment of Type 2 diabetes 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 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. Sukkarto SR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.

Sukkarto SR is associated with either a stable body weight or modest weight loss.

Sukkarto 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 Sukkarto SR

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.

3. How to take Sukkarto SR

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor may prescribe Sukkarto SR for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.

Swallow the tablets whole with a glass of water, do not chew.

The recommended dose is:

Usually you will start treatment with 500 mg Sukkarto SR daily. After you have been taking Sukkarto SR for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000 mg of Sukkarto SR.

If you have reduced kidney function, your doctor may prescribe a lower dose.

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 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.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

Sukkarto SR may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Sukkarto SR and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Sukkarto SR may cause abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice (may affect up to 1 user in 10,000). 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 (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 your tablets with or immediately after a meal.

Common (may affect up to 1 in 10 people):

  • Taste disturbance.

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

  • Skin rashes including redness, itching and hives.
  • Decreased vitamin B12 levels.

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.

5. How to store Sukkarto SR

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

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. Contents of the pack and other information

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.

Marketing Authorisation Holder

Morningside Healthcare Ltd.
Unit C
Harcourt Way
Leicester
LE19 1WP
UK

Manufacturer

Morningside Pharmaceuticals Ltd.
5 Pavilion Way
Loughborough
LE11 5GW
UK

This leaflet is available in large font or audio format upon request.

This leaflet was last revised in September 2018.

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.

Version: V007/15/07/19/PL20117/0110

Supersedes: V006/22/03/18/PL20117/0110