Metformin Flamingo SR 750 mg 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 onto 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.
• Metformin Flamingo SR 500mg, 750mg and 1000mg prolonged release tablets are referred as Metformin Flamingo SR in this leaflet.

1. What Metformin Flamingo SR are and what they are used for
2. What you need to know before you take Metformin Flamingo SR
3. How to take Metformin Flamingo SR
4. Possible side effects
5. How to store Metformin Flamingo SR
6. Contents of the pack and other information

• you are allergic to metformin or to 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 liver problems
• you have severely reduced kidney function
• you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood gIucose), 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 lost too much water from your body (dehydration). which may happen in cases of prolonged or severe diarrhoea or repeated vomiting' Dehydration or shock may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions').
• 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 been treated for acute heart problems or have recently had a heart attack or have severe circulatory problems (such as shock) 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.

Metformin Flamingo 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.

Talk to your doctor promptly for further instructions if:

• You are known to suffer from a genetically inherited disease affecting mitochondria (the energy-producing components within cells) such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic acidosis and Stroke-like episodes) or Maternal inherited diabetes and deafness (MIDD).
• You have any of these symptoms after starting metformin: seizure, declined cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness.

Stop taking Metformin Flamingo 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, diarrhea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Metformin Flamingo 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 Metformin Flamingo SR during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin Flamingo SR.

During treatment with Metformin Flamingo 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 Metformin Flamingo 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 a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Metformin FlamingoSR before or at the time of injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin Flamingo 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 Metformin Flamingo 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 Metformin Flamingo 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 Metformin Flamingo SR since this may increase the risk of lactic acidosis (see section 'Warnings and precautions').

If you are pregnant, think you may be pregnant or are planning to have a baby, speak to your doctor in case any changes will be needed to your treatment or monitoring of your blood glucose levels.

This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.

Women of childbearing potential:

Metformin Flamingo SR can stimulate ovulation (release of an egg from the ovaries), in women who do not ovulate properly. Beware of an increased chance of becoming pregnant when using Metformin Flamingo SR.

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

Information about ingredient of Metformin Flamingo SR This medicine contains less than 1 mmol sodium (23 mg) 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, stomach ache (abdominal pain) 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 Metformin Flamingo 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

• Each prolonged release tablet contains 500, 750 or 1000 milligrams of the active ingredient metformin hydrochloride.
• The other ingredients are microcrystalline cellulose, hypromellose, colloidal silicon dioxide and sodium stearyl fumarate.

What Metformin Flamingo SR looks like and contents of the pack Metformin Flamingo SR500 mg prolonged release tablets are white to off white coloured, round shaped, biconvex tablets debossed with '500' on one side and plain on other side.

Metformin Flamingo SR750 mg prolonged release tablets are white to off white coloured, capsule shaped, biconvex tablets debossed with '750' on one side and plain on other side. Metformin Flamingo SR1000 mg prolonged release tablets are white to off white coloured, modified capsule shaped, biconvex tablets debossed with '1000' on one side and plain on other side. Metformin Flamingo SR are available in blister strips composed of PVC/PVDC-ALU

500mg: 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180, 600 tablets.

750 mg: 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180 or 600 tablets.

1000 mg: 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180 or 600 tablets.

Not all pack sizes may be marketed.

Product license number:

PL 43461/0170 / PL 43461/0171 / PL 43461/0172