Metformin Teva ER Extended-Release Tablets

Metformin Teva ER 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. Metformin Teva ER 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 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. Metformin Teva ER makes the body more sensitive to insulin and helps return to normal the way your body uses glucose. Metformin Teva ER Extended Release Tablets are specially made to release the medicine slowly in your body. Metformin Teva ER can be given alone as initial therapy or can be administered in combination with other oral antidiabetic medicines or with insulin.

Do not take METFORMIN TEVA ER if:

• you are hypersensitive to metformin hydrochloride or any of the other ingredients of Metformin Teva ER (listed in section 6).
• 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 reduced kidney function or kidney failure.
• 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 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 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 have pancreatitis.
• you have liver problems.
• you are a heavy drinker of alcohol.
• you are receiving intravascular iodinated contrast media.
• you are pregnant.

Warnings and precautions

Take special care with Metformin Teva ER:

• if you are at risk of developing lactic acidosis - Lactic acidosis is a rare, but serious and life-threatening complication that can occur when lactic acid builds up in the blood stream faster than it can be removed. The risk of developing lactic acidosis is also increased with if your kidneys are not working properly, 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). Talk to your doctor if you think you may be at risk of developing lactic acidosis.
• 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, you should stop taking Metformin Teva ER for a short time and talk to your doctor for further instructions.
• if you are elderly and/or if you have worsening kidney function, your doctor will check your kidney function at least once a year or more frequently during treatment with Metformin Teva ER and your dosage will be adjusted based on your kidney function.
• if you are elderly, your serum creatinine levels will be determined before initiating treatment and two to four times in a year thereafter. Decreased kidney function in elderly patients happen frequently and may not present with any symptoms. Special precaution should thus be exercised if you are at risk of your kidney function becoming impaired, for example if you are being started on medication for high blood pressure, a diuretic or a NSAID.
• if you need to have major surgery you must stop taking Metformin Teva ER during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin Teva ER.
• if you see some remains of the tablets in your stools, you should not worry as 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.

Children and adolescents

Metformin Teva ER is not for use in children.

Other medicines and METFORMIN TEVA ER

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Tell your doctor is you are taking or receiving any of the following medicines:

• Contrast medium injection that contains iodine, for example in the context of an X-ray or scan, you must stop taking Metformin Teva ER before or at the time of injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin Teva ER.
• Medicines used to treat pain and inflammation (NSAID and COX-2 inhibitors, such as ibuprofen and celecoxib).
• 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).
• Steroids such as prednisolone, mometasone, beclometasone.
• Sympathomimetic medicines including adrenaline (epinephrine) and dopamine used to treat heart attacks and low blood pressure. Adrenaline (epinephrine) is also included in some dental anaesthetics.
• Medicines that may change the amount of Metformin Teva ER in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Do not share medicines prescribed for you with any other person. Always take Metformin Teva ER exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Metformin Teva ER 500: Usually you will start treatment with 500 milligrams Metformin Teva ER daily. After you have been taking Metformin Teva ER for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2 000 milligrams (4 tablets of 500 mg) of Metformin Teva ER.

Metformin Teva ER 750: The usual starting dose is one tablet daily taken with the evening meal. Your doctor may adjust your dose after 10 to 15 days. The recommended dosage is 2 tablets daily.

Metformin Teva ER 1 000: The usual starting dose is one tablet daily taken with the evening meal at a maximum, recommended dose of 2 tablets per day. Metformin Teva ER 1000 is intended as maintenance therapy for patients currently treated with either 1 000 mg or 2 000 mg metformin hydrochloride.

Switching you to prolonged release tablets: the starting dose of the prolonged release tablets should be the same as the daily dose of the immediate release tablets. If your dose is above 2 000 mg daily, you should not take Metformin Teva ER tablets.

Combination therapy with Insulin: The usual starting dose is Metformin Teva ER 500 once daily with the evening meal, while insulin dosage is adjusted on the basis of blood glucose measurements. Switching to Metformin Teva ER 1 000 may be considered after titration.

If you have reduced kidney function, your doctor may prescribe a lower dose. Swallow the tablets whole with a glass of water, do not chew.

If you take more METFORMIN TEVA ER than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. If the overdose is large, lactic acidosis is more likely. Symptoms of lactic acidosis are non-specific, such as vomiting, belly ache 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.

If you forget to take METFORMIN TEVA ER: Do not take a double dose to make up for forgotten individual doses.

If you stop taking METFORMIN TEVA ER: Do not stop taking Metformin Teva ER without speaking to your doctor.

Metformin Teva ER can have side effects. Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking Metformin Teva ER, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking Metformin Teva ER and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• lactic acidosis with symptoms such as vomiting, stomach pain, muscle cramps, not feeling well with severe tiredness, reduced body temperature and heartbeat,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to Metformin Teva ER. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• yellowing of the eyes and/or skin

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects

• taste disturbance
• diarrhoea
• nausea
• vomiting
• stomach pain
• loss of appetite

Less frequent side effects

• decreased vitamin B12 levels
• blood tests that show abnormal liver function tests
• superficial reddening of the skin, usually in patches
• hives

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of Metformin Teva ER.

Store all medicine out of reach of children. Store at or below 25 °C in the original package. Do not remove blister from carton until required for use. Do not use the tablets after the expiry date shown on the container. Return the expired medicine to your pharmacist for safe disposal.