Fortese XR Extended-Release Tablets

FORTESE XR Extended 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. FORTESE XR is used together with diet and exercise to lower the risk of developing Type 2 diabetes in overweight adults, where diet and exercise alone have not been enough to control blood glucose (sugar) or when insulin cannot be used. FORTESE XR Extended release Tablets are specially made to release the medicine slowly in your body and therefore are different to many other types of tablet containing metformin.

Do not take FORTESE XR if:

• 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 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 lost too much water from your body (dehydration). Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis.
• 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.
• you have been treated for acute heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties (such as asthma). These conditions may deprive your body of oxygen supply to tissue which can put you at risk for lactic acidosis.
• you have pancreatitis (inflammation of the pancreas).
• you take excessive quantities of alcohol or medicines that contain alcohol, like cough mixtures.
• you are a child under the age of 12.
• you are pregnant, plan to be pregnant or breast-feeding.

Warnings and Precautions:

Take special care with FORTESE XR

• If you develop the following symptoms while taking FORTESE XR: stomach pain, hyperventilation (fast and deep breathing), exhaustion, rapid heartbeat, nausea and vomiting. Contact your doctor immediately if you experience the listed symptoms, as you may have had a life-threatening condition called lactic acidosis.
• If you recently had an X-ray where iodine containing dye was injected.
• If you are taking any medicine used to manage high blood pressure.
• If you are taking FORTESE XR 48 hours before going to surgery. Talk to your doctor, as your doctor may temporarily stop the treatment.
• If you are on a low calorie diet.
• If you are on long-term treatment of FORTESE XR and need to initiate Vitamin B12 and folic treatment, as they may reduce the absorption of nutrients from the intestine, which may lead to anaemia.
• If have a condition that may be associated with dehydration (significant loss of body fluids), diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking FORTESE XR 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.

Your doctor may prescribe FORTESE XR for you to take on its own, or in combination with other oral antidiabetic medicines or insulin. Always take FORTESE XR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets whole with a glass of water, do not chew.

Recommended dose: Usually you will start treatment with 500 mg of FORTESE XR daily after evening meal. After you have been taking FORTESE XR for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000 mg of FORTESE XR (4 tablets of 500 mg or 3 tablets of 750 mg). 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 FORTESE XR 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 heart beat. If you experience some of these symptoms, you should immediately seek medical attention, as lactic acidosis may lead to coma. Stop taking FORTESE XR immediately and contact a doctor or the nearest hospital straightaway.

If you forget to take FORTESE XR: 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 stop taking FORTESE XR: Do not stop taking FORTESE XR unless your doctor tells you to.

FORTESE XR can have side effects. Not all side effects reported for FORTESE XR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FORTESE XR, please consult your health care provider for advice.

If any of the following happens, stop taking / using FORTESE XR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• a very rare but very serious side effect called lactic acidosis (see section ‘Warnings and precautions’). Lactic acidosis may lead to coma.

These are all very serious side effects. If you have them, you may have had a serious reaction to FORTESE XR. 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:

• abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice.
• If you develop yellowing of the eyes and/or skin contact your doctor immediately.

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:

• Diarrhoea, nausea, vomiting, stomach ache or loss of appetite and taste disturbance.

Less frequent side - effects:

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

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

Reporting of side effects:

If you get side effects, talk to your doctor or 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 FORTESE XR.

Store at or below 25 °C. Do not remove blister from carton until required for use. Keep bottle tightly closed. Store in the original package in order to protect from moisture. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton, the blister and the bottle. Do not throw away any medicines in drains or sewage systems. Return all unused medicine to the pharmacist.