Diamet XR Extended-Release Tablets

DIAMET 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.

DIAMET XR 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. DIAMET XR makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.

DIAMET XR extended release tablets are specially made to release the drug slowly in your body and therefore are different to many other types of tablets containing metformin.

Do not take DIAMET 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 (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 are a heavy drinker of alcohol.
• you are pregnant.

Do not share medicines prescribed for you with any other person. Your doctor may prescribe DIAMET XR for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.

Always take DIAMET 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.

The usual dose is:

DIAMET XR 500
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 maximum recommended dosage is usually not more than 4 tablets daily.

DIAMET XR 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 maximum recommended dosage is usually not more than 2 tablets daily.

DIAMET XR 1000
The usual starting dose is one tablet daily taken with the evening meal at a maximum recommended dose of 2 tablets per day. DIAMET XR 1000 is intended as maintenance therapy for patients currently treated either 1000 mg or 2000 mg of metformin hydrochloride.

If you have the impression that the effect of DIAMET XR is too strong or too weak, tell your doctor or pharmacist.

If you take more DIAMET 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 heartbeat. If you experience some of these symptoms, you should immediately seek medical attention, as lactic acidosis may lead to coma.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take a dose of DIAMET XR:
Try to take DIAMET XR as prescribed by your healthcare professional. However, if you miss a dose, do not take a double dose to make up for forgotten individual doses.

DIAMET XR can have side effects. Not all side-effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• Swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Difficulty breathing, dizziness (severe hypersensitivity).

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

If any of the following happens, tell your doctor immediately or go to the nearest hospital immediately.

• DIAMET XR may cause a less frequent but very serious side effect called lactic acidosis (see section ‘Warnings and precautions’)
• DIAMET XR may cause 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.
• Hypoglycaemia (very low blood sugar levels). These are serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent:

• 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 the tablets with or immediately after a meal.
• Taste disturbance

Less Frequent:

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

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

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 Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of DIAMET XR.

STORE ALL MEDICINE OUT OF REACH OF CHILDREN

Store DIAMET XR at or below 30 °C in an outer carton. Protect from moisture. Do not use this medicine after the expiry date shown on the pack. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or the sewerage system (e.g. toilets).