Romidab XR 500 mg/750 mg Extended-Release Tablets

ROMIDAB XR contains the active ingredient metformin, which is used for the treatment of Type 2 (noninsulin dependent) diabetes mellitus when diet and exercise changes alone have not been enough to control blood glucose (sugar). ROMIDAB XR assists the body to utilise glucose and help bring the blood glucose levels to normal readings. ROMIDAB XR extended-release tablets are made to release the medicine slowly in your body.

Do not take ROMIDAB XR:

• If you are hypersensitive to metformin hydrochloride or any of the ingredients of ROMIDAB XR.
• You have severe complications of your diabetes such as diabetic ketoacidosis, a metabolic state resulting from a profound lack of insulin.
• Your kidneys do not work properly or do not work at all.
• You suffer from short term conditions that may affect your kidney function e.g. dehydration, severe infection, shock, administration of iodinated contrast media through the veins.
• You suffer from short or long term conditions that may cause a lack of oxygen to your tissues such as heart or breathing failure, a recent heart attack, shock.
• If you have liver problems, suffer from acute alcohol intoxication, alcoholism (acute or chronic).
• If you are pregnant.

Take special care with ROMIDAB XR:

• 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. Symptoms include nausea, vomiting, abdominal pain and low body temperature. This complication could happen when ROMIDAB XR accumulates in your blood, especially if you have serious kidney dysfunction. ROMIDAB XR treatment should be stopped and you should be hospitalised.
• ROMIDAB XR should be discontinued 48 hours before surgery with general anaesthesia and should not be usually resumed earlier than 48 hours afterwards.
• Since ROMIDAB XR is excreted by kidney, tests to determine if the kidneys are working should be conducted: - annually in patients with normal renal function, - At least two to four times a year if you suffer from high serum creatinine levels and if you are older than 65 years old.
• Other precautions: - All patients should continue their diet with a regular distribution of carbohydrate intake during the day. Overweight patients should continue their energy-restricted diet. - If you are taking vitamin B12, ROMIDAB XR may cause malabsorption of vitamin B12. You should check your vitamin B12 levels annually. - If you are administered an iodinated contrast agent (which can cause renal failure), ROMIDAB XR should be stopped prior and you should only start taking ROMIDAB XR again once it has been established that your kidneys are working normally. - The usual laboratory tests for diabetes monitoring should be performed regularly.

Although ROMIDAB XR alone never causes hypoglycaemia, caution is advised when it is used in combination with insulin or sulphonylureas.

Children ROMIDAB should not be given to children, as there is no data available.

Do not share medicines prescribed for you with any other person. Always take ROMIDAB XR exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with ROMIDAB XR will last. If you have the impression that the effect of ROMIDAB XR is too strong or too weak, talk to your doctor or pharmacist.

Your individual dose will be decided by your doctor after laboratory tests and examinations. Always take this medicine as the doctor has instructed you.

ROMIDAB XR 500 mg: 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.

ROMIDAB XR 750 mg: 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 3 tablets daily.

If you take more ROMIDAB XR than you should In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison center. Hypoglycaemia can occur when ROMIDAB XR range is given concomitantly with a sulphonylurea, insulin or alcohol. Lactic acidosis may develop. Treatment is supportive and symptomatic.

If you forget to take ROMIDAB XR If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

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

If any of the following happens, stop taking ROMIDAB XR 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.
• If your body breaks out in a severe rash characterised by blisters or you experience severe itching.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ROMIDAB 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: Nausea, vomiting, diarrhoea or abdominal pain - this could be a sign of lactic acidosis (see ‘Take special care with ROMIDAB XR’ above).

Tell your doctor if you notice any of the following: The following side effects occur frequently:

• Taste disturbances
• Nausea, vomiting, diarrhoea, abdominal pain
• Loss of appetite
• Decrease in vitamin B12 absorption

The following side effects occur less frequently:

• Abnormalities in liver function tests
• Hepatitis (inflamed liver) resolving on ROMIDAB XR range discontinuation

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

Reporting of side effects If you get 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 via https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of this medicine.

Store at or below 25 °C. Keep the blisters in the carton until required for use. Keep HDPE containers tightly closed. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).