Romidab 500 mg/850 mg/1000 mg Tablets

The active substance is metformin hydrochloride. ROMIDAB 500 mg: Each film - coated tablet contains 500 mg metformin hydrochloride equivalent to 390 mg metformin. ROMIDAB 850 mg: Each film - coated tablet contains 850 mg metformin hydrochloride equivalent to 663 mg metformin. ROMIDAB 1000 mg: Each film - coated tablet contains 1 000 mg metformin hydrochloride equivalent to 780 mg metformin. The other ingredients are magnesium stearate, Opadry YS - 1R - 7006 and povidone.

ROMIDAB is an oral hypoglycaemic medicine used for Type 2 (non - insulin dependent) diabetes mellitus when diet has failed and especially if you are overweight. You can take ROMIDAB alone as initial therapy, or you can take it in combination with other oral antidiabetic medicines or insulin.

Do not take ROMIDAB:

• If you are hypersensitive (allergic) to metformin hydrochloride or any of the other ingredients of ROMIDAB.
• If you have experienced diabetic coma (coma occurring due to diabetic complications).
• If you suffer from diabetic ketoacidosis, a condition with symptoms such as your breath smelling like acetone, nausea, vomiting, excessive thirst and urination and abdominal pain.
• If you have impaired kidney function.
• If you suffer from chronic liver disease.
• If you suffer from acute or chronic diseases such as inflammation of the pancreas, heart or respiratory failure, or if you have experienced a recent heart attack, all of which may cause an inadequate supply of oxygen to the organs.
• If you have a history of, or experience states associated with lactic acidosis such as shock or heart problems which may manifest with symptoms such as nausea, vomiting, heavy and fast breathing, lethargy, fast heart beat and anxiety.
• If you suffer from alcoholism.
• If you experience conditions associated with a low level of oxygen in the blood which may manifest with symptoms such as a change in your mental status, shortness of breath, increase in blood pressure, changes in your heart rate and cold hands and feet.
• Do not use in children as safety and efficacy has not been established.
• If you are pregnant and breastfeeding your baby.

Take special care with ROMIDAB:

• If you experience lactic acidosis manifested as nausea, vomiting, abdominal pain, lethargy, anxiety, hyperventilation, irregular and fast heart rate, contact your doctor immediately or go to the nearest hospital.
• If you are starting to drink medicines for high blood pressure or if you start drinking anti-inflammatory painkillers such as aspirin or ibuprofen, you should inform your doctor as it may affect your kidney function when taking ROMIDAB at the same time.
• If you are scheduled to undergo any radiological tests such as x-rays or scans, you should inform your doctor that you are taking ROMIDAB as you will have to stop taking ROMIDAB before the test and can only start taking it again in 48 hours or as your doctor determines, depending on your kidney function.
• If you are scheduled to undergo any surgery, you should inform your doctor that you are taking ROMIDAB as you will have to stop taking it 48 hours before the surgery.
• ROMIDAB is used for Type 2 diabetes.
• If you are taking ROMIDAB, your doctor will have to check your vitamin B12 levels every year, since ROMIDAB may cause mal-absorption of vitamin B12 and folic acid.
• If you are taking other oral anti-diabetic medicines with ROMIDAB, you should have your blood glucose regularly monitored to prevent hypoglycaemia.
• If you are overweight, you should continue on your energy-restricted diet.
• Your doctor will have to perform regular tests to make sure your kidney function is normal.
• If you are suffering from serious infections, trauma or on a low calorie intake.

Taking ROMIDAB with food and drink: It is important that you take ROMIDAB with meals. Avoid consumption of alcohol and alcohol-containing medications while on treatment with ROMIDAB.

Always take ROMIDAB exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of ROMIDAB is too strong or too weak, talk to your doctor or pharmacist.

Adults: The usual dose is one 500 mg tablet three times a day, or one 1000 mg or 850 mg tablet twice a day, with or after food. Your doctor will prescribe the correct dose for you. After 10 - 15 days, your doctor may adjust your dose depending on your response to the treatment. Good diabetic control may be achieved within a few days, but it is not unusual for the full effect to be delayed for up to two weeks.

Elderly: Your doctor will adjust your dose based on your kidney function.

Children 12 years and above: The usual starting dose is 500 mg or 850 mg taken once daily, however as with adults the doctor may adjust the dose after 10 - 15 days.

If you take more ROMIDAB than you should: In excessive doses lactic acidosis manifested as nausea, vomiting, abdominal pain, lethargy, anxiety, hyperventilation, irregular and fast heart rate may occur. If this occurs you should contact your doctor immediately or go to the nearest hospital. 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 ROMIDAB: If you forget 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 can have side - effects. If you experience the following side - effects you should report to your doctor or hospital IMMEDIATELY:

• Manifestations of lactic acidosis such as nausea, vomiting, abdominal pain, lethargy, anxiety, hyperventilation, irregular and fast heart rate.
• Manifestations of hypoglycaemia such as an irregular heartbeat, clamminess, a feeling of numbness or ‘pins and needles’, nausea, vomiting, headache, change in mood, weakness, confusion or blurred vision.
• Allergic reactions such as a rash, swelling of the skin, itchiness, sneezing, swelling and redness of eyes, or difficulty breathing.
• Persistent jaundice (yellow discoloration of skin and eyes), and itchy skin which may be as a result of a condition called cholestatic hepatitis.

If you experience the following side - effects you should report to your doctor AS SOON AS POSSIBLE:

• Gastrointestinal side - effects such as nausea, vomiting, constipation, diarrhoea, abdominal pain and a metallic taste in your mouth.
• An allergic reaction.

Not all side effects reported for ROMIDAB are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, while taking ROMIDAB, please consult your doctor, pharmacist or other health care professional for advice.

Store all medicines out of reach of children. Store at or below 25 °C. Keep container tightly closed. Keep blisters in outer carton until required for use. Protect from light and moisture. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).