Macloglymin 500 mg Film-Coated Tablets

MACLOGLYMIN is used to treat patients with type II diabetes (also called ‘non-insulin dependent diabetes’) when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients.

• Adults can take MACLOGLYMIN alone or together with other medicines to treat diabetes (medicines taken by mouth or insulin injection).
• Children 12 years and over, and adolescents can take MACLOGLYMIN alone or together with insulin injection.

Do not take or give MACLOGLYMIN:

• if you or your child are hypersensitive (allergic) to metformin hydrochloride or to any of the ingredients of MACLOGLYMIN.
• if you have, nausea, vomiting, dehydration, rapid weight loss 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 unusual fruity odour of the breath.
• if you have been diagnosed with kidney failure or kidney dysfunction.
• if you lost too much water from your body (dehydration), due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘Take special care with MACLOGLYMIN below).
• if 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 ‘Take special care with MACLOGLYMIN below).
• if you are treated for heart failure or recently had a heart attack or have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack in oxygen supply to tissues which can put you at risk for lactic acidosis (see ‘Take special care with MACLOGLYMIN below).
• if you have inflammation of the pancreas (symptoms like severe upper stomach pain, often with nausea and vomiting).
• if you drink a lot of alcohol or have liver problems.
• if you are pregnant or breastfeeding.
• if you need to have an injection of contrast medicines that contain iodine into your bloodstream for examinations such as X-ray or scans. You must stop taking MACLOGLYMIN for a certain period of time before and after the examination.

Warnings and precautions

Tell your doctor or health care professional before you take or give MACLOGLYMIN. Take special care with MACLOGLYMIN:

• MACLOGLYMIN may cause a less frequent, but serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting, liver problems or alcohol intake or if you become dehydrated due to severe diarrhoea or vomiting, fever or reduced fluid intake or if you taking medicines for high blood pressure, diuretics (medicines that help to reduce the amount of water in the body) or NSAIDs (anti-inflammatory medicines for pain and fever). Symptoms of lactic acidosis are vomiting, stomach ache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking MACLOGLYMIN immediately and contact a doctor or the nearest hospital straight away.
• Your doctor will monitor your kidney function before starting treatment with MACLOGLYMIN and on a regular basis thereafter.
• Inform your doctor if you are taking medicines for high blood pressure, diuretics or NSAIDs as these medicines may cause your kidneys not to work properly.
• Tell your doctor if you have any heart conditions before starting MACLOGLYMIN. Your doctor will monitor your heart function before starting treatment with MACLOGLYMIN.
• Make sure you ask your doctor for advice:
• if you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream.
• if you need to have major surgery. You must stop taking MACLOGLYMIN for a certain period of time before and after the examination or the surgery. Your doctor will decide whether you need any other treatment for this time. It is important that you follow your doctor’s instructions precisely.
• MACLOGLYMIN will only be prescribed in children over 12 years and in adolescents who have type II diabetes confirmed by their doctor.
• Continue your exercise and diet program and test your blood sugar regularly while taking MACLOGLYMIN. Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally.
• Long term use of MACLOGLYMIN may cause a deficiency of vitamin B12. Inform your doctor if you have symptoms of fatigue, muscle weakness, loss of appetite/weight loss, diarrhoea, nausea, fast heartbeat, smooth or tender tongue, tingling in hands and feet, numbness in extremities. You doctor will test your vitamin B12 levels annually.
• Monitor your blood glucose levels regularly if you are taking MACLOGLYMIN with other anti-diabetic medicines such as a sulphonylurea or insulin.

• Do not share medicines prescribed for you or your child with any other person.

• Always take or give MACLOGLYMIN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• If you have the impression that the effect of MACLOGLYMIN is too strong or too weak talk to your doctor or pharmacist.

• Your doctor will tell you exactly how much medicine to take or give and when to take or give it.

• MACLOGLYMIN must be taken orally and swallowed with sufficient quantity of liquid and may be taken with or after a meal. This will avoid you having side effects affecting your digestion.

• The usual dose is:

• Adults: Initially, one 500 mg tablet three times a day, or one 850 mg or 1000 mg tablet twice a day, with or after a meal.
• Children from 12 years of age and adolescents: The usual starting dose is 500 mg or 850 mg once daily, given during meals or after meals.

If you take or give more MACLOGLYMIN than you should

In the event of overdosage consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison control centre. Symptoms of overdose may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, increase in heartbeat, vomiting, stomach ache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing.

If you forget to take or give MACLOGLYMIN

It is important to take your MACLOGLYMIN regularly at the same time each day. If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. In that case, just carry on with the next dose as normal. Do not take a double dose to make up for forgotten individual doses.

If you stop taking or giving MACLOGLYMIN

Do not stop taking MACLOGLYMIN just because you feel better. Take or give MACLOGLYMIN for as long as your doctor recommends. Do not stop taking or giving MACLOGLYMIN unless your doctor tells you to.

MACLOGLYMIN can have side effects. Not all side effects reported for MACLOGLYMIN are included in this leaflet. Should your or your child’s general health worsen or if you or your child experiences any untoward effects while taking MACLOGLYMIN, please consult your doctor, pharmacist or other healthcare professional for advice.

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

• Sudden signs of allergy – including skin rash, itching or hives; swelling of the face, lips or tongue, shortness of breath or difficulty breathing. These are all very serious side effects. If you or your child have them, you or your child may have had a serious reaction to MACLOGLYMIN. You may need urgent medical attention or hospitalization.
• Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• Lactic acidosis. This is a very rare but serious complication particularly if your kidneys are not working properly. Symptoms of lactic acidosis are vomiting, stomach ache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Stop taking MACLOGLYMIN immediately and contact a doctor or the nearest hospital straight away.
• Hypoglycaemia - low sugar (glucose) levels in the blood, especially if you are taking MACLOGLYMIN with other anti-diabetic medicines such as a sulphonylurea or insulin. Symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heartbeat.
• Hepatitis (inflammation of the liver) - this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking MACLOGLYMIN and talk to your doctor.
• Pancreatitis - inflammation of the pancreas with severe upper stomach pain, often with nausea and vomiting.
• Paleness of the skin, shortness of breath, dizziness and irregular heartbeat (symptoms of megaloblastic anaemia). These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent: Digestive problems such as feeling sick (nausea), being sick (vomiting), diarrhoea, stomach ache (abdominal pain) and loss of appetite.
• Taste disturbance.
• Decrease of vitamin B12 absorption.

Less frequent:

• Decrease of folic acid absorption.
• Weight loss.
• Abnormal liver function tests.
• Superficial reddening of the skin, usually in patches, hives, itching.

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

Reporting of side effects

If you or your child get side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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 MACLOGLYMIN.

Store all medicines out of reach of children.

Store at or below 25 °C.

Store in the original package / container. Keep the HDPE containers tightly closed. Protect from light and moisture.

Do not store in a bathroom.

Do not use after the expiry date stated on the label / carton / bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).