Avandamet (Rosiglitazone, metformin)
How does it work?
Avandamet tablets contain two active ingredients, rosiglitazone maleate and metformin hydrochloride. These are both medicines that are used to help control blood sugar levels in people with type 2 or non-insulin dependent diabetes (NIDDM).
People with diabetes mellitus have a deficiency or absence of a hormone produced by the pancreas called insulin. Insulin is the main hormone responsible for the control of sugar in the blood. In type 2 diabetes the pancreas does not produce sufficient insulin and the cells of the body are resistant to the low levels of insulin circulating in the blood. Insulin would normally make the cells remove sugar from the blood, hence in type 2 diabetes blood sugar levels can rise too high.
Rosiglitazone maleate is a type of antidiabetic medicine known as a thiazolidinedione or glitazone. It helps to control blood sugar levels by increasing the sensitivity of liver, fat and muscle cells to insulin. This enables these cells to remove sugar from the blood more effectively. Rosiglitazone also preserves the functioning of the cells in the pancreas (beta cells) that produce insulin.
Metformin hydrochloride is a type of antidiabetic medicine known as a biguanide. It works in a number of ways to decrease the amount of sugar in the blood. Firstly, it reduces the amount of sugar produced by cells in the liver. Secondly, it increases the sensitivity of muscle cells to insulin. This enables these cells to remove sugar from the blood more effectively. Finally, it also delays absorption of sugar from the intestines into the bloodstream after eating.
This combination of medicines helps people with type 2 diabetes control their blood sugar levels both directly after meals and between meals.
What is it used for?
- Type 2 (non-insulin dependent) diabetes.
It is used for people with type 2 diabetes, particularly overweight people, whose blood sugar is not controlled by the maximum tolerated dose of metformin alone. It may also be used in combination with a sulphonylurea medicine, such as gliclazide, for people whose blood sugar is not controlled on the maximum tolerated dose of metformin plus a sulphonylurea.
- OCTOBER 2010 - SUSPENSION OF LICENCE. Avandamet is being withdrawn in the UK following a recommendation by the European Medicines Agency (EMA) on 23rd September 2010 regarding rosiglitazone-containing medicines. The EMA have been reviewing safety data accumulated since the launch of rosiglitazone and have decided that the benefits of this medicine no longer outweigh its risks. New research has shown that rosiglitazone is associated with an increased risk of heart problems, including heart attacks and heart failure. Unfortunately the new research has not identified any particular groups of patients for whom the benefits of rosiglitazone outweigh the risks and, as a result, its licence has been suspended and it will be taken off the market. If you are taking Avandamet it is important that you make an appointment with your doctor in order for you to be changed onto a different treatment for your diabetes. However, it is important that you don't stop taking your medicine until you have consulted your doctor about alternative treatment.
- You should have a blood test to monitor your liver function before starting treatment with this medicine. Your doctor may then want to monitor your liver function during treatment. Consult your doctor if you develop any of the following symptoms while taking this medicine, as they may be signs of liver problems: unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the eyes or skin (jaundice).
- People taking this medicine should also have regular blood tests to monitor their kidney function.
- This medicine can cause weight gain. You should stick to a calorie controlled diet and monitor your weight closely. Consult your doctor if your weight increases.
- Rosiglitazone may rarely cause fluid retention that may cause heart failure. For this reason you should consult your doctor immediately if you experience shortness of breath, swollen ankles, or rapid and excessive weight gain (which may be due to fluid retention) while taking this medicine.
- This medicine may cause women who have stopped ovulating, for example due to polycystic ovary syndrome, to start ovulating again. These women will therefore need to use contraception to prevent pregnancy. If you get pregnant or wish to become pregnant you should tell your doctor, as you will need to stop taking this medicine.
- If you notice any problems with your eyesight while taking this medicine, in particular any new or worsening problems with blurred vision or seeing fine detail, you should let your doctor know. He may want you to have an eye test.
- Consult your doctor if your experience the following symptoms while taking this medicine, as they may be indicative of a rare but serious side effect of metformin, called lactic acidosis: nausea, vomiting, abdominal pain, general feeling of illness, loss of appetite, weight loss, rapid and/or weak breathing, weakness.
- You should avoid drinking alcohol while you are taking this medicine, as it can increase the risk of low blood sugar (hypoglycaemia) and lactic acidosis.
- Consult your doctor about your diabetes treatment if you are due to have surgery under a general anaesthetic. In these situations blood sugar is normally controlled by insulin, so your doctor may ask you to stop taking this medicine 48 hours before surgery.
- Your doctor will ask you to stop taking this medicine temporarily if you are going to have a certain type of X-ray involving an injection of iodinated dye. Tell your doctor that you are taking this medicine if you are due to have this type of X-ray. You should not start taking this medicine again until 48 hours after the X-ray, and only after your kidney function has been tested and found to be normal.
Use with caution in
- Elderly people.
- People with low levels of haemoglobin in their blood.
- Swelling of the back of the eye (macular oedema).
Not to be used in
- Decreased kidney function.
- Kidney failure.
- Decreased liver function.
- Alcohol intoxication.
- Heart failure or a history of this.
- Acute coronary syndromes, eg unstable angina or heart attack.
- People who have recently had a heart attack.
- Reduced blood flow to vital internal organs (shock).
- Severe breathing difficulties.
- Severe infections.
- Diabetic keto-acidosis.
- Diabetic pre-coma (due to ketoacidosis in severe and inadequately treated diabetes).
- Rare hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption (Avandamet tablets contain lactose).
- This medicine is not recommended for children and adolescents under 18 years of age, as there is no information regarding its safety and efficacy in this age group.
- This medicine is not recommended for people with heart disease caused by inadequate blood flow to the heart (ischaemic heart disease, eg angina), or narrowing of the arteries in the extremities (peripheral arterial disease).
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
- This medicine should not be used during pregnancy because its safety has not been established. Diabetes is usually controlled using insulin during pregnancy, because this provides a more stable control of blood sugar. If you get pregnant while taking this medicine, or are planning a pregnancy, you should seek medical advice from your doctor.
- There is no information available about the safety of this medicine during breastfeeding. For this reason, the manufacturer states that it should not be used by women who are breastfeeding. Seek medical advice from your doctor.
- Take this medication with or after food.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
- Low blood glucose level (hypoglycaemia).
- Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
- Metallic taste.
- Excessive fluid retention in the body tissues, resulting in swelling (oedema).
- Increase in the level of fats such as cholesterol in the blood.
- Low red blood cell count (anaemia).
- Weight gain.
- Changes in appetite.
- Muscle pain.
- Heart failure.
- Liver disorders.
- Fluid in the lungs (pulmonary oedema).
- Swelling of the back of the eye (macular oedema).
- Skin reactions such as rash or itching.
- Decrease in the body's absorption of vitamin B12.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
You should tell your doctor or pharmacist what medicines you are using before you start treatment with this medicine. This includes those bought without a prescription and herbal medicines. Likewise, check with your doctor or pharmacist before starting any new medicines while you are taking this one, so they can check that the combination is safe.
There may be an increased risk of heart failure if this medicine is used in combination with insulin. If you are taking this medicine in combination with insulin it is important to let your doctor know if you experience any shortness of breath, weight gain or swelling, particularly of the ankles.
There may be an increased risk of fluid retention (oedema) if non-steroidal anti-inflammatory drugs (NSAIDs) such as diclofenac or ibuprofen are taken with this medicine.
If this medicine is used in triple therapy, in combination with a sulphonylurea such as gliclazide, the chance of your blood sugar dropping too low (hypoglycaemia) may be increased. Your doctor may need to alter your dose of sulphonylurea to avoid this.
When this medicine is used as triple therapy, in combination with a sulphonylurea, there may also be an increased risk of fluid retention and heart failure. You can ask your doctor for more information about this. It may be more suitable to use insulin instead of triple therapy and your doctor should discuss this option with you.
Gemfibrozil may increase your blood level of rosiglitazone. If you are taking gemfibrozil in combination with this medicine your doctor may therefore need to lower your rosiglitazone dose, depending on your blood sugar levels.
The following medicines may decrease the blood level of rosiglitazone and make it less effective at lowering blood sugar:
- the herbal remedy St John's wort.
If you are taking any of these with this medicine your blood sugar should be monitored to make sure the rosiglitazone is still effective.
Cimetidine may increase the blood level of metformin. Your doctor may need to reduce your metformin dose if you take cimetidine with this medicine.
The following medicines can raise blood sugar levels and may therefore oppose the effect of this medicine:-
- beta-2-agonists, such as salbutamol
- corticosteroids, such as prednisolone
- diuretics, such as bendroflumethiazide
Your blood sugar should be monitored more frequently if you start or stop treatment with any of these while taking this medicine, and if necessary your doctor may alter your dose of this medicine.
Low blood sugar levels (hypoglycaemia) may occur, sometimes unpredictably, if ACE inhibitors such as captopril are taken with this medicine.
Your doctor will ask you to stop taking this medicine temporarily if you are going to have a certain type of X-ray involving an injection of iodinated dye. Tell your doctor that you are taking this medicine if you are due to have this type of X-ray. You should not start taking this medicine again until 48 hours after the X-ray, and only after your kidney function has been tested and found to be normal.
Other medicines containing the same active ingredients
There are currently no other medicines available in the UK that contain both rosiglitazone and metformin.
Avandia contains rosiglitazone alone.
Glucophage contains metformin alone.