Avandia

How does it work?

Avandia tablets contain the active ingredient rosiglitazone maleate, which is an antidiabetic medicine used to treat 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 is a type of antidiabetic medicine known as a thiazolidinedione or glitazone. It helps to lower 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.

The overall effect of this medicine is therefore to help the body control blood sugar levels and prevent them becoming too high.

What is it used for?

Type 2 (non-insulin dependent) diabetes

Rosiglitazone is used to treat people with type 2 diabetes, particularly overweight people, whose blood sugar is not sufficiently controlled by diet and exercise alone, and who cannot take metformin. (Metformin is the standard first-line medicine for overweight people with type 2 diabetes whose blood sugar is not controlled by diet alone.)

Rosiglitazone can also used for people with type 2 diabetes whose blood sugar is not controlled by the maximum doses of either metformin, or another type of antidiabetic medicine known as a sulphonylurea, for example gliclazide. In these cases rosiglitazone is added to treatment with the oral antidiabetic already being taken.

Rosiglitazone can be used as dual therapy in combination with metformin (particularly in overweight people), as dual therapy in combination with a sulphonylurea (only in people who cannot take metformin), or as triple therapy in combination with metformin AND a sulphonylurea.

Warning!

You should have a blood test to check your liver function before starting treatment with this medicine and your liver function should be monitored regularly 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 skin or whites of the eyes (jaundice).

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.

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.

This medicine 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.

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.

Use with caution in

Decreased kidney function

People with low haemoglobin levels in their blood

Swelling of the back of the eye (macular oedema).

Not to be used in

Heart failure or people with a history of this

Decreased liver function

People receiving insulin treatment

Pregnancy

Breastfeeding

Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Avandia tablets contain lactose).

This medicine is not recommended for children and adolescents under 18 years of age.

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.

Side effects

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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Low blood glucose level (hypoglycaemia)

Excessive fluid retention in the body tissues, resulting in swelling (oedema)

Constipation

Low red blood cell count (anaemia)

Increase in the level of fats, eg cholesterol, in the blood (hyperlipidaemia)

Headache

Weight gain

Increased appetite

Fatigue

Dizziness

Pain in the muscles

Pins and needles (paraesthesia)

Difficulty in breathing (dyspnoea)

Heart failure

Decrease in the number of platelets in the blood (thrombocytopenia)

Abnormal liver function

Fluid in the lungs (pulmonary oedema)

Swelling of the back of the eye (macular oedema)

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.

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