How does it work?

In people with diabetes mellitus, there is 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. Rosiglitazone is an antidiabetic medicine which is used in those people with type 2 or non-insulin dependent diabetes (NIDDM). In this type of diabetes 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. Rosiglitazone helps to lower blood sugar levels by increasing the sensitivity of liver, fat and muscle cells to insulin. This enables the 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. Rosiglitazone is only licensed for people whose blood sugar is not controlled by the maximum doses of either metformin or a sulphonylurea such as gliclazide. Rosiglitazone cannot be taken on its own. It is taken in addition to the oral antidiabetic already being taken. Rosiglitazone must be used in combination with metformin (in obese people) or in combination with a sulphonylurea (in people who cannot take metformin). This, in conjunction with a diet low in sugar and fat, allows people with type 2 diabetes to control their blood sugar levels more effectively.

What is it used for?

Additional treatment of poorly controlled type 2 diabetes

Warning!

Blood tests to monitor liver function are required prior to starting treatment, every 2 months for the first year of treatment and regularly thereafter.

This medicine can cause weight gain. You should stick to a calorie controlled diet and monitor your weight closely.

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.

Consult your doctor if you develop unexplained nausea, vomiting, abdominal pain, fatigue, loss of appetite, darkened urine or yellowing of the eyes or skin (jaundice), as these may be signs of liver problems.

This medicine may cause women who have stopped ovulating to resume ovulating. Adequate contraception should therefore be used to prevent pregnancy. If pregnancy occurs or you wish to become pregnant, inform your doctor, as treatment with this medicine will need to be discontinued.

Use with caution in

Elderly people

Kidney failure

People with low haemoglobin levels

Not to be used in

Breastfeeding

Current or previous heart failure

Decreased liver function

People receiving insulin treatment

Pregnancy

Severely decreased kidney function

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.

The manufacturer states not to use this medicine during pregnancy and breastfeeding as there is insufficient safety information available. 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.

Headache

Rash

Excess gas in the stomach and intestines (flatulence)

Fatigue

Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain

Weight gain

Low blood glucose level (hypoglycaemia)

High blood glucose level (hyperglycaemia)

Indigestion (dyspepsia)

Dizziness

Low red blood cell count (anaemia)

Difficulty in breathing (dyspnoea)

Hair loss (alopecia)

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

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

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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