Actos (pioglitazone)

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How does it work?

Actos tablets contain the active ingredient pioglitazone hydrochloride, which is a type of medicine called a thiazolidinedione or glitazone. It is used to help control blood sugar levels in people with type 2 diabetes.

People with diabetes 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.

Pioglitazone helps to lower blood glucose levels by increasing the sensitivity of liver, fat and muscle cells, to insulin. This enables the cells to remove glucose from the blood more effectively. Pioglitazone also reduces the amount of glucose produced by the liver, and 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.

Pioglitazone can be used on its own 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 inadequately controlled by diet.)

Pioglitazone can also be used in combination with metformin or another type of antidiabetic medicine known as a sulphonylurea, eg gliclazide, or both, for people with type 2 diabetes whose blood sugar is not controlled by the maximum doses of these medicines.

It can also be used in combination with insulin for type 2 diabetics whose blood sugar is not sufficiently controlled by insulin and who cannot take metformin.

Warning!

- This medicine can cause weight gain. You should stick to a calorie controlled diet and monitor your weight closely. Consult your doctor if you put on weight.
- 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. You may need to have an eye test.
- Your liver function should be monitored regularly while you are taking this medicine. Consult your doctor if you develop any of the following symptoms, 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 due to polycystic ovary syndrome to start ovulating again. If you have PCOS you may therefore need to use contraception to prevent pregnancy. If you get pregnant or want to try for a baby you should tell your doctor, as you will need to stop taking this medicine.

Use with caution in

- People over 75 years of age
- Heart disease
- 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
- Diabetic ketoacidosis
- Decreased liver function
- People having kidney dialysis
- Pregnancy
- Breastfeeding
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Actos 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 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 as its safety has not been established in pregnant women. You should therefore use contraception to avoid getting pregnant while you are taking this medicine. Control of diabetes mellitus in pregnancy is usually achieved using insulin, 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.
- It is not known if this medicine passes into breast milk. 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.

- Visual disturbances
- Weight gain
- Decreased sense of touch
- Upper airway infections
- Low red blood cell count (anaemia)
- Pain in the joints (arthralgia)
- Headache
- Excessive fluid retention in the body tissues, resulting in swelling (oedema)
- Blood in the urine (haematuria)
- Impotence (erectile dysfunction)
- Dizziness
- Excess gas in the stomach and intestines (flatulence)
- Difficulty in sleeping (insomnia)
- Low blood glucose level (hypoglycaemia), particularly if taken in combination with a sulphonylurea medicine, eg gliclazide, or insulin
- Presence of glucose in the urine (glycosuria)
- Presence of protein in the urine
- Sweating

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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