This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Actos 15 mg, 30 mg or 45 mg tablets
Pioglitazone
1. What Actos is and what it is used for 2. Before you take Actos 3. How to take Actos 4. Possible side effects 5. How to store Actos 6. Further information
Actos contains pioglitazone. It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus, when metformin is not suitable or has failed to work adequately. This is the diabetes that usually develops in adulthood.
Actos helps control the level of sugar in your blood when you have type 2 diabetes by helping your body make better use of the insulin it produces. Your doctor will check whether Actos is working 3 to 6 months after you start taking it.
Actos may be used on its own in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to other therapies (such as metformin, sulphonylurea or insulin) which have failed to provide sufficient control in blood sugar.
Tell your doctor before you start to take this medicine
If you take Actos with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
You may also experience a reduction in blood count (anaemia).
Broken bones
A higher number of bone fractures was seen in women (but not in men) taking pioglitazone. Your doctor will take this into account when treating your diabetes.
Use in children under 18 years is not recommended.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
You can usually continue to take other medicines whilst you are being treated with Actos. However, certain medicines are especially likely to affect the amount of sugar in your blood:
Tell your doctor or pharmacist if you are taking any of these. Your blood sugar will be checked, and your dose of Actos may need to be changed.
You may take your tablets with or without food. You should swallow the tablets with a glass of water.
Tell your doctor if
Your doctor will advise you to discontinue this medicine.
Pioglitazone will not affect your ability to drive or use machines but take care if you experience abnormal vision.
This medicine contains lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Actos.
One tablet of 15 mg, 30 mg or 45 mg of pioglitazone should be taken once daily. If necessary your doctor may tell you to take a different dose.
If you have the impression that the effect of Actos is too weak, talk to your doctor.
When Actos is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Your doctor will ask you to have blood tests periodically during treatment with Actos. This is to check that your liver is working normally.
If you are following a diabetic diet, you should continue with this while you are taking Actos.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately. Your blood sugar could fall below the normal level and can be increased by taking sugar. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice.
Take Actos daily as prescribed. However if you miss a dose, just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten tablet.
Actos should be used every day to work properly. If you stop using Actos, your blood sugar may go up. Talk to your doctor before stopping this treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Actos can cause side effects, although not everybody gets them.
In particular, patients have experienced the following serious side effects:
Heart failure has been experienced commonly (1 to 10 users in 100) in patients taking Actos in combination with insulin. Symptoms are unusual shortness of breath or rapid increase in weight or localised swelling (oedema). If you experience any of these, especially if you are over the age of 65, seek medical advice straight away.
Bladder cancer has been experienced uncommonly (1 to 10 users in 1000) in patients taking Actos. Signs and symptoms include blood in your urine, pain when urinating or a sudden need to urinate. If you experience any of these, talk to your doctor as soon as possible.
Localised swelling (oedema) has also been experienced very commonly in patients taking Actos in combination with insulin. If you experience this side effect, talk to your doctor as soon as possible.
Broken bones have been reported commonly (1 to 10 users in 100) in women patients taking Actos. If you experience this side effect, talk to your doctor as soon as possible.
Blurred vision due to swelling (or fluid) at the back of the eye (frequency not known) has also been reported in patients taking Actos. If you experience this symptom for the first time, talk to your doctor as soon as possible. Also, if you already have blurred vision and the symptom gets worse, talk to your doctor as soon as possible.
The other side effects that have been experienced by some patients taking Actos are:
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
not known (frequency cannot be estimated from the available data)
The other side effects that have been experienced by some patients when Actos is taken with other antidiabetic medicines are:
very common (affects more than 1 user in 10)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Actos after the expiry date which is stated on the carton and the blister pack after the word “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Actos15 mg tablets are white to off white, round, convex tablets marked ‘15’, on one face and ‘ACTOS’ on the other face.
Actos 30 mg tablets are white to off white, round, flat tablets marked ‘30’ on one face and ‘ACTOS’ on the other face.
Actos 45 mg tablets are white to off white, round, flat tablets marked ‘45’ on one face and ‘ACTOS’ on the other face
The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets. Not all the pack sizes may be marketed.
Marketing authorisation holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last approved in
December 2011
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Link to this document from your website:http://www.medicines.ie/medicine/11864/XPIL/Actos/