This is an X-PIL, which is a text only patient information leaflet, designed for people with sight problems.
Table of Contents
Competact 15 mg/850 mg film-coated tablets
Pioglitazone/Metformin hydrochloride
1. What Competact is and what it is used for 2. Before you take Competact 3. How to take Competact 4. Possible side effects 5 How to store Competact 6. Further information
Competact contains pioglitazone and metformin. It is an anti-diabetic medicine used in adults to treat type 2 (non-insulin dependent) diabetes mellitus when treatment with metformin alone is not sufficient. This type 2 diabetes usually develops in adulthood particularly as a result of the person being overweight and where the body either does not produce enough insulin (a hormone that controls blood sugar levels), or cannot effectively use the insulin it produces. Your doctor will check whether Competact is working 3 to 6 months after you start taking it.
Competact 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.
Tell your doctor before you start to take this medicine
If you take Competact 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.
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 Competact may need to be changed.
You may take your tablets with or just after food to reduce the chance of an upset stomach.
Avoid alcohol or medicines containing alcohol while taking Competact since alcohol may increase the risk of lactic acidosis (please see section “Possible side effects”).
This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.
Always take Competact exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet taken twice daily. If necessary your doctor may tell you to take a different dose. You should swallow the tablets with a glass of water. You may take your tablets with or just after food to reduce the chance of an upset stomach.
If you are following a diabetic diet, you should continue with this while you are taking Competact.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.
Your doctor will ask you to have blood tests periodically during treatment with Competact. This is to check that your liver is working normally. At least once a year (more often if you are elderly or have kidney problems) your doctor will check that your kidneys are working normally.
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 Competact 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.
Competact should be used every day to work properly. If you stop using Competact, 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, Competact can cause side effects, although not everybody gets them.
Very rarely patients taking metformin (one of the active substances of Competact) have experienced a condition called lactic acidosis (excess of lactic acid in your blood), particularly those whose kidneys are not working properly. Symptoms include feeling cold and uncomfortable, severe nausea and vomiting, abdominal pain, unexplained weight loss, or rapid breathing. If you experience any of these symptoms, stop taking Competact and consult a doctor immediately.
Bladder cancer has been experienced uncommonly (1 to 10 users in 1000) in patients taking Competact. 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.
Blurred vision due to swelling (or fluid) at the back of the eye has been reported (frequency not known). If you experience these symptoms for the first time talk to your doctor as soon as possible. Also, if you already have blurred vision and the symptoms get worse, talk to your doctor as soon as possible.
The following side effects have been experienced by some patients taking Competact
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency can not be estimated from the available data)
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 Competact after the expiry date which is stated on the carton and the blister pack after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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.
Competact tablets are white to off white, oblong, convex, film-coated tablets (tablets) embossed ‘15 / 850’ on one face and ‘4833M’ on the other. The tablets are supplied in aluminium/aluminium blister packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, 196 (2 x 98) tablets or 60 x 1 tablets in aluminium/aluminium perforated unit dose blisters.
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 website http://www.ema.europa.eu.
Link to this document from your website:http://www.medicines.ie/medicine/12337/XPIL/Competact/