Active ingredient
- metformin hydrochloride
- pioglitazone hydrochloride
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/06/354/001, EU/1/06/354/002, EU/1/06/354/003, EU/1/06/354/004, EU/1/06/354/005, EU/1/06/354/006, EU/1/06/354/007, EU/1/06/354/008, EU/1/06/354/009, EU/1/06/354/010, EU/1/06/354/011, EU/1/06/354/012.
Competact 15 mg/850 mg film-coated Tablets
Package leaflet: Information for the patient
Competact 15 mg/850 mg film-coated tablets
pioglitazone/metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Competact is and what it is used for
2. What you need to know before you take Competact
3. How to take Competact
4. Possible side effects
5 How to store Competact
6. Contents of the pack and other information
1. What Competact is and what it is used for
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.
2. What you need to know before you take Competact
Do not take Competact:
Warnings and precautions
Talk to your doctor or pharmacist before taking Competact (see also section 4).
You may also experience a reduction in blood count (anaemia).
Risk of lactic acidosis
Competact may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
If any of the above apply to you, talk to your doctor for further instructions.
Stop taking Competact for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.
Stop taking Competact and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Symptoms of lactic acidosis include:
Lactic acidosis is a medical emergency and must be treated in a hospital.
During treatment with Competact, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
If you need to have major surgery you must stop taking Competact during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Competact.
Hypoglycaemia
If you take Competact with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia). If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, fast heart-beating, vision disorders or difficulty in concentration, you should take some sugar to increase your blood sugar level again. Ask your doctor or pharmacist for more information if you are not sure how to recognise this. It is recommended that you carry some sugar lumps, sweets, biscuits or sugary fruit juice
Broken bones
A higher number of bone fractures was seen in patients, particularly women taking pioglitazone. Your doctor will take this into account when treating your diabetes.
Children and adolescents
Use in children and adolescents under 18 years is not recommended.
Other medicines and Competact
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Competact before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Competact.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dose of Competact. It is especially important to mention the following:
Competact with alcohol
Avoid excessive alcohol intake while taking Competact since this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).
Pregnancy and breast-feeding
Driving and using machines
This medicine will not affect your ability to drive or use machines but take care if you experience abnormal vision.
3. How to take Competact
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet taken twice daily. If necessary your doctor may tell you to take a different dose. If you have reduced kidney function, your doctor may prescribe a lower dose, which may need to be given as separate tablets of pioglitazone and metformin.
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 special diet for diabetes, 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 take more Competact than you should
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.
If you have taken more Competact that you should have, you may experience lactic acidosis (see section “Risk of lactic acidosis”).
If you forget to take Competact
Take Competact daily as prescribed. However if you miss a dose, skip the missed dose and just carry on with the next dose as normal. Do not take a double dose to make up for a forgotten tablet.
If you stop taking Competact
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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Competact may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Risk of lactic acidosis”). If this happens you must stop taking Competact and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Bladder cancer has been experienced uncommonly (may affect up to 1 in 100 people) 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.
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Competact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Competact. 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 (macular oedema) has been reported (frequency cannot be estimated from available data). 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.
Allergic reactions have been reported with frequency not known (cannot be estimated from available data) in patients taking Competact. If you have a serious allergic reaction, including hives and swelling of the face, lips, tongue, or throat that may cause difficulty in breathing or swallowing, stop taking this medicine and talk to your doctor immediately.
The following side effects have been experienced by some patients taking Competact:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Very rare (may affect up to 1 in 10,000)
Not known (frequency can not be estimated from the available data)
Reporting of side effects
If you get any side effects talk to your doctor. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Competact
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Competact contains
What Competact looks like and contents of the pack
The film-coated tablets (tablets) are white to off white, oblong, convex, embossed ‘15 / 850’ on one face and ‘4833M’ on the other. They are supplied in aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multipacks of 196 (2 packs of 98) tablets or in aluminium/aluminium perforated unit dose blisters in packs of 60 x 1 tablets.
Not all 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 revised in 09/2018.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
1 Kingdom Street, London, W2 6BD, UK
+44 3333 000 181
+44 (0)3333 000 181