Competact (Com-pet-act) is a medicine which is used in diabetes mellitus. Competact contains metformin hydrochloride/pioglitazone hydrochloride. It is supplied by Takeda UK Ltd.

To get the most benefit from your medicine, take it exactly as prescribed. You should also take care to look after your medicine.

Diabetes leads to problems controlling blood sugar levels. Competact contains two medicines– metformin hydrochloride and pioglitazone hydrochloride. Both medicines work in different ways to help keep blood sugar levels under control.

It is very important that your blood sugar level is well controlled. Blood sugar levels which are too high or too low can be dangerous. Your prescriber or a member of your diabetes team will be able to give you information on how to recognise the warning signs of high and low blood sugar levels. They will also be able to tell you what to do if either of these occurs.

Warning signs can vary from person to person. If the usual warning signs of poorly controlled blood sugar levels change or disappear, you should contact your prescriber or a member of your diabetes team.

Your prescriber or your diabetes team may also advise you to measure your blood sugar regularly – they will show you how to do this. If you are having problems controlling or measuring your blood sugar, you should contact your prescriber or a member of your diabetes team.

Other information about Competact:

Do not share your medicine with other people. It may not be suitable for them and may harm them.

The pharmacy label on your medicine tells you how much medicine you should take. It also tells you how often you should take your medicine. This is the dose that you and your prescriber have agreed you should take. You should not change the dose of your medicine unless you are told to do so by your prescriber.

If you feel that the medicine is making you unwell or you do not think it is working, then talk to your prescriber.

Some medicines work best if they are taken at a specific time of day. Getting the most from your medicine can also be affected by what you eat, when you eat and the times at which you take other medicines. Make sure you follow any specific instructions given to you by your prescriber or that are in the Patient Information Leaflet that comes with this medicine.

Some medicines have specific instructions about how to take them. This is because they work better when taken correctly. These instructions can include getting the right dose and special instructions for preparing the medicine.

In the case of Competact:

If you are having problems taking this form of Competact, you should talk to your prescriber or pharmacist. They may be able to give you advice on other ways to take your medicine or other preparations that are easier for you to take.

Taking extra doses of some medicines can be harmful. In some cases even one extra dose can cause you problems. If you take extra doses of your medicine, you must get medical advice immediately. You may need a test to assess the effect of taking extra doses. This is because the effects of taking too much medicine are very complex so it is very important that you seek medical advice.

Contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47 for advice.

Make sure you take all of your medicine containers with you if you are advised to go to hospital.

Suddenly stopping your medicine may cause your original condition to return. This is why you must speak to your prescriber if you are having any problems taking your medicine.

If you are not having any problems taking this medicine then do not stop taking it, even if you feel better, unless advised to do so by your prescriber.

If you are in any doubt, contact your prescriber, pharmacist, specialist clinic or NHS Direct on 0845 46 47.

The instructions on how you should keep your medicine are on the pharmacy label. It is a good idea to keep your medicine in the original container. This will help to keep your medicine in the best condition and also allow you to check the instructions. Do not take the medicine if the packaging appears to have been tampered with or if the medicine shows any signs of damage. Make sure that the medicine is out of the sight and reach of children.

In the case of Competact:

You must not take the medicine after the expiry date shown on the packaging. If you have any unused medicine, return it to your pharmacist who will dispose of it safely.

Your prescriber will not give you this medicine if they know of any reasons why you must not take it. Sometimes it is necessary to prescribe this medicine with extra caution. For more information see the ‘Whether this medicine is suitable for you’ section.

If you have been prescribed this medicine you need to be aware of the side-effects that you could develop while taking this medicine. For more information see the 'Side-effects' section.

Competact is not suitable for everyone and some people should never use it. Other people should only use it with special care. It is important that the person prescribing this medicine knows your full medical history.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

Furthermore, the prescriber may only prescribe this medicine with special care or may not prescribe it at all for someone who is under 18 years of age or at risk of going into a coma.

As part of the process of assessing suitability to take this medicine a prescriber may also arrange tests:

Over time it is possible that Competact can become unsuitable for some people, or they may become unsuitable for it. If at any time it appears that Competact has become unsuitable, it is important that the prescriber is contacted immediately.

A medicine is only made available to the public if the clinical trials have shown that the benefits of taking the medicine outweigh the risks.

Once a medicine has been licensed, information on the medicine's effects, both intended and unintended, is continuously recorded and updated.

Some side-effects may be serious while others may only be a mild inconvenience. Very occasionally, certain side-effects can be beneficial.

Everyone's reaction to a medicine is different. It is difficult to predict which side-effects you will have from taking a particular medicine, or whether you will have any side-effects at all. The important thing is to tell your prescriber or pharmacist if you are having problems with your medicine.

Competact contains two medicines– metformin hydrochloride and pioglitazone hydrochloride. For a full list of side-effects of the individual medicines, please see the Summary of Product Characteristics for metformin hydrochloride and pioglitazone hydrochloride.

Very common: More than 1 in 10 people who take Competact

• gastrointestinal problems such as nausea, vomiting, diarrhoea, stomach pain or loss of appetite - these gastrointestinal problems may be reduced by taking Competact with or after a meal

Common: More than 1 in 100 people who take Competact

• blood in the urine
• blood problems
• erectile dysfunction
• eye or eyesight problems - seek medical advice if you develop eye or eyesight problems
• headaches
• hypoaesthesia
• joint pain
• oedema
• taste changes
• upper respiratory tract infection
• weight gain - seek medical advice if you gain any weight

Uncommon: More than 1 in 1000 people who take Competact

• difficulty sleeping
• flatulence
• sinusitis

Very rare: Fewer than 1 in 10,000 people who take Competact

• itching
• lactic acidosis which may lead to a coma - seek immediate medical advice if you get any breathing difficulties, stomach pain or hypothermia
• redness of the skin
• urticaria
• vitamin B12 levels reduced when Competact is taken for a long time

Isolated reports

• liver problems - some of these liver problems may be fatal. Seek medical advice if you have nausea, vomiting, stomach pain, tiredness, loss of appetite, jaundice or if your urine is dark in colour

The frequency of these side-effects is unknown

• abnormal laboratory test results
• bone fractures
• decreased blood sugar levels
• fluid retention which may lead to worsening or precipitation of certain heart problems
• increased fertility in people who have polycystic ovary syndrome as a result of their diabetes

If you feel unwell or if you have concerns about a side-effect, you will need to seek advice. If you feel very ill, get medical help straight away. Contact your prescriber, pharmacist, nurse or call NHS Direct on 0845 46 47.

If you have been prescribed this medicine you and your prescriber may need to think about whether you need to change any of your everyday activities. You must also discuss with your prescriber any other medicines and any complementary preparations you are taking.

If you are taking more than one medicine they may interact with each other. At times your prescriber may decide to use medicines that interact, in other cases this may not be appropriate.

The decision to use medicines that interact depends on your specific circumstances. Your prescriber may decide to use medicines that interact, if it is believed that the benefits of taking the medicines together outweigh the risks. In such cases, it may be necessary to alter your dose or monitor you more closely.

Tell your prescriber the names of all the medicines that you are taking so that they can consider all possible interactions. This includes all the medicines which have been prescribed by your GP, hospital doctor, dentist, nurse, health visitor, midwife or pharmacist. You must also tell your prescriber about medicines which you have bought over the counter without prescriptions.

The following medicines may interact with Competact:

The following types of medicine may interact with Competact:

If you are taking Competact and one of the above medicines or types of medicines, make sure your prescriber knows about it.

Medicines can interact with complementary preparations and vitamins. In general, there is not much information available about interactions between medicines and complementary preparations or vitamins.

If you are planning to take or are already taking any complementary preparations and vitamins you should ask your prescriber whether there are any known interactions with Competact.

Your prescriber can advise whether it is appropriate for you to take combinations that are known to interact. They can also discuss with you the possible effect that the complementary preparations and vitamins may have on your condition.

If you experience any unusual effects while taking this medicine in combination with complementary preparations and vitamins, you should tell your prescriber.

When taking any medicine you should be aware that it might interfere with your ability to drive or operate machinery safely.

Like all medicines Competact can cause side effects. You should see how this medicine affects you and then judge if you are safe to drive or operate machinery. If you are in any doubt, talk to your prescriber.

Medicines can interact with certain foods. In some cases, this may be harmful and your prescriber may advise you to avoid certain foods.

In the case of Competact:

For more advice speak to your prescriber, nutritionist or pharmacist.

Alcohol can interact with certain medicines.

In the case of Competact:

It is best to avoid drinking alcohol while you are taking this medicine.

Taking this medicine could have an impact on your decisions relating to family planning, pregnancy and breast-feeding.

Most medicines, in some way, can affect the development of a baby in the womb. The effect on the baby differs between medicines and also depends on the stage of pregnancy that you have reached when you take the medicine.

In the case of Competact:

People with diabetes may start to have insulin instead of Competact to control their blood sugar during pregnancy. If you are taking Competact and are planning to become pregnant, become pregnant or think that you are pregnant, talk to a member of your diabetes team. For more information on managing your diet and your diabetes during your pregnancy, talk to your prescriber or a member of your diabetes or antenatal team.

Certain medicines can pass into breast milk and may reach your baby through breast-feeding.

In the case of Competact:

Before you have your baby you should discuss breast-feeding with your doctor or midwife. If you wish to breast-feed you should discuss with your prescriber whether there are any other medicines you could take which would also allow you to breast-feed. You should not stop this medicine without taking advice from your doctor.

Medicines contain active ingredients. They may also contain other, additional ingredients that help ensure the stability, safety and effectiveness of the medicine. They are also added to improve the medicine's taste and appearance and to make it easier to take. Some may be used to prolong the life of the medicine.

You should check that you are able to take the ingredients in your medicine, especially if you have any allergies.

Competact contains:

If you are not able to take any of the ingredients in your medicine, talk to your prescriber or pharmacist to see if they can suggest an alternative medicine. If you have reacted badly to Competact before, do not take Competact. Talk to your prescriber, pharmacist or nurse as soon as possible.