Competact 15 mg/850 mg film-coated tablets

Competact tablets are an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus. This is the diabetes that usually develops in adulthood.

Competact tablets help 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.

Do not take Competact:

• If you are allergic (hypersensitive) to pioglitazone, metformin or any of the other ingredients of Competact tablets.
• If you have heart failure.
• If you recently had a heart attack, have severe circulatory problems including shock, or breathing difficulties.
• If you have liver disease.
• If you drink alcohol excessively (either every day or only from time to time).
• If you have diabetic ketoacidosis (complication of diabetes with rapid weight loss, nausea or vomiting).
• If you have a problem with your kidneys.
• If you have a severe infection or are dehydrated.
• If you are going to have a certain type of X-ray with an injectable dye. You will need to stop taking Competact tablets at the time of and for a few days after the procedure.
• If you are breast-feeding.

Take special care with Competact:

Tell your doctor before you start to take this medicine:

• If you have a special type of diabetic eye disease called macular oedema (swelling of the back of the eye).
• If you are planning to become pregnant.
• If you are going to have an operation under general anaesthetic, as you may need to stop taking Competact for a couple of days before and after the procedure.
• If you have polycystic ovary syndrome. There may be an increased possibility of your becoming pregnant because of how your medicine works.
• If you are under 18 years of age because use in such patients is not recommended.
• If you already take any other tablets to treat diabetes.

Taking other medicines:

Please let your doctor know if you already take cimetidine, glucocorticoids, beta-2-agonists, diuretics or ACE inhibitors. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Tell your doctor if you are, you think you might be or are planning to become pregnant. Your doctor will advise you to discontinue this medicine. You should not use Competact if you are breast-feeding or are planning to breast-feed your baby.

Driving and using machines:

This medicine will not affect your ability to drive or operate machinery.

Always take Competact tablets 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 take the 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 tablets.

Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).

In clinical trials in which pioglitazone was compared to other oral anti diabetic drugs or placebo (dummy pill), 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.

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 tablets 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.

If you forget to take Competact:

Try to take Competact tablets 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.

If you stop taking Competact:

Do not stop taking Competact tablets without first discussing it with your doctor.
If you have any further questions on the use of Competact tablets ask your doctor or pharmacist.

Like all medicines, Competact can have side effects.

Some patients experience the following side effects whilst taking pioglitazone and/or metformin (the two active substances of Competact).

Very rarely patients taking metformin 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 some of these symptoms stop taking Competact and consult a doctor immediately.

Blurred vision due to swelling (or fluid) at the back of the eye has been reported. If you experience these symptoms for the first time or if they get worse talk to your doctor as soon as possible.

Between 1 in 10 and 1 in 100 patients experience

• localised swelling (oedema)
• weight gain
• headache
• respiratory infection
• abnormal vision
• joint pain
• impotence
• blood in urine
• anaemia

Between 1 in 100 and 1 in 1000 patients experience

• sinusitis
• flatulence
• insomnia

Between 1 in 1000 and 1 in 10000 patients experience

• impaired liver function

Less than 1 in 10,000 patients experience

• a condition called lactic acidosis (excess of lactic acid in your blood) due to metformin, particularly those whose kidneys are not working properly
• blurred vision due to swelling (or fluid) in the back of the eye.

Keep out of the reach and sight of children.

Do not use Competact after the expiry date which is stated on the carton and blister.

This medicinal product 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.

What Competact Tablets contain

The active substances are 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.

The other ingredients are, microcrystalline cellulose, povidone (K 30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide.

What Competact Tablets look like and contents of the pack

Competact tablets are white to off white, oblong, convex, film-coated tablets embossed ?15 / 850? on one face and ?4833M? on the other. The tablets are supplied in blister packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180 or 196 (2 x 98) tablets.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder: Takeda Global Research and Development Centre (Europe) Ltd, 61 Aldwych, London WC2B 4AE, United Kingdom.

Manufacturer: Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland. Takeda Italia Farmaceutici SpA, Via Crosa, 86, I-28065 Cerano (NO), Italy.
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien Takeda Global R D Centre Europe, Royaume-Uni TélTel 44 020 3116 8953 LuxembourgLuxemburg Takeda Global R D Centre Europe, Royaume-Uni TélTel 44 020 3116 8954

Magyarország Lilly Hungária Kft. Tel 36 1 328 5100 Takeda Global R D Centre Europe, Te. 44 020 3116 8000

eská republika ELI LILLY R, s.r.o. Tel 420 234 664 111 Malta Takeda Italia Farmaceutici SpA Tel 39 06 5026 01

Nederland Eli Lilly Nederland B.V. Tel 31 0 30 60 25 800 Danmark Takeda Global R D Centre Europe, Storbritannien Tlf 44 020 3116 8952

Deutschland Takeda Pharma GmbH Tel 49 0 241 941-0 Norge Takeda Global R D Centre Europe, Storbritannia

Tlf: + 44 (0)20 3116 8950

Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 3726441100 Österreich Takeda Pharma Ges.m.b.H. Tel 43 1 524 40 64

- .... 30 210 629 4600 Polska Takeda Global R D Centre Europe, Wielka Brytania Tel. 44 020 3116 8000

España Lilly S.A. Tel 34 91 663 50 00 Portugal Lilly Portugal - Produtos Farmacêuticos, Lda Tel 351 21 412 6600

France Laboratoires Takeda Tél 33 01 46 25 16 16 România Eli Lilly România S.R.L. Tel 40 21 4023000

Ireland Takeda UK Ltd Tel 44 01628 537 900 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10

Ísland Icepharma hf. Sími 354 540 8000 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111

Italia Takeda Italia Farmaceutici SpA Tel 39 06 5026 01 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358 09 8545250

Takeda Global R D Centre Europe, 44 020 3116 8000 Sverige Takeda Global R D Centre Europe, Storbritannien Tel 44 020 3116 8951

Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 7364000 United Kingdom Takeda UK Ltd Tel 44 01628 537 900

Lietuva
Eli Lilly Holdings Limited atstovyb-
Tel. +370 (5) 2649600

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