15 mg / 850 mg film-coated tablets 
pioglitazone / metformin hydrochloride

1. What Competact is and what it is used for

Competact contains pioglitazone and metformin. It is a treatment for diabetes used in adults to treat type 2 (non-insulin-dependent) diabetes mellitus when treatment with metformin is not sufficient. This type 2 diabetes usually develops in adulthood, especially in obese people who cannot produce enough insulin (a hormone that controls blood sugar levels) or cannot use the insulin that is produced. 3 to 6 months after starting treatment, your doctor will check if Competact works for you.

Competact helps keep blood sugar levels under control in type 2 diabetes so that the body can make better use of the insulin that is formed.

2. What you need to know before taking Compatect

Do not take Competact

  • if you are allergic to pioglitazone, metformin, or any of the other ingredients of this medicine (listed in section 6).
  • if you have or have had heart failure in the past.
  • if you have recently had a heart attack, have severe circulatory problems including shock, or difficulty breathing.
  • if you have any liver disease.
  • if you have a high alcohol intake (either every day or only occasionally).
  • if you have uncontrolled diabetes with, for example, severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, rapid weight loss, lactic acidosis (see section “Risk of lactic acidosis”), or ketoacidosis. Ketoacidosis is a condition in which substances called ketone bodies to accumulate in the blood, which can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, or that your breath gets a different, fruity odor.
  • if you have or have ever had bladder cancer.
  • if you have blood in your urine that your doctor has not examined further.
  • if you have severe renal impairment.
  • if you have a serious infection or are dehydrated.
  • if you are going to have a certain type of x-ray with an injectable contrast agent, talk to your doctor as you will have to stop taking Competact for a while before and after the examination.
  • if you are breast-feeding.

Warnings and cautions

Talk to your doctor or pharmacist before taking Competact (see also section 4).

  • if you have heart problems. Some patients who have had type 2 diabetes for many years and heart disease or have had strokes treated with pioglitazone and insulin at the same time have suffered from heart failure. Tell your doctor as soon as possible if you get signs of heart failure such as sudden shortness of breath, rapid weight gain, or local swelling ( edema ).
  • if you are accumulating water ( fluid retention ) or have problems with heart failure, especially if you are over 75 years old. Tell your doctor if you are taking anti-inflammatory medications that may cause you to accumulate fluid and swell.
  • if you have macular edema, a specific diabetic eye disease (swelling in the back of the eye), talk to your doctor if you notice any change in vision.
  • if you have ovarian cysts ( polycystic ovary syndrome ). This can lead to an increased chance of getting pregnant because you may ovulate again when you take Competact. If this affects you, use appropriate contraception to avoid unplanned pregnancy.
  • if you have liver problems. Before you start using Competact, you will be given blood tests to check your liver function. This check may be repeated at intervals. Tell your doctor as soon as possible if you get signs of liver disease (such as unexplained nausea, vomiting, stomach pain, fatigue, loss of appetite, and/or dark urine) as your liver function should be checked.

You may also experience a decrease in the number of blood cells ( anemia ).

Risk of lactic acidosis

Competact can cause the very rare, but very serious side effect of lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased in uncontrolled diabetes, severe infections, long-term fasting or alcohol consumption, dehydration (see more information below), liver problems, and conditions where part of the body has reduced oxygen supply (including acute severe heart disease).

If any of the above apply to you, talk to your doctor for further information.

Stop taking Competact for a short time if you have a condition that may be associated with dehydration, such as severe vomiting, diarrhea, fever, exposure to heat, or if you drink less fluid than normal. Talk to a doctor for further instructions.

Stop taking Competact and contact a doctor or nearest hospital immediately if you experience any of the symptoms of lactic acidosis as the condition may lead to coma.

Symptoms of lactic acidosis include:

  • vomiting
  • abdominal pain (stomach pain)
  • muscle cramps
  • a general feeling of not feeling well and pronounced fatigue
  • hard to breathe
  • lowered body temperature and heart rate.

Lactic acidosis is an acute medical condition that must be treated in a hospital.

During treatment with Competact, your doctor will check your kidney function at least once a year or more often if you are older and/or if your kidney function is deteriorating.

If you are going to undergo a major operation, you must stop taking Competact during the operation and a certain time after it. Your doctor will decide when to stop taking Competact and when to start taking it again.

Hypoglycemia

If you use Competact with other diabetes medicines, it is likely that your blood sugar may drop below normal levels (hypoglycemia). If you experience symptoms of hypoglycemia such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances, or difficulty concentrating, you should eat something sweet to raise your blood sugar level again. If you are not sure how to recognize hypoglycemia talk to your doctor or pharmacist for more information. It is recommended that you bring sugar cubes, sweets, biscuits, or fruit drinks that contain sugar.

Fracture

A higher incidence of bone fractures has been observed in patients, especially in women taking pioglitazone. Your doctor will take this into account when treating your diabetes.

Children and young people

Use in children and adolescents under 18 years of age is not recommended.

Other medicines and Competact

If you need to get an injection in the blood with contrast media that contain iodine, for example in connection with X-rays or computed tomography, you must stop taking Competact before or at the time of injection. Your doctor will decide when to stop taking Competact and when to start taking it again.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. You may need to do more blood sugar and kidney function tests, or your doctor may need to adjust the dose of Competact. It is especially important that you mention the following:

The following medicines are very likely to affect the amount of sugar in your blood:

  • gemfibrozil (cholesterol-lowering)
  • rifampicin (used to treat tuberculosis and other infections )
  • cimetidine (used to reduce stomach acid)
  • glucocorticosteroids (used to treat inflammation )
  • beta-2 agonists (for the treatment of asthma )drugs that increase urine production ( diuretics )
  • drugs used to treat pain and inflammation ( NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
  • certain medicines for the treatment of high blood pressure (angiotensin converters ( ACEs ) and angiotensin II receptor antagonists).

Competact with alcohol

Avoid high alcohol intake while taking Competact as alcohol may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).

Pregnancy and breastfeeding

  • If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine. Competact is not recommended during pregnancy. If you want to get pregnant, your doctor will advise you to stop taking this medicine.
  • Do not use Competact if you are breast-feeding or planning to breast-feed your baby (see section “Do not take Competact”).

Driving and using machines

This medicine does not affect your ability to drive or use machines, but use caution if you experience visual disturbances.

3. How to take Competact

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one tablet twice daily. If necessary, your doctor may ask you to take another dose. If you have impaired kidney function, your doctor may prescribe a lower dose, which may need to be given as separate tablets of pioglitazone and metformin.

The tablets should be swallowed together with a glass of water. You should take the tablets with or just after food to reduce the risk of stomach upset.

If you are recommended a special diet for diabetes, you should continue with this while taking Competact.

Check your weight regularly and tell your doctor if the weight increases.

Your doctor will take blood samples regularly during treatment with Competact. This is done to check that the liver is functioning normally. At least once a year (more often if you are elderly or have kidney problems), your doctor will check that your kidneys are functioning 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 can fall below normal levels and can be increased by consuming sugar. It is a recommendation to carry sugar cubes, sweets, biscuits, or sugary fruit drinks.

If you take more Competact than you should you may have lactic acidosis (see section “Risk of lactic acidosis”).

If you forget to take Competact

Try to take Competact daily as prescribed. However, if you miss a dose, skip the missed dose and just continue with the next dose as usual. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Competact

Competact should be used daily to achieve the desired effect. If you stop taking Competact, your blood sugar level may increase. Talk to your doctor before stopping this treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Competact can cause the very rare (may affect up to 1 in 10,000), but very serious side effects a lactic acidosis (see section “Risk of lactic acidosis”). If this happens to you, stop taking Competact and contact your doctor or nearest hospital immediately as lactic acidosis may lead to a coma.

Bladder cancer has been detected in some patients (may affect up to 1 in 100 people) taking Competact. Signs and symptoms of this can be blood in the urine, pain when urinating, or urinary incontinence (sudden need to urinate). Contact your doctor as soon as possible if you experience any of these symptoms.

It has been common (may affect up to 1 in 10 users) that female patients taking Competact have reported bone fractures. Bone fractures have also been reported in male patients taking Competact (occurs in an unknown number of users). Contact your doctor as soon as possible if you experience this side effect.

Visual disturbances associated with swelling (or fluid) in the posterior part of the eye (macular edema) have been reported (no known frequency, can not be calculated from the available data). Talk to your doctor as soon as possible if you experience these symptoms for the first time. If you already have visual disturbances and the symptoms worsen, talk to your doctor immediately even then.

Allergic reactions have been reported with no known frequency (cannot be calculated from the available data) in patients taking Competact. If you get a severe allergic reaction such as hives or swelling of your face, lips, tongue, or throat, which may cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor immediately.

Some patients have experienced the following side effects from Competact

Very common (may affect more than 1 user in 10)

  • magont
  • the feeling of nausea (nausea)
  • vomiting
  • diarrhea
  • loss of appetite

Common (may affect up to 1 in 10 people)

  • limited swelling ( edema )
  • weight gain
  • headache
  • respiratory tract infection
  • visual impairment
  • joint pain
  • impotence
  • blood in the urine
  • reduction of red blood cells ( anemia )
  • loss of sensation
  • taste disorders

Uncommon (may affect up to 1 in 100 people):

  • sinusitis ( sinusitis )
  • weather voltage
  • insomnia ( insomnia )

Very rare (may affect up to 1 user in 10,000):

reduction of vitamin B12 in the blood

reddening of the skin

itching

hives (raised itchy rash)

No known frequency (cannot be calculated from the available data)

  • liver inflammation ( hepatitis )
  • impaired liver function (altered levels of liver enzymes)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. Postal address

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 blister after EXP. The expiration date is the last day of the specified month.

No special storage instructions are required for this medicine.

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

6. Contents of the packaging and other information

Content declaration

  • The active substances are pioglitazone and metformin hydrochloride. Each tablet contains 15 mg of pioglitazone (as hydrochloride) and 850 mg of metformin hydrochloride.
  • The other ingredients are microcrystalline cellulose, povidone (K 30), sodium croscarmellose, magnesium stearate, hypromellose, magrocol 8000, talc, and titanium dioxide (E171).

What the medicine looks like and the contents of the pack

The film-coated tablets (tablets) are white to off-white, oblong, cupped, film-coated tablets (tablet) and marked “15/850” on one side and “4833M” on the other. They come in aluminum / aluminum blisters in packs of 14, 28, 30, 50, 56, 60, 90, 98, 112, 180, multiple packs of 196 (2 packs of 98) tablets or in perforated single-dose blisters of aluminum / aluminum in packs of 60 x 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Takeda Pharma A / S

Dybendal Alle 10

2630 Taastrup

Denmark

Manufacturer

Takeda Ireland Limited, Bray Business Park, Kilruddery, County Wicklow, Ireland.

Delpharm Novara Srl, Via Crosa, 86, I-28065 Cerano (NO), Italy.

Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:Show larger

Belgium / Belgique / BelgienTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com LithuaniaEli Lilly Holdings Limited sharesTel. +370 (5) 2649600
BulgariaTakade BulgariaTel .: + 359 2 958 27 36;+ 359 2 958 15 29 Luxembourg / LuxemburgTakeda BelgiumTel: +32 2 464 06 11takeda-belgium@takeda.com
Czech RepublicELI LILLY ČR, sroTel: + 420 234 664 111 HungaryLilly Hungary Kft.Tel: + 36 1 328 5100
DenmarkTakeda Pharma A / STel: +45 46 77 11 11 MaltaTakeda Italia SpATel: +39 06 502601
GermanyTakeda GmbHTel: 0800 825 3325medinfo@takeda.de The NetherlandsEli Lilly Netherlands BVTel: +31 (0) 30 60 25 800
EestiTakeda Pharma ASTel: +372 617 7669 NorwayTakeda ASTel: +47 6676 3030infonorge@takeda.com
GreeceΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.:Ηλ: +30 210 629 4600 AustriaTakeda Pharma Ges.mbHTel: +43 (0) 800 20 80 50
SpainLilly SATel: + 34 (91) 663 50 00 PolandTakeda Polska Sp. z ooTel .: + 48 22 608 13 00
FranceTakeda France SASTel: +33 1 46 25 16 16 PortugalLilly Portugal – Pharmaceutical Products, LdaTel: + 351 21 412 6600
CroatiaTakeda Pharmaceuticals Croatia dooTel: +385 1 377 88 96 RomaniaEli Lilly România SRLTel: +40 21 4023000
IrelandTakeda Products Ireland LimitedTel: +353 (0) 1 6420021 SloveniaTakeda GmbH, Podružnica SlovenijaPhone + 386 (0) 59 082 480
IcelandVistor hf.Phone: +354 535 7000vistor@vistor.is Slovak RepublicTakeda Pharmaceuticals Slovakia sroTel: +421 (2) 20 602 600
ItalyTakeda Italia SpATel: +39 06 502601 Finland / FinlandOy Eli Lilly Finland AbPuh / Tel: +358 (0) 9 8545250
LatviaEli Lilly Holdings Limited is a Latvian companyTel: +371 6 7 364 000 United KingdomTakeda UK LtdTel: +44 (0) 1628 537 900

Muhammad Nadeem

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