COMPETACT 15 mg/850 mg Film-Coated Tablets

Зміст інструкції

1. Competact 15 mg/850 mg film-coated tablets
   1. What Competact is and what it is used for
   2. What you need to know before taking Competact
   3. How to take Competact
   4. Possible side effects
   5. How to store Competact
   6. Contents of the pack and other information

Competact 15 mg/850 mg film-coated tablets

pioglitazone/metformin hydrochloride

Read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 for the
treatment of type 2 diabetes mellitus (non-insulin dependent) when treatment with
metformin is not sufficient. This type of diabetes usually occurs in adults, particularly
as a result of being overweight and where the body is unable to produce a sufficient amount
of insulin (a hormone that controls blood sugar levels), or is unable to use
insulin effectively that it produces. The doctor will check if Competact is working 3-6 months after
the start of treatment.
Competact helps to control the level of sugar in your blood in patients who suffer from type 2
diabetes by allowing your body to make better use of the insulin produced.

2. What you need to know before taking Competact

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 heart failure or have had heart failure in the past.
• if you have recently had a heart attack or have serious circulatory problems including shock, or difficulty breathing.
• if you have liver problems.
• if you drink alcohol in excess (whether daily or occasionally).
• if you have uncontrolled diabetes associated with, for example, severe hyperglycemia (high blood glucose levels), 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” accumulate in the blood and can lead to diabetic precoma. Symptoms include stomach pain, rapid and deep breathing, drowsiness and breath with an unusually fruity odor.
• if you have or have ever had bladder cancer (bladder tumor).
• if you have blood in your urine for which your doctor has not yet carried out investigations
• if you have severely reduced kidney function.
• if you have a severe infection or are dehydrated.
• if you are to undergo a radiological examination with an injectable contrast agent; consult your doctor, as you will need to stop treatment with Competact for a certain period of time before and after the examination.
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Competact (see also section 4)

• if you have problems with your heart. Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who have been treated with pioglitazone and insulin together have developed heart failure. Tell your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid weight gain or localized swelling (edema).
• if you retain water (fluid retention) or have heart failure problems, especially if you are over 75 years of age. You should also tell your doctor if you are taking anti-inflammatory medicines, which can also cause fluid retention and swelling.
• if you have a particular type of diabetic eye disease called macular edema (swelling of the back of the eye), consult your doctor if you notice any changes in your vision.
• if you have cysts on the ovaries (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, because ovulation may resume when you take Competact. If this is the case, use adequate contraception to avoid the risk of an unwanted pregnancy.
• if you have liver problems. Before starting to take Competact, you will have a blood test to check your liver function. This test should be repeated periodically. Tell your doctor immediately if you experience symptoms suggesting a liver problem (such as unexplained nausea, vomiting, stomach pain, fatigue, loss of appetite and/or dark urine) as, in this case, liver function must be checked.

A decrease in the number of red blood cells (anemia) may also occur.

Risk of lactic acidosis
Competact can cause a very rare but very serious side effect called lactic acidosis, in
particular if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in
the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption,
dehydration (see below for more information), liver problems and any other
medical condition characterized by a reduced supply of oxygen to a part of the body (such as
in the case of severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further
instructions.

Stop taking Competact for a short period of time if you have a medical
condition that may be associated with dehydration(significant loss of body fluids) such as severe
vomiting, diarrhea, fever, exposure to heat or if you drink less fluids than usual. Consult your doctor
for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Competact and
seek immediate medical attention or go to the nearest hospital, as lactic acidosis can lead to coma.
The symptoms of lactic acidosis include:

• vomiting
• stomach pain (abdominal pain)
• muscle cramps
• a general feeling of unwellness associated with severe fatigue
• difficulty breathing
• reduced body temperature and slower heartbeat

Lactic acidosis is a medical emergency and must be treated in 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 your kidney function worsens.
If you are to undergo major surgery, you must stop taking
Competact during the surgery and for a certain period of time thereafter. Your doctor
will decide when you should stop and when you should resume treatment with Competact.

Hypoglycemia
If you take Competact with other medicines for diabetes, it is more likely that your blood sugar
level may drop below normal (hypoglycemia). If you experience symptoms of
hypoglycemia such as weakness, dizziness, increased sweating, rapid heartbeat,
vision disturbances or difficulty concentrating, you should eat sugar to raise your
blood sugar level. If you have doubts about how to recognize hypoglycemia, ask your doctor or pharmacist for further
information. It is advisable to carry sugar cubes, sweets,
biscuits or sugary fruit juices with you.

Bone fractures
A higher number of bone fractures has been found in patients, especially in women who
take pioglitazone. Your doctor will take this into account when treating your diabetes.

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

Other medicines and Competact
If you are to be injected with an iodinated contrast agent into the bloodstream, for
example to perform an X-ray, you must stop taking Competact before or during
the injection. Your doctor will decide when you should stop and when you should resume treatment with
Competact.
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. You may need to have your blood glucose and
kidney function checked more frequently, or your doctor may decide to adjust the dose of Competact. It is
particularly important to mention the following:

• gemfibrozil (used to reduce cholesterol levels)
• rifampicin (used to treat tuberculosis and other infections)
• cimetidine (used to reduce stomach acidity)
• glucocorticoids (used to treat inflammation)
• beta-2-agonists (used to treat asthma)
• medicines that increase urine production (diuretics)
• medicines used for the treatment of pain and inflammation (NSAIDs and COX 2 inhibitors, such as ibuprofen and celecoxib)
• some medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)

Competact with alcohol
Avoid excessive alcohol consumption during treatment with Competact as this may increase
the risk of lactic acidosis (see section “Risk of lactic acidosis”).

Pregnancy and breastfeeding

• If you are pregnant, suspect you are pregnant or are planning to become pregnant, tell your doctor. Competact is not recommended during pregnancy. If you wish to become pregnant, your doctor will advise you to stop treatment with this medicine.
• Do not use Competact if you are breastfeeding or are planning to breastfeed (see section “Do not take Competact”).

Driving and using machines
This medicine does not interfere with your ability to drive or operate machinery, but be
careful if you experience vision disturbances.

Competact contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take Competact

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The recommended dose is one tablet to be taken twice a day. 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 eventually have to be taken in the form of separate tablets of
pioglitazone and metformin.
You must take the tablets with a glass of water. You can take the tablets during or
immediately after meals, to reduce the possibility of stomach upset.
If you are following a special diet for diabetes, you should continue it while taking Competact.
Your weight should be checked at regular intervals; if your weight increases, tell your doctor.
Your doctor will ask you to have blood tests periodically during treatment with
Competact. This is to check the normal functioning of your liver.
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 another person or a child takes your
tablets, contact your doctor or pharmacist immediately. Your blood sugar level
may decrease below normal levels and can be increased by taking
sugar. It is advisable to carry sugar cubes, sweets, biscuits or sugary fruit juices
with you.
If you have taken more Competact than you should, you may experience lactic acidosis (see
paragraph “Risk of lactic acidosis”).

If you forget to take Competact
Take Competact every day as prescribed. However, if you forget to take a dose, skip the
missed dose and continue normally with the next dose. Do not take a double dose to
make up for the missed tablet.

If you stop taking Competact
Competact must be used every day to work properly. If you stop using Competact,
your blood sugar level may increase. Talk to your doctor before stopping the
treatment.
If you have any doubts about 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 can cause a very rare (may affect up to 1 in 10,000 people) but very serious side effect called lactic acidosis (see section “Risk of lactic acidosis”). If this occurs, you must stop taking Competact and immediately contact your doctoror the nearest hospital, because lactic acidosis can lead to coma. Uncommon cases of bladder carcinoma (bladder cancer) (may affect up to 1 in 100 people) have occurred in patients treated with Competact. Signs and symptoms include blood in the urine, pain when urinating, or a sudden need to urinate. If you experience any of these symptoms, talk to your doctor as soon as possible.

• Common bone fractures have been reported in female patients and also in male patients taking Competact (available data do not allow an estimate of the frequency). If you experience this side effect, inform your doctor as soon as possible.
  Blurred vision due to swelling (edema) of the back of the eye (macular edema) has been reported (frequency cannot be defined based on available data). Tell your doctor as soon as possible if you notice the onset of these symptoms for the first time. Also, tell your doctor as soon as possible if you already suffer from blurred vision and these symptoms worsen.
  Allergic reactions with unknown frequency (frequency cannot be defined based on available data) have been reported in patients taking Competact. If you have a severe allergic reaction, including hives and swelling of the face, lips, tongue or throat that may cause difficulty breathing or swallowing, stop taking this medicine and talk to your doctor immediately.
  The following side effects have occurred in some patients taking Competact:
  Very common (may affect more than 1 in 10 people)

• stomach pain
• feeling unwell (nausea)
• vomiting
• diarrhea
• loss of appetite

Common (may affect up to 1 in 10 people)

• localized swelling (edema)
• weight gain
• headache
• respiratory infection
• abnormal vision
• joint pain
• impotence
• blood in urine
• decreased number of blood cells (anemia)
• numbness
• altered taste

Uncommon (may affect up to 1 in 100 people)

• inflammation of the sinuses (sinusitis)
• intestinal gas
• difficulty sleeping (insomnia)

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

• decrease in the amount of vitamin B in the blood
• skin redness
• skin itching
• raised and itchy rash (urticaria)

Not known (frequency cannot be defined based on available data)

• inflammation of the liver (hepatitis)
• the liver does not work as it should (change in liver enzymes)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system indicated in Annex V. 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 package and on the blister after
“Expiry date/EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Competact contains

• The active ingredients are pioglitazone and metformin hydrochloride. Each tablet contains 15 mg pioglitazone (as hydrochloride) and 850 mg metformin hydrochloride.
• The other ingredients are: microcrystalline cellulose, povidone (K30), sodium croscarmellose, magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).

Description of the appearance of Competact and contents of the pack
The film-coated tablets (tablets) are white to off-white, oblong,
biconvex, with ‘15/850’ imprinted on one side and “4833M” on the other.
They are supplied in aluminium/aluminium blisters in packs of 56 and 112 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

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

Other sources of information
More detailed information on this medicine is available on the website of the European
Medicines Agency http://www.ema.europa.eu .