PIOGLITAZONE 15 mg Tablets

Зміст інструкції

1. Pioglitazone Accord 15 mg tablets, 30 mg tablets, 45 mg tablets
   1. What Pioglitazone Accord is and what it is used for
   2. What you need to know before taking Pioglitazone Accord
   3. How to take Pioglitazone Accord
   4. Possible side effects
   5. How to store Pioglitazone Accord
   6. Package contents and other information

Pioglitazone Accord 15 mg tablets, 30 mg tablets, 45 mg tablets

Pioglitazone

Read this leaflet carefully before you start taking this medicine as 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 Pioglitazone Accord is and what it is used for
• 2. What you need to know before you take Pioglitazone Accord
• 3. How to take Pioglitazone Accord
• 4. Possible side effects
• 5. How to store Pioglitazone Accord
• 6. Contents of the pack and other information

1. What Pioglitazone Accord is and what it is used for

Pioglitazone Accord contains pioglitazone. It is an anti-diabetic medicine used for the treatment of
type 2 diabetes mellitus (non-insulin dependent) in adults, when metformin is not suitable or
has not worked adequately. This type of diabetes usually occurs in adults.
Pioglitazone Accord helps to control blood sugar levels when affected by type 2 diabetes,
helping the body to make better use of the insulin it produces. The doctor will check if
Pioglitazone Accord is working 3-6 months after the start of treatment.
Pioglitazone Accord can be used alone in patients who are unable to take
metformin, and where dietary and exercise therapy has not led to blood sugar control, or it may be added to other therapies (such as metformin, a sulfonylurea or
insulin), which have not provided sufficient blood sugar control.

2. What you need to know before taking Pioglitazone Accord

Do not take Pioglitazone Accord

• if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from heart failure or have suffered from heart failure in the past.
• if you suffer from liver problems.
• if you have suffered from diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea or vomiting).
• 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.

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

• if you retain water (fluid retention) or have problems with heart failure, especially if you are over 75 years old. You should also inform 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).
• if you have cysts on the ovaries (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, because ovulation may resume when you take Pioglitazone Accord. If this is the case, use adequate contraception to avoid the risk of an unwanted pregnancy.
• if you have problems with your liver or heart. Before starting to take Pioglitazone Accord, you will have a blood test to check your liver function. This test may be repeated periodically. Some patients with type 2 diabetes mellitus of long duration and heart disease or previous stroke who have been treated with Pioglitazone Accord and insulin 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 take Pioglitazone Accord with other medicines for diabetes, it is more likely that your blood sugar level may fall below normal (hypoglycemia).
You may also experience a decrease in the number of blood cells (anemia).
Bone fractures
A higher number of bone fractures has been found in patients, especially in women who are taking pioglitazone. Your doctor will take this into account when treating your diabetes.

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

Other medicines and Pioglitazone Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those available without a prescription.
Normally, you can continue to take other medicines while being treated with Pioglitazone Accord
However, some medicines in particular are likely to affect the amount of sugar in your blood:

• gemfibrozil (used to reduce cholesterol levels)
• rifampicin (used to treat tuberculosis and other infections) Tell your doctor or pharmacist if you are taking any of these medicines. Your blood sugar level will be checked and it may be necessary to adjust the dose of Pioglitazone Accord.

Pioglitazone Accord with food and drink
You can take the tablets with or without food. You should take the tablets with a glass of water.

Pregnancy and breastfeeding
Tell your doctor if

• you are pregnant, suspect you may be pregnant or are planning to become pregnant.
• you are breastfeeding or are planning to breastfeed. Your doctor will advise you to stop treatment with this medicine.

Driving and using machines
This medicine has no effect on the ability to drive or operate machinery, but be careful if you experience visual disturbances.

Pioglitazone Accord contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Pioglitazone Accord.

3. How to take Pioglitazone Accord

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
The usual starting dose is one 15 mg or 30 mg pioglitazone tablet to be taken once a
day. Your doctor may increase the dose up to a maximum of 45 mg per day. Your doctor will
tell you which dose to take.
If you feel that the effect of Pioglitazone Accord is too weak, talk to your doctor.
When Pioglitazone Accord tablets are taken in combination with other medicines used
for the treatment of diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your
doctor will tell you if it is necessary to take a lower dose of the other medicines.
Your doctor will ask you to have blood tests periodically during treatment with
Pioglitazone Accord. This is to check the normal functioning of the liver.
If you are following a special diet for diabetes, you should continue it while taking Pioglitazone
Accord.
Your weight should be checked at regular intervals; if your weight increases, tell your doctor.

If you take more Pioglitazone Accord 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 lumps, sweets, biscuits or sugary fruit juices
with you.

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

If you stop taking Pioglitazone Accord
Pioglitazone Accord must be used every day to work properly. If you stop using
Pioglitazone Accord, your blood sugar level may increase. Talk to your doctor
before stopping treatment.
If you have any questions about using 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.
In particular, the following serious side effects have occurred in some patients:
Cases of common (may affect up to 1 in 10 people) heart failure have occurred in patients who were
taking Pioglitazone Accord in combination with insulin. Symptoms are unusual shortness of breath or
rapid weight gain or localized swelling (edema). If you experience any of these symptoms, especially if
you are over 65 years of age, consult your doctor immediately.
Cases of uncommon bladder cancer (bladder tumor) (may affect up to 1 in 100 people) have occurred in
patients treated with Pioglitazone Accord. Signs and symptoms include blood in the urine, pain during
urination or a sudden need to urinate. If you experience any of these symptoms, consult your doctor
immediately.
Very common cases of localized swelling (edema) (may affect more than 1 in 10 people) have also
occurred in patients who were taking Pioglitazone Accord in combination with insulin. If you experience
this side effect, consult your doctor immediately.
Common cases (may affect up to 1 in 10 people) of bone fractures have been reported in female patients
taking Pioglitazone Accord, as well as in male patients (the frequency cannot be defined based on
available data) taking Pioglitazone Accord. If you experience this side effect, consult your doctor
immediately.
Blurred vision due to swelling (or fluid presence) in the back of the eye (the frequency cannot be
defined based on available data) has also been reported in patients taking Pioglitazone Accord. Consult
your doctor immediately if you notice the onset of these symptoms for the first time. Consult your doctor
immediately also if you already have blurred vision and the symptom worsens.
Allergic reactions (the frequency cannot be defined based on available data) have been reported in
patients taking Pioglitazone Accord. If you have a severe allergic reaction, including hives and swelling
of the face, lips, tongue or throat that can cause difficulty breathing or swallowing, stop taking this
medicine and talk to your doctor as soon as possible.
Other side effects that have occurred in some patients taking Pioglitazone Accord are:
common (may affect up to 1 in 10 people)

• respiratory infections
• abnormal vision
• weight gain
• numbness

uncommon (may affect up to 1 in 100 people)

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

not known (the frequency cannot be defined based on available data)

• increased liver enzymes
• allergic reactions

Other side effects that have occurred in some patients when they took Pioglitazone Accord together with
other antidiabetic medicines are:
very common (may affect more than 1 in 10 people)

• low blood sugar (hypoglycemia)

common (may affect up to 1 in 10 people)

• headache
• dizziness
• joint pain
• impotence
• back pain
• shortness of breath
• a slight decrease in the number of red blood cells in the blood
• flatulence

uncommon (may affect up to 1 in 100 people)

• sugar in the urine, protein in the urine
• increased enzymes
• feeling of spinning (vertigo)
• sweating
• fatigue
• increased appetite

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Pioglitazone Accord

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 cardboard packaging after
“Exp.” and on the blister after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage precautions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pioglitazone Accord contains

• The active ingredient of Pioglitazone Accord is pioglitazone.
• Each Pioglitazone Accord 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
• Each Pioglitazone Accord 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
• Each Pioglitazone Accord 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
• The other ingredients are lactose monohydrate, calcium carmellose, hydroxypropylcellulose (E 465), magnesium stearate (E 572).

Description of the appearance of Pioglitazone Accord and package contents

• Pioglitazone Accord 15 mg tablets are white to off-white in colour, round, biconvex, uncoated tablets with ‘P’ imprinted on one side and '15’ on the other side.
• Pioglitazone Accord 30 mg tablets are white to off-white in colour, flat, round, uncoated tablets with bevelled edges, with ‘PIO’ imprinted on one side and '30’ on the other side.
• Pioglitazone Accord 45 mg tablets are white to off-white in colour, flat, round, uncoated tablets with bevelled edges, with ‘PIO’ imprinted on one side and '45’ on the other side. Pioglitazone Accord is available in aluminium/aluminium blister packs containing 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
More detailed information on this medicine is available on the website of the European
Medicines Agency:
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.