PIOGLITAZONE 15 mg Coated Tablet

Содержание инструкции

1. What is PIOGLITAZONE ZENTIVA and what is it used for
2. What you need to know before you take PIOGLITAZONE ZENTIVA
3. How to take PIOGLITAZONE ZENTIVA
4. Possible side effects
5. How to store PIOGLITAZONE ZENTIVA
6. Package Contents and Other Information

PIOGLITAZONE ZENTIVA15 mg tablets

PIOGLITAZONE ZENTIVA30 mg tablets
Generic medicine

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 Zentiva is and what it is used for
• 2. What you need to know before you take Pioglitazone Zentiva
• 3. How to take Pioglitazone Zentiva
• 4. Possible side effects
• 5. How to store Pioglitazone Zentiva
• 6. Contents of the pack and other information

1. What is PIOGLITAZONE ZENTIVA and what is it used for

Pioglitazone Zentiva contains pioglitazone. It is an antidiabetic medicine used for the
treatment of type 2 diabetes mellitus in adults (non-insulin-dependent), when
metformin is not indicated or has not worked adequately. This type of diabetes
usually occurs in adulthood.
Pioglitazone Zentiva helps to control blood sugar levels when affected by
type 2 diabetes, helping the body to make better use of the insulin produced. The doctor
will check if Pioglitazone Zentiva is working 3-6 months after starting treatment.
Pioglitazone Zentiva can be used alone in patients who are unable to take
metformin and where the treatment associated with diet and exercise has not led to
control of blood sugar levels, or it can be added to other therapies
(such as metformin, sulfonylurea or insulin) that have not provided sufficient control of
blood sugar levels.

2. What you need to know before you take PIOGLITAZONE ZENTIVA

Do not take PIOGLITAZONE ZENTIVA

• 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 if you have suffered from heart failure in the past; 1/7
• if you suffer from a liver disease;
• if you have suffered from diabetic ketoacidosis (a complication of diabetes that causes rapid weight loss, nausea or vomiting);
• if you have or have had bladder cancer;
• if you have blood in your urine for which your doctor has not yet carried out investigations.

Warnings and precautions
Tell your doctor or pharmacist before taking Pioglitazone Zentiva (see also section
4):

• If you retain fluids (water retention) or if you have problems with heart failure, especially if you are over 75 years old;
• If you are taking anti-inflammatory medicines that can cause water retention and swelling, you should inform your doctor.
• If you suffer from 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 probability of becoming pregnant may increase, because ovulation may resume when you take Pioglitazone Zentiva. If this is the case, use adequate contraceptionto avoid the risk of an unwanted pregnancy;
• If you have problems with your liver or heart. Before starting to take Pioglitazone Zentiva, 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 Zentiva 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 Zentiva with other medicines for diabetes, it is more likely that your blood
sugar level may drop below normal (hypoglycemia).
You may also experience a decrease in the number of red blood cells in your blood (anemia).
Bone fractures
A higher number of bone fractures has been found in patients, in particular in
women taking pioglitazone. Your doctor will take this into account when treating your diabetes.

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

Other medicines and PIOGLITAZONE ZENTIVA
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Normally, you can continue to take other medicines while being treated with
Pioglitazone Zentiva.
However, some medicines in particular are likely to affect the amount of sugar
in your blood:
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• 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 will be monitored and it may be necessary to adjust the dose of Pioglitazone Zentiva.

PIOGLITAZONE ZENTIVA with food and drink
You can take the tablets with or without food. You should swallow the tablets with a glass
of water.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor or pharmacist for advice before taking
this medicine
Your doctor will recommend that you stop taking this medicine.

Driving and using machines
This medicine has no effects on the ability to drive and operate machines, but

be careful if you experience vision disturbances.

PIOGLITAZONE ZENTIVA contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact them before
taking Pioglitazone Zentiva.

3. How to take PIOGLITAZONE ZENTIVA

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 15 mg pioglitazone tablet to be taken once a day.
If necessary, your doctor may tell you to take a different dose. If you feel that the effect of Pioglitazone Zentiva is too weak, talk to your doctor.
When you take Pioglitazone Zentiva 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 Zentiva. This is to check the normal functioning of the liver.
If you are following a special diet for diabetics, you should continue it while taking
Pioglitazone Zentiva.
Your weight should be checked at regular intervals. If your weight increases, tell your doctor.
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If you take more PIOGLITAZONE ZENTIVA than you should
If you accidentally take too many tablets, or if another person or a child takes
your tablets, seek immediate medical or pharmacist advice. The level of sugar
in the blood may decrease below normal levels and can be increased by
taking sugar. It is recommended to carry sugar lumps, sweets,
biscuits or sugary fruit juices with you.

If you forget to take PIOGLITAZONE ZENTIVA
Take Pioglitazone Zentiva 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 ZENTIVA
Pioglitazone Zentiva must be used every day to work properly. If you stop
taking Pioglitazone Zentiva, it is possible that your blood sugar level will increase.
Talk to your doctor before stopping treatment.
If you have any further questions on 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 everyone will experience them.
In particular, patients may experience the following serious side effects:

• Cases of heart failurehave been reported (may affect up to 1 in 10 people) in patients taking Pioglitazone Zentiva in combination with insulin. Symptoms are unusual shortness of breathor a rapid weight gainor localized swelling(edema). If you experience any of these symptoms, especially if you are over 65 years old, consult your doctor immediately.
• Cases of bladder cancerhave been reported (may affect up to 1 in 100 people) in patients taking Pioglitazone Zentiva. Signs and symptoms include blood in the urine, pain when urinatingor a sudden need to urinate. If you experience any of these symptoms, consult your doctor as soon as possible.
• Cases of localized swelling(edema) have been reported very commonly (may affect more than 1 in 10 people) in patients taking Pioglitazone Zentiva in combination with insulin. If you experience this side effect, consult your doctor as soon as possible.
• Cases of bone fractureshave been reported commonly (may affect up to 1 in 10 people) in female patients taking Pioglitazone Zentiva, and have also been reported in male patients (the frequency cannot be established based on available data) taking Pioglitazone Zentiva. If you experience this side effect, consult your doctor as soon as possible.
• Blurred visionhas also been reported, due to swelling (or fluid presence) in the back of the eye (the frequency cannot be defined based on available data) in patients taking Pioglitazone Zentiva. Consult your doctor as soon as possible if you notice the onset of these symptoms for the first time. 4/7

Consult your doctor as soon as possible if you already have blurred vision and the symptom
worsens.

• Allergic reactionshave been reported (the frequency cannot be defined based on available data) in patients who have taken pioglitazone. If you experience severe allergic reactions, including hives and swelling of the face, lips, tongue or throat, which can cause difficulty breathing or swallowing, stop taking this medicine and contact your doctor as soon as possible.

Other side effects that have been reported in some patients taking Pioglitazone
Zentiva are:

Common(may affect up to 1 in 10 people):

• respiratory tract infection;
• abnormal vision;
• weight gain;
• numbness.
• Uncommon(may affect up to 1 in 100 people):
• inflammation of the sinuses (sinusitis);
• difficulty falling asleep (insomnia).

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

• increased liver enzymes.
• allergic reactions

The following additional side effects have been reported in some patients when
taking Pioglitazone Zentiva with other antidiabetic medicines:

Very common(may affect more than 1 in 10 people):

• decreased blood sugar levels (hypoglycemia). Common(may affect up to 1 in 10 people):
• headache;
• dizziness;
• joint pain;
• impotence;
• back pain;
• shortness of breath;
• mild decrease in the number of red blood cells in the blood;
• flatulence; Uncommon(may affect up to 1 in 100 people): 5/7
• sugar in the urine, protein in the urine;
• increased enzymes;
• sensation of spinning (vertigo);
• sweating;
• fatigue;
• increased appetite. Reporting of side effectsIf you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can contribute to providing more information about the safety of this medicine.

5. How to store PIOGLITAZONE ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after EXP. The expiry
date refers to the last day of that month.
Store at a temperature below 25° C in the original packaging to protect the
medicine from moisture.
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. Package Contents and Other Information

What PIOGLITAZONE ZENTIVA contains
The active ingredient is pioglitazone.
Pioglitazone Zentiva 15 mg tablets: each tablet contains 15 mg of pioglitazone
(as hydrochloride).
Pioglitazone Zentiva 30 mg tablets: each tablet contains 30 mg of pioglitazone
(as hydrochloride).
The other ingredients are: lactose monohydrate, sodium croscarmellose, hydroxypropylcellulose,
partially substituted hydroxypropylcellulose, magnesium stearate.

Description of the appearance of PIOGLITAZONE ZENTIVA and package contents
PIOGLITAZONE ZENTIVA 15 mg tablets: round, biconvex, white tablets.
PIOGLITAZONE ZENTIVA 30 mg tablets: round, flat, white tablets, with
“30” imprinted on one side.
The tablets are provided in OPA-aluminum-PVC/Al blisters in packs of 14, 28, 30, 50,
56, 60, 84, 90, 98, 100, 112, 120 or 196 tablets. Not all pack sizes
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may be marketed.

Marketing Authorisation Holder and Manufacturer
Zentiva Italia S.r.l.
Viale Bodio, 37/B
20158 Milan

Manufacturer
ZENTIVA K.s.
U kabelovny 130, Prague 10, Dolnì Mecholupy,
Zip code 102 37 CZECH REPUBLIC

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

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