Pioglitazone Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE USER

PIOGLITAZONE ZENTIVA 15 mg tablets, 30 mg tablets

Equivalent medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult 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 taking 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 Pioglitazone Zentiva is and what it is used for

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

2. What you need to know before taking PIOGLITAZONE ZENTIVA

Do not take PIOGLITAZONE ZENTIVA

• if you are allergic to pioglitazone or to any of the other ingredients of this medicine (listed in section 6);
• if you have heart failure or have previously had heart failure;
• if you have liver disease;
• if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting);
• if you have or have previously had bladder cancer;
• if you have blood in your urine and your doctor has not yet investigated the cause.

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

• If you retain fluid (fluid retention) or have heart failure problems, especially if you are over 75 years old;
• If you are taking anti-inflammatory medicines that may cause fluid retention and swelling, you must inform your doctor.
• If you have a specific type of diabetic eye disease called macular edema (swelling in the back part of the eye);
• If you have ovarian cysts (polycystic ovary syndrome). The likelihood of becoming pregnant may increase, as ovulation may resume when you take Pioglitazone Zentiva. If this applies to you, use an appropriate contraceptive method to avoid the risk of an unplanned pregnancy;
• If you have liver or heart problems. Before starting Pioglitazone Zentiva, you will have a blood test to check liver function. This test may be repeated periodically. Some patients with long-standing type 2 diabetes and heart disease or a history of stroke who were treated with Pioglitazone Zentiva and insulin developed heart failure. Inform your doctor as soon as possible if you experience signs of heart failure, such as unusual shortness of breath, rapid weight gain, or localized swelling (edema).

If you take Pioglitazone Zentiva together with other diabetes medicines, 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
An increased number of bone fractures has been observed in patients, particularly in women, taking pioglitazone. Your doctor will take this into account when managing your diabetes.
Children and adolescents
Use in children and adolescents under 18 years of age is not recommended.
Other medicines and PIOGLITAZONE ZENTIVA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Generally, you can continue taking other medicines while being treated with Pioglitazone Zentiva.
However, certain medicines may particularly affect your blood sugar levels:
2/7

• gemfibrozil (used to lower cholesterol levels),
• rifampicin (used to treat tuberculosis and other infections). Inform your doctor or pharmacist if you are taking any of these medicines. Your blood sugar will be monitored and the dose of Pioglitazone Zentiva may need to be adjusted.

PIOGLITAZONE ZENTIVA with food and drink
You may take the tablets with or without food. Swallow the tablets with a glass of water.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will advise you to stop treatment with this medicine.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery, but be cautious if you experience vision disturbances.
PIOGLITAZONE ZENTIVA contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking Pioglitazone Zentiva.

3. How to take PIOGLITAZONE ZENTIVA

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one 15 mg pioglitazone tablet taken once daily.
If necessary, your doctor may instruct you to take a different dose. If you feel that the effect of Pioglitazone Zentiva is too weak, speak to your doctor.
When taking Pioglitazone Zentiva in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide), your doctor will tell you if you need to take a lower dose of these other medicines.
Your doctor will ask you to have regular blood tests during treatment with Pioglitazone Zentiva. These tests are to monitor normal liver function.
If you are following a special diabetic diet, you must continue it while taking Pioglitazone Zentiva.
Your weight should be monitored at regular intervals. If your weight increases, inform your doctor.
3/7

If you take more PIOGLITAZONE ZENTIVA than you should
If you accidentally take too many tablets, or if someone else or a child takes your tablets, contact your doctor or pharmacist immediately. Your blood sugar level may drop below normal levels, which can be treated by taking sugar. It is recommended to always carry sugar lumps, sweets, biscuits, or sugared 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, simply take the next dose as scheduled. Do not take a double dose to make up for the missed tablet.

If you stop taking PIOGLITAZONE ZENTIVA
Pioglitazone Zentiva must be taken every day to work properly. If you stop taking Pioglitazone Zentiva, your blood sugar level may increase. Talk to your doctor before stopping treatment.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In particular, patients may experience the following serious side effects:

• Common cases (may affect up to 1 in 10 people) of heart failure have occurred in patients taking Pioglitazone Zentiva in combination with insulin. Symptoms include unusual shortness of breath, a rapid weight gain, or localized swelling (edema). If you experience any of these symptoms, especially if you are over 65 years old, contact your doctor immediately.
• Uncommon cases (may affect up to 1 in 100 people) of bladder cancer have occurred in patients taking Pioglitazone Zentiva. Signs and symptoms include blood in the urine, pain when urinating, or a sudden need to urinate. If you experience any of these symptoms, consult your doctor as soon as possible.
• Very common cases (may affect more than 1 in 10 people) of localized swelling (edema) have occurred in patients taking Pioglitazone Zentiva in combination with insulin. If you experience this side effect, consult your doctor as soon as possible.
• Common cases (may affect up to 1 in 10 people) of bone fractures have occurred in female patients taking Pioglitazone Zentiva, and have also occurred in male patients (frequency cannot be determined based on available data) taking Pioglitazone Zentiva. If you experience this side effect, consult your doctor as soon as possible.
• Blurred vision, due to swelling (or fluid accumulation) in the back of the eye, has also been reported (frequency cannot be determined 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.

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

• Allergic reactions have been reported (frequency cannot be determined 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 may cause difficulty breathing or swallowing, stop taking this medicine immediately and contact your doctor without delay.

Other side effects observed 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 paranasal sinuses (sinusitis);
• difficulty falling asleep (insomnia).

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

• increased liver enzymes;
• allergic reactions.

The following additional side effects have been observed in some patients when Pioglitazone Zentiva was taken together with other antidiabetic medicines:
Very common (may affect more than 1 in 10 people):

• decrease in blood sugar levels (hypoglycaemia).

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

• headache;
• dizziness;
• joint pain;
• impotence;
• back pain;
• shortness of breath;
• 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;
• sensation of dizziness (vertigo);
• sweating;
• fatigue;
• increased appetite.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on 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 packaging after EXP. The expiry
date refers to the last day of that month.
Store below 25°C in the original packaging to protect the medicine from moisture.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What PIOGLITAZONE ZENTIVA contains
The active substance 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 components are: monohydrate lactose, croscarmellose sodium, hydroxypropylcellulose, partially substituted hydroxypropylcellulose, magnesium stearate.

Description of the appearance of PIOGLITAZONE ZENTIVA and contents of the pack
PIOGLITAZONE ZENTIVA 15 mg tablets: white, round, biconvex tablets.
PIOGLITAZONE ZENTIVA 30 mg tablets: white, round, flat tablets with "30" engraved on one side.
The tablets are supplied 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 may be marketed.

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

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

This medicinal product is authorized in the European Economic Area countries under the following names:
6/7

7/7