PIOGLITAZONE 15 mg Tablet

Зміст інструкції

1. PIOGLITAZONE DOC Generici 15 mg tablets, 30 mg tablets, 45 mg tablets
   1. WHAT IS PIOGLITAZONE DOC Generici AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PIOGLITAZONE DOC Generici
   3. HOW TO TAKE PIOGLITAZONE DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE PIOGLITAZONE DOC Generici
   6. PACKAGE CONTENTS AND OTHER INFORMATION

PIOGLITAZONE DOC Generici 15 mg tablets, 30 mg tablets, 45 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 they have the same symptoms as you, as it may 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 DOC Generici is and what it is used for
• 2. What you need to know before you take PIOGLITAZONE DOC Generici
• 3. How to take PIOGLITAZONE DOC Generici
• 4. Possible side effects
• 5. How to store PIOGLITAZONE DOC Generici
• 6. Contents of the pack and other information

1. WHAT IS PIOGLITAZONE DOC Generici AND WHAT IT IS USED FOR

PIOGLITAZONE DOC Generici 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 DOC Generici helps to control blood sugar levels when you are affected by type 2
diabetes by helping the body to make better use of the insulin it produces. The
doctor will check if PIOGLITAZONE DOC Generici is working 3-6 months after the start of
treatment.
PIOGLITAZONE DOC Generici can be used alone in patients who are unable to
take metformin, and where diet and exercise therapy has not led to blood sugar control, or it can 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 YOU TAKE PIOGLITAZONE DOC Generici

Do not take PIOGLITAZONE DOC Generici

• 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. 1/6

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine

• if you retain water (fluid retention) or have problems with heart failure, especially if you are over 75 years old. You should also see your doctor if you are taking anti-inflammatory medicines that can 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 DOC Generici. 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 DOC Generici, 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 DOC Generici 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 DOC Generici 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 blood cells (anemia).
Bone fractures
A higher number of bone fractures has been found in patients, particularly in women 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 DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines you bought without a prescription.
As a rule, you can continue to take other medicines while being treated with PIOGLITAZONE
DOC Generici.
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 DOC Generici.

Taking PIOGLITAZONE DOC Generici 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
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Ask your doctor if:

• if you are pregnant, think you may be pregnant or are planning a pregnancy,
• if you are breastfeeding or are planning to breastfeed your baby. The doctor will advise you to stop this medicine

Driving and using machines
Pioglitazone has no effects on the ability to drive or operate machines, but be careful if
you experience vision problems.

PIOGLITAZONE DOC Generici contains lactose monohydrate.
PIOGLITAZONE DOC Genericicontains lactose monohydrate. If your doctor has diagnosed
you with intolerance to certain sugars, contact him before taking PIOGLITAZONE DOC Generici.

3. HOW TO TAKE PIOGLITAZONE DOC Generici

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is one 15 mg or 30 mg tablet once a day. Your
doctor may increase the dose up to a maximum of 45 mg once a day. Your doctor will tell you
which dose to take.
If you feel that the effect of PIOGLITAZONE DOC Generici is too weak, talk to your
doctor.
When PIOGLITAZONE DOC Generici 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 DOC Generici. This is to check the normal functioning of the liver.
If you are following a diet for diabetics, you should continue it while taking PIOGLITAZONE
DOC Generici.
Your weight should be checked at regular intervals; if your weight increases, inform your doctor.

If you take more PIOGLITAZONE DOC Generici tablets 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 drop 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 DOC Generici tablets
Try to take PIOGLITAZONE DOC Generici 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 a missed tablet.

If you stop taking PIOGLITAZONE DOC Generici
PIOGLITAZONE DOC Generici must be used every day to work properly. If
you stop using PIOGLITAZONE DOC Generici, your blood sugar level
may increase. Talk to your doctor before stopping treatment.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
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4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
In particular, the following serious side effects have occurred in some patients:
Cases of common (up to 1 in 10 patients) heart failure have occurred in patients who were taking PIOGLITAZONE DOC Generici in combination with insulin. Symptoms include 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, seek medical advice immediately.
Cases of uncommon bladder cancer (bladder tumor) (up to 1 in 100 patients) have occurred in patients treated with PIOGLITAZONE DOC Generici. Signs and symptoms include blood in the urine, pain during urination, or a sudden need to urinate. If you experience any of these symptoms, talk to your doctor as soon as possible.
Very common cases (more than 1 in 10 patients) of localized swelling (edema) have occurred in patients taking PIOGLITAZONE DOC Generici in combination with insulin. If you experience this side effect, inform your doctor as soon as possible.
Common cases (up to 1 in 10 patients) of bone fractures have been reported in female patients taking PIOGLITAZONE DOC Generici and also in male patients (the frequency cannot be defined based on available data). If you experience this side effect, inform your doctor as soon as possible.
Blurred vision due to swelling (or fluid presence) in the back of the eye has also been reported (the frequency cannot be defined based on available data) in patients taking PIOGLITAZONE DOC Generici. Inform your doctor as soon as possible if you notice the onset of these symptoms for the first time. Also inform your doctor as soon as possible if you already have blurred vision and the symptom worsens.
Allergic reactions have been reported with unknown frequency (cannot be defined based on available data) in patients taking pioglitazone. If you experience 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 DOC Generici are:
common (affects up to 1 in 10 patients)

• respiratory tract infection
• abnormal vision
• weight gain
• torpor

uncommon (affects up to 1 in 100 patients)

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

unknown frequency (frequency cannot be defined based on available data)
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• increased liver enzymes
• allergic reactions

Other side effects that have occurred in some patients when taking PIOGLITAZONE DOC Generici together with other antidiabetic medicines are:
very common (affects more than 1 in 10 patients)

• low blood sugar (hypoglycemia)

common (may affect up to 1 in 10 patients)

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

uncommon (may affect up to 1 in 100 patients)

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

Reporting of side effects
If 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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE PIOGLITAZONE DOC Generici

• 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 box and blister after the word “Exp.”. The expiry date refers to the last day of that month.
• This medicinal product does not require any particular storage conditions.
• 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 DOC Generici contains
The active ingredient is pioglitazone. Each tablet contains 15/30/45 mg of pioglitazone (as
hydrochloride).
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The other ingredients are lactose monohydrate, calcium carmellose, hydroxypropylcellulose (E 463) and
magnesium stearate (E 572).

Description of the appearance of PIOGLITAZONE DOC Generici and package contents
15 mg: white to off-white, round, biconvex uncoated tablets imprinted with 'P' on one
side and '15' on the other.
30 mg: white to off-white, flat, round, uncoated tablets with chamfered corners imprinted with
'PIO' on one side and '30' on the other.
45 mg: white to off-white, flat, round, uncoated tablets with chamfered corners imprinted with
'PIO' on one side and '45' on the other.
The tablets of PIOGLITAZONE DOC Generici are provided in blisters, in packs of 14, 28,
30, 50, 56, 84, 90, 98, 112 or 196 tablets. Not all pack sizes may be
marketed.

Marketing Authorisation Holder
DOC Generici Srl, Via Turati 40, 20121 Milan

Manufacturer
Bioton S.A, Poland
LABORATORI FUNDACIÓ DAU, 08040 Barcelona, Spain

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Italy PIOGLITAZONE DOC Generici 15/30/45 mg tablets
Poland Pioglitazone Bioton
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