Pioglitazone Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

PIOGLITAZONE DOC Generici 15 mg tablets, 30 mg tablets, 45 mg tablets

Generic medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 taking 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 PIOGLITAZONE DOC Generici IS AND WHAT IT IS USED FOR

PIOGLITAZONE DOC Generici contains pioglitazone. It is an antidiabetic medicine used to treat 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 control blood sugar levels in type 2 diabetes by helping the body make better use of the insulin it produces. Your doctor will assess whether PIOGLITAZONE DOC Generici is effective 3–6 months after starting treatment.
PIOGLITAZONE DOC Generici can be used alone in patients who are unable to take metformin and in whom diet and exercise alone have not provided adequate blood glucose control, or it can be added to other therapies (such as metformin, a sulphonylurea, or insulin) that have not achieved sufficient glycaemic control.

2. WHAT YOU NEED TO KNOW BEFORE TAKING PIOGLITAZONE DOC Generici

Do not take PIOGLITAZONE DOC Generici

• 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 problems.
• if you have had diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting).
• if you have or have ever had bladder cancer (bladder tumour).
• 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 heart failure problems, especially if you are over 75 years old. You should also consult your doctor if you are taking anti-inflammatory medicines that may cause fluid retention and swelling.
• if you have a specific type of diabetic eye disease called macular oedema (swelling at the back of the eye).
• if you have ovarian cysts (polycystic ovary syndrome). The chance of becoming pregnant may increase, as ovulation may resume when you take PIOGLITAZONE DOC Generici. If this applies to you, use an appropriate contraceptive method to avoid the risk of unplanned pregnancy.
• if you have liver or heart problems. Before starting PIOGLITAZONE DOC Generici, you will have a blood test to check your 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 DOC Generici 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 (oedema).

If you take PIOGLITAZONE DOC Generici with other diabetes medicines, your blood sugar level may drop below normal (hypoglycaemia).
You may also experience a reduction in blood cell count (anaemia).
Bone fractures
A higher 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 DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
Generally, you can continue taking other medicines while being treated with PIOGLITAZONE DOC Generici.
However, certain medicines are likely to affect blood sugar levels:

• gemfibrozil (used to reduce 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 level will be monitored and the dose of PIOGLITAZONE DOC Generici may need to be adjusted.
Taking PIOGLITAZONE DOC Generici with food and drink
You may take the tablets with or without food. Swallow the tablets with a glass of water.
Pregnancy and breastfeeding
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Ask your doctor:

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

Driving and using machines
Pioglitazone has no effect on the ability to drive or use machines, but be cautious if you experience vision disturbances.
PIOGLITAZONE DOC Generici contains lactose monohydrate.
PIOGLITAZONE DOC Generici contains lactose monohydrate. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking PIOGLITAZONE DOC Generici.

3. HOW TO TAKE PIOGLITAZONE DOC Generici

Take this medicine exactly as directed by 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 daily. Your doctor may increase the dose up to a maximum of 45 mg once daily. Your doctor will tell you which dose to take.
If you feel that the effect of PIOGLITAZONE DOC Generici is too weak, speak to your doctor.
When PIOGLITAZONE DOC Generici tablets are taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide), your doctor will tell you whether a lower dose of these other medicines is needed.
Your doctor will ask you to have periodic blood tests during treatment with PIOGLITAZONE DOC Generici. These tests are to monitor normal liver function.
If you are following a diabetic diet, you should continue it while taking PIOGLITAZONE DOC Generici.
Your weight should be monitored at regular intervals; if you gain weight, 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 could drop below normal levels, and this can be corrected by taking sugar. It is advisable to carry sugar cubes, 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, take your next dose as scheduled. Do not take a double dose to make up for the missed tablet.

If you stop taking PIOGLITAZONE DOC Generici
PIOGLITAZONE DOC Generici must be taken every day to work properly. If you stop taking PIOGLITAZONE DOC Generici, your blood sugar level may rise. Talk to your doctor before stopping treatment.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.
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4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
In particular, the following serious adverse reactions have been observed in some patients:

Common cases (up to 1 in 10 patients) of heart failure have occurred in patients taking PIOGLITAZONE DOC Generici in combination with insulin. Symptoms include unusual shortness of breath, rapid weight gain, or localized swelling (edema). If you experience any of these symptoms, especially if you are over 65 years old, seek immediate medical advice.

Uncommon cases of bladder cancer (up to 1 in 100 patients) have been reported in patients treated with PIOGLITAZONE DOC Generici. Signs and symptoms include blood in the urine, pain during urination, or sudden need to urinate. If you experience any of these symptoms, speak 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 adverse reaction, 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, as well as in male patients (frequency cannot be determined based on the available data). If you experience this side effect, inform 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 the 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 determined based on the available data) in patients taking pioglitazone. If you experience a severe allergic reaction, 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 adverse reactions observed in some patients taking PIOGLITAZONE DOC Generici are:
Common (affects up to 1 in 10 patients)

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

Uncommon (affects up to 1 in 100 patients)

• sinus inflammation (sinusitis)
• difficulty sleeping (insomnia)

Not known (frequency cannot be determined based on the available data)
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• increased liver enzymes
• allergic reactions

Other adverse reactions observed in some patients when taking PIOGLITAZONE DOC Generici together with other antidiabetic medicines are:
Very common (affects more than 1 in 10 patients)

• decrease in blood sugar (hypoglycaemia)

Common (may affect up to 1 in 10 patients)

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

Uncommon (may affect up to 1 in 100 patients)

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

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at the website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, 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 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 special storage conditions.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. PACK CONTENT AND OTHER INFORMATION

What PIOGLITAZONE DOC Generici contains
The active substance is pioglitazone. Each tablet contains 15/30/45 mg of pioglitazone (as
hydrochloride).
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The other components are monohydrate lactose, calcium carmellose, hydroxypropylcellulose (E 463), and
magnesium stearate (E 572).
Description of the appearance of PIOGLITAZONE DOC Generici and packaging 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 bevelled edges, imprinted with 'PIO' on one side and '30' on the other.
45 mg: white to off-white, flat, round, uncoated tablets with bevelled edges, imprinted with 'PIO' on one side and '45' on the other.
PIOGLITAZONE DOC Generici tablets are supplied in blisters, in pack sizes of 14, 28,
30, 50, 56, 84, 90, 98, 112 or 196 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano
Manufacturer
Bioton S.A., Poland
LABORATORI FUNDACIÓ DAU, 08040 Barcelona, Spain
This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: PIOGLITAZONE DOC Generici 15/30/45 mg tablets
Poland: Pioglitazone Bioton
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