Pioglitazone bioton

Package leaflet: Information for the user

PIOGLITAZONE BIOTON 15 mg, tablets
PIOGLITAZONE BIOTON 30 mg, tablets
PIOGLITAZONE BIOTON 45 mg, tablets
Pioglitazonum
Please read carefully the entire leaflet before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Pioglitazone Bioton is and what it is used for
2. Important information before taking Pioglitazone Bioton
3. How to take Pioglitazone Bioton
4. Possible side effects
5. How to store Pioglitazone Bioton
6. Contents of the pack and other information

1. What Pioglitazone Bioton is and what it is used for
Pioglitazone Bioton tablets contain pioglitazone. It is an antidiabetic medicine used in adults for the treatment of type 2 diabetes (non-insulin-dependent diabetes), when metformin is not suitable or not effective enough. This type of diabetes usually develops in adults. Pioglitazone Bioton helps control blood sugar (glucose) levels in people with type 2 diabetes by improving the body's use of insulin.
Your doctor should assess whether Pioglitazone Bioton is having the desired effect within 3 to 6 months after starting treatment.
Pioglitazone Bioton may be used as the only medicine in patients who cannot take metformin and in whom blood sugar levels cannot be adequately controlled by diet and physical activity alone. Pioglitazone Bioton may also be used in combination with other antidiabetic medicines (such as metformin, sulfonylurea derivatives, or insulin) if blood sugar control is not sufficient.

2. Important information before taking Pioglitazone Bioton

When not to take Pioglitazone Bioton:

• if you are allergic (hypersensitive) to pioglitazone or to any of the other ingredients of this medicine (listed in section 6),
• if you have heart failure or have had heart failure in the past,
• if you have liver disease,
• if you have diabetic ketoacidosis (a complication of diabetes causing rapid weight loss, nausea or vomiting),
• if you have or have ever had bladder cancer,
• if there is blood in your urine and this has not been evaluated by a doctor.

Warnings and precautions
Before starting treatment, inform your doctor if:

• you have fluid retention or heart failure, especially if you are elderly (over 75 years of age). If you are taking non-steroidal anti-inflammatory drugs (NSAIDs), which may cause fluid retention and swelling, you should also inform your doctor.
• you have a specific eye condition related to diabetes called macular edema (swelling at the back of the eye),
• you have ovarian cysts (polycystic ovary syndrome). Pioglitazone may increase the likelihood of becoming pregnant, as the medicine may restart ovulation. Women affected by this condition should use appropriate contraception to avoid unplanned pregnancy.
• you have liver or heart disease. Before starting treatment, a blood test should be performed to check liver function. This test should be repeated periodically. In some patients with long-standing type 2 diabetes and heart disease or a history of stroke who were treated with pioglitazone and insulin, heart failure has been observed. You should contact your doctor immediately if symptoms of heart failure occur, such as shortness of breath, rapid weight gain, or localized swelling.

If you are taking Pioglitazone Bioton together with other antidiabetic medicines, your blood sugar level may drop below normal (hypoglycaemia).
Anaemia (reduced number of red blood cells) may also occur.
Bone fractures
An increased number of bone fractures has been observed in patients, particularly in women, taking pioglitazone. Your doctor should consider the possibility of this complication.
Children and adolescents
The use of pioglitazone in children and adolescents under 18 years of age is not recommended.
Other medicines and Pioglitazone Bioton
Tell your doctor about all medicines you are currently taking or have recently taken, including those you plan to take and those available without a prescription.
Generally, you can take other medicines while using Pioglitazone Bioton.
However, some medicines may affect your blood sugar levels:

• gemfibrozil (used to lower cholesterol levels),
• rifampicin (used to treat tuberculosis and other infections).

Inform your doctor or pharmacist if you are taking these medicines, as additional monitoring of blood sugar levels may be needed and the dose of Pioglitazone Bioton may require adjustment.
Pioglitazone Bioton with food and drink
This medicine can be taken during or between meals. Swallow the tablets with a glass of water.
Pregnancy and breastfeeding
Tell your doctor if

• you are pregnant or suspect you may be pregnant, or if you are planning to become pregnant,
• you are breastfeeding or planning to breastfeed. Your doctor will advise you to discontinue the medicine.

Driving and operating machinery
Pioglitazone does not affect the ability to drive or operate machinery. However, you should exercise caution if you experience any visual disturbances.
Pioglitazone Bioton contains monohydrate lactose.
Pioglitazone Bioton contains monohydrate lactose. If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking Pioglitazone Bioton.
3. How to take Pioglitazone Bioton
This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The usual starting dose is 15 mg or 30 mg taken once daily. Your doctor may increase the dose up to a maximum of 45 mg once daily. Your doctor will determine the appropriate dose for you.
If you feel that the effect of Pioglitazone Bioton is too weak, consult your doctor.
If Pioglitazone Bioton is taken together with other antidiabetic medicines (e.g. insulin, chlorpropamide, glibenclamide, glimepiride or tolbutamide), your doctor will decide whether the dose of these medicines needs to be reduced.
While taking Pioglitazone Bioton, your doctor will recommend periodic blood tests. These tests are to check whether liver function is normal.
Patients on a diabetic diet should continue to follow it while taking Pioglitazone Bioton.
Patients should regularly monitor their body weight. Inform your doctor if your weight increases.
Taking more Pioglitazone Bioton than prescribed
If you accidentally take too many tablets, or if someone else, especially a child, takes the medicine, contact your doctor or pharmacist immediately.
In such a person, blood sugar levels may drop significantly; in this case, consume a sugary product such as a sugar cube or a teaspoon of sugar, sweets, biscuits, or drink a sweet fruit juice.
If you miss a dose of Pioglitazone Bioton
Try to take Pioglitazone Bioton every day as prescribed by your doctor. If you miss a dose, take the next dose according to the prescribed dosing schedule.
Do not take a double dose.
Stopping Pioglitazone Bioton
Pioglitazone Bioton should be taken daily to achieve the proper treatment effect. Stopping treatment may cause an increase in blood sugar levels.
Do not stop taking this medicine without consulting your doctor.
If you have any other questions about the use of Pioglitazone Bioton, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not every patient will experience them.
In particular, the following serious adverse effects have been observed:

Heart failure occurred frequently (in no more than 1 in 10 patients) in patients taking pioglitazone together with insulin. Symptoms of heart failure include: shortness of breath, sudden weight gain, or swelling. If any of these symptoms occur, especially in patients over 65 years of age, contact a doctor immediately.

Bladder cancer occurred uncommonly (in no more than 1 in 100 patients) in patients taking pioglitazone. If symptoms such as blood in the urine, pain during urination, difficulty urinating, or a feeling of urgency to urinate occur, contact a doctor immediately.

Oedema (swelling) occurred very frequently (in more than 1 in 10 patients) in patients taking pioglitazone together with insulin. If oedema occurs, contact a doctor immediately.

Bone fractures occurred frequently (in no more than 1 in 10 patients) in women taking pioglitazone. Cases of fractures have also been observed in men taking pioglitazone (based on available data, the frequency of fractures in this patient group has not been established). If a fracture occurs, contact a doctor immediately.

Blurred vision (decreased visual acuity) due to swelling (or fluid) in the back of the eye has been observed in patients taking pioglitazone (frequency based on available data has not been established). If this symptom occurs for the first time or worsens, contact a doctor immediately.

Allergic reactions of unknown frequency (based on available data, the frequency has not been established) have been observed in patients taking pioglitazone. If a severe allergic reaction occurs, including hives or swelling of the face, lips, tongue, throat, and/or difficulty breathing or swallowing, discontinue the medicine immediately and contact a doctor.

Other adverse effects observed in some patients taking pioglitazone include:

Frequent (may affect up to 1 in 10 patients):

• respiratory tract infections
• visual disturbances
• weight gain
• numbness

Uncommon (may affect up to 1 in 100 patients):

• sinusitis
• difficulty sleeping (insomnia)

Frequency not known (cannot be estimated from available data):

• increased liver enzyme activity
• allergic reactions

Other adverse effects observed in some patients taking pioglitazone in combination with other antidiabetic medicines:

Very frequent (may affect more than 1 in 10 patients):

• decreased blood sugar levels (hypoglycaemia)

Frequent (may affect up to 1 in 10 patients):

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

Uncommon (may affect up to 1 in 100 patients):

• presence of sugar (glucose) and protein in urine
• increased liver enzyme activity
• dizziness
• excessive sweating
• fatigue
• increased appetite

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can also be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Pioglitazone Bioton

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister after EXP and on the carton. The expiry date refers to the last day of the stated month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Pioglitazone Bioton contains
The active substance is pioglitazone.
Each tablet contains 15/30/45 mg of pioglitazone (as hydrochloride).
Other ingredients are:
monohydrate lactose, calcium carmellose, hydroxypropylcellulose (E 463), magnesium stearate (E 572).

What Pioglitazone Bioton looks like and contents of the pack
Pioglitazone Bioton 15 mg tablets are white or cream-coloured, round, convex, uncoated tablets, with "P" embossed on one side and "15" on the other side.
The tablets are packed in blisters containing 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.

Pioglitazone Bioton 30 mg tablets are white or cream-coloured, round, flat, uncoated tablets with bevelled edges, with "PIO" embossed on one side and "30" on the other side.
The tablets are packed in blisters containing 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.

Pioglitazone Bioton 45 mg tablets are white or cream-coloured, round, flat, uncoated tablets with bevelled edges, with "PIO" embossed on one side and "45" on the other side.
The tablets are packed in blisters containing 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
BIOTON S.A.
02-516 Warsaw
ul. Starościńska 5
Poland

Manufacturer
BIOTON S.A.
ul. Starościńska 5
02-516 Warsaw
Poland

Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow HA1 4HF, Middlesex
United Kingdom

LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040
Spain

For further information, please contact the Marketing Authorisation Holder:
BIOTON S.A.
02-516 Warsaw
ul. Starościńska 5
Tel: +48 (22) 721 40 00

This medicinal product has been authorised in the following European Union countries:

| Country | Name of the medicinal product | |--------|-------------------------------| | Italy | PIOGLITAZONE DOC Generici 15/30/45 mg tablets | | Poland | Pioglitazone Bioton |