Pioglitazone Bioton

B. PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the patient

PIOGLITAZONE BIOTON 15 mg, tablets

PIOGLITAZONE BIOTON 30 mg, tablets

PIOGLITAZONE BIOTON 45 mg, tablets

Pioglitazone

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Pioglitazone Bioton and what is it 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 is Pioglitazone Bioton and what is it used for

Pioglitazone Bioton in tablet form contains pioglitazone. It is an anti-diabetic medicine used in adults to treat type 2 diabetes (non-insulin-dependent) when metformin is not suitable or does not work properly. This type of diabetes usually develops in adults. Pioglitazone Bioton helps control blood sugar levels in people with type 2 diabetes by making better use of the insulin produced by the body. The doctor will assess whether Pioglitazone Bioton is working after 3 to 6 months of treatment. Pioglitazone Bioton can be used as the only medicine in patients who cannot take metformin and whose blood sugar levels cannot be controlled with diet and physical activity alone. Pioglitazone Bioton can also be used in combination with other anti-diabetic medicines (such as metformin, sulfonylureas, or insulin) if blood sugar control is not sufficient.

2. Important information before taking Pioglitazone Bioton

When not to take Pioglitazone Bioton:

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

Warnings and precautions

Before starting treatment, inform your doctor if:

• there is fluid retention in the body or the patient has heart failure, especially if the patient is elderly (over 75 years old). If the patient is taking non-steroidal anti-inflammatory drugs that can cause fluid retention and swelling, they should also inform their doctor.
• there is a specific eye disease associated with diabetes, called macular edema (swelling in the back of the eye),
• there are cysts on the ovaries (polycystic ovary syndrome). Pioglitazone may increase the likelihood of becoming pregnant, as the medicine may resume ovulation. Patients with polycystic ovary syndrome should use appropriate contraception to avoid unplanned pregnancy.
• there are liver or heart diseases. Before starting treatment, a blood test should be performed to check liver function. This test should be performed periodically. In some patients with long-standing type 2 diabetes and heart disease or stroke who were treated with pioglitazone and insulin, heart failure developed. Patients should inform their doctor immediately if they experience symptoms of heart failure such as shortness of breath or sudden weight gain, or local swelling.

If the patient is taking Pioglitazone Bioton with other anti-diabetic medicines, it is possible that blood sugar levels may drop below normal (hypoglycemia). It may also cause a decrease in red blood cell count (anemia). Bone fractures have been observed in patients taking pioglitazone, especially in women. The doctor should consider the possibility of such a complication.

Children and adolescents

Pioglitazone should not be used in children and adolescents under 18 years of age.

Other medicines and Pioglitazone Bioton

Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take, including those available without a prescription. It is usually possible to take other medicines while taking Pioglitazone Bioton. However, some medicines may affect blood sugar levels:

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

Inform your doctor or pharmacist about taking these medicines, as additional blood sugar control and a change in the Pioglitazone Bioton dose may be necessary.

Pioglitazone Bioton with food and drink

The medicine can be taken with or without food. The tablets should be swallowed with a glass of water.

Pregnancy and breastfeeding

Inform your doctor if:

• the patient is pregnant or thinks they may be pregnant, or plans to become pregnant
• the patient is breastfeeding or plans to breastfeed their child. The doctor will advise stopping the medicine.

Driving and using machines

Pioglitazone does not affect the ability to drive or use machines. However, caution should be exercised if vision is impaired. Pioglitazone Bioton contains lactose monohydrate. Pioglitazone Bioton contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking Pioglitazone Bioton.

3. How to take Pioglitazone Bioton

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist. The usual initial dose is 15 mg or 30 mg taken once a day. The doctor may recommend increasing the dose to a maximum of 45 mg once a day. The doctor will determine the dose to be taken. If the patient feels that the effect of Pioglitazone Bioton is too weak, they should consult their doctor. If Pioglitazone Bioton is taken with other anti-diabetic medicines (e.g., insulin, chlorpropamide, glibenclamide, gliclazide, or tolbutamide), the doctor will decide whether it is necessary to reduce the dose of these medicines. During treatment with Pioglitazone Bioton, the doctor will recommend periodic blood tests to check liver function. Patients on a diabetic diet should continue to follow it while taking Pioglitazone Bioton. Patients should regularly check their weight. They should inform their doctor if their weight increases.

Taking a higher dose of Pioglitazone Bioton than recommended

If the patient accidentally takes too many tablets or if someone else or a child takes the medicine, they should immediately contact a doctor or pharmacist. The person's blood sugar level may drop significantly; in such a situation, they should consume a product containing sugar, such as a sugar cube or spoonful of sugar, sweets, cakes, or a sweet fruit juice.

Missing a dose of Pioglitazone Bioton

Patients should try to take Pioglitazone Bioton every day as directed by their doctor. If a dose is missed, they should take the next dose as scheduled. They should not take a double dose.

Stopping treatment with Pioglitazone Bioton

Pioglitazone Bioton should be taken every day to achieve the proper treatment effect. Stopping treatment may cause an increase in blood sugar levels. Patients should not stop taking the medicine without consulting their doctor. If they have any other questions about taking Pioglitazone Bioton, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Pioglitazone Bioton can cause side effects, although not everybody gets them. In particular, the following serious side effects have been observed: Heart failure occurred frequently (in more than 1 in 10 patients) in patients taking pioglitazone with insulin. Symptoms of heart failure are shortness of breath, sudden weight gain, or swelling. If any of these symptoms occur, especially in patients over 65 years old, they should contact their doctor immediately. Bladder cancer occurred infrequently (in less than 1 in 100 patients) in patients taking pioglitazone. If symptoms such as blood in the urine, pain while urinating, difficulty urinating, or a feeling of urgency to urinate occur, patients should contact their doctor immediately. Swelling occurred very frequently (in more than 1 in 10 patients) in patients taking pioglitazone with insulin. If swelling occurs, patients should contact their doctor immediately. Bone fractures occurred frequently (in less than 1 in 10 patients) in women taking pioglitazone. Fractures have also been observed in men taking pioglitazone (the frequency of fractures in this group of patients has not been determined). If a fracture occurs, patients should contact their doctor immediately. Blurred vision (reduced visual acuity) caused by swelling (or fluid) in the back of the eye has been observed in patients taking pioglitazone (the frequency of occurrence has not been determined). If this symptom occurs for the first time or worsens, patients should contact their doctor immediately. Allergic reactions have been observed with an unknown frequency (the frequency of allergic reactions has not been determined) in patients taking pioglitazone. If a patient experiences a severe allergic reaction, including hives or swelling of the face, lips, tongue, throat, and difficulty breathing or swallowing, they should stop taking the medicine and contact their doctor immediately. Other side effects that have occurred in some patients taking pioglitazone include:

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

infrequently (in less than 1 in 100 patients)

• sinusitis
• difficulty sleeping (insomnia) with an unknown frequency (cannot be estimated from available data)
• increased liver enzyme activity
• allergic reactions

Other side effects observed in some patients taking pioglitazone with other anti-diabetic medicines:

• low blood sugar (hypoglycemia) very frequently (in more than 1 in 10 patients)

frequently (in less than 1 in 10 patients)

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

infrequently (in less than 1 in 100 patients)

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

Reporting side effects

If any side effects occur, including any not listed in the leaflet, patients should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Pioglitazone Bioton

The medicine should be stored out of sight and reach of children. Do not use the medicine after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the month stated. The medicine does not require special storage conditions. Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines they no longer use. This will 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). The other ingredients are lactose monohydrate, calcium carmellose, hydroxypropyl cellulose (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-colored, round, convex, uncoated with "P" embossed on one side and "15" on the other. The tablets are packaged in blisters containing 28, 30, 50, 56, 84, 90, 98, 112, or 196 tablets. Pioglitazone Bioton 30 mg tablets are white or cream-colored, round, flat, uncoated with a beveled edge, with "PIO" embossed on one side and "30" on the other. The tablets are packaged in blisters containing 28, 30, 50, 56, 84, 90, 98, 112, or 196 tablets. Pioglitazone Bioton 45 mg tablets are white or cream-colored, round, flat, uncoated with a beveled edge, with "PIO" embossed on one side and "45" on the other. The tablets are packaged in blisters containing 28, 30, 50, 56, 84, 90, 98, 112, or 196 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

BIOTON S.A., 02-516 Warsaw, ul. Starościńska 5

Manufacturer

BIOTON S.A., ul. Starościńska 5, 02-516 Warsaw, 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 more information, contact the marketing authorization holder. Bioton S.A., 02-516 Warsaw, ul. Starościńska 5, Tel: +48 (22) 721 40 00

This medicine has been authorized in the following EU countries:

Country Name of the medicine

Italy
PIOGLITAZONE DOC Generici 15/30/45 mg compresse
Poland
Pioglitazone Bioton
Date of leaflet approval: July 2022