Pioglitazone Bioton

B. PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

PIOGLITAZONE BIOTON 15 mg, tablets

PIOGLITAZONE BIOTON 30 mg, tablets

PIOGLITAZONE BIOTON 45 mg, tablets

Pioglitazone

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet so that you can read it again if you need to.
• If you have any doubts, you should consult your 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 a single medicine in patients who cannot take metformin and in whom blood sugar levels cannot be controlled with diet and physical activity. Pioglitazone Bioton can also be used in combination with other anti-diabetic 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 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 that causes rapid weight loss, nausea, or vomiting),
• if you have or have ever had bladder cancer,
• if there is blood in your urine and it has not been evaluated by your doctor.

Warnings and precautions

Before starting treatment, you should inform your doctor if:

• you have fluid retention in your body or heart failure, especially if you are elderly (over 75 years old). If you are taking non-steroidal anti-inflammatory drugs that can cause fluid retention and swelling, you should also inform your doctor.
• you have a specific eye disease associated with diabetes, called macular edema (swelling in the back of the eye),
• you have cysts on the ovaries (polycystic ovary syndrome). Pioglitazone may increase the likelihood of becoming pregnant, as the medicine may resume ovulation. Women who are affected should use appropriate contraception to avoid unplanned pregnancy.
• you have liver or heart disease. Before starting treatment, you should have a blood test 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 has been observed. You should inform your doctor as soon as possible if you experience symptoms of heart failure such as shortness of breath or sudden weight gain, or localized swelling.

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

You should inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription. You can usually take other medicines while taking 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).

You should inform your doctor or pharmacist about taking these medicines, as additional blood sugar control and adjustment of 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

You should tell your doctor if:

• you are pregnant or think you may be pregnant, or plan to become pregnant
• you are breastfeeding or plan to breastfeed your child. Your doctor will advise you to stop taking the medicine.

Driving and using machines

Pioglitazone does not affect your ability to drive or use machines. However, you should be careful if you experience vision disturbances. Pioglitazone Bioton contains lactose monohydrate. Pioglitazone Bioton contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking Pioglitazone Bioton.

3. How to take Pioglitazone Bioton

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist. The usual starting dose of the medicine is 15 mg or 30 mg taken once a day. Your doctor may recommend increasing the dose to a maximum of 45 mg once a day. Your doctor will determine the dose you should take. If you feel that the effect of Pioglitazone Bioton is too weak, you should consult your doctor. If Pioglitazone Bioton is taken with other anti-diabetic medicines (such as insulin, chlorpropamide, glibenclamide, gliclazide, or tolbutamide), your doctor will decide whether it is necessary to reduce the dose of these medicines. While taking Pioglitazone Bioton, your doctor will recommend periodic blood tests to check liver function. Patients on a diabetic diet should continue to follow it while taking Pioglitazone Bioton. You should regularly check your weight. You should inform your doctor if your weight increases.

Taking a higher dose of Pioglitazone Bioton than recommended

If you accidentally take too many tablets or if someone else or a child takes the medicine, you should immediately contact your doctor or pharmacist. The person's blood sugar levels may drop significantly; in such a situation, you 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

You should try to take Pioglitazone Bioton every day as directed by your doctor. If you miss a dose, you should take the next dose as scheduled. Do 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. You should not stop taking the medicine without consulting your doctor. If you have any other questions about taking Pioglitazone Bioton, you should consult your 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 no 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 you experience any of these symptoms, especially if you are over 65 years old, you should contact your doctor immediately. Bladder cancer occurred infrequently (in no more than 1 in 100 patients) in patients taking pioglitazone. If you experience symptoms such as blood in your urine, pain while urinating, difficulty urinating, or a feeling of urgency to urinate, you should contact your doctor immediately. Swelling occurred very frequently (in more than 1 in 10 patients) in patients taking pioglitazone with insulin. If you experience swelling, you should contact your doctor immediately. Bone fractures occurred frequently (in no more than 1 in 10 patients) in women taking pioglitazone. Fractures have also been observed in men taking pioglitazone (based on available data, the frequency of fractures in this group of patients has not been determined). If you experience a fracture, you should contact your 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 based on available data has not been determined). If this symptom occurs for the first time or worsens, you should contact your doctor immediately. Allergic reactions have been observed with an unknown frequency (based on available data, the frequency of allergic reactions has not been determined) in patients taking pioglitazone. If you experience a severe allergic reaction, including hives or swelling of the face, lips, tongue, throat, and difficulty breathing or swallowing, you should stop taking the medicine and contact your doctor immediately. Other side effects that have occurred in some patients taking pioglitazone include: Frequently (may occur in no more than 1 in 10 patients)

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

Infrequently (may occur in no more than 1 in 100 patients)

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

Other side effects observed in some patients taking pioglitazone with other anti-diabetic medicines: Very frequently (may occur in more than 1 in 10 patients)

• low blood sugar (hypoglycemia)

Frequently (may occur in no more than 1 in 10 patients)

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

Infrequently (may occur in no more than 1 in 100 patients)

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Pioglitazone Bioton contains

The active substance of the medicine is pioglitazone. Each tablet contains 15/30/45 mg of pioglitazone (in the form of hydrochloride). The other ingredients of the medicine 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 side. 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 side. 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 side. 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, UK, LABORATORI FUNDACIÓ DAU, C/ C, 12-14 Pol. Ind. Zona Franca, Barcelona 08040, Spain. For more detailed information, you should contact the representative of the marketing authorization holder. BIOTON S.A., 02-516 Warsaw, ul. Starościńska 5, Tel: +48 (22) 721 40 00

This medicine has been authorized for marketing 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