Pirazinamid Farmapol

Package Leaflet: Information for the User

PYRAZINAMID FARMAPOL

500 mg, tablets

Pyrazinamide

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

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

1. What Pyrazinamid Farmapol is and what it is used for

Pyrazinamid Farmapol contains pyrazinamide, an active substance with strong anti-tuberculosis activity (inhibiting the growth of tuberculosis bacteria). Pyrazinamid Farmapol is used in combination with other anti-tuberculosis medicines to increase the effectiveness of treatment and reduce the number of relapses.

Indications for use:

• in the first phase of tuberculosis treatment, i.e. during intensive treatment (first two months) in combination with rifampicin and isoniazid; this increases the effectiveness of treatment, accelerates sputum conversion, and reduces the number of relapses;
• in the treatment of pulmonary and extrapulmonary tuberculosis caused by bacteria resistant to major anti-tuberculosis chemotherapeutics (isoniazid or rifampicin), always in combination with other anti-tuberculosis medicines.

2. Important information before taking Pyrazinamid Farmapol

When not to take Pyrazinamid Farmapol

Do not take Pyrazinamid Farmapol if you have:

• hypersensitivity to the active substance or any of the other ingredients of this medicine (listed in section 6);
• liver failure;
• gout (a disease characterized by excessive production of uric acid in the body, which deposits in the form of crystals in joints and periarticular tissues, causing severe pain);
• porphyria (a disease characterized by abnormal production of heme - a component of hemoglobin). If you are pregnant or breastfeeding.

Warnings and precautions

Pyrazinamid Farmapol may cause:

• increased uric acid levels in the blood and the occurrence of gout symptoms. At the beginning of treatment, the doctor will recommend determining uric acid levels in the blood. If the patient experiences symptoms of acute arthritis, the medicine should be discontinued and the doctor contacted.
• liver damage. If the patient experiences any liver function disorders, the medicine should be discontinued and the doctor contacted. The doctor will recommend liver function tests before starting treatment and regularly during treatment. Pyrazinamid Farmapol should be used:
• with caution in patients with a history of liver disease and in patients with an increased risk of liver inflammation (e.g. those who abuse alcohol). The medicine should not be used in these patients if liver function tests already indicate liver failure before starting treatment.
• with caution in patients with renal impairment; the doctor will determine the dosage and duration of treatment.
• with caution in patients with diabetes, as the medicine may cause difficulties in its treatment.

In adults, it is recommended to start taking the medicine in a hospital, then the medicine can be taken under the supervision of a specialist doctor.

Children

Pyrazinamid Farmapol can be used in children only in a hospital setting.

Pyrazinamid Farmapol and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take. Before taking Pyrazinamid Farmapol, inform your doctor if you are taking:

• insulin or oral anti-diabetic medicines (used to treat diabetes);
• allopurinol, colchicine, probenecid, sulfinpyrazone (medicines used to treat gout), as Pyrazinamid Farmapol reduces their effectiveness; the doctor will adjust the doses of these medicines;
• cyclosporine (a medicine used in patients after organ transplantation), as Pyrazinamid Farmapol may reduce its effectiveness; therefore, the doctor will monitor cyclosporine levels and adjust its dosage;
• levofloxacin (a medicine used to treat certain bacterial infections) - it should not be taken at the same time as Pyrazinamid Farmapol due to the risk of side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine if you are pregnant, breastfeeding, or think you may be pregnant.

Driving and using machines

There are no data on the effect on psychophysical abilities, ability to drive vehicles, and operate machinery.

3. How to take Pyrazinamid Farmapol

Take this medicine always exactly as your doctor has told you. If you are not sure, ask your doctor.

Recommended dosage

Usually, 20 to 30 mg per kilogram of body weight is administered in a single dose per day. In adults, 3 tablets (1.5 g) are usually taken once a day. Do not take more than 4 tablets (2 g) per day. The medicine should be taken orally, with water. The medicine can be taken regardless of meals.

Patients with renal impairment

The doctor will recommend a lower dose than usual.

Overdose of Pyrazinamid Farmapol

If you have taken more than the recommended dose of the medicine, contact your doctor immediately.

Missed dose of Pyrazinamid Farmapol

If you forget to take a dose of Pyrazinamid Farmapol, but remember within 12 hours of the time you usually take it, take the missed dose immediately, and then take the next dose at the usual time. If you forget for more than 12 hours, simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Pyrazinamid Farmapol

Only your doctor can decide to stop treatment.

4. Possible side effects

Like all medicines, Pyrazinamid Farmapol can cause side effects, although not everybody gets them. The following side effects may occur:

• liver damage (the first symptoms may be jaundice, increased liver enzyme activity in the blood AlAT and AspAT); the harmful effect of the medicine on the liver depends on the dose and may occur at any time during treatment;
• increased uric acid levels in the blood, leading to the occurrence of gout (joint inflammation with redness, swelling, warmth, and severe pain);
• nausea, vomiting, loss of appetite;
• iron deficiency anemia (also known as anemia, characterized by progressive weakness, easy fatigue, pallor of the skin and mucous membranes, concentration disorders, nail fragility, hair loss);
• sideroblastic anemia (a type of anemia caused by excessive iron deposition in the bone marrow);
• thrombocytopenia (reduced platelet count, increasing the risk of bleeding and bruising);
• blood coagulation disorders (rarely);
• mild joint pain and muscle pain;
• malaise;
• allergic reactions (such as skin rash, urticaria, itching);
• fever (rarely);
• photosensitivity;
• porphyria (a disease characterized by abnormal production of heme - a component of hemoglobin);
• urination disorders;
• kidney function disorders (interstitial nephritis).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 Pyrazinamid Farmapol

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Store in the original package to protect from moisture. Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Pyrazinamid Farmapol contains

• The active substance is pyrazinamide. One tablet contains 500 mg of pyrazinamide.
• The other ingredients are: potato starch, talc, sodium carboxymethyl starch (type C).

What Pyrazinamid Farmapol looks like and contents of the pack

Pyrazinamid Farmapol is a white, round tablet with the inscription "PYRAZINAMID" embossed on one side. The pack contains 250 tablets.

Marketing authorization holder and manufacturer

Pharmaceutical Company Farmapol Sp. z o.o., ul. Święty Wojciech 29, 61-749 Poznań, tel.: +48 61 852 63 53, e-mail: [email protected]. For more detailed information, please contact the representative of the marketing authorization holder. Information for the blind and visually impaired:the content of the leaflet is available on a free phone number: 800 706 848. Date of leaflet approval: 06/2021