PYRAZINAMIDE PRODES 250 mg TABLETS

Introduction

Package Leaflet: Information for the User

Pirazinamida Prodes 250 mg Tablets

pirazinamida

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Pirazinamida Prodes and what is it used for
2. What you need to know before taking Pirazinamida Prodes
3. How to take Pirazinamida Prodes
4. Possible side effects
5. Storage of Pirazinamida Prodes
6. Package Contents and Additional Information

1. What is Pirazinamida Prodes and what is it used for

Pirazinamida Prodes is a medication that belongs to the group of medications called antitubercular agents.

Pirazinamida Prodes is used, in combination with other antitubercular medications, in the initial phase of tuberculosis treatment, which usually lasts 2 months.

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2. What you need to know before taking Pirazinamida Prodes

Do not take Pirazinamida Prodes:

• if you are allergic to pirazinamida or any of the other components of this medication (listed in section 6).
• if you have acute liver problems or have had a previous liver problem caused by medication use,
• if you have severe kidney problems,
• if you have hyperuricemia (elevated uric acid levels in the blood) or a history of gout, as this medication decreases uric acid elimination.
• if you have been diagnosed with a condition called porphyria.

Do not take Pirazinamida Prodes if you are in any of the above circumstances.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Pirazinamida Prodes.

Before starting to take this medication, inform your doctor if you have any of the following conditions:

• liver problems and chronic liver disease,
• kidney problems,
• gout,
• diabetes mellitus,
• porphyria.

Inform your doctor if you are pregnant or think you may be pregnant.

Do not interrupt treatment with Pirazinamida Prodes without consulting your doctor.

Other Medications and Pirazinamida Prodes

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Pirazinamida may affect or be affected by other medications. For example:

• With some antitubercular medications, such as isoniazid, rifampicin, and ethionamide, liver toxicity may occur, requiring close monitoring of liver function during treatment.
• With probenecid, an increase in blood uric acid levels and worsening of gout symptoms may occur.
• When pirazinamida and cyclosporin (an immunosuppressant medication) are used simultaneously, a decrease in cyclosporin blood levels may be observed.
• When pirazinamida and zidovudine (an HIV treatment medication) are used simultaneously, a decrease in pirazinamida blood levels may be observed.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will determine if it is possible to continue treatment with this medication during pregnancy.

It is essential to inform your doctor if you are breastfeeding or plan to breastfeed before taking this medication. Your doctor will determine if it is possible to continue treatment with this medication during breastfeeding.

There is no human data available on the long-term effects of pirazinamida on fertility.

Driving and Using Machines

The effects of pirazinamida on the ability to drive and use machines have not been studied. The influence of this product on these functions cannot be predicted.

Pirazinamida Prodes Contains Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Pirazinamida Prodes Contains Sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to Take Pirazinamida Prodes

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose depends on the patient's weight and the frequency of administration:

• Daily administration: the recommended dose ranges from 20 to 30 mg per kg of body weight per day in a single daily dose. The usual dose is 25 mg per kg of body weight per day, but in severe infections, such as meningitis, a higher dose (e.g., 30 mg per kg of body weight per day) may be used.
• Administration three days a week: the recommended dose ranges from 30 to 40 mg per kg of body weight per day in a single daily dose. The usual dose is 35 mg per kg of body weight per day.

The amount of this medication administered to each person may be different, as it depends on their body weight. Your doctor will indicate your daily dose and treatment duration. Do not stop treatment before completing it. Do not exceed the dose of 2g/day (8 tablets/day).

Use in Children

Children ≥ 3 months

The dose for children is based on their weight. It usually ranges from 30 to 35 mg per kg of body weight per day.

The usual dose for children for the treatment of tuberculosis is 35 mg per kg of body weight per day. In children with weight alterations, a dose reduction may be necessary. In severe infections, such as meningitis, a higher dose (e.g., 40 mg per kg of body weight per day) may be used.

There is insufficient data to establish a recommendation for children under three months.

If You Take More Pirazinamida Prodes Than You Should

If you take more tablets than you should, seek advice from your doctor or pharmacist.If possible, show them the package or this package leaflet.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Pirazinamida Prodes

If you forget to take a dose, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next tablet at the usual time. Do not take a double dose to make up for missed doses.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The following side effects have been reported with pirazinamida:

Common: may affect up to 1 in 10 patients

• Allergic reactions.
• Hyperuricemia (elevated uric acid in the blood). Treatment should be discontinued in case of severe hyperuricemia. The induction of hyperuricemia by pirazinamida is dose-related.
• Lack of appetite, abdominal pain, nausea, and vomiting.
• Elevated liver enzymes.
• Muscle and joint pain. This side effect is dose-dependent and is less frequent and more moderate at the recommended dose.
• Worsening of porphyria and acute intermittent porphyria (a group of disorders characterized by photosensitivity, skin lesions, anemia, psychosis, and acute abdominal pain).

Rare: may affect up to 1 in 1,000 patients

• Anemia (sideroblastic), coagulation disorders, changes in platelet count, splenomegaly.
• Dose-related hepatotoxicity, jaundice (yellowing of the skin due to elevated bilirubin), liver hypertrophy.
• Skin rash, urticaria, itching, photosensitivity reactions (after sun exposure), acne.
• Urination disorders, interstitial nephritis (inflammation of the renal tubules).
• Fever.

It is recommended that, in the case of prolonged treatments, liver function tests be performed periodically.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pirazinamida Prodes

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE Pointof the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Pirazinamida Prodes

• The active ingredient is pirazinamida. Each tablet contains 250 mg of pirazinamida.
• The excipients are lactose, magnesium stearate, povidone, talvo (E-553b), and sodium croscarmellose.

Appearance of the Product and Package Contents

White, flat, round tablets with a central score line on the lower and upper smooth surface. The score line should not be used to divide the tablet.

Packages of 100 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Package Leaflet:November 2022.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.