Package Insert: Information for the User

Pirazinamida Prodes 250 mg Tablets

pirazinamida

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Pirazinamida Prodes is a medication that belongs to the group of medications known as antituberculosos.

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

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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 the use of medications,
• if you have severe kidney problems,
• if you have hyperuricemia (elevated levels of uric acid in the blood) or a history of gout, as this medication decreases the elimination of uric acid.
• if you have been confirmed to have a disease 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 diseases:

• 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 taken recently, 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, toxic effects in the liver may appear, requiring close monitoring of liver function during treatment.
• With probenecid, an increase in uric acid levels in the blood and worsening of gout symptoms may occur.
• When pirazinamida and ciclosporin (immunosuppressant medication) are used simultaneously, a decrease in ciclosporin concentrations in the blood may be observed.
• When pirazinamida and zidovudine (medication for HIV treatment) are used simultaneously, a decrease in pirazinamida concentrations in the blood may be observed.

Pregnancy,breastfeeding, and fertility

If you are pregnant, think you may be pregnant, or intend 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 intend to do so before taking this medication. Your doctor will determine if it is possible to continue treatment with this medication during breastfeeding.

No long-term data in humans are available on the ability of pirazinamida to alter fertility.

Driving and operating machines

The effects of pirazinamida on the ability to drive and operate 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 indicated 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".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

• Administration every day: the recommended dose ranges from 20 to 30 mg per kg of body weight per day in a single daily dose. The most common dose is 25 mg per kg of body weight per day, but in severe infections, for example, meningitis, a higher dose (such as 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 most common 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 inform you of your daily dose and the duration of your treatment. Do not discontinue your treatment prematurely. Do not exceed a dose of 2g/day (8 tablets/day).

Use in children

Children ≥ 3 months

The dose for children is based on their weight. Normally, it ranges from 30 mg 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, for example, meningitis, a higher dose, such as 40 mg per kg of body weight per day, may be used.

There are not enough 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, ask your doctor or pharmacist for advice. If possible, show them the packaging or this leaflet.

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

If you forgot to takePirazinamida Prodes

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

A list of adverse effects is shown below.

The following adverse effects have been reported with pirazinamida:

Frequent: may affect up to 1 in 10 patients

• Allergic reactions.
• Hyperuricemia (elevation of uric acid in blood). Treatment should be discontinued in case of severe hyperuricemia. The induction of hyperuricemia by pirazinamida is dose-related.
• Loss of appetite, abdominal pain, nausea, and vomiting.
• Elevation of liver enzymes.
• Muscle and joint pain. This side effect depends on the dose, and is less frequent and more moderate at the recommended dose.
• Worsening of porphyria and intermittent acute porphyria (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 (yellow discoloration of skin due to elevated bilirubin), hepatomegaly.
• Dermatological reactions, urticaria, pruritus, photosensitivity reactions (after exposure to sunlight), acne.
• Urination difficulties, interstitial nephritis (inflammation of renal tubules).
• Fever.

It is recommended, in the case of very prolonged treatments, to perform periodic liver function tests.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pirazinamida Prodes

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

Appearance of the product and content of the packaging

White, round, flat-edged tablets with a central groove on the lower face and a smooth upper face. The groove should not be used to divide the contents.

Packaging of 100 tablets.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:November 2022.

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