PARACETAMOL STADAPHARM 1 g TABLETS

2. What you need to know before taking Paracetamol Stadapharm

Do not take Paracetamol Stadapharm

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Paracetamol Stadapharm:

• if you have liver problems, including liver problems due to excessive alcohol consumption (3 or more alcoholic drinks per day);
• if you have kidney problems;
• if you have glucose-6-phosphate dehydrogenase deficiency;
• if you have anorexia, bulimia, cachexia, or chronic malnutrition;
• if you have dehydration or hypovolemia;
• if you are taking a medicine to treat epilepsy, you should consult your doctor before taking this medicine, as when used at the same time, it decreases the efficacy and increases the hepatotoxicity of paracetamol, especially in high-dose paracetamol treatments (see below in this section "Other medicines and Paracetamol Stadapharm");
• if you have Gilbert's disease (also known as Meulengracht's disease);
• if you have heart problems, respiratory failure, or anemia; in these situations, administration should be done under surveillance and only for short periods;
• if you have asthma and are sensitive to acetylsalicylic acid.

During treatment with Paracetamol Stadapharm, inform your doctor immediately if:

• you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Paracetamol may cause severe skin reactions, such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the symptoms of severe skin reactions and the use of the medicine should be discontinued at the first symptom of skin rash or any other symptom of hypersensitivity.

Do not take more paracetamol than recommended in section 3 "How to take Paracetamol Stadapharm"). You should avoid the simultaneous use of this medicine with other medicines that contain paracetamol, such as medicines for flu and colds, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor. If you suffer an overdose, seek medical attention immediately (see "If you take more Paracetamol Stadapharm than you should").

This medicine should not be used for self-medication of high fever (over 39°C), fever that lasts more than 3 days, or recurrent fever, unless your doctor prescribes it, as these situations may require medical evaluation and treatment.

The administration of paracetamol doses higher than recommended implies a very serious risk of liver injury. Medicines that contain paracetamol should not be taken for more than a few days or in high doses, unless your doctor indicates it.

The prolonged use of analgesics or the inadequate use of high doses can cause headaches, which should not be treated with higher doses of the medicine.

Interference with laboratory tests:If you are going to have any laboratory tests (including blood tests, urine tests, etc.), inform your doctor that you are taking this medicine, as it may alter the results. Paracetamol may alter the values of analytical determinations of uric acid and glucose.

Children and adolescents

In children and adolescents under 16 years, consult your doctor or pharmacist, as there may be other presentations available with doses that are suitable for these patients.

Other medicines and Paracetamol Stadapharm

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

In particular, if you are using some of the following medicines, it may be necessary to modify the dose of some of them or interrupt treatment:

Medicines to treat seizures (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine): the combination of paracetamol and antiepileptic medicines can cause or worsen liver damage.

Lamotrigine: The effect of lamotrigine may decrease.

Medicines to treat high blood pressure and heart rhythm disorders (arrhythmias) (propranolol): the combination of paracetamol and propranolol can increase the action and/or toxicity.

Medicines to treat gout (probenecid): causes a reduction of almost 2 times in the excretion of paracetamol. The dose of paracetamol should be considered when concomitant treatment with probenecid is administered.

Medicines to treat tuberculosis (rifampicin, isoniazid): the combination of paracetamol and rifampicin or isoniazid can cause or worsen liver damage.

Salicylamide, a medicine to treat fever and pain: can prolong the elimination half-life (t1/2) of paracetamol.

Medicines to reduce cholesterol levels in the blood (cholestyramine): reduces the absorption of paracetamol. To avoid this, paracetamol should be administered one hour before or 4 hours after the resin.

Medicines to prevent nausea and vomiting (metoclopramide and domperidone): the simultaneous ingestion of medicines that cause gastric emptying acceleration, e.g., metoclopramide and domperidone, increase the absorption and anticipate the onset of the action of paracetamol. However, it is not necessary to avoid concomitant use.

Medicines to prevent blood clots (oral anticoagulants such as acenocoumarol, warfarin): paracetamol can increase the effects of oral anticoagulants. The prolonged use of this medicine in patients treated with oral anticoagulants should only be done under medical supervision. The potentiation of the effects of warfarin has been observed with continued high doses of paracetamol.

Medicines to increase urine production (loop diuretics such as furosemide): the effects of diuretics may be reduced.

Chloramphenicol, a medicine to treat infections: the simultaneous administration of paracetamol and chloramphenicol can significantly delay the elimination of chloramphenicol, increasing its plasma concentrations and causing a higher risk of toxicity.

Zidovudine (AZT), a medicine used in viral diseases: the concomitant administration of paracetamol and AZT can increase the incidence of neutropenia or worsen it (reduction of white blood cell count). Paracetamol should only be taken simultaneously with AZT if your doctor recommends it.

Concomitant use of substances that induce hepatic enzymes, such as barbiturics, carbamazepine, isoniazid, rifampicin, or ethanol, should be taken into account, as they may potentiate the toxic effect of paracetamol.

Inform your doctor if this medicine is taken with medicines that delay gastric emptying (e.g., propanteline) or accelerate gastric emptying (e.g., metoclopramide and domperidone).

Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anion gap) that should be treated urgently (see section 2).

Taking Paracetamol Stadapharm with alcohol

Do not drink alcohol during treatment with paracetamol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Paracetamol can be used during pregnancy if necessary. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding

Paracetamol passes into breast milk. Therapeutic doses of paracetamol can be administered during breastfeeding.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant. However, during treatment with paracetamol, you may observe side effects such as mild drowsiness and dizziness.

Paracetamol Stadapharm contains sodium

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

3. How to take Paracetamol Stadapharm

Follow the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 16 years (or weight over 50 kg):

The usual dose is one tablet (1 g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 3 grams (3 tablets) in 24 hours.

The tablet can be divided into equal doses.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsens or other symptoms appear, you should discontinue treatment and consult your doctor.

Patients with liver disease: before taking this medicine, they must consult their doctor. They should take the prescribed amount of medicine by their doctor with a minimum interval of 8 hours between each dose. They should not take more than 2 grams of paracetamol in 24 hours, divided into two doses. In chronic alcoholics, the dose should not exceed 2 g per day.

Patients with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 mg per dose. Due to the dose, 1 g of paracetamol is not indicated for this group of patients.

Elderly patients: should consult their doctor.

Use in children and adolescents

This medicine is not recommended for children and adolescents under 16 years or weight under 50 kg.

If you think the action of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses of paracetamol are required per dose, other presentations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol Stadapharm than you should

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not manifest until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours after ingestion of the medicine.

Patients treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service, phone 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Paracetamol Stadapharm

Do not take a double dose to make up for forgotten doses, simply take the forgotten dose when you remember, taking the following doses with the separation between doses indicated in each case (at least 4 hours).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been reported in patients treated with paracetamol:

Rare(may affect up to 1 in 1,000 people):

• Discomfort.
• Low blood pressure (hypotension).
• Increased liver enzymes.

Very rare(may affect up to 1 in 10,000 people):

• Changes in blood, including changes in blood cell counts (such as abnormally low levels of certain blood elements that can cause, for example, bleeding through the nose or gums) and bleeding.
• Allergic reactions (symptoms such as edema, shortness of breath, sweating, nausea, sudden drop in blood pressure).
• Disruption of blood sugar.
• Jaundice (yellowing of the skin), liver failure.
• Skin reactions such as allergic dermatitis, urticaria, itching, skin rash.
• Changes in urination (difficult or painful urination, decreased amount of urine, and blood in the urine).

Frequency not known(cannot be estimated from the available data):

• A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting of 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 Medicines and Health Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Stadapharm

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines that you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Stadapharm

• The active substance is paracetamol. Each tablet contains 1 g of paracetamol.
• The other components (excipients) are sodium starch glycolate (type A), povidone, pregelatinized corn starch, stearic acid.

Appearance of the product and contents of the pack

White or almost white tablets, capsule-shaped with a score line marked on one face with "10" and "00" on either side of the score line and on the other face with "PA" and "RA" on either side of the score line. The tablet can be divided into equal doses.

Paracetamol Stadapharm is available in blisters containing 10 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

Manufacturer

Qualimetrix S.A.

579 Mesogeion Avenue, Agia Paraskevi,

Athens, 15343

Greece

Date of the last revision of this package leaflet:January 2025

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