Paracetamol Stadapharm 500 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paracetamol Stadapharm 500 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens, or if fever persists beyond 3 days of treatment, or pain beyond 5 days.

Contents of the leaflet

1. What Paracetamol Stadapharm is and what it is used for
2. What you need to know before taking Paracetamol Stadapharm
3. How to take Paracetamol Stadapharm
4. Possible adverse effects
5. How to store Paracetamol Stadapharm
6. Contents of the pack and other information

1. What Paracetamol Stadapharm is and what it is used for

Paracetamol Stadapharm is an analgesic medicine (relieves pain) and antipyretic (reduces fever).

It is used for the short-term symptomatic treatment of mild to moderate pain (lasting no more than 5 days) and/or fever (lasting no more than 3 days), in adults and adolescents aged 12 years and older (or with body weight above 40 kg).

2. What you need to know before using Paracetamol Stadapharm

Do not take Paracetamol Stadapharm

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

Warnings and precautions

Talk to 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 are dehydrated or have hypovolemia;
• if you are taking medication for epilepsy, you should consult your doctor before taking this medicine, as its simultaneous use may reduce the efficacy and increase the hepatotoxicity of paracetamol, especially with 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 under medical supervision 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 serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Paracetamol may cause serious 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 serious skin reactions, and use of the medicine must be discontinued at the first sign of skin rash or any other symptom of hypersensitivity.

Do not take more paracetamol than recommended in section 3 “How to take Paracetamol Stadapharm”.

Concurrent use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor. If you experience an overdose, seek immediate medical attention (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 lasting more than 3 days, or recurrent fever, unless prescribed by your doctor, as these conditions may require medical evaluation and treatment.

Taking paracetamol doses higher than recommended poses a risk of severe liver injury. Medicines containing paracetamol should not be taken for more than a few days or in high doses unless directed by your doctor.

Prolonged use of analgesics or inappropriate use of high doses may cause headaches, which should not be treated with higher doses of the medicine.

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

Children and adolescents

This medicine must not be used in children under 12 years of age or weighing less than 40 kg.

Other medicines and Paracetamol Stadapharm

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

In particular, if you are taking any of the following medicines, dose adjustments or discontinuation of treatment may be necessary:

Medicines for treating seizures (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine): the combination of paracetamol and antiepileptic drugs may cause or worsen liver damage.

Lamotrigine: The effect of lamotrigine may be reduced.

Medicines for treating high blood pressure and heart rhythm disorders (cardiac arrhythmias) (propranolol): the combination of paracetamol and propranolol may increase the action and/or toxicity.

Medicines for treating gout (probenecid): causes a reduction of almost 2-fold in the excretion of paracetamol. A reduction in the dose of paracetamol should be considered when probenecid is used concomitantly.

Medicines for treating tuberculosis (rifampicin, isoniazid): the combination of paracetamol and rifampicin or isoniazid may cause or worsen liver damage.

Salicylamide, a medicine for treating fever and pain: may prolong the elimination half-life (t1/2) of paracetamol.

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

Medicines to prevent nausea and vomiting (metoclopramide and domperidone): simultaneous intake of medicines that accelerate gastric emptying, e.g., metoclopramide and domperidone, increases the absorption of paracetamol and advances the onset of its action. However, concomitant use does not need to be avoided.

Medicines to prevent blood clots (oral anticoagulants such as acenocoumarol, warfarin): paracetamol may enhance the effects of oral anticoagulants. Prolonged use of this medicine in patients treated with oral anticoagulants should only be done under medical supervision. Potentiation of warfarin effects has been observed with continued high-dose paracetamol.

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

Chloramphenicol, a medicine used to treat infections: simultaneous administration of paracetamol and chloramphenicol may 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: concomitant administration of paracetamol and AZT may increase the incidence of neutropenia or worsen it (reduction in white blood cell count). Paracetamol should only be taken simultaneously with AZT if your doctor recommends it.

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

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

Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap), which requires urgent treatment (see section 2).

Taking Paracetamol Stadapharm with alcohol

You should not drink alcohol during treatment with paracetamol.

Pregnancy and breastfeeding

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

Pregnancy

Paracetamol may be used during pregnancy if necessary. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor or midwife if pain or fever does not improve or if you need to take the medicine more frequently.

Breastfeeding

Paracetamol passes into breast milk. Therapeutic doses of paracetamol may be taken during breastfeeding.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is negligible or none. However, during treatment with paracetamol, mild drowsiness and dizziness may occur as adverse effects.

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 exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults is 1 to 2 tablets, one to three times daily (a maximum of 6 tablets per day) with a large glass of water. Maximum daily dose: 3 g/day.

The prolonged use of high daily doses of paracetamol should be avoided, as it increases the risk of adverse effects, such as liver damage.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment must be discontinued and you should consult your doctor.

Liver diseases

Consult your doctor before taking this medicine. You should take the amount of medicine prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not exceed 2 grams of paracetamol (4 tablets) in 24 hours. In chronic alcoholics, the dose should not exceed 2 g per day.

Kidney diseases

Consult your doctor before taking this medicine. Take a maximum of 1 tablet. Depending on the severity of your kidney disease, your doctor will advise whether you should take your medicine with a minimum interval of 6 or 8 hours.

Elderly patients

No dose adjustment is necessary.

Use in children and adolescents

• Between 12 and 15 years of age (or body weight above 40 kg): 1 tablet, one to three times daily with a large glass of water.
• Over 15 years of age (and body weight above 55 kg): follow adult use recommendations.
• This medicine is not recommended for children and adolescents under 12 years of age or weighing less than 40 kg. This medicine is not intended for children and adolescents under 12 years of age or weighing less than 40 kg. Ask your pharmacist.

If you take more Paracetamol Stadapharm than you should

Contact your doctor or pharmacist immediately, even if you feel well. Symptoms of severe liver damage may be delayed by 1 to 2 days. Proper management of paracetamol overdose requires immediate treatment. Despite the absence of early symptoms, patients should be taken to hospital for immediate treatment.

Symptoms of overdose include nausea, vomiting, anorexia, pallor, malaise, diaphoresis, and abdominal pain, and usually appear within the first 24 hours.

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

If you forget to take Paracetamol Stadapharm

If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Remember to leave at least four hours between doses. Do not take a double dose to make up for a missed dose.

If you stop treatment with Paracetamol Stadapharm

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

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

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

• Blood disorders may occur, including changes in blood cell counts (such as abnormally low levels of certain blood components which may cause, for example, bleeding from the nose or gums) and bleeding.
• Allergic reactions (symptoms such as edema, shortness of breath, sweating, nausea, sudden drop in blood pressure).
• Disturbance in blood sugar levels.
• Jaundice (yellowing of the skin), liver failure.
• Skin reactions such as allergic dermatitis, urticaria, itching, rash.
• Changes in urination (difficulty or pain when urinating, decreased amount of urine, blood in the urine).

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

• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es By reporting adverse 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 any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Stadapharm

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other components (excipients) are sodium carboxymethylstarch potato (type A), povidone, pregelatinized corn starch, stearic acid.

Nature of the product and pack contents

White, capsule-shaped tablets marked with “500” on one side and smooth on the other.

Paracetamol Stadapharm is available in blisters containing 20 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 most recent review of this leaflet: January 2025

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