Paracetamol Stadapharm 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paracetamol Stadapharm 1 g 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 given 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 side effects
5. How to store Paracetamol Stadapharm
6. Contents of the pack and further information

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

Paracetamol Stadapharm belongs to a group of medicines called analgesics and antipyretics.

It is used for the treatment of mild to moderate pain and febrile conditions in adults and adolescents aged 16 years and older (or with a body weight above 50 kg).

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 ingredients 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 suffer from 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 efficacy and increase 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 cases, 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 taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing 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 life-threatening. Patients should be informed about the symptoms of severe skin reactions, and the medicine should be discontinued at the first sign of a 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 take an overdose, seek medical attention immediately (see “If you take more Paracetamol Stadapharm than you should”).

This medicine should not be used for self-treatment 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 serious 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 or urine tests), inform your doctor that you are taking this medicine, as it may alter test results. Paracetamol may affect analytical determinations of uric acid and glucose levels.

Children and adolescents

In children and adolescents under 16 years of age, consult your doctor or pharmacist, as other formulations with doses appropriate for these patients may be available.

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 using any of the following medicines, dose adjustments or discontinuation of treatment may be necessary:

Medicines used to treat seizures (antiepileptics such as carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine): combining paracetamol with antiepileptic medicines may cause or worsen liver damage.

Lamotrigine: The effect of lamotrigine may be reduced.

Medicines used to treat high blood pressure and heart rhythm disorders (cardiac arrhythmias) (propranolol): combining paracetamol with propranolol may increase its action and/or toxicity.

Medicines used to treat gout (probenecid): causes a nearly two-fold reduction in paracetamol excretion. Paracetamol dosage should be reduced when administered concomitantly with probenecid.

Medicines used to treat tuberculosis (rifampicin, isoniazid): combining paracetamol with rifampicin or isoniazid may cause or worsen liver damage.

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

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

Medicines used 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 shortens the onset of its action. However, concomitant use does not need to be avoided.

Medicines used 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 on oral anticoagulant therapy should only be done under medical supervision. Potentiation of warfarin effects has been observed with continued high-dose paracetamol.

Medicines used 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 raising the risk of toxicity.

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

Concomitant use of substances that induce liver enzymes, such as barbiturates, carbamazepine, isoniazid, rifampicin, or ethanol, should be considered, as they may enhance the toxic effects 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 disturbances (called metabolic acidosis with high anion gap) that 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Paracetamol may be used during pregnancy if necessary. Use the lowest effective 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 used during breastfeeding.

Driving and using machines

The effect 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; hence, it is essentially “sodium-free”.

3. How to take Paracetamol Stadapharm

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 16 years of age (or weighing more than 50 kg):

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

The tablet may be divided into equal doses.

High daily doses of paracetamol should be avoided over prolonged periods, as this 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 should be discontinued and you should consult your doctor.

Patients with liver disease: Before taking this medicine, you must consult your doctor. You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not exceed 2 grams of paracetamol in 24 hours, divided into two doses. In chronic alcoholics, the daily dose should not exceed 2 g.

Patients with kidney disease: Before taking this medicine, you must consult your doctor. Take a maximum of 500 mg per dose. Due to the dosage, 1 g of paracetamol is not indicated for this patient group.

Elderly patients: You should consult your doctor.

Use in children and adolescents

This medicine is not recommended for use in children and adolescents under 16 years of age or weighing less than 50 kg.

If you feel the effect of paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses than 1 g of paracetamol per dose are required, other formulations of paracetamol adapted to the required dosage should be used.

If you take more Paracetamol Stadapharm than you should

Contact your doctor or pharmacist immediately.

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

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

Patients undergoing treatment with barbiturates 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 Toxicology Information Service at telephone 915 620 420, stating 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 missed dose when you remember, then take the following doses at the recommended intervals (at least 4 hours apart).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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.
• Jaundice (yellowing of the skin), liver failure.
• Skin reactions such as allergic dermatitis, urticaria, itching, skin rash.
• Changes in urination (difficulty or pain when urinating, decreased amount of urine, blood in the urine).

Frequency not known (cannot be estimated from 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 adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Paracetamol Stadapharm Storage

Keep this medicine out of 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unwanted medicines and their containers should be taken to the SIGRE Point at your pharmacy. If you are in doubt, 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 1 g of paracetamol.
• The other components (excipients) are sodium carboxymethylstarch derived from potato (type A), povidone, pregelatinized corn starch, stearic acid.

Appearance of the product and contents of the pack

White or almost white capsule-shaped tablets, with a score line on one side marked “10” and “00” on either side of the score, and on the other side marked “PA” and “RA” on either side of the score. 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 most recent review of this leaflet: January 2025

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