Paracetamol Qualigen 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Paracetamol Qualigen 1 g tablets EFG

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

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

Contents of the leaflet

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

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

Paracetamol belongs to a group of medicines called analgesics and antipyretics. Paracetamol Qualigen is indicated for the treatment of symptoms of moderate pain and fever.

2. What you need to know before taking Paracetamol Qualigen

Do not take Paracetamol Qualigen

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

Warnings and precautions

Do not take more than the recommended dose stated in section 3. How to take Paracetamol Qualigen.

In asthmatic patients who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

Consult your doctor or pharmacist before starting to take Paracetamol Qualigen:

• if you have liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells),

• if you are being treated with antiepileptic medicines, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxic potential of paracetamol, especially with high-dose paracetamol regimens.

• In chronic alcoholics, caution should be taken not to exceed 2 g/24 hours of paracetamol.

• If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, consult your doctor and reassess the clinical situation.

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

You have serious underlying conditions such as severe renal impairment 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 known as metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Children and adolescents

In children under 10 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

Interaction of Paracetamol Qualigen with other medicines

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

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: oral anticoagulants (acenocoumarol, warfarin),
• Medicines for epilepsy: antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine),
• Medicines for tuberculosis: (isoniazid, rifampicin),
• Medicines for depression and seizures: barbiturates (used as hypnotics, sedatives, and anticonvulsants),
• Medicines to lower blood cholesterol levels: (cholestyramine),
• Medicines used to increase urine elimination (loop diuretics such as furosemide),
• Medicines used in the treatment of gout (probenecid and sulfinpyrazone),
• Medicines used to prevent nausea and vomiting: metoclopramide and domperidone,
• Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) requiring urgent treatment (see section 2).

Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking any other medicine. In patients on oral anticoagulants, paracetamol may occasionally be used as the analgesic of choice.

Interference with laboratory tests

If you are scheduled to undergo any laboratory tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Paracetamol Qualigen with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day: beer, wine, spirits, etc.) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you might be, consult your doctor before taking this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Paracetamol Qualigen may 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 duration. Contact your doctor if pain or fever does not subside, or if you need to take the medicine more frequently.

Breast-feeding

Consult your doctor or pharmacist before using any medication.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and using machines

The effect of paracetamol on the ability to drive and operate machinery is none or negligible.

3. How to take Paracetamol Qualigen

Follow exactly the instructions for use of this medicine as given by your doctor. If you are unsure, consult your doctor again.

Remember to take your medicine.

Instructions for use:

Paracetamol Qualigen is available in tablet form and must be taken orally. According to your preference, the tablets can be swallowed whole or split in half, with a glass of liquid, preferably water. The tablets are scored, which allows them to be divided into equal doses.

Consult your doctor or pharmacist if you have any doubts.

Consult your doctor or pharmacist if you have any doubts.

Recommended dose:

Adults and adolescents over 15 years of age: The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.

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 take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: Before taking this medicine, you must consult your doctor.

Take a maximum of 500 milligrams per dose (half a tablet).

Elderly patients: You should consult your doctor.

Use in children and adolescents

It is necessary to follow the dosages based on body weight. The child's age according to weight is provided for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 doses per day, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours. The recommended dose for children weighing 33 kg or more is half a tablet per dose.

• Children weighing between 33 and 40 kg (aged 10 to 12 years): Half a tablet per dose, every 6 hours, up to a maximum of 2 tablets per day.
• Children weighing between 41 and 50 kg (aged 12 to 15 years): Half a tablet per dose, every 4 hours, up to a maximum of 3 tablets per day.

If you feel that the effect of Paracetamol Qualigen is too strong or too weak, inform your doctor or pharmacist.

When doses lower than 1 g of paracetamol per administration are required, it is recommended to use other paracetamol formulations better suited to the required dosage.

If you take more Paracetamol Qualigen than you should

You must consult your doctor or pharmacist immediately. In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

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.

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

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.

If you forget to take Paracetamol Qualigen

Do not take a double dose to make up for a missed dose. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).

If you stop taking Paracetamol Qualigen

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

4. Possible adverse effects

Like all medicines, Paracetamol Qualigen may produce adverse effects, although not everyone experiences them.

Rare adverse effects (occurring in up to 1 in 1,000 people) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in up to 1 in 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Paracetamol may damage the liver when taken in high doses or during prolonged treatment.

Very rare cases of serious skin reactions have been reported.

Adverse effects with unknown frequency (cannot be estimated from the available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in critically ill patients using paracetamol (see section 2).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Paracetamol Qualigen

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

No special storage conditions are required. Store in the original packaging.

Expiry:

Do not use this medicine after the expiry date stated on the packaging. 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 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 Qualigen 1 g tablets EFG

• The active substance is paracetamol.
• The other components are: pregelatinized corn starch, stearic acid, povidone, crospovidone, microcrystalline cellulose and vegetable magnesium stearate.

Appearance of the medicine and contents of the pack

Paracetamol Qualigen 1 g tablets are presented as tablets for oral administration, packed in PVC/PVDC/Aluminum blisters, in packs of 20 and 40 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69 (Sant Joan Despí) – 08970

(Spain).

Date of the most recent revision of this leaflet: February 2025

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