PARACETAMOL QUALIGEN 1 g TABLETS

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 components of this medication (listed in section 6).

Warnings and precautions

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

In patients with asthma who are sensitive to acetylsalicylic acid, you should consult your doctor before taking this medication.

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

• if you have any liver, kidney, heart, or lung disease, or if you have anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells),
• when you are being treated with any medication for epilepsy, you should consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially in treatments with high doses of paracetamol.

• In chronic alcoholics, you should be cautious not to take more than 2 g/24 hours of paracetamol.
• 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 consult your doctor and reevaluate the clinical situation.

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

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 if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in the 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 of discomfort (nausea) and vomiting.

Children and adolescents

In children under 10 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

Interaction of Paracetamol Qualigen with other medications

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

Paracetamol may interact with the following medications:

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin),
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine),
• Medications for treating tuberculosis: (isoniazid, rifampicin),
• Medications for treating depression and convulsions: Barbiturics (used as hypnotics, sedatives, and anticonvulsants),
• Medications for reducing cholesterol levels in the blood: (cholestyramine),
• Medications used to increase urine elimination (loop diuretics such as furosemide),
• Medications used for the treatment of gout (probenecid and sulfinpyrazone),
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone,
• Medications used in the treatment of high blood pressure and heart rhythm disorders (arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medication. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests

If you are going to undergo any analytical test (including blood tests, urine tests, skin tests that use allergens, etc…), inform your doctor that you are taking this medication, 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 beverages per day: beer, wine, liquor....per day) may cause liver damage.

Taking this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

In case of necessity, Paracetamol Qualigen can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever does not decrease or if you need to take the medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Small amounts of paracetamol may appear in breast milk, so it is recommended that you consult your doctor or pharmacist before taking this medication.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

3. How to take Paracetamol Qualigen

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

Remember to take your medication.

Mode of use:

Paracetamol Qualigen is presented in tablet form and should be taken orally. According to your preferences, the tablets can be taken directly or broken in half, with the help of a glass of liquid, preferably water. The tablets are scored, which allows the tablet 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.

The recommended dose is:

Adults and adolescents over 15 years:The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. The 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 medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval between each dose of 8 hours. Do not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: Before taking this medication, they must consult their doctor.

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

Elderly patients:Must consult their doctor

Use in children and adolescents

It is necessary to respect the dosages defined according to weight. The age of the child according to weight is given for informational purposes.

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

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

If you think the action of Paracetamol Qualigen is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol are required, it is recommended to use other presentations of paracetamol that adapt to the required dosage.

If you take moreParacetamol Qualigenthan you should

You should 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 medication and the amount ingested.

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

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

Treatment of the overdose is more effective if started within 4 hours of taking the medication.

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

If you forget to takeParacetamol Qualigen

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

If you stop treatment with Paracetamol Qualigen

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Paracetamol Qualigen can cause side effects, although not everyone will experience them.

Rare side effects that may occur (up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Paracetamol may damage the liver when taken in high doses or in prolonged treatments.

Very rare cases of severe skin reactions have been reported.

Side effects with unknown frequency (cannot be estimated from available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

If you think any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of Paracetamol Qualigen

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

No special storage conditions are required. Keep in the original package.

Expiration date:

Do not use this medication after the expiration date shown on the package. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Qualigen 1 g tablets EFG

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

Appearance of the product and package contents

Paracetamol Qualigen 1 g tablets are presented in oral tablet form, packaged in PVC/PVDC/Aluminum blisters, in packages of 20 and 40 tablets.

Marketing authorization holder and manufacturer

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 last revision of this prospectus: February 2025

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