Prospecto:Information for the User

Paracetamol Qualigen1 g Tablets EFG

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

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

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

2.What you need to know before starting to take Paracetamol Qualigen

3.How to take Paracetamol Qualigen

4.Possible adverse effects

5.Storage of Paracetamol Qualigen

6. Contents of the package and additional information

Paracetamolbelongs to a group of medicines called analgesics and antipyretics.Paracetamol Qualigen, isindicated for the treatment of symptoms of moderate painand fever.

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 as stated in section 3, Taking Paracetamol Qualigen.

In patients with asthma sensitive to acetylsalicylic acid, 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 have anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells),
• when you are being treated with any medication for epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is decreased and the hepatotoxicity of paracetamol is increased, especially in treatments with high doses of paracetamol.

• In chronic alcoholics, be careful 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 the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.

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

You have severe diseases, such as severe renal insufficiency 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 (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

In children under 10 years, consult your doctor or pharmacist, as there are other presentations with doses adapted to this group of patients.

Interactions of Paracetamol Qualigen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants),
• Medications to lower cholesterol levels in the blood: (cholestyramine),
• Medications used to increase urine elimination (diuretics such as furosemide),
• Medications used to treat gout (probencid and sulfinpyrazone),
• Medications used to prevent nausea and vomiting: metoclopramide and domperidone,
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): propranolol.
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid alteration (called metabolic acidosis) that must receive 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 inform your doctor or pharmacist if you are being treated with another medication. In the case of oral anticoagulants, Paracetamol Qualigen can be administered occasionally as the preferred analgesic.

Interference with analytical tests

If you are to undergo any analytical test (including blood, urine, skin tests using 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 regularly consume alcohol (three or more alcoholic beverages per day: beer, wine, liquor, etc.) may cause liver damage.

The taking of this medication with food does not affect the efficacy of the medication.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend 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 consumption of medications during pregnancy can be hazardous to the embryo or fetus, and should be monitored by your doctor.

In the event of a need, Paracetamol Qualigen can be used during pregnancy. 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 do not decrease or if you need to take the medication more frequently.

Lactation

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

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

Remember to take your medication.

Mode of use:

Paracetamol Qualigense is presented in the form of tablets and should be taken orally. According to your preference, the tablets can be ingested directly or divided in half, with the help of a 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 doubts.

Consult your doctor or pharmacist if you have doubts.

The recommended dose is:

Adults and adolescents over 15 years old:The usual dose is 1 tablet (1 g of paracetamol) 3 times a day. The doses should be spaced at least 4 hours apart. No more than 4 tablets (4 g) should be taken 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 of 8 hours between each dose. They should 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).

Older patients:They should 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 information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 daily doses, that is15 mg/kg every 6 hours or 10 mg/kg every 4 hours.The recommended dose in childrenover 33 kgis half a tablet per dose.

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

If it is estimated that the action ofParacetamol Qualigenis too strong or too weak, inform your doctor or pharmacist.

When requiring the administration of doses less than 1 g of paracetamol per dose, it isrecommendedto use other paracetamol presentations 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 Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you have ingested an overdose, go immediately to a medical center even if you do not notice the symptoms, as they often do not manifest until 3 days after the 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.

The treatment of overdose is more effective if it is initiated within 4 hours of the ingestion of the medication.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to takeParacetamol Qualigen

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

If you interrupt the treatment with Paracetamol Qualigen

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

Like all medications, Paracetamol Qualigen can produce adverse effects, although not all people experience them.

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

Severe skin reactions have been reported very rarely.

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

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

Keepthis medicationout ofsightand out ofreach of children.

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

Expiration Date:

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Paracetamol Qualigen 1 g tablets EFG

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

Appearance of the product and content of the container

Paracetamol Qualigen 1 g tablets are presented in the form of oral tablets for administration in PVC/PVDC/Aluminum blisters, in containers of 20 and 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona - Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

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

(Spain).

Last review date of this leaflet: February 2025

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