PARACETAMOL QUALIGEN 1g EFFERVSCENT TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Qualigen 1 g Effervescent Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet

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

1. What is Paracetamol Qualigen and what is it 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 you take 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 in section 3. How to take Paracetamol Qualigen.

In asthmatic patients 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 any liver, kidney, heart or lung disease, or if you have anemia (reduced hemoglobin level in the blood, due to or not due to a reduction in red blood cells),
• when you are being treated with any medicine for epilepsy, you should consult your doctor before taking this medicine, because when used at the same time, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in treatments with high doses of paracetamol.

• in chronic alcoholics, caution should be exercised 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 worsens or other symptoms appear, you should consult your doctor and reassess 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 suffer from 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 together with flucloxacillin. The symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children and Adolescents

In children and adolescents under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are adapted to this group of patients.

Interaction of Paracetamol Qualigen with other medicines

Inform your doctor or pharmacist if you are using, have recently used or may need to use any other medicine.

Paracetamol may interact with the following medicines:

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

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

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with another medicine. 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 have any analytical test (including blood tests, urine tests, skin tests that use 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 beverages per day: beer, wine, liquor... per day) 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy can be dangerous for 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 medicine more frequently.

Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

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

Driving and Using Machines

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

Paracetamol Qualigen contains sorbitol (E-420), lactose, and sodium

• This medicine contains 205.50 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor before taking this medicine.
• This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.
• This medicine contains 330 mg of sodium (main component of table salt/cooking salt) in each tablet. This is equivalent to 16.5% of the maximum daily sodium intake recommended for an adult.

3. How to take Paracetamol Qualigen

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

Remember to take your medicine.

Mode of employment:

Paracetamol Qualigen is presented in the form of effervescent tablets and should be taken orally. Dissolve the tablet completely in a glass of water. Before ingesting the medicine, it is necessary that the effervescence ceases.

Consult your doctor or pharmacist if you have 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 medicine, they must consult their doctor. They should take the amount of medicine prescribed by their doctor with a minimum interval between each dose of 8 hours. They should not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

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

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, the medicine is not indicated for this group of patients.

Elderly patients:They should consult their doctor

Use in children and adolescents

Do not use in children or adolescents under 15 years of age.

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

When it is necessary to administer doses lower than 1 g of paracetamol per dose, other presentations of paracetamol that adapt to the required dosage should be used.

If you take more Paracetamol Qualigen than 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 medicine 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, since they often do not appear until 3 days after ingestion, 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 overdose is more effective if started within 4 hours of ingestion of the medicine.

Patients being treated with barbiturics 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 forgotten doses, simply take the forgotten dose when you remember, taking the next doses with the indicated separation between doses (at least 4 hours).

If you stop taking Paracetamol Qualigen

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

4. Possible Side Effects

Like all medicines, Paracetamol Qualigen can cause side effects, although not everybody gets 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 can 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 the available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of Paracetamol Qualigen

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

Do not store above 30°C.

Keep in the original package to protect from moisture.

Expiry date:

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Qualigen 1 g Effervescent Tablets EFG

• The active substance is paracetamol.
• The other ingredients are: Sodium bicarbonate, anhydrous citric acid (E-330), sorbitol (E-420), lactose monohydrate, sodium saccharin (E-954ii), lemon flavor, L-Leucine, ascorbic acid (E-300) and povidone.

Appearance of the product and contents of the pack

Paracetamol Qualigen 1 g Effervescent Tablets EFG are presented in the form of white effervescent tablets with a slight lemon flavor and scored, which are packaged in propylene tubes with a polyethylene cap and a silica gel desiccant and are presented in packs of 20 tablets (1 tube of 20 tablets) and 40 tablets (2 tubes of 20 tablets).

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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- Barcelona

Spain.

Date of the last revision of this leaflet: February 2025

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