PARACETAMOL QUALIX 1 g TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Qualix 1g Coated Tablets EFG

Paracetamol

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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

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

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

It is indicated for the treatment of symptoms of pain and fever.

2. What you need to know before you take Paracetamol Qualix

Do not take Paracetamol Qualix:

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

Be cautious with Paracetamol Qualix:

• Do not take more than the recommended dose in section 3. How to take Paracetamol Qualix.
• In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have any kidney, liver, 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), you should consult your doctor before taking this medicine.
• When being treated with any medication for epilepsy, consult your doctor before taking this medicine, as the efficacy of paracetamol may be decreased and hepatotoxicity increased, especially with high doses of paracetamol.
• In chronic alcoholics, be cautious not to take more than 2g/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, consult your doctor and reassess the clinical situation.
• In children under 15 years of age, consult your doctor or pharmacist, as there are other formulations with doses suitable for this group of patients.
• During treatment with Paracetamol Qualix, 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 organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in 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 respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Taking other medicines and Paracetamol Qualix

Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines for treating tuberculosis: (isoniazid, rifampicin)
• Medicines for treating depression and convulsions: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medicines for reducing cholesterol levels in the blood: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used for treating gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used for treating 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 tests (including blood tests, 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 Qualix with food, drinks, and alcohol:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor... per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine.

If necessary, Paracetamol Qualix 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.

Taking medicines during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Small amounts of paracetamol may appear in breast milk, so 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 negligible or nonexistent.

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

3. How to take Paracetamol Qualix

Follow these instructions unless your doctor has given you different instructions. Remember to take your medicine. Paracetamol should be taken orally.

The normal dose is:

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

Patient 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 of 8 hours between each dose.

Do not take more than 2 grams of paracetamol in 24 hours, divided into 2 doses.

Patient with kidney disease: before taking this medicine, they must consult their doctor. Take a maximum of 500 milligrams per dose.

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

Elderly patients: should consult their doctor.

Use in children: Do not use in children under 15 years of age.

If the effect of Paracetamol is too strong or too weak, inform your doctor or pharmacist. When lower doses of 1000 milligrams of paracetamol per dose are required, other paracetamol formulations that adapt to the required dosage should be used.

If you take more Paracetamol Qualix than you should:

Consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning. Treatment of overdose is more effective if started within 4 hours after ingestion of the medicine.

Patient on barbiturates or chronic alcoholics may be more susceptible to paracetamol toxicity.

In case of overdose or accidental ingestion, go to a medical center or call the Toxicological Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If you forget to take Paracetamol Qualix

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).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare side effects that may occur (between 1 and 10 in every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may occur (in less than 1 in every 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). Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Paracetamol can damage the liver when taken in high doses or in prolonged treatments.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Qualix

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is 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. 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 Qualix:

Each tablet contains 1g of paracetamol as the active ingredient.

The other ingredients (excipients) are potato starch glycolate (Type A), pregelatinized corn starch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and pack contents:

Paracetamol Qualix is presented in tablets for oral administration.

The tablets are oblong, biconvex, white, with a score line on one face and marked with PC on the other face.

In packs of 20 and 40 tablets and a clinical pack of 500 tablets, packaged in PVC/PVdC/Aluminum blisters.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Qualix Pharma S.L

C/ Botánica 137-139

08908 L’Hospitalet de Llobregat (Barcelona)

Spain

Manufacturer

SAG Manufacturing S.L.U

Crta. N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona

Spain

Date of 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/