Paracetamol Qualix 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Qualix 1 g 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, as you may need to read it again. If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Paracetamol belongs to the group of medicines known as analgesics and antipyretics.

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

2. What you need to know before taking Paracetamol Qualix

Do not take Paracetamol Qualix:

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

Take special care with Paracetamol Qualix:

• Do not take more than the recommended dose indicated in section 3, How to take Paracetamol Qualix.
• In asthmatic patients who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.
• If you have kidney, liver, heart, or lung disease, or suffer from anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), consult your doctor before taking this medicine.
• If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.
• In chronic alcoholics, caution should be taken not to exceed 2 g of paracetamol in 24 hours.
• 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 reevaluate the clinical situation.
• For children under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.
• During treatment with Paracetamol Qualix, inform your doctor immediately if you develop serious conditions such as severe renal failure 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 called 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 breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Taking other medicines with Paracetamol Qualix

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

Paracetamol may interact with the following medicines:

• Medicines 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 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 group)
• 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 abnormalities (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 another medicine. In patients treated with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

Interference with laboratory tests:

If you are scheduled for 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 such tests.

Taking Paracetamol Qualix with food, drinks, and alcohol:

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., 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 may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever does not improve or if you need to take the medicine more frequently.

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

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.

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

3. How to take Paracetamol Qualix

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

The usual dose is:

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

Patients with liver disease: you must consult your doctor before taking this medicine. 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: you must consult your doctor before taking this medicine. Take a maximum of 500 milligrams per dose.

Due to the dosage (1 g of paracetamol), this medicine is not indicated for this group of patients.

Elderly patients: you should consult your doctor.

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

If you think the effect of Paracetamol Qualix is too strong or too weak, tell your doctor or pharmacist. When doses lower than 1000 milligrams of paracetamol per dose are required, other formulations of paracetamol adapted to the required dosage should be used.

If you take more Paracetamol Qualix than you should:

You must contact your doctor or pharmacist immediately.

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

If you have taken an overdose, 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. 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.

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

If you forget to take Paracetamol Qualix

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Rare adverse effects (occurring in 1 to 10 out of 10,000 people) include: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (occurring in fewer than 1 out of 10,000 people) include: 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). Very rare cases of severe skin reactions have been reported.

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who use paracetamol (see section 2).

Paracetamol may damage the liver when taken at high doses or during prolonged treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. 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 empty containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Paracetamol Qualix:

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

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

Appearance of the product and contents of the packaging:

Paracetamol Qualix is presented as tablets for oral administration.

The tablets are oblong, biconvex, white in colour, with a score line on one side and marked "PC" on the other side.

Packaged in blister packs of PVC/PVdC/Aluminium, available in packs of 20 and 40 tablets, and hospital pack of 500 tablets.

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 the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/