Label: information for the user

Paracetamol SUN 500 mg tablets EFG

Read this label carefully before starting to take the medicationbecause it contains important information for you.

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor, pharmacist, or nurse.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience severe adverse effects or any adverse effect not mentioned in this label, inform your doctor or pharmacist.

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

2. Before starting to take Paracetamol SUN

3. How to take Paracetamol SUN

4. Possible adverse effects

5. Storage of Paracetamol SUN

6. Additional information

This medication belongs to a group of medications called analgesics and antipyretics. It is indicated for the treatment of mild to moderate pain symptoms and fever.

Do not take Paracetamol SUN:

- If you are allergic (hypersensitive) to paracetamol, propacetamol hydrochloride, or any of the other components of the medication (listed in section 6).

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to take Paracetamol SUN:

If you take more than the recommended dose in section 3.

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

If you have kidney, heart, or lung disease, or have anemia (decreased hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medication.

When undergoing treatment with an antiepileptic medication, consult your doctor before taking this medication, as when used together, the efficacy is decreased and the hepatotoxicity of paracetamol is increased, especially in high-dose paracetamol treatments.

In chronic alcoholics, be careful not to take more than 4 tablets of 500 mg or 2 g per day of paracetamol.

• If you have dehydration, underweight, or chronic malnutrition.
• If you are taking warfarin or other oral anticoagulants.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, interrupt treatment and consult your doctor.

In children under 8 years, consult your doctor or pharmacist, as there are other presentations with doses adapted to this group of patients.

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 if you 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 distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used:

- Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis with high anion imbalance) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and when using the maximum daily doses of paracetamol.

- Any other medication, including those purchased without a prescription.

Paracetamol may interact with the following medications:

- Blood clot prevention medication: Oral anticoagulants (acenocoumarol, warfarin)

- Epilepsy treatment medication: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

- Tuberculosis treatment medication: (isoniazid, rifampicin)

- Depression and convulsion treatment medication: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)

- Medications used to lower blood cholesterol levels: (colestiramine)

- 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 anomaly (metabolic acidosis) that must be treated urgently (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 taking another medication. In cases of oral anticoagulant treatment, paracetamol may 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 SUN with food and beverages:

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

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

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication.

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

In case of need, Paracetamol SUN may 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.

Small amounts of paracetamol may appear in breast milk, therefore, consult your doctor or pharmacist before taking this medication during lactation.

Driving and operating machinery

No effects have been described that modify the ability to drive and operate machinery.

Follow these instructions unless your doctor has given you different instructions.

Remember to take your medication. This medication must be taken orally.

According to your preferences, the tablets can be taken with water, milk, or fruit juice. Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

Adults and children over 15 years old: the usual dose is 1 or 2 tablets 3-4 times a day. Doses should be spaced at least 4 hours apart. No more than 8 tablets (4 g) should be taken in 24 hours.

Children: The defined dosages must be respected according to weight. The child's age 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, i.e. 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

- Children weighing 26-40 kg (8-13 years old): 1 tablet per dose, every 6 hours,up to a maximum of 4 tablets per day.

- Children weighing 41-50 kg (12-15 years old): 1 tablet per dose, every 4 hours,up to a maximum of 6 tablets per day.

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 or 4 tablets of 500 mg of paracetamol in 24 hours.

Patients with kidney disease: Before taking this medication, they must consult their doctor. They should take a maximum of 500 mg per dose.

Patients with advanced age: They should consult their doctor.

If it is estimated that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

When administering doses less than 500 mg per dose, other paracetamol presentations should be used that adapt to the required dosage.

If you take more Paracetamol SUN than you should:

If you have taken more paracetamol than you should, consult your doctor or the Toxicological Information Service (phone 915 620 420) immediately. If you have taken an overdose, you should go to a medical center immediately, even if you do not have symptoms, as they often do not appear until three days after the overdose, even in cases of severe poisoning. The symptoms of an overdose can be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

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

Patients being treated with barbiturates or those with chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forgot to take Paracetamol SUN:

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

This medication may produce the following adverse effects:

- Rare (between 1 and 10 per 10,000 patients): Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

- Very rare (less than 1 per 10,000 patients): Kidney diseases, cloudy urine, severe skin reactions, allergic dermatitis (skin rash, angioedema, and Stevens-Johnson syndrome), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

Bronchial spasm in patients allergic to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs).

- Unknown frequency (cannot be estimated with available data): Headache induced by analgesic abuse, a severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

- Stop taking this medication and talk to a doctor immediately if:

- Experiences allergic reactions such as skin rash or itching, sometimes with breathing problems or swelling of the lips, tongue, throat, or face.

- Suffers from a skin eruption or peeling, or mouth ulcers.

- Has previously experienced breathing problems with aspirin or NSAIDs, and experiences a similar reaction with this medication.

- Experiences bruising or unexplained bleeding.

These reactions are rare.

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

Very rarely, severe skin reactions have been reported.

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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

This medication does not require special conditions for conservation.

Do not use this medication after the expiration date that appears on the packaging (after CAD.). 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol SUN 500 mg tablets:

The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.

The other components are: pregelatinized cornstarch, povidone, sodium croscarmellose and stearic acid.

Appearance of the product and contents of the package:

Paracetamol SUN 500 mg is presented in the form of oral tablets, in packages of 20 tablets.

Holder of the marketing authorization:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Responsible for Manufacturing:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Alkaloida Chemical Company Zrt.

Kabay Janós u. 29.,

Tiszavasvári - 4440

Hungary

Local Representative:

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 – Barcelona

Spain

Tel: +34 93 342 78 90

Date of the last review of this leaflet: January 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.es/