PARACETAMOL SUN 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol SUN 500 mg Tablets EFG

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as 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. 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 serious side effects or any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

1. What is Paracetamol SUN and what is it used for
2. What you need to know before taking Paracetamol SUN
3. How to take Paracetamol SUN
4. Possible side effects
5. Storage of Paracetamol SUN
6. Further information

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

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

2. What you need to know before taking PARACETAMOL SUN

Do not take Paracetamol SUN:

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

Warnings and Precautions:

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

• Do not take more than the recommended dose of medicine, as stated in section 3, How to take Paracetamol SUN, as this can cause serious liver damage.
• Avoid taking this medicine simultaneously with other medicines that contain paracetamol, such as medicines for flu and colds, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.

• Chronic alcoholics should be cautious not to take more than 2 grams (4 tablets) of paracetamol in 24 hours.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medicine.
• When being treated with 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.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

You should consult your doctor or pharmacist before taking this medicine:

• If you have any liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, due to or not due to a reduction in red blood cells).
• If you suffer from dehydration, low weight, or chronic malnutrition.
• If you are taking warfarin or other oral anticoagulants.
• If you regularly consume alcohol.
• As it may be necessary not to take this medicine or to limit the amount of paracetamol you take.

During treatment with this medicine, inform your doctor immediately if:

• You have severe illnesses, such as severe kidney 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 serious 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 with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interference with laboratory tests

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Children

Due to the amount of paracetamol it contains, children (under 12 years) cannot take this medicine.

Taking Paracetamol SUN with other medicines:

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medicine, including those obtained without a prescription.

In particular, if you are taking any of the following medicines, it may be necessary to modify the dose of one of them or to interrupt treatment:

• 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 convulsions: Barbiturates (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 to treat 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).

Taking Paracetamol SUN with food and drink:

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

If necessary, Paracetamol SUN 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.

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

Driving and Using Machines

No effects have been described that alter the ability to drive or operate machinery.

3. How to Take PARACETAMOL SUN

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

Remember to take your medicine. This medicine should 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 normal dose is:

Adults and children over 15 years: the usual dose is 1 or 2 tablets, 3-4 times a day. The doses should be spaced at least 4 hours apart. Do not take more than 8 tablets (4 grams) in 24 hours.

Children: It is necessary to respect the dosages defined according to weight. The age of the child is given for information purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

• Children between 26 and 40 kg in weight (from 8 to 13 years): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

• Between 41 and 50 kg in weight (from 12 to 15 years): 1 tablet per dose, every 4 hours, up to a maximum of 6 tablets per day.

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 between each dose of 8 hours. They should not take more than 2 grams or 4 tablets of 500 mg of paracetamol in 24 hours.

Patient with kidney disease: before taking this medicine, they must consult their doctor. They should take a maximum of 500 mg per dose.

Elderly patients: they should consult their doctor.

If you think the action of this medicine is too strong or too weak, inform your doctor or pharmacist.

When lower doses of paracetamol are required, other presentations of paracetamol that adapt to the required dosage should be used.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of adverse effects such as liver damage increases.

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 stop treatment and consult your doctor.

If you take more Paracetamol SUN than you should

If you have taken more paracetamol than you should, consult your doctor or the Toxicology Information Service (telephone 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 may not appear until three days after taking the overdose, even in cases of severe poisoning. Symptoms of overdose may include: 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 taking the medicine.

Patient taking barbiturates or suffering from chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take Paracetamol SUN

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 them (at least 4 hours).

If you stop taking Paracetamol SUN

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

4. Possible Side Effects

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

This medicine can cause the following side effects:

• Rare (between 1 and 10 in 10,000 patients): Malaise, low blood pressure (hypotension), and increased transaminase levels in the blood.
• Very rare (in less than 1 in 10,000 patients): Kidney disease, cloudy urine, some cases of severe skin reactions, allergic dermatitis (skin rash, angioedema, and Stevens-Johnson syndrome), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Bronchospasm in patients allergic to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

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

Stop taking this medicine and talk to a doctor immediately if:

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

-You suffer from skin rash or peeling, or mouth ulcers.

-You have previously had breathing problems with aspirin or non-steroidal anti-inflammatory drugs, and you experience a similar reaction with this medicine.

-You experience bruising or bleeding without explanation.

These reactions are rare.

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

Very rarely, cases of severe skin reactions have been reported.

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PARACETAMOL SUN

Keep out of the reach and sight of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date 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. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Paracetamol SUN 500 mg Tablets:

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

The other ingredients are: pregelatinized corn starch, povidone, sodium croscarmellose, and stearic acid.

Appearance of the Product and Packaging Contents:

Paracetamol SUN 500 mg is presented in the form of tablets for oral administration, in packs of 20 tablets.

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

Manufacturer:

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 Revision of this Leaflet: July 2025

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