Paracetamol Sun 500 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol SUN 500 mg tablets EFG

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

Always follow exactly the instructions for use of this medicine as described in this leaflet or as given by your doctor, pharmacist, or nurse.

• 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 and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any serious adverse effects or any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet:

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

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

This medicine belongs to a 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 starting to take PARACETAMOL SUN

Do not take Paracetamol SUN:

• If you are allergic (hypersensitive) to paracetamol, propacetamol hydrochloride, or to any of the other ingredients 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 medication than the amount recommended in section 3, How to take Paracetamol SUN, as serious liver damage may occur.

• Simultaneous use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, since high doses may lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

• Chronic alcoholics should take care not to exceed 2 grams (4 tablets) of paracetamol in 24 hours.

• Patients with kidney, liver, heart, or lung disease, or patients with anemia, should consult their 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 treatments.

• Asthmatic patients who are 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 liver, kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells).
• If you suffer from dehydration, low body weight, or chronic malnutrition.
• If you are taking warfarin or other oral anticoagulants.
• If you regularly consume alcohol.
• As it may be necessary to avoid taking this medicine or to limit the amount of paracetamol you take.

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

• You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you have 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 together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Interference with laboratory tests

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

Children

Due to the amount of paracetamol it contains, this medicine must not be given to children (under 12 years of age).

Taking Paracetamol SUN with other medicines:

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

In particular, inform your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

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

Taking Paracetamol SUN with food and drinks:

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

Taking this medicine with food does not affect its effectiveness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous to the embryo or fetus and should be monitored by your doctor.

If necessary, Paracetamol SUN may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and take it for the shortest possible time. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine during breastfeeding.

Driving and using machines

No effects affecting the ability to drive or operate machinery have been reported.

3. How to take PARACETAMOL SUN

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

Remember to take your medicine. This medicine is taken orally.

Depending on your preference, the tablets may 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 of age: The usual dose is 1 or 2 tablets 3-4 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 8 tablets (4 g) in 24 hours.

Children: It is necessary to respect the dosages established according to body weight. The child's age corresponding to body weight is provided for informational purposes only.

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

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

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

Patients with liver disease: You must consult your doctor before taking this medicine. You should take only the amount prescribed by your doctor, with a minimum interval of 8 hours between doses. Do not take more than 2 grams or 4 tablets of 500 mg paracetamol in 24 hours.

Patients with kidney disease: You must consult your doctor before taking this medicine. Take a maximum of 500 mg per dose.

Elderly patients: You should consult your doctor.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

When doses lower than 500 mg of paracetamol per dose are required, other paracetamol formulations better suited to the required dosage should be used.

The prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new 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, contact your doctor or the Toxicology Information Service immediately (telephone number: 915 620 420). If you have taken an overdose, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until three days after 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 for overdose is most effective if started within 4 hours after taking the medicine.

Patients undergoing treatment with barbiturates or those 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 a missed dose. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (at least 4 hours apart).

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 adverse effects

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

This medicine may cause the following adverse effects:

• Rare (between 1 and 10 in every 10,000 patients): Malaise, low blood pressure (hypotension), and increased blood transaminase levels.
• Very rare (in less than 1 in every 10,000 patients): Kidney disorders, cloudy urine, some cases of serious skin reactions have been reported, allergic dermatitis (skin rash, angioedema, and Stevens-Johnson syndrome), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

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

• Frequency unknown (cannot be estimated from available data): headache caused by analgesic overuse, a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

Stop taking this medicine and contact a doctor immediately if:

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

• You develop a skin rash or peeling, or mouth ulcers.

• You have previously experienced breathing problems with aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), and have a similar reaction with this medicine.

• You experience unexplained bruising or bleeding.

These reactions are rare.

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

Very rarely, cases of serious 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 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 unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Paracetamol SUN 500 mg tablets:

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

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

Appearance of the product and contents of the container:

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

Marketing Authorization Holder:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Manufacturer responsible:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The 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 most recent review of this leaflet: July 2025

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