PARACETAMOL SUN 650 mg TABLETS

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 medication (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 recommended in section 3, How to take Paracetamol SUN, as serious liver damage may occur.
• The simultaneous use of this medication with other medications containing paracetamol, such as flu medications, should be avoided, as high doses can cause liver damage. Do not use more than one medication containing 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 diseases, and patients with anemia, should consult their doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, 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 medication.

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

• If you have liver, kidney, heart, or lung disease, or if you have anemia (decreased hemoglobin levels in the blood, with or without a decrease in red blood cells).
• If you have 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 medication or to limit the amount of paracetamol you take.

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

• You have serious diseases, 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 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. The symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling of discomfort (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 medication, as it may alter the results.

Children

Due to the amount of paracetamol it contains, children (under 12 years) should not take this medication.

Taking Paracetamol SUN with other medications:

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

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

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and convulsions: Barbiturics (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower cholesterol levels in the blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications 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 beverages:

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

Taking this medication with food does not affect its efficacy.

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications 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 medication more frequently.

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

Driving and Using Machines

No effects have been described that modify 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 medication. This medication 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 doubts.

The normal dose is:

Adults and children over 15 years: the usual dose is 1 tablet (650 mg of paracetamol) every 4 or 6 hours. The doses should be spaced at least 4 hours apart. Do not take more than 6 tablets in 24 hours.

Patient 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 between each dose of 8 hours. They should not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patient with kidney disease: before taking this medication, they must consult their doctor.

Take a maximum of 500 mg per dose.

Due to the dose, 650 mg 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.

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

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 after taking the medication.

Patient taking barbiturics or chronic alcoholics may be more susceptible to paracetamol toxicity.

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 (at least 4 hours).

If you stop treatment with Paracetamol SUN

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

This medication can cause the following adverse effects:

• Rare (between 1 and 10 out of 10,000 patients): Discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.
• Very rare (in less than 1 out of 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 with 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 medication 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 experienced breathing problems with aspirin or non-steroidal anti-inflammatory drugs and experience a similar reaction with this medication.

-You experience bruising or bleeding without explanation.

These reactions are rare.

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

Very rarely, cases of 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 package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of PARACETAMOL SUN

Keep out of the reach and sight of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging (after EXP.). The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Paracetamol SUN 650 mg tablets:

The active ingredient is paracetamol. Each tablet contains 650 mg of paracetamol.

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

Appearance of the product and packaging content:

Paracetamol SUN 650 mg is presented in the form of oral tablets, in packages of 20 and 40 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 package leaflet: July 2025

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