PARACETAMOL KERN PHARMA 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Paracetamol Kern Pharma 500 mg Tablets EFG

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

• Keep this package leaflet, 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Paracetamol Kern Pharma and what is it used for
2. What you need to know before you take Paracetamol Kern Pharma
3. How to take Paracetamol Kern Pharma
4. Possible side effects

5 Conservation of Paracetamol Kern Pharma

1. Contents of the pack and further information

1. What is Paracetamol Kern Pharma and what is it used for

Paracetamol is effective for reducing pain and fever.

This medicine is used for the symptomatic relief of mild or moderate pain as well as febrile conditions, in adults and children with a weight over 33 kg (10-12 years, approximately).

2. What you need to know before you take Paracetamol Kern Pharma

Do not take Paracetamol Kern Pharma

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before taking Paracetamol Kern Pharma.

• Do not take more than the recommended dose in section 3. How to take Paracetamol Kern Pharma.
• Chronic alcoholics should be cautious not to take more than 2 g/24 hours of paracetamol.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medicine.
• When being treated with any medicine for epilepsy, consult your doctor before taking this medicine, as when used at the same time, the efficacy is decreased and the hepatotoxicity of paracetamol is potentiated, especially in high-dose treatments of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

During treatment with Paracetamol Kern Pharma, inform your doctor immediately if:

If you have severe diseases, such as severe renal 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 severe 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 breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Interaction of Paracetamol Kern Pharma with other medicines

Tell your doctor or pharmacist that you are taking or have recently taken or might take any other medicines.

In particular, if you are taking any of the following medicines, as it may be necessary to modify the dose of some of them or 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 blood cholesterol levels (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 alteration of blood and fluids (called metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Interference with analytical tests

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

Interaction of Paracetamol Kern Pharma with food, drink, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Medicine use during pregnancy can be hazardous for the embryo or fetus and should be monitored by your doctor.

If necessary, Paracetamol 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.

Paracetamol passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is zero or insignificant.

3. How to take Paracetamol Kern Pharma

Follow these instructions unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults:

Take 1 tablet as needed every 4-6 hours.

If necessary, you can take 2 tablets every 6-8 hours, 3 or 4 times a day. Do not take more than 4 g of paracetamol (8 tablets) in 24 hours, divided into several doses. Never exceed 2 tablets per dose.

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 4 tablets of this medicine in 24 hours, divided into several doses.

Patient with kidney disease:

Before taking this medicine, they must consult their doctor.

Take a maximum of 1 tablet per dose.

Depending on their disease, their doctor will indicate if they should take their medicine with a minimum interval of 6 or 8 hours.

They should not take more than 6 tablets in 24 hours, divided into several doses, never exceeding 1 tablet per dose.

Use in children and adolescents

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

• Children between 33 kg and 42 kg (approximately 10-12 years): 1 tablet per dose, every 6 hours, up to a maximum of 4 tablets per day.

• Adolescents between 42 kg and 50 kg (approximately 12-14 years): 1 tablet per dose, every 4-6 hours as needed, up to a maximum of 6 tablets per day.

• Adolescents from 15 years and weighing more than 50 kg can follow the adult dosage.

Children under 33 kg should not take this medicine. The use of other presentations more suitable for the treatment of this group of patients is recommended.

Tablets should be swallowed whole or broken or crushed, with the help of a glass of liquid, preferably water.

Always take the lowest effective dose.

Taking this medicine is subject to the appearance of pain or fever. As they disappear, treatment should be discontinued.

If you take more Paracetamol Kern Pharma than you should

Consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, go immediately to a medical center, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

Treatment of overdose is more effective if started within 4 hours of ingestion of the medicine.

Patient treated 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), indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, Paracetamol Kern Pharma can cause side effects, although not everybody gets them.

Rare side effects that may affect up to 1 in 1,000 people are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may affect up to 1 in 10,000 people are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

Side effects of unknown frequency (cannot be estimated from the available data): A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

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

Very rare cases of severe skin reactions have been reported.

If you think you have any of the side effects that are serious or if you notice any side effects not listed in this package leaflet, tell your doctor or pharmacist.

5. Conservation of Paracetamol Kern Pharma

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging after ‘EXP’. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Paracetamol Kern Pharma

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamol.
• The other ingredients are pregelatinized corn starch, stearic acid, and povidone.

Appearance of the product and contents of the pack

Paracetamol Kern Pharma tablets are white, round, and have a score line on one face. The tablet can be divided into two equal halves.

They are presented in PVC/aluminum blisters packaged in boxes of 20 tablets.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this package leaflet: February 2025

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