


Ask a doctor about a prescription for PARACETAMOL KERN PHARMA 500 mg TABLETS
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.
Contents of the package leaflet:
5 Conservation of Paracetamol Kern Pharma
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).
Do not take Paracetamol Kern Pharma
Warnings and precautions
Consult your doctor, pharmacist, or nurse before taking Paracetamol Kern Pharma.
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:
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.
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.
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.
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.
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.
Composition of Paracetamol Kern Pharma
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
The average price of PARACETAMOL KERN PHARMA 500 mg TABLETS in January, 2026 is around 0.67 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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