Paracetamol Kern Pharma 500 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Paracetamol Kern Pharma 500 mg tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Paracetamol Kern Pharma is and what it is used for
2. What you need to know before taking Paracetamol Kern Pharma
3. How to take Paracetamol Kern Pharma
4. Possible side effects
5. How to store Paracetamol Kern Pharma
6. Contents of the pack and other information

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

Paracetamol is effective in reducing pain and fever.

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

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

Do not take Paracetamol Kern Pharma

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

Warnings and precautions

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

• Do not take more medicine than the recommended dose stated in section 3, How to take Paracetamol Kern Pharma.
• Chronic alcoholics should take care not to exceed 2 g/24 hours of paracetamol.
• Patients with kidney, liver, heart, or lung disease, or those with anemia, should consult their doctor before taking this medicine.
• If you are being treated with any 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 regimens.
• Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

During treatment with Paracetamol Kern Pharma, 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 suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance 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, malaise (nausea), and vomiting.

Interaction of Paracetamol Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

In particular, if you are taking any of the following medicines, as it may be necessary to adjust the dose of some of them or discontinue 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 seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).
• Medicines to lower blood cholesterol levels (cholestyramine).
• Medicines used to increase urine output (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 imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Interference with laboratory tests

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

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

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks—beer, wine, spirits, etc.—per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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

Taking medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

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

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

Driving and using machines

The effect of paracetamol on the ability to drive and operate machinery is negligible or none.

3. How to take Paracetamol Kern Pharma

Follow these instructions unless your doctor has given you different ones. 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 may take 2 tablets every 6–8 hours, 3 or 4 times a day. Do not exceed 4 g of paracetamol (8 tablets) in 24 hours, divided into several doses. Under no circumstances should you exceed 2 tablets per dose.

Patients with liver disease:

Before taking this medicine, you must consult your doctor.

You should take the amount prescribed by your doctor, with a minimum interval of 8 hours between doses.

Do not take more than 4 tablets of this medicine in 24 hours, divided into several doses.

Patients with kidney disease:

Before taking this medicine, you must consult your doctor.

Take a maximum of 1 tablet per dose.

Depending on your condition, your doctor will advise whether you should take the medicine at intervals of at least 6 or 8 hours.

Do not take more than 6 tablets in 24 hours, divided into several doses, and under no circumstances exceed 1 tablet per dose.

Use in children and adolescents

It is necessary to follow the dosages defined according to body weight. The age ranges given for children based on weight are provided for informational purposes only.

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

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

• Adolescents aged 15 years and older and weighing more than 50 kg may follow the adult dosage.

Children weighing less than 33 kg must not take this medicine. The use of other formulations more suitable for this patient group is recommended.

The tablets should be swallowed whole or split or crushed, taken with a glass of liquid, preferably water.

Always use the lowest effective dose.

This medicine should only be taken when pain or fever occurs. Treatment should be discontinued as symptoms subside.

If you take more Paracetamol Kern Pharma than you should

You should contact your doctor or pharmacist immediately.

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

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

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

Patients undergoing treatment 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 adverse effects

Like all medicines, Paracetamol Kern Pharma can produce adverse effects, although not everyone will experience them.

Rare adverse effects (may affect up to 1 in 1,000 people): malaise, low blood pressure (hypotension), and increased blood transaminase levels.

Very rare adverse effects (may affect up to 1 in 10,000 people): kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar).

Adverse effects with frequency not known (cannot be estimated from the available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

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

Very rarely, serious skin reactions have been reported.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Paracetamol Kern Pharma

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Paracetamol Kern Pharma

• The active substance is paracetamol. Each tablet contains 500 mg of paracetamod.
• The other components are pregelatinized maize 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 side. The tablet can be divided into equal halves.

They are presented in PVC/aluminum blisters packed 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 the most recent review of this leaflet: February 2025

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