Leaflet: Information for the user

Paracetamol Kern Pharma 500 mg tablets EFG

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

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3.How to take Paracetamol Kern Pharma

4.Possible side effects

5Storage of Paracetamol Kern Pharma

6.Contents of the pack and additional information

Paracetamol is effective in reducing pain and fever.

This medication is used for symptomatic relief of mild to moderate pain as well as febrile states, in adults and children with a body weight of 33 kg or more (approximately 10-12 years old).

Do not take Paracetamol Kern Pharma

-If you are allergic to paracetamol or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Paracetamol Kern Pharma.

• Do not take more medication than recommended in section 3. How to take Paracetamol Kern Pharma.
• Chronic alcoholics should be careful not to take more than 2 g/24 hours of paracetamol.
• Patients with kidney, liver, heart, or lung diseases and patients with anemia should consult their doctor before taking this medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as it may reduce the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.

Inform your doctor immediately if you experience any of the following during treatment with Paracetamol Kern Pharma:

Severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Interaction of Paracetamol Kern Pharma with other medications

Inform your doctor or pharmacist that you are using or have used recently or may need to use any other medication.

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

-Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

-Medications to treat epilepsy: Antiepileptic drugs (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

-Medications to treat tuberculosis (isoniazid, rifampicin).

-Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants).

-Medications to lower cholesterol levels in the blood (cholestyramine).

-Medications used to increase urine elimination (diuretics such as furosemide).

-Medications used to treat gout (probencid and sulfinpyrazone).

-Medications used to prevent nausea and vomiting: Metoclopramide and domperidone.

-Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.

- Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

Interference with laboratory tests

Inform your doctor that you are taking/using this medication, as it may affect the results of any laboratory tests (including blood, urine, etc…).

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

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

The taking of this medication with food does not affect its efficacy.

Pregnancy and breastfeeding

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

The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

In case of need, Paracetamol can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if pain or fever do not decrease or if you need to take the medication more frequently.

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

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible 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.

In case of need, you can take 2 tablets every 6-8 hours, 3 or 4 times a day. Do not take more than 4 grams of paracetamol (8 tablets) in 24 hours, divided into several doses. Do not exceed 2 tablets per dose.

Patients with liver disease:

Before taking this medication, you must consult your doctor.

You should take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

You should not take more than 4 tablets of this medication in 24 hours, divided into several doses.

Patients with kidney disease:

Before taking this medication, you must consult your doctor.

Take a maximum of 1 tablet per dose.

Your doctor will indicate if you should take your medication with a minimum interval of 6 or 8 hours, depending on your condition.

You should not take more than 6 tablets in 24 hours, divided into several doses, and not exceeding 1 tablet per dose.

Use in children and adolescents

You must respect the dosages defined according to weight. The child's age according to weight is given for information purposes only.

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

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

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

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

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

Always take the smallest effective dose.

The taking of this medication is subject to the appearance of pain or fever. As these symptoms disappear, treatment should be discontinued.

If you take more Paracetamol Kern Pharma than you should

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice), and abdominal pain.

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

The treatment of overdose is more effective if it is initiated within 4 hours of medication ingestion.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

Like all medications, Paracetamol Kern Pharma may produce adverse effects, although not all people will experience them.

Rare adverse 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 adverse effects that may affect up to 1 in 10,000 people are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

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

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

There have been very rare cases of severe skin reactions reported.

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

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications.By doing so, you will help protect the environment.

Composition of Paracetamol Kern Pharma

-The active ingredient is paracetamol. Each tablet contains 500 mg of paracetamol.

-The other components are pregelatinized cornstarch, stearic acid, and povidone.

Appearance of the product and content of the packaging

Paracetamol Kern Pharma tablets are white, round, and have a notch on one of the faces. The tablet can be divided into two equal halves.

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

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)www.aemps.gob.es