Leaflet: Information for the User

Paracetamol Kern Pharma 1 g 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.

Paracetamol Kern Pharma belongs to a group of medicines called analgesics and antipyretics.

It is indicated for the relief or treatment of occasional mild or moderate pain, such as headache, dental pain, muscle pain (contractures) or back pain (lumbago) and in febrile states.

Consult a doctor if symptoms worsen or persist after 5 days or fever lasts more than 3 days.

Do not take Paracetamol Kern Pharma

• If you are allergic to paracetamol or any of the other components of Paracetamol Kern Pharma.
• If you have any liver disease.

Warnings and precautions

• Do not take more than the recommended dose.
• If you have kidney, heart, or lung disease, or have anemia (a decrease in the hemoglobin level in the blood, due or not to a decrease in red blood cells), consult your doctor before taking this medication.
• In chronic alcoholics, be careful not to take more than 2 g/day of paracetamol.
• If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, interrupt treatment and consult your doctor.
• In children and adolescents under 15 years, consult your doctor or pharmacist as there are other presentations with doses adapted to this group of patients.

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

If you have 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 malnutrition, chronic alcoholism, or 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.

Use of Paracetamol Kern Pharma with other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

Paracetamol may interact with the following medications:

• Antibiotics (cloranfenicol)
• Anticoagulants (used to treat thromboembolic diseases)
• Antiepileptics (used to treat epileptic seizures)
• Contraceptives
• Diuretics (used to increase urine elimination)
• Isoniazid (used to treat tuberculosis)
• Lamotrigine (used to treat epilepsy)
• Probenecid (used to treat gout)
• Propranolol (used to treat hypertension, cardiac arrhythmias)
• Rifampicin (used to treat tuberculosis)
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestines, and bladder)
• Zidovudine (used to treat HIV infections)
• Colestiramine (used to reduce cholesterol levels in the blood)

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

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to inform your doctor or pharmacist if you are being treated with other medications. In the case of oral anticoagulants, paracetamol may be administered occasionally as the preferred analgesic.

Interference with diagnostic tests

Inform your doctor if you are undergoing any diagnostic tests (including blood, urine, skin tests using allergens, etc...) as this medication may alter the results.

Use of Paracetamol Kern Pharma with food and drink

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

Small amounts of paracetamol may appear in breast milk, therefore, it is recommended to consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No effects have been described that modify the ability to drive and operate machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and children over 15 years:1 tablet (1 gof paracetamol) 3–4 times a day. Doses should be spaced at least 4 hours apart. Do not take more than 4 tablets (4 g) in 24 hours.

Patients with liver or kidney disease:should consult their doctor.

Older patients:should consult their doctor.

When requiring administration of doses lower than1 gof paracetamol per dose, other paracetamol presentations should be used that adapt to the required dosing.

The groove is only for breaking the tablet if it is difficult to swallow whole.Paracetamol Kern Pharma should be taken orally. According to preference, tablets can be taken directly or broken in half with water or another liquid.

If it is estimated that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

If you take more Paracetamol Kern Pharma than you should

If you have taken more Paracetamol than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone:91 562 04 20, indicating the medication and the amount ingested.

If a overdose has been taken, you should go to a medical center immediately, even if there are no symptoms, as they often do not appear until three days after the overdose, even in cases of severe poisoning.

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

The treatment of an overdose is more effective if initiated within 4 hours of taking the medication.

Patients undergoing barbiturate treatment or suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forgot to take Paracetamol Kern Pharma

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated spacing between doses (at least 4 hours).

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

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

Paracetamol Kern Pharma may produce the following adverse effects:

• Rare (may affectup to1 in 1,000 people): discomfort and blood pressure decrease.
• Very rare (may affectup to1 in 10,000 patients): allergic reactions (such as skin reactions), blood glucose decrease, blood alterations, and liver and kidney alterations.
• Unknown frequency (cannot be estimated from available data): A severe disease that may make the blood more acidic (designated metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

There have been very rare reports of severe skin reactions.

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of the sight and reach of children.

This medication does not require special conditions for conservation.

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.

Medicines should not be thrown down the drains or into the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.By doing so, you will help protect the environment.

Composition of Paracetamol Kern Pharma

• The active ingredient is paracetamol. Each tablet contains1 gof paracetamol.
• The other components are: maize pregelatinized starch, stearic acid and povidone.

Appearance of the product and content of the packaging

Paracetamol Kern Pharma1 gis presented in oral tablets. The tablets arewhite, oval and scored on one side.The boxes are of 20 or 40 tablets conditioned in PVC/aluminium blister.

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 of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/