PARACETAMOL KERN PHARMA 1 g TABLETS

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

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 if you have anemia (decreased hemoglobin level in the blood, due to or not due to a decrease in red blood cells), you should consult your doctor before taking this medicine.
• In chronic alcoholics, it is recommended 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 the pain or fever worsens or other symptoms appear, treatment should be discontinued and your doctor consulted.
• In children and adolescents under 15 years of age, consult your doctor or pharmacist, as there are other presentations with doses that are suitable for this group of patients.

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 have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious 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 of discomfort (nausea) and vomiting.

Using Paracetamol Kern Pharma with other medicines

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

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol)
• 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 stomach, intestine, and bladder spasms or contractions)
• Zidovudine (used to treat HIV infections)
• Colestyramine (used to decrease blood cholesterol levels)

• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis with high anionic imbalance) that should be treated urgently (see section 2).

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

As a general rule for any medicine, it is recommended to systematically inform your doctor or pharmacist if you are being treated with other medicines. In the case of treatment with oral anticoagulants, it can be administered occasionally as the analgesic of choice.

Interference with analytical tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Using Paracetamol Kern Pharma with food and drink

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of paracetamol may appear in breast milk, so it is recommended that you consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

3. How to take Paracetamol Kern Pharma

Follow the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. If you have any doubts, ask your doctor, pharmacist, or nurse.

The recommended dose is:

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

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

Elderly patients: should consult their doctor.

When a dose lower than 1 g of paracetamol per dose is required, other presentations of paracetamol that are suitable for the required dose should be used.

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

If you think the action of this medicine 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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

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

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

Patient taking barbiturates or suffering from chronic alcoholism may be more susceptible to a paracetamol overdose.

If you forget to take Paracetamol Kern Pharma

Do not take a double dose to make up for forgotten doses, simply take the forgotten 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.

4. Possible side effects

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

Paracetamol Kern Pharma may cause the following side effects:

• Rare (may affect up to 1 in 1,000 people): discomfort and low blood pressure.
• Very rare (may affect up to 1 in 10,000 patients): allergic reactions (such as skin reactions), low blood sugar, blood disorders, and liver and kidney disorders.
• Frequency not known (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 who use paracetamol (see section 2).

Very rare cases of severe skin reactions have been reported.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Paracetamol Kern Pharma

Keep out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Paracetamol Kern Pharma

• The active ingredient is paracetamol. Each tablet contains 1 g of paracetamol.
• The other ingredients are: pregelatinized corn starch, stearic acid, and povidone.

Appearance of the product and package contents

Paracetamol Kern Pharma 1 g is presented in tablets for oral administration. The tablets are white, oblong, and scored on one face. The boxes are of 20 or 40 tablets packaged in PVC/aluminum blisters.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

or

Toll Manufacturing Services, S. L.

C/ Aragonenes, 2

28108 Alcobendas – Madrid

Spain

Date of the last revision of this 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) http://www.aemps.gob.es/