PARACETAMOL KERN PHARMA 650 mg TABLETS

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

Paracetamol Kern Pharma belongs to the group of medications called analgesics and antipyretics.

This medication is indicated for the symptomatic treatment of mild or moderate pain and to reduce fever.

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 in section 3. How to take Paracetamol Kern Pharma.

If the pain persists for more than 5 days (3 days for children), the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, treatment should be discontinued and a doctor consulted.

This medication should not be administered to children under 6 years of age because it does not allow for dosing of less than 325 mg per dose (half a tablet). For administration of the indicated doses in this population, other presentations should be used.

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

In chronic alcoholics, the precaution should be taken not to take more than 2 g/day of paracetamol.

In patients with kidney, heart, or lung disease, and in patients with anemia, consult a doctor before taking the medication.

During treatment with Paracetamol Kern Pharma, inform your doctor immediately if:

If you have severe diseases, such as severe kidney failure 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 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.

Interference with Analytical Tests

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

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:

• Isoniazid and rifampicin (used to treat tuberculosis)
• Antiepileptics: barbiturics, carbamazepine, hydantoins, lamotrigine (used to treat epileptic seizures)
• Anticoagulants (used to treat thromboembolic diseases)
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestine, and bladder)
• Propranolol (used to treat hypertension, cardiac arrhythmias)
• Activated charcoal (used to treat intoxications)
• Contraceptives
• Diuretics (used to increase urine elimination)
• Probenecid (used to treat gout)
• Zidovudine (used to treat HIV infections)

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

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

Pregnancy and Breastfeeding

Consult your doctor or pharmacist before using any medication.

Taking medications during pregnancy can be hazardous to the embryo and fetus. If you are pregnant or think you may be pregnant, consult your doctor before taking Paracetamol Kern Pharma.

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 medication more frequently.

Paracetamol is excreted in breast milk, so breastfeeding women should consult a doctor before using this medication.

Driving and Using Machines

No effects have been described that affect driving and using machines.

3. How to Take Paracetamol Kern Pharma

Follow the administration instructions of the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Adults: the usual dose for adults is ½ to 1 tablet (325 to 650 mg) every 4-6 hours. Do not take more than 6 tablets every 24 hours.

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

Children under 6 years: other presentations should be used because Paracetamol Kern Pharma contains more than the dose that should be administered to these children.

Children from 6 to 11 years: the usual dose is ½ tablet (325 mg), every 4-6 hours. Do not take more than 2 and a half tablets (1.625 mg) every 24 hours.

Children over 12 years: the usual dose is ½ to 1 tablet, every 4-6 hours. Do not take more than 5 tablets every 24 hours.

Method of Use and Administration Route:

The tablets should be taken orally with a glass of water, and if you want to administer half the dose of the tablet, it should be split at the score line.

If you think 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 Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested.

If you have taken an overdose, you should go quickly to a medical center, even if you have no 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 after ingestion of the medication.

Patients being treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of 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 and take the next doses with the indicated time interval (4-6 hours).

4. Possible Side Effects

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

Paracetamol Kern Pharma may damage the liver at high doses or with prolonged treatment. Skin rashes and blood disorders may also appear.

Very rare cases of serious skin reactions have been reported.

Side effects of unknown frequency (cannot be estimated from 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).

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 package leaflet, inform your doctor or pharmacist.

5. Storage of Paracetamol Kern Pharma

Keep out of sight and reach of children.

This medication does not require special storage conditions.

Do not use Paracetamol Kern Pharma after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Kern Pharma

• The active ingredient is Paracetamol. Each tablet contains 650 mg of paracetamol.
• The other components are: pregelatinized cornstarch, stearic acid, and povidone.

Appearance of the Product and Package Contents

Paracetamol Kern Pharma are white, oblong, biconvex, and scored tablets.

The boxes are 20 or 40 tablets packaged in PVC/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the Last Revision of this Package Leaflet: February 2025

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.