Paracetamol Kern Pharma 650 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Paracetamol Kern Pharma 650 mg Tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet.

Leaflet contents:

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

This medicine is indicated for the symptomatic treatment of mild to moderate pain, and for reducing 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 to any of the other ingredients of Paracetamol Kern Pharma.
• If you have any liver disease.

Warnings and precautions

Do not take a higher dose than the one recommended in section 3. How to take Paracetamol Kern Pharma.

If pain persists for more than 5 days (3 days in children), fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment must be stopped and a doctor should be consulted.

This medicine should not be administered to children under 6 years of age, as it does not allow for dosing below 325 mg per dose (half a tablet). Other formulations should be used for administering the recommended doses in this population group.

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

In chronic alcoholics, care should be taken not to exceed 2 g/day of paracetamol.

Patients with renal, cardiac, or pulmonary diseases, or with anemia, 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 abnormality 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, feeling unwell (nausea), and vomiting.

Interference with diagnostic tests

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

Use of Paracetamol Kern Pharma with other medicines

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

Paracetamol may interact with the following medicines:

• Isoniazid and rifampicin (used to treat tuberculosis)
• Antiepileptics: barbiturates, carbamazepine, hydantoins, lamotrigine (used to treat epileptic seizures)
• Anticoagulants (used to treat thromboembolic disorders)
• Anticholinergics (used to relieve spasms or contractions of the stomach, intestine, and bladder)
• Propranolol (used to treat hypertension and cardiac arrhythmias)
• Activated charcoal (used to treat poisonings)
• 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 blood and fluid disturbances (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

Do not use with other analgesics (medicines that reduce pain) without consulting your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Taking medications during pregnancy can be dangerous for 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 may be used during pregnancy. Use the lowest possible dose that reduces pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever do not improve, or if you need to take the medication more frequently.

Paracetamol is excreted in breast milk; therefore, women who are breastfeeding should consult their doctor before using this medication.

Driving and operating machinery

No effects on driving and operating machinery have been reported.

3. How to take Paracetamol Kern Pharma

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult 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 in any 24-hour period.

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

Children under 6 years: Other formulations should be used, as Paracetamol Kern Pharma contains higher doses than recommended for these children.

Children aged 6 to 11 years: The usual dose is half a tablet (325 mg) every 4–6 hours. Do not take more than 2½ tablets (1,625 mg) in any 24-hour period.

Children over 12 years: The usual dose is ½ to 1 tablet every 4–6 hours. Do not take more than 5 tablets in any 24-hour period.

Method and route of administration:

The tablets should be taken orally with a glass of water. If a half dose is required, the tablet can be split along the break line.

If you feel that the effect 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 recommended, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested.

If an overdose has occurred, you should seek urgent medical attention even if there are no symptoms, as symptoms often do not appear until after three days following the overdose, even in cases of severe poisoning.

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

Treatment for overdose is most effective when started within 4 hours after ingestion of the medicine.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects of a paracetamol overdose.

If you forget to take Paracetamol Kern Pharma

Do not take a double dose to make up for missed doses. Simply take the missed dose as soon as you remember, and then take the following doses at the recommended intervals (every 4–6 hours).

4. Possible adverse effects

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

Paracetamol Kern Pharma may damage the liver at high doses or during prolonged treatment. Skin rashes and blood abnormalities may also occur.

Very rare cases of serious skin reactions have been reported.

Adverse effects with unknown frequency (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).

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 out of sight and reach of children.

This medicine does not require any special storage conditions.

Do not use Paracetamol Kern Pharma after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 650 mg of paracetamol.
• 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, oblong, biconvex, and scored.

The packs contain 20 or 40 tablets 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 most recent revision 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) http://www.aemps.gob.es/.