Paracetamol Kern Pharma 1 g tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Paracetamol Kern Pharma 1 g tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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 they are adverse effects 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 side 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.

It is indicated for the relief or treatment of mild to moderate occasional pain, such as headache, dental pain, muscular pain (muscle spasms), or back pain (lumbago), and for feverish conditions.

You should consult your doctor if symptoms worsen or persist beyond 5 days, or if fever lasts more than 3 days.

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 more than the recommended dose.
• If you have kidney, heart, or lung disease, or if you have anemia (reduced hemoglobin levels in the blood, with or without a decrease in red blood cells), you should consult your doctor before taking this medicine.
• Chronic alcoholics should take care not to exceed 2 g/day of paracetamol.
• If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be stopped and a doctor consulted.
• In children and adolescents under 15 years of age, consult your doctor or pharmacist, as other formulations with doses adapted to this patient group are available.

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 have 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 for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Use of Paracetamol Kern Pharma with other medicines

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

Paracetamol may interact with the following medicines:

• Antibiotics (chloramphenicol)

• Anticoagulants (used for the treatment of thromboembolic disorders)

• Antiepileptics (used for the treatment of epileptic seizures)

• Contraceptives

• Diuretics (used to increase urine elimination)

• Isoniazid (used for the treatment of tuberculosis)

• Lamotrigine (used for the treatment of epilepsy)

• Probenecid (used for the treatment of gout)

• Propranolol (used for the treatment of hypertension, cardiac arrhythmias)

• Rifampicin (used for the treatment of tuberculosis)

• Anticholinergics (used to relieve spasms or contractions of the stomach, intestine, and bladder)

• Zidovudine (used for the treatment of HIV infections)

• Colestyramine (used to reduce blood cholesterol levels)

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid disorder (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.

As a general rule for any medicine, it is advisable to systematically inform your doctor or pharmacist if you are taking other medicines. Paracetamol may occasionally be used as a preferred analgesic in patients receiving oral anticoagulants.

Interference with diagnostic tests

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

Use of Paracetamol Kern Pharma with food and drink

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of paracetamol may pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

No effects affecting the ability to drive or operate 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. In case of doubt, consult 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. Doses should be spaced at least 4 hours apart. Do not exceed 4 tablets (4 g) in 24 hours.

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

Elderly patients: should consult their doctor.

When doses lower than 1 g of paracetamol per administration are required, other paracetamol formulations adapted to the required dosage should be used.

The score line is intended solely for dividing the tablet if you find it difficult to swallow whole. Paracetamol Kern Pharma should be taken orally. Tablets may be swallowed whole or split in half with water or another liquid, according to your preference.

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 you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If an overdose has occurred, you must go immediately to a medical center even if there are no symptoms, as symptoms often do not appear until three days after 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 of overdose is most effective if started within 4 hours after taking the medicine.

Patients undergoing treatment with barbiturates or who suffer from chronic alcoholism may be more susceptible to paracetamol overdose.

If you forget to take Paracetamol Kern Pharma

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

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

4. Possible adverse effects

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

Paracetamol Kern Pharma may cause the following adverse effects:

• Rare (may affect up to 1 in 1,000 people): malaise and decreased blood pressure.
• Very rare (may affect up to 1 in 10,000 patients): allergic reactions (such as skin reactions), decreased glucose levels, blood disorders, and liver and kidney abnormalities.
• Frequency not known (cannot be estimated from 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).

Very rare cases of severe skin reactions have been reported.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects 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 any special storage conditions.

Do not use this medicine 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 properly dispose of unused medicines and their packaging. 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 1 g of paracetamol.
• The other components are: pregelatinized corn starch, stearic acid, and povidone.

Nature of the product and pack contents

Paracetamol Kern Pharma 1 g is presented as oral tablets. The tablets are white, oblong, and scored on one side. The packs contain 20 or 40 tablets 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 most recent review of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/