Paracetamol Kern Pharma 100 mg/ml oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Paracetamol Kern Pharma 100 mg/ml oral solution EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet.
• You should consult a doctor if you get worse or if you do not improve after 3 days.

Contents of the leaflet:

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 febrile conditions and for the relief of mild to moderate pain.

2. What you need to know before starting to take Paracetamol Kern Pharma

Do not take Paracetamol Kern Pharma

• If you are allergic to paracetamol, to other medicines in the group of antipyretics or analgesics, or to any of the other ingredients of Paracetamol Kern Pharma.
• If you have any liver disease.

Warnings and precautions

• Do not exceed the recommended dose indicated in section 3. How to take Paracetamol Kern Pharma.
• In patients with kidney, heart, or lung diseases, and in patients with anemia (reduced hemoglobin levels in the blood, due to or unrelated to a decrease in red blood cells), consult your doctor before taking the medicine.
• Consumption of alcoholic beverages may cause paracetamol to cause liver damage.
• If pain persists for more than 3 days in children or 5 days in adults (2 days for sore throat), or if fever lasts more than 3 days, or if symptoms worsen or new symptoms appear, treatment should be stopped and a doctor consulted.
• Avoid prolonged treatments.

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 for prolonged periods 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.

Children

It is advised to consult a doctor before administering this medicine to children under 3 years of age.

Interference with diagnostic tests

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

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.

Do not use with other analgesics (medicines that reduce pain) without consulting your doctor. To avoid the risk of overdose, ensure that you are not taking other medicines containing paracetamol. Prolonged and simultaneous use of paracetamol with salicylates is not recommended, as chronic administration and high doses of both analgesics significantly increase the risk of kidney toxicity.

Paracetamol may increase the toxicity of chloramphenicol.

Barbiturates may enhance the toxicity of paracetamol.

When undergoing treatment with oral anticoagulants, paracetamol may occasionally be administered as the analgesic of choice.

In particular, if you are taking medicines containing any of the following active substances, dose adjustment or discontinuation of treatment may be necessary:

• Antibiotics (chloramphenicol)

• Oral anticoagulants (acenocoumarol, warfarin)

• Oral contraceptives and estrogen treatments

• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

• Antituberculosis agents (isoniazid, rifampicin)

• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)

• Activated charcoal, used for diarrhea or treatment of gas

• Cholestyramine (used to reduce blood cholesterol levels)

• Medicines used to treat gout (antigout agents) (probenecid and sulfinpyrazone)

• Certain medicines used to increase urine elimination (loop diuretics such as furosemide)

• Medicines used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics)

• Medicines used for heart conditions (digitalis glycosides)

• Metoclopramide and domperidone (used to prevent nausea and vomiting)

• Propranolol, used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)

• Zidovudine (used in the treatment of patients infected with the human immunodeficiency virus causing AIDS)

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis with high anion gap) that requires urgent treatment (see section 2).

• Use of Paracetamol Kern Phawith food and drink

Paracetamol Kern Pharma may be diluted with water, milk, or fruit juice. The use of paracetamol in patients who habitually consume alcohol (three or more alcoholic drinks per day) may damage the liver.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

In women, although no controlled studies exist, teratogenic effects have not been demonstrated. However, as a general rule, its use is not recommended during the first trimester of pregnancy, and if used, it should always be based on an assessment of the potential risks and benefits of treatment. If necessary, paracetamol may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible duration. Contact your doctor if pain or fever do not subside or if you need to take the medicine more frequently. Paracetamol passes into breast milk; therefore, women who are breastfeeding should consult their doctor before using this medicine.

Driving and use of machines

May impair the ability to drive or operate machinery due to the presence of propylene glycol, which may produce symptoms similar to those of alcohol.

Paracetamol Kern Pharma contains propylene glycol and glucose

This medicine contains 2.72 mg of propylene glycol in each ml.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol.

This medicine contains glucose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Paracetamol Kern Pharma

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor, pharmacist, or nurse.

The dosage of Paracetamol Kern Pharma is measured in ml (100 mg/ml), using the 2 or 5 ml oral syringe provided.

The recommended dose is:

Children from 0 to 10 years:

These doses may be repeated every 6 hours.

A dosing regimen of 15 mg/kg per dose every 6 hours, with a total daily dose of 60 mg/kg/day, may also be established, especially in children under 1 year of age.

If the desired effects have not been achieved within 3–4 hours after administration, the dosing interval may be reduced to every 4 hours, in which case 10 mg/kg should be administered.

Administration of the preparation should be based on the occurrence of painful or febrile symptoms. As these symptoms subside, this medication should be discontinued.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

Method of administration and route

Oral use.

30 ml bottle:

Draw the prescribed amount using the 2 ml dosing syringe.

60 ml bottle with 5 ml oral syringe:

1. Open the bottle following the instructions indicated on the cap (on first opening, the seal will break).

2. Insert the oral syringe by pressing it into the pierced opening of the cap.

3. Invert the bottle and withdraw the required dose.

4. Administer directly or dilute with water, milk, or fruit juice.

5. The oral syringe should be washed with water after each use.

Close the bottle tightly after each administration.

If you take more Paracetamol Kern Pharma than you should

If you have taken more paracetamol than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91-562 04 20, indicating the name of the medicine and the amount taken. It is recommended to bring the medicine package and leaflet to the healthcare professional.

If an overdose has been ingested, seek immediate medical attention even if no symptoms are present, as serious symptoms may not appear until 3 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.

An overdose of paracetamol is considered when a single dose exceeding 6 g is ingested in adults, or more than 100 mg per kg of body weight in children. Treatment for overdose is most effective when initiated within 4 hours of ingestion of the medicine.

In patients undergoing treatment with barbiturates or suffering from chronic alcoholism, increased susceptibility to paracetamol overdose may occur.

If you forget to take Paracetamol Kern Pharma

Do not take a double dose to make up for missed doses.

If you have missed a dose, take it as soon as possible and continue with your regular schedule. However, if the next dose is due soon, skip the missed dose and take the next dose at the usual time.

4. Possible adverse effects

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

Adverse reactions to paracetamol are generally rare (may affect up to 1 in 1,000 patients) or very rare (may affect up to 1 in 10,000 patients).

Liver damage may very rarely occur at high doses or with prolonged treatment. Very rarely, skin rashes and blood disorders such as neutropenia or leucopenia may also occur.

Very rare cases of serious skin reactions have been reported.

Frequency not known (cannot be estimated from available data): A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness who are taking 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 the sight and reach of children.

Store the bottle in the outer packaging to protect it from light.

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.

After opening, the contents of the bottle should be used within 6 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and containers. 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 ml of solution contains 100 mg of paracetamol.
• The other components (excipients) are: macrogol 600, glycerol (E-422), sucralose (E-955), flavouring agent (contains propylene glycol (E-1520)), strawberry flavour (contains propylene glycol (E-1520)), carmine red (E-120) (contains glucose), and water.

Appearance of the medicinal product and contents of the container

Paracetamol Kern Pharma 100 mg/ml is presented as a red, transparent oral solution with a characteristic strawberry odour.

30 ml bottle with a 2 ml dosing syringe and 60 ml bottle with a 5 ml dosing syringe.

Marketing Authorisation Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.