Leaflet: information for the user

Paracetamol Kern Pharma 100 mg/ml oral solution EFG

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

Follow exactly the administration instructions for 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

-You should consult a doctor if your condition worsens or does not improve after 3 days.

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

This medication is indicated for febrile states and for relief of mild to moderate pain.

Do not takeparacetamolKern Pharma

• If you are allergic to paracetamol, other antipyretic or analgesic medications, or any of the other components of Paracetamol Kern Pharma.
• If you have any liver disease.

Warnings and Precautions

• Do not exceed the recommended dose in section 3. How to take Paracetamol Kern Pharma.
• In patients with kidney, heart, or lung disease, and in patients with anemia (decreased hemoglobin levels in the blood, due or not to a decrease in red blood cells), consult with your doctor before taking the medication.
• The consumption of alcoholic beverages may cause paracetamol to cause liver damage.
• If the pain persists for more than 3 days in children or 5 days in adults (2 days for sore throat) or fever for more than 3 days, or worsens or other symptoms appear, discontinue treatment and consult your doctor.
• Avoid prolonged treatments.

Inform your doctor immediately if you experience any of the following during treatment with Paracetamol Kern Pharma:

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 chronic malnutrition, alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children

It is recommended to consult your doctor before administering it to children under 3 years old.

Interference with diagnostic tests

Inform your doctor if you are undergoing any diagnostic tests (including blood, urine, etc...), as this medication 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.

Do not use with other analgesics (pain-relieving medications) without consulting your doctor. To avoid the risk of overdose, ensure that you are not taking other medications containing paracetamol. Prolonged and simultaneous use of paracetamol with salicylates is not recommended due to the increased risk of kidney toxicity.

Paracetamol may increase the toxicity of chloramphenicol.

Barbiturates may potentiate the toxicity of paracetamol.

In cases of anticoagulant oral treatments, paracetamol may be administered occasionally as the preferred analgesic.

Particularly if you are using medications containing the following active principles, as it may be necessary to modify the dose or discontinue treatment with any of them:

• Antibiotics (chloramphenicol)
• Oral anticoagulants(acenocoumarol, warfarin)
• Oral contraceptives and hormone replacement therapy
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, metharbital, primidone, carbamazepine)
• Antituberculars (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Activated charcoal, used for diarrhea or gas treatment
• Colestiramine (used to reduce blood cholesterol levels)
• Medications used to treat gout (antigout medications) (probencid and sulfinpyrazone)
• Diuretics of the loop, such as furosemide
• Medications used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics)
• Medications used for the heart (digitalis glycosides)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol used to treat high blood pressure (hypertension) and cardiac arrhythmias
• Zidovudine (used to treat patients infected with the human immunodeficiency virus, causing AIDS)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid imbalance (metabolic acidosis with high anion gap) that must be treated urgently (see section 2).

• Use of ParacetamolKern Pharmawith food and drink

paracetamolKern Pharmacan be diluted with water, milk, or fruit juice.The use of paracetamol in patients who regularly consume alcohol (three or more alcoholic beverages per day) may damage the liver.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

In women, although there are no controlled studies, no teratogenic effects have been reported. However, as a general rule, it is not recommended to use it during the first trimester of pregnancy, and in the case of use, it should always be evaluated considering the possible risks and benefits of treatment. If necessary, Paracetamol can be used during pregnancy. 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 passes into breast milk, so women in the lactation period should consult their doctor before using this medication.

Driving and operating machinery

It may reduce your ability to drive or operate machinery due to the presence of propylene glycol, as it may cause symptoms similar to those of alcohol.

Paracetamol Kern Pharma contains propylene glycol and glucose

This medication contains 2.72 mg of propylene glycol per ml.

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

This medication contains glucose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

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

The recommended dose is:

Children from0 to10 years:

These doses can be repeated every 6 hours.

An alternative dosing schedule of 15 mg/kg per dose, every 6 hours, with a total daily dose of 60 mg/kg, can be established, especially in children under 1 year.

If the desired effects are not obtained 3-4 hours after administration, the dose can be advanced every 4 hours, in which case 10 mg/kg will be administered.

The administration of the preparation is subject to the appearance of painful or feverish symptoms. As these symptoms disappear, this medication should be discontinued.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Form of use and route of administration

Oral route.

Bottle of 30 ml:

Extract the prescribed amount with the help of the 2 ml oral syringe.

Bottle of 60 ml with 5 ml oral syringe:

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

2.- Insert the oral syringe, pressing on the perforated cap.

3.- Invert the bottle and remove the necessary dose.

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

5.- The oral syringe must be washed with water after each dose.

Close the bottle tightly after each administration.

If you take moreParacetamolKern Pharma than you should

If you have taken more paracetamol than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, telephone 91-562 04 20, indicating the medication and the amount used. It is recommended to bring the packaging and the leaflet to the healthcare professional.

If an overdose has been ingested, go quickly to a Medical Center, even if there are no symptoms, as severe symptoms often do not appear until 3 days after ingestion, even in cases of severe intoxication. The symptoms of an overdose may include dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

An overdose of paracetamol is considered to be the ingestion of a single dose of more than 6 g in adults and more than 100 mg per kg of body weight in children.The treatment of an overdose is more effective if initiated within 4 hours of ingestion of the medication.

In the case of patients undergoing treatment with barbiturates or suffering from chronic alcoholism, they may be more susceptible to an overdose of paracetamol.

If you forgot to takeParacetamolKern Pharma

Do not take a double dose to compensate for the missed doses.

If you have forgotten a dose, take another 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 its regular time.

Like all medications,ParacetamolKern Pharma may produce adverse effects, although not all people will experience them.

The adverse reactions of paracetamol are, in general, rare (they may affectup to1 in1,000 patients) or very rare (they may affectup to1 in10,000 patients).

Very rarely, it may damage the liver at high doses or prolonged treatments. It may also very rarely cause skin eruptions and blood alterations such as neutropenia or leucopenia.

Very rarely, severe skin reactions have been reported.

Unknown frequency (cannot be estimated from available data): A severe disease that may make the blood more acidic (known as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

If you consider that any of the adverse effects you experience are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of sight and reach of children.

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

Do not use this medication after the expiration date indicated on the packaging after CAD. The expiration date is the last day of the month indicated.

Once opened, the contents of the bottle must be used within 6 months.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol Kern Pharma

• The active ingredient is paracetamol. Each ml of solution contains 100 mg of paracetamol.
• The other components (excipients) are:macrogol 600,glycerol (E-422), sucralose (E-955), flavor enhancer (contains propylene glycol (E-1520)), strawberry aroma(contains propylene glycol (E-1520)), red cochineal (E-120) (contains glucose)and water.

Appearance of the product and content of the packaging

Paracetamol Kern Pharma 100 mg/ml is presented in the form of a transparent, red-colored oral solution with a characteristic strawberry odor.

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

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.