Leaflet: Information for the user

Gelocatil pediatric 100 mg/ml oral solution

Paracetamol

Read this leaflet carefully before you start taking this medicine, as it contains important information for you

• Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your pharmacist.
• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or if fever or pain persists for more than 3 days (2 days for sore throat), you should consult a doctor.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet (see section 4).

Gelocatil pediatricbelongs to a group of medicines called analgesics and antipyretics.

Gelocatil pediatric is indicated in children from 0 to 10 years for occasional symptomatic relief of mild to moderate intensity pain, and to reduce fever.

Do not take Gelocatil pediatric

• If you are allergic to paracetamol, chlorhydrate of propacetamol, or any of the other components of this medication (listed in section 6).
• If you have a severe liver disease.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Gelocatil pediatric.

Do not take more medication than recommended in section 3, How to take Gelocatil pediatric. Avoid simultaneous use of this medication with other medications containing paracetamol, as high doses may cause liver damage. Do not use more than one medication containing paracetamol without consulting your doctor.

In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

If you have liver, kidney, heart, or lung disease, chronic malnutrition, dehydration, or anemia (decrease in hemoglobin levels in the blood, due or not to a decrease in red blood cells), consult your doctor before taking this medication.

Consuming alcoholic beverages may cause paracetamol to cause liver damage.

If the pain persists for more than 3 days (2 days for throat pain), fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, discontinue treatment, consult your doctor, and reevaluate the clinical situation. Avoid prolonged treatments.

During treatment with Gelocatil pediatric, immediately inform your doctor if: You have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have chronic malnutrition, chronic 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 difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children

In children over 10 years old (weight over 32 kg), it is recommended to use other presentations of Gelocatil. For more information, consult your doctor or pharmacist.

Other medications and Gelocatil pediatric:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Paracetamol may interact with the following medications:

• Blood clotting medications: Oral anticoagulants (acenocoumarol, warfarin)
• Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications for treating tuberculosis: (isoniazid, rifampicin)
• Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications for lowering cholesterol levels in the blood: (colestiramine)
• Medications used to increase urine elimination (diuretics of the loop, such as the furosemide group)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

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

Interference with analytical tests:

Consult your doctor if the patient needs to undergo a blood or urine test.

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

Taking Gelocatil with food, drinks, and alcohol

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

Taking this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Consult your doctor or pharmacist before taking any medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. Consuming medications during pregnancy may be hazardous to the embryo or fetus, and should be monitored by your doctor.

If necessary, Gelocatil pediatric may 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 do not decrease or if you need to take the medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before taking any medication.

Small amounts of paracetamol may appear in breast milk, so it is recommended to consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

Gelocatil pediatric contains propylene glycol, sorbitol, p-hydroxybenzoate of methyl, p-hydroxybenzoate of propyl, amaranth, and sodium

This medication contains 400 mg of propylene glycol in each ml equivalent to 400 mg/ml.

If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney insufficiency, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

This medication contains 100 mg of sorbitol in each ml equivalent to 100 mg/ml.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

This medication may cause allergic reactions (possibly delayed) because it contains p-hydroxybenzoate of methyl and p-hydroxybenzoate of propyl (E-218 and E-216).

This medication may cause allergic reactions because it contains amaranth (E-123). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Gelocatil pediatric is intended for use in children up to 32 kg (approximately 0 months to 10 years).

The dose of Gelocatil pediatric depends on the child's weight. The approximate age is given for informational purposes only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, which is divided into 4 or 6 daily doses, that is15 mg/kg every 6 hoursor10 mg/kg every 4 hours.

For the administration of15 mg/kg every 6 hours, the schedule is as follows:

To make a direct calculation, the child's weight in kg can be multiplied by 0.15. The result is the volume of solution to be administered.

These doses can be repeated every 6 hours.

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.

To make a direct calculation, the child's weight in kg can also be multiplied by 0.10. The result is the volume of solution to be administered.

These doses can be repeated every 4 hours.

Doses for children under 2 years will always be established under medical advice.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, this medication should be discontinued.

Instructions for the correct administration of the preparation:

This medication should be taken orally. According to the patient's preferences, dilute in water, milk, or fruit juice, or take directly.

Open the bottle following the instructions indicated on the cap (in the first opening the seal will break). Insert the dosing syringe by pressing on the orifice of the perforated cap, invert the bottle, and remove the amount to be taken. The dosing syringe should be washed with water after each dose.

If the child takes more Gelocatil pediatric than they should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 915 620 420, indicating the medication and the amount ingested. If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion of 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), abdominal pain, and pancreatitis (inflammation of the pancreas).

The treatment of overdose is more effective if initiated within 4 hours of ingestion of the medication.

Patients on barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to take Gelocatil pediatric

Do not give the child a double dose to compensate for the missed doses, simply give the missed dose when you remember, taking the next doses with the indicated interval (4-6 hours).

Like all medications, this medication may produce adverse effects, although not all people will experience them.

• Rare adverse effects that may occur (in up to 1 in 1,000 people), are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.
• Very rare adverse effects that may occur (in up to 1 in 10,000 people) are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Paracetamol can damage the liver when taken in high doses or prolonged treatments. Rarely, severe skin reactions have been reported.
• -Adverse effects of unknown frequency (cannot be estimated from available data): A serious disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This product does not require special storage conditions.

Keep this medication out of the sight and reach of children.

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

Do not dispose of medications through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofGelocatil pediatric

The active ingredient is paracetamol. Each milliliter contains 100 mg of paracetamol.

The other components (excipients) are sodium saccharin, propylene glycol, macrogol, glycerol (E-422), sorbitol (E-420), p-hydroxybenzoate of methyl and p-hydroxybenzoate of propyl (E-218 and E-216), amaranth (E-123), strawberry and raspberry flavor, citric acid, purified water.

Appearance of the product and content of the packaging

Gelocatil pediatric is a transparent oral solution of paracetamol with a red color and a strawberry flavor and odor, presented in a polyethylene terephthalate bottle with a tamper-evident and safety closure, containing 60 ml of oral solution. It includes a graduated dosing syringe in milliliters (divided into 1 ml) with a maximum volume of 5 ml.

Holder of the marketing authorization

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94 – 08028 Barcelona

Responsible for manufacturing

Laboratorio Reig Jofre, S.A.

Gran Capità, 10 – 08970 Sant Joan Despí (Barcelona)

Date of the last review of this leaflet: February 2025

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