GELOCATIL PEDIATRIC 100mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Gelocatil Pediatric 100 mg/ml Oral Solution

Paracetamol

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

• Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 the symptoms worsen or if the fever or pain persists for more than 3 days (2 days for throat pain), you should consult a doctor.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet (see section 4).

Contents of the Package Leaflet

1. What is Gelocatil Pediatric and what is it used for
2. What you need to know before taking Gelocatil Pediatric
3. How to take Gelocatil Pediatric
4. Possible side effects
5. Storage of Gelocatil Pediatric
6. Contents of the pack and further information

1. What is Gelocatil Pediatric and what is it used for

Gelocatil Pediatric belongs to the group of medicines called analgesics and antipyretics.

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

2. What you need to know before taking Gelocatil Pediatric

Do not take Gelocatil Pediatric

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

Warnings and precautions

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

Do not take more medicine than recommended in section 3. How to take Gelocatil Pediatric. The simultaneous use of this medicine with other medicines that contain paracetamol should be avoided, as high doses can lead to liver damage. Do not use more than one medicine that contains paracetamol without consulting your doctor.

In patients with asthma who are sensitive to acetylsalicylic acid, consultation with the doctor is necessary before taking this medicine.

If you have any liver, kidney, heart, or lung disease, suffer from chronic malnutrition, or are dehydrated or have anemia (decrease in hemoglobin levels in the blood, due to or not due to a decrease in red blood cells), you should consult your doctor before taking this medicine.

Consumption of alcoholic beverages can cause paracetamol to produce liver damage.

If the pain persists for more than 3 days (2 days for throat pain), the fever for more than 3 days, or the pain or fever worsens or other symptoms appear, treatment should be discontinued, and the doctor consulted to reassess the clinical situation. Prolonged treatments should be avoided.

During treatment with Gelocatil Pediatric, inform your doctor immediately if: you have severe diseases, such as severe renal insufficiency 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 disease called metabolic acidosis (an anomaly in the blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken together with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children

For 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 medicines and Gelocatil Pediatric

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Paracetamol may interact with the following medicines:

• Medicines to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medicines to treat tuberculosis: (isoniazid, rifampicin)
• Medicines to treat depression and convulsions: Barbiturics (used as hypnotics, sedatives, and anticonvulsants)
• Medicines to lower cholesterol levels in the blood: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as furosemide)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not use with other analgesics (pain-relieving medicines) 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 going to undergo any analytical test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results of these tests.

Taking Gelocatil with food, drinks, and alcohol

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

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The consumption of medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

If necessary, Gelocatil Pediatric can be used during pregnancy. You should 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 medicine more frequently.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is nil or insignificant.

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

This medicine contains 400 mg of propylene glycol per ml, equivalent to 400 mg/ml.

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

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

If the child is under 5 years old, consult your doctor or pharmacist, especially if they have been given other medicines that contain propylene glycol or alcohol.

This medicine contains 100 mg of sorbitol per ml, equivalent to 100 mg/ml.

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

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

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

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

3. How to take Gelocatil Pediatric

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

Remember to take your medicine.

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

The dose of Gelocatil Pediatric depends on the child's weight. The approximate age is given for information purposes.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e., 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

For administration of 15 mg/kg every 6 hours, the schedule is as follows:

For a direct calculation, you can multiply the child's weight in kg by 0.15. The result is the ml of solution to be administered.

These doses can be repeated every 6 hours.

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

For a direct calculation, you can also multiply the child's weight in kg by 0.10. The result is the ml of solution to be administered.

These doses can be repeated every 4 hours.

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

Administration of this medicine is subject to the appearance of pain or fever. As they disappear, this medication should be suspended.

Instructions for the correct administration of the preparation:

This medicine should be taken orally. According to the patient's preferences, it can be diluted in water, milk, or fruit juice or taken directly.

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

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 Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount ingested. If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, since they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

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).

Treatment of overdose is more effective if started within 4 hours after ingestion of the medicine.

Patients being treated with barbiturics or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forget to take Gelocatil Pediatric

Do not give the child a double dose to make up for forgotten doses; simply give the forgotten dose when you remember, taking the next doses with the indicated interval between them (4-6 hours).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Rare side 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 side effects that may occur (in up to 1 in 10,000 people) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing 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 in prolonged treatments. Very rare cases of severe skin reactions have been reported.
• Side effects of unknown frequency (cannot be estimated from the available data): a serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Gelocatil Pediatric

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging (after EXP). The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Gelocatil Pediatric

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

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

Appearance of the product and packaging contents

Gelocatil Pediatric is a clear, red, oral paracetamol solution with a strawberry flavor, presented in a polyethylene terephthalate bottle with a tamper-evident cap and a child-resistant 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.

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94 – 08028 Barcelona

Manufacturer

Laboratorio Reig Jofre, S.A.

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

Date of the last revision of this leaflet: February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/