Gelocatil Pediatric 100 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Gelocatil paediatric 100 mg/ml oral solution

Paracetamol

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

• Follow exactly the administration instructions 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 your doctor.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if these are adverse effects not listed in this leaflet (see section 4).

Leaflet contents

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

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

Gelocatil pediatric belongs to a group of medicines called analgesics and antipyretics.

Gelocatil pediatric is indicated in children from 0 to 10 years of age for the occasional symptomatic relief of mild to moderate pain, and for reducing 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 ingredients 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 the recommended dose stated in section 3, How to take Gelocatil pediatric. Avoid using this medicine simultaneously with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

In asthmatic patients who are sensitive to acetylsalicylic acid, consult your doctor before taking this medicine.

If you have liver, kidney, heart, or lung disease, suffer from chronic malnutrition, are dehydrated, or have anemia (reduced hemoglobin levels in the blood, with or without a reduction in red blood cells), you should consult your doctor before taking this medicine.

Consumption of alcoholic beverages may increase the risk of liver damage caused by paracetamol.

If pain persists for more than 3 days (2 days for sore throat), fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be stopped, a doctor should be consulted, and the clinical condition reassessed. Avoid prolonged treatments.

During treatment with Gelocatil pediatric, 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 circumstances 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 difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children

In children aged 10 years and older (body weight above 32 kg), it is recommended to use other formulations of Gelocatil. For further information, consult your doctor or pharmacist.

Other medicines and Gelocatil pediatric:

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

Paracetamol may interact with the following medicines:

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

Do not use with other analgesics (medicines that relieve pain) without consulting your doctor.

Interference with laboratory tests:

Consult your doctor if the patient is due to undergo blood or urine tests.

If you are scheduled for any laboratory tests (including blood and urine analyses, 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 drinks per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, 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 might be, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.

If necessary, Gelocatil paediatric may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. Contact your doctor if pain or fever do not improve 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 pass into breast milk; therefore, it is recommended that you consult your doctor or pharmacist before taking this medicine.

Driving and use of machines

The influence of paracetamol on the ability to drive and operate machinery is none or negligible.

Gelocatil paediatric 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 recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

If you have hepatic or renal impairment, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine.

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

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

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder 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 may provoke asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Gelocatil paediatric

Follow exactly the administration instructions for this medicine provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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

The dose of Gelocatil paediatric 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, divided into 4 or 6 doses per day, 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 dosing schedule is as follows:

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

These doses may be repeated every 6 hours.

If the desired effects are not achieved within 3-4 hours after administration, the dosing interval may be shortened to every 4 hours; in this case, 10 mg/kg should be administered.

For direct calculation, the child's weight in kg may alternatively be multiplied by 0.10. The result is the volume in ml of solution to be administered.

These doses may be repeated every 4 hours.

Dosages for children under 2 years of age should always be determined under medical advice.

Administration of this medicine should be based on the presence of pain or fever. As these symptoms subside, the medication should be discontinued.

Instructions for correct administration of the preparation:

This medicine is for oral use. It may be diluted in water, milk, or fruit juice according to patient preference, or taken directly.

Open the bottle following the instructions on the cap (on first opening, the security seal will break). Insert the dosing syringe by pressing it into the perforated hole in the cap, invert the bottle, and withdraw the required amount. The dosing syringe should be washed with water after each use.

If the child takes more Gelocatil paediatric than they should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 620 420, indicating the medicine and amount ingested. If an overdose has been taken, you must go immediately to a medical center even if no symptoms are apparent, as symptoms often do 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), abdominal pain, and inflammation of the pancreas (pancreatitis).

Treatment of overdose is most effective if initiated within 4 hours of ingestion of the medicine.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to give Gelocatil paediatric

Do not give the child a double dose to make up for a missed dose. Simply administer the missed dose as soon as you remember, and then continue with the next doses at the recommended intervals (4-6 hours).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

• Rare adverse effects (occurring in up to 1 in 1,000 people) include: malaise, low blood pressure (hypotension), and increased blood transaminase levels.
• Very rare adverse effects (occurring in up to 1 in 10,000 people) include: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Paracetamol may cause liver damage when taken at high doses or during prolonged treatment. Very rare cases of serious skin reactions have been reported.
• Adverse effects with unknown frequency (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).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish System for Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 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 collection point at your pharmacy. If you are unsure, 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 Gelocatil Pediatric

The active substance is paracetamol. Each millilitre contains 100 mg of paracetamol.

The other components (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 flavouring, citric acid, purified water.

Appearance of the product and contents of the container

Gelocatil Pediatric is a red, transparent, strawberry-scented and flavoured oral solution of paracetamol, supplied in a polyethylene terephthalate (PET) bottle fitted with a tamper-evident cap and child-resistant closure, containing 60 ml of oral solution. It includes a graduated dosing syringe marked in millilitres (divided into 1 ml increments) with a maximum volume of 5 ml.

Marketing Authorisation Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94 – 08028 Barcelona (Spain)

Manufacturer

Laboratorio Reig Jofre, S.A.

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

Local Representative

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona (Spain)

Date of the most recent revision 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/