Gelocatil Pediatric 325 mg granules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gelocatil paediatric 325 mg granules

Paracetamol

Read the entire leaflet carefully before starting to use this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If symptoms worsen or if fever or pain persists for more than 3 days, you must consult a doctor.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they 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 adverse 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

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscular pain (muscle spasms), and for the treatment of fever.

Gelocatil pediatric is indicated for children weighing between 25 and 43 kg (from 8 to 11 years of age).

2. What you need to know before taking Gelocatil pediatric

Do not take Gelocatil pediatric

• If you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

Take special care with 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, such as cold and flu remedies, because high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

• You should consult your doctor before taking this medicine if you:

• Have kidney, liver, heart, or lung disease, or if you have anemia.

• Are an asthmatic patient sensitive to acetylsalicylic acid.

• During treatment with Gelocatil pediatric, inform your doctor immediately if:

You have serious medical 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 the blood and body fluids) has been reported in patients under these circumstances when paracetamol is used at regular doses over a prolonged period 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.

Use of Gelocatil pediatric with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

In particular, if you are taking medicines containing any of the following active ingredients, it may be necessary to reduce the dose of some of these medicines or discontinue treatment:

• Antibiotics (chloramphenicol)
• Oral anticoagulants (acenocoumarol, warfarin)
• Oral contraceptives and estrogen treatments
• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculosis medicines (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Activated charcoal used for diarrhea or gas treatment
• Cholestyramine (used to lower blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• 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 to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter the test results.

Taking Gelocatil pediatric with food and drinks

Taking this medicine with food does not affect its effectiveness.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

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 pain or fever do not improve or if you need to take the medicine more frequently.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

Paracetamol is excreted in breast milk; therefore, women who are breast-feeding should consult their doctor or pharmacist before using this medicine.

Children

Do not use in children weighing less than 25 kg (approximately under 6 years of age), as it does not allow for dosing lower than 1 sachet per dose (325 mg).

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is none or negligible.

Gelocatil pediatric contains aspartame, sodium, sucrose, and glucose:

• This medicine contains 15.35 mg of aspartame per sachet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

• This medicine contains 58.5 mg of sodium (main component of table/cooking salt) per sachet. This corresponds to 2.92% of the maximum daily recommended sodium intake for an adult.
• This medicine contains sucrose and glucose (as maltodextrin). If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Gelocatil paediatric

Follow exactly the administration instructions for this medicine provided in this leaflet or as directed by your pharmacist. If in doubt, ask your doctor or pharmacist.

It is essential to adhere to the dosages defined according to the child's weight, and therefore, select the appropriate dosage. The approximate age corresponding to body weight is provided 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.

• Children weighing between 25 and 43 kg (approximately 8 to 11 years of age): 1 sachet of 325 mg every 4–6 hours as needed. Depending on body weight, children weighing less than 33 kg should not exceed 5 sachets in 24 hours, and those weighing more than 33 kg should not exceed 6 sachets in 24 hours.

Patients with liver or kidney disease: must consult their doctor before taking this medicine. If your doctor prescribes this medicine to you, you must wait at least 8 hours between doses.

Gelocatil paediatric is taken orally.

Open the sachet and pour the contents directly into the mouth. The granules disperse immediately in saliva and are then swallowed.

It may be taken with or without food.

Always use the lowest effective dose.

High daily doses of paracetamol should be avoided during prolonged periods, as this increases the risk of adverse effects such as liver damage.

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

If pain or fever persists for more than 3 days, or if pain or fever worsens or new symptoms appear, treatment must be stopped and a doctor consulted.

If the child takes more Gelocatil paediatric than they should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested.

If an overdose has been taken, seek urgent medical attention even if there are no symptoms, 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 started 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 forget 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 give the following doses at the recommended intervals (4–6 hours).

4. Possible adverse effects

Like all medicines, Gelocatil pediatric can have adverse effects, although not everyone will experience them.

• Rare adverse effects (occurring in up to 1 in 1,000 patients) are: malaise, low blood pressure (hypotension), and increased blood transaminase levels.

• Very rare adverse effects (occurring in up to 1 in 10,000 patients) are: 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). Very rare cases of serious skin reactions have been reported.

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

• Adverse effects of unknown frequency (cannot be estimated from the 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Human Medicines: 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

Keep out of the sight and reach of children.

No special storage conditions are required.

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 should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gelocatil paediatric

The active substance is paracetamol. Each sachet contains 325 mg of paracetamol.

The other components (excipients) are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), mask it (a compound containing natural flavourings, flavourings identical to natural ones, maltodextrin (contains glucose), sucrose, aspartame (E-951) and potassium acesulfame (E-950)), mannitol (E-421), lemon flavour, amorphous silica, glycerol (E-422) diester type 1, sodium croscarmellose, sodium carboxymethyl starch (potato starch type A), ethyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol 400.

Appearance of the product and pack size

Gelocatil paediatric is a white granulate with lemon odour supplied in sachets for oral administration.

Packaged in boxes of 12 and 20 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Madrid

or

Edefarm, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante,

Valencia

Local Representative:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - 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 for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/