Leaflet: information for the user

Gelocatil pediatric 325 mg granulated

Paracetamol

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

2.What you need to know before starting to take Gelocatil pediatric

3.How to take Gelocatil pediatric

4.Possible adverse effects

5.Storage of Gelocatil pediatric

6.Contents of the pack and additional information.

Paracetamol is effective in reducing pain and fever.

It is indicated for symptomatic relief of occasional mild or moderate pain, such as headache, toothache, muscle pain (spasms) and fever.

Gelocatil pediatric is indicated in children between 25 and 43 kg (8 to 11 years old).

Do not takeGelocatil pediatric

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

Special precautions for Gelocatil pediatric

• Do not take more than the recommended amount of medication as stated in section 3, Taking Gelocatil pediatric.
• Avoid using this medication with other medications that contain paracetamol, such as cold and flu medications, as high doses may cause liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• Consult your doctor before taking this medication:

• Patients with kidney, liver, heart, or lung diseases and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.

• Inform your doctor immediately if you experience:

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 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Use of Gelocatil pediatric 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.

Particularly, if you are using medications that contain the following active ingredients, as it may be necessary to reduce the dose of some of them or discontinue treatment:

• Antibiotics (cloranfenicol)
• Oral anticoagulants (acenocoumarol, warfarin)
• Oral contraceptives and hormone replacement therapy
• Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculars (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Activated charcoal used for diarrhea or gas treatment
• Colestiramine (used to lower blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to relieve spasms or contractions of the stomach, intestines, and bladder (anticholinergics)
• Medications used to treat the heart (digitalis glycosides)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias)

Interference with laboratory tests:

Inform your doctor if you are undergoing any laboratory tests (including blood and urine tests) as this medication may affect the results of these tests.

Taking Gelocatil pediatric with food and beverages

The taking of this medication with food does not affect its efficacy.

Pregnancy

Consult your doctor or pharmacist before using any medication.

This medication may be used during pregnancy if necessary. 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 decrease or if you need to take the medication more frequently.

Lactation

Consult your doctor or pharmacist before using any medication.

Paracetamol is excreted in breast milk, so women in the lactation period should consult their doctor or pharmacist before using this medication.

Children

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

Driving and operating machinery

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

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

• This medication contains 15.35 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

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

It is necessary to respect the dosages defined according to the child's weight, and therefore, choose the appropriate dosage. The approximate age according to weight is given for information purposes only.

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

• Children between 25 and 43 kg (approximately 8 to 11 years old): 1 tablet of 325 mg every 4-6 hours as needed. According to weight, children with a weight below 33 kg should not exceed 5 packets in 24 hours and those with a weight above 33 kg up to 6 packets in 24 hours.

Patients with liver or kidney disease:should consult their doctor before taking this medication. If their doctor prescribes this medication, they should wait at least 8 hours between doses.

Gelocatil pediatric is taken orally.

Open the packet and pour the contents directly into the mouth. The granule disperses immediately in the saliva and is then swallowed.

It can be taken both with food and without it.

Always use the smallest effective dose.

It is essential to avoid high daily doses of paracetamol for prolonged periods of time, as this increases the risk of adverse effects such as liver damage.

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

If the pain or fever persists for more than 3 days or worsens, or if other symptoms appear, treatment should be interrupted and the doctor consulted.

If the child takes more Gelocatil pediatric than they should

In case of overdose or accidental ingestion, consult a doctor or pharmacist or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested..

If an overdose has been ingested, go quickly to a medical center, even if there are no 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 inflammation of the pancreas (pancreatitis).

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

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

If they forgot to take Gelocatil pediatric

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

Like all medications, Gelocatil pediatric may have adverse effects, although not everyone will experience them.

- Rare adverse effects that may occur (up to 1 in 1,000 patients) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

- Very rare adverse effects that may occur (up to 1 in 10,000 patients) 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). Rarely, severe skin reactions have been reported.

The paracetamol can damage the liver when taken in high doses or prolonged treatments.

- Adverse effects of unknown frequency (cannot be estimated from available data): A severe 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 or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

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

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

Composition of Gelocatil pediatric

The active ingredient 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 consisting of natural flavorings, flavorings identical to natural ones, maltodextrin (contains glucose), sucrose, aspartame (E-951), and potassium acesulfame (E-950)), mannitol (E-421), lemon aroma, amorphous silica, glycerol (E-422) diestearate type 1, sodium croscarmellose, sodium carboxymethylcellulose (potato starch type A), ethyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol 400.

Appearance of the product and packaging size

Gelocatil pediatric is a white granulated product with a lemon scent that is presented in sachets for oral administration.

Packed in boxes of 12 and 20 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing

Farmalider, S.A.

C/Aragoneses, 2

28108 Madrid

or

Edefarm, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante,

Valencia

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/