GELOCATIL PEDIATRIC 250 mg granules

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

Do not takePediatric Gelocatil

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

Be careful with Pediatric Gelocatil

• Do not take more medication than recommended in section 3. How to take Pediatric Gelocatil.
• The simultaneous use of this medication with other medications that contain paracetamol, such as flu and cold medications, should be avoided, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting a doctor.
• The following patients should consult their doctor before taking this medication:

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

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

If you have severe diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in 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 with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Using Pediatric Gelocatil with other medications

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

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

• Antibiotics (chloramphenicol)
• Oral anticoagulants (acenocoumarol, warfarin)
• Oral contraceptives and estrogen treatments
• 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
• Colestyramine (used to decrease blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to relieve stomach, intestine, and bladder spasms or contractions (anticholinergics)
• Medications used for heart conditions (digitalis glycosides)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol used in the treatment of high blood pressure and heart rhythm disorders (cardiac arrhythmias)

Interference with analytical tests:

If you are going to have any analytical test (including blood, urine, etc.), tell your doctor that you are taking this medication, as it may alter the result of these tests.

Taking Pediatric Gelocatil with food and drinks

Taking this medication with food does not affect its efficacy.

Pregnancy

Consult your doctor or pharmacist before using any medication.

If necessary, Pediatric Gelocatil 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 medication more frequently.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Children

Do not use in children with a weight of less than 19 kg (less than 5 years old) because it does not allow dosing of doses less than 1 sachet per intake (250 mg).

Driving and using machines

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

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

• This medication contains 11.81 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

• This medication contains 45 mg of sodium (main component of table salt/cooking salt) in each sachet. This is equivalent to 2.25% of the maximum daily sodium intake recommended for an adult.
• This medication contains sucrose and glucose (as maltodextrin). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may produce cavities.

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3. How to take Pediatric Gelocatil

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

It is necessary to respect the posologies defined according to the child's weight, and therefore, choose the appropriate dosage. The approximate age based on weight is given for informational purposes.

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 19 and 24 kg (from 5 to 7 years old): the recommended dose is 1 sachet (250 mg of paracetamol) every 4-6 hours as needed, without exceeding 5 sachets in 24 hours.

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

Pediatric Gelocatil is taken orally.

Open the sachet and pour the contents directly into the mouth. The granule disperses immediately in saliva and then swallows.

It can be taken with or without food.

Always use the lowest effective dose.

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

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

If the pain or fever persists for more than 3 days or worsens, or if other symptoms appear, you should interrupt treatment and consult your doctor.

If the child takes more Pediatric Gelocatil 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 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 manifest until 3 days after ingestion, 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).

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

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

If you forgot to take Pediatric Gelocatil

Do not give the child a double dose to make up for the forgotten dose, simply give the forgotten dose when you remember, taking the following doses with the indicated separation in each case (4-6 hours).

4. Possible adverse effects

Like all medications, Pediatric Gelocatil can have adverse effects, although not all people experience them.

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

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

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

Adverse effects of unknown frequency (cannot be estimated from available data): a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Pediatric Gelocatil

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.

Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Pediatric Gelocatil

The active ingredient is paracetamol. Each sachet contains 250 mg of paracetamol.

The other components (excipients) are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), mask it (composed of natural flavorings, natural identical flavorings, maltodextrin(contains glucose), sucrose, aspartame (E-951), and potassium acesulfame (E-950)), mannitol (E-421), lemon flavor, amorphous silica, glycerol (E-422) diester type 1, sodium croscarmellose, sodium carboxymethyl starch (type A potato starch), ethylcellulose, hydroxypropyl methylcellulose, polyethylene glycol 400.

Appearance of the product and package size

Pediatric Gelocatil is a white granule with a lemon odor, presented in sachets for oral administration.

Packaged in a box of 12 and 20 sachets.

Marketing authorization holder and manufacturer

Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Madrid

or

Biofabri, S.L.

A relva, S/n,

O Porriño

36400 Pontevedra

or

Edefarm, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante,

Valencia

Date of the last revision of this prospectus:February 2025

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