Leaflet: information for the user

Gelocatil 500 mg granulated

Paracetamol

Paracetamol is effective in reducing pain and fever.

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

Gelocatil is indicated in adults and adolescents over 44 kg (from 12 years old).

Do not takeGelocatil

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

Warnings and precautions

• Consult your doctor or pharmacist before starting to take Gelocatil.
• Do not take more medication than recommended in section 3, How to take Gelocatil.
• Use of this medication with other medications that contain paracetamol, such as cold and flu medications, may lead to liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor.
• Chronic alcoholics should not take more than 2 g (4 sachets) of paracetamol in 24 hours, divided into several doses.
• You should consult your doctor before taking this medication:

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

• Inform your doctor immediately if you experience any of the following during treatment with Gelocatil:

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 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 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 interrupt 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 cardiac arrhythmias

Interference with analytical tests:

Inform your doctor if you are to undergo any analytical tests (including blood and urine tests) as this medication may alter the results of these tests.

Taking Gelocatil with food, drinks, and alcohol

Using paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this 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 the pain or fever do not subside or if you need to take the medication more frequently.

Breastfeeding

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

Children

Do not use in children weighing less than 44 kg (approximately under 12 years old) as it does not allow for dosing of doses less than 1 sachet per dose (500 mg).

Driving and operating machinery

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

Gelocatil contains aspartame, sodium, sucrose, and glucose

• This medication contains 23.82 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 107.92 mg of sodium (main component of table salt/for cooking) in each sachet, which is equivalent to 5.4% of the recommended daily maximum sodium intake for an adult. Consult your doctor or pharmacist if you need 4 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-sodium diet.
• This medication contains sucrose, if your doctor has advised you that you have an intolerance to certain sugars, consult with them before taking this medication.
• May cause tooth decay.

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

The recommended dose is:

• Adults: the recommended dose is 1 tablet (500 mg paracetamol) every 4-6 hours as needed. If necessary, 2 tablets of 500 mg every 6-8 hours may be taken, without exceeding 6 tablets in 24 hours. Do not take more than 3 grams (6 tablets) in 24 hours.

• Adolescents over 44 kg (from 12 years): the recommended dose is 1 tablet (500 mg of paracetamol) every 4-6 hours as needed, without exceeding 5 tablets 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 is taken orally.

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

It can be taken both with food and without it.

Always use the lowest effective dose.

The use of high daily doses of paracetamol for prolonged periods of time should be avoided, as it 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 disappear, this medication should be discontinued.

If the pain persists for more than 5 days, the fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, treatment should be interrupted and the doctor consulted.

If you take more Gelocatil than you should

In case of overdose or accidental ingestion, consult your 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, yellowish discoloration 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 undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

If you forgot to take Gelocatil

Do not take a double dose to compensate for the missed doses.

Like all medications, Gelocatilmay have adverse effects, although not all people 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.

- Paracetamol can damage the liver when taken in high doses or for prolonged periods.

- Adverse effects of unknown frequency (cannot be estimated from available data): A serious 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.Deposit the packaging and unused medicines at the SIGRE collection pointof the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and unused medicines.This will help protect the environment.

Composition of Gelocatil

The active ingredient is paracetamol. Each blister pack contains 500 mg of paracetamol.

The other components (excipients) are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), flavoring (contains potato maltodextrin, sucrose, and aspartame (E-951)), mannitol (E-421), lemon aroma (contains corn maltodextrin), amorphous silica, glycerol (E-422) diester 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 is a white granule with a lemon scent that is presented in blister packs for oral administration.

Packed in boxes of 12 and 20 blister packs.

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/