GELOCATIL 1 g ORAL SOLUTION

2. Before taking Gelocatil

Do not take Gelocatil if:

• you are allergic (hypersensitive) to paracetamol or any of the other components of Gelocatil.

Be careful with Gelocatil:

• Do not take more medication than recommended in section 3. How to take Gelocatil.
• The simultaneous use of this medication with other medications containing 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 containing paracetamol without consulting your doctor.
• Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medication.
• When being treated with medication for epilepsy, consult your doctor before taking this medication, as the effectiveness of paracetamol may be decreased and its hepatotoxicity increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• During treatment with Gelocatil, inform your doctor immediately if:

If you have severe illnesses, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the 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 unwell (nausea) and vomiting.

Use of other medications:

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of some of them or interrupt treatment:

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

Interference with analytical tests:

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

Taking Gelocatil with food and drinks

Taking this medication with food does not affect its effectiveness.

Use in children

Do not use in children under 18 years of age.

Pregnancy

Consult your doctor or pharmacist before using any medication.

In case of necessity, 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 passes into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and using machines:

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

Gelocatil contains propylene glycol, sorbitol, methyl p-hydroxybenzoate (E-218), propyl p-hydroxybenzoate (E-216), and sodium:

This medication contains 2000 mg of propylene glycol in each sachet.

If you are pregnant or breastfeeding, do not take this medication unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

If you have liver or kidney failure, do not take this medication unless it is recommended by your doctor. Your doctor may perform additional checks while you are taking this medication.

This medication contains 2000 mg of sorbitol in each sachet.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, in which the patient cannot break down fructose, consult your doctor before taking this medication.

It may cause allergic reactions (possibly delayed) because it contains methyl p-hydroxybenzoate (E-218) and propyl p-hydroxybenzoate (E-216).

This medication contains less than 23 mg of sodium (1mmol) per sachet; it is essentially "sodium-free".

3. How to take Gelocatil

Follow these instructions unless your doctor has given you different instructions. Consult your doctor or pharmacist if you have doubts.

The normal dose is:

Adults:

Take 1 sachet every 6-8 hours, as needed. Do not take more than 3 grams (3 sachets) in 24 hours.

Patients with liver disease: before taking this medication, they must consult their doctor.

They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.

They should not take more than 2 sachets of paracetamol in 24 hours, divided into 2 doses.

Patients with kidney disease: before taking this medication, they must consult their doctor.

Take a maximum of 500 milligrams per dose.

Due to the dose, 1 gram of paracetamol, this medication is not indicated for this group of patients.

This medication is taken orally.

The contents of the sachet can be taken diluted in a liquid, preferably water, or directly. Once the sachet is opened, consume its entire contents.

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, treatment should be discontinued.

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

If you take more Gelocatil than you should:

You should consult your doctor or pharmacist immediately.

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).

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

Treatment of overdose is most 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.

In case of overdose or accidental ingestion, go to a medical center immediately or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible adverse effects

Like all medications, Gelocatil can have adverse effects, although not everyone experiences them.

• Rare adverse effects that may occur (between 1 and 10 in every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.
• Very rare adverse effects that may occur (in less than 1 in every 10,000 people) 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 for prolonged periods.

• Adverse effects of unknown frequency (cannot be estimated from available data): A serious disease called metabolic acidosis (an anomaly in the blood and fluids) in patients with severe illness using paracetamol (see section 2).

Reporting adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gelocatil 1 g Oral Solution

Keep out of the reach and sight of children.

This medication does not require special storage conditions.

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

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

6. Additional information

Composition of Gelocatil:

Each sachet contains 1 gram of paracetamol as the active ingredient.

The other components (excipients) are sodium saccharin, propylene glycol, macrogol, sorbitol (E-420), methyl p-hydroxybenzoate and propyl p-hydroxybenzoate (E-218 and E-216), povidone K12, neohesperidin DC, ammonium sulfite caramel (E-150-d), raspberry flavor, strawberry flavor, ascorbic acid or sodium hydroxide, and purified water.

Appearance of the product and packaging content:

Gelocatil is a clear oral solution with a slight amber tone, presented in single-dose sachets.

The boxes are available in 4 and 10 sachets.

Marketing authorization holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Manufacturer:

Ferrer Internacional, S.A.

Joan XXIII, 10

08950 – Esplugues de Llobregat (Barcelona)

or

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 – Sant Cugat del Vallés (Barcelona)

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/