GELOCATIL 1 g Oral Solution

Paracetamol

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 (cramps) or back pain (lumbago) and in febrile states.

Gelocatil is indicated for adults.

Do not take Gelocatil if:

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

Be careful with Gelocatil:

• Do not take more than the recommended amount of medication as stated in the section 3. How to take Gelocatil.
• 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.
• Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung diseases and patients with anemia should consult their doctor before taking this medication.
• When taking medication for epilepsy, consult your doctor before taking this medication, as it may decrease the effectiveness and increase the hepatotoxicity of paracetamol, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• Inform your doctor immediately if you experience any of the following during treatment with Gelocatil:

If you have 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 chronic malnutrition, 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 other medications:

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

• Medications to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin)
• Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Medications to treat tuberculosis: (isoniazid, rifampicin)
• Medications to treat depression and seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)
• Medications to lower blood cholesterol levels: (colestiramine)
• Medications used to increase urine elimination (diuretics such as furosemide)
• Medications used to treat gout (probencid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests:

Inform your doctor if you are undergoing any analytical tests (including blood and urine tests, etc.) as this medication may alter the results.

Taking Gelocatil with food and drinks:

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

Use in children:

Do not use in children under 18 years old.

Pregnancy:

Consult your doctor or pharmacist before using any medication.

In case of need, Gelocatil can 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 the pain or fever does not decrease or if you need to take the medication more frequently.

Lactation:

Consult your doctor or pharmacist before using any medication.

Paracetamol passes into breast milk, so women in the lactation period should consult their doctor or pharmacist before taking this medication.

Driving and operating machinery:

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

Gelocatil contains propylene glycol, sorbitol, p-hydroxybenzoic acid methyl ester (E-218), p-hydroxybenzoic acid propyl ester (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 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 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 indicated that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

You may experience allergic reactions (possibly delayed) because it contains p-hydroxybenzoic acid methyl ester (E-218) and p-hydroxybenzoic acid propyl ester (E-216).

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

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

The usual dose is:

Adults:

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

Patients with liver disease: consult your doctor before taking this medication.

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

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

Patients with kidney disease: consult your doctor before taking this medication.

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 packet can be taken diluted in a liquid, preferably water, or directly. Once the packet is opened, consume all its contents.

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, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or other symptoms appear, you should interrupt treatment and consult your doctor.

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.

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.

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

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

• Rare adverse effects that may occur (between 1 and 10 in every 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.
• Very rare adverse effects that may occur (in fewer than 1 in every 10,000 people) 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 severe disease that can make the blood more acidic (designated as 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 prospectus. 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 about the safety of this medication.

Keep out of the reach and sight of children.

This medication does not require special conditions for conservation.

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 thrown into the drains or trash.Dispose of the packaging and medicines that you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

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), p-hydroxybenzoate of methyl and p-hydroxybenzoate of propyl (E-218 and E-216), povidone K12, neohesperidin DC, ammonium sulfite caramel (E-150-d), raspberry essence, strawberry essence, ascorbic acid or sodium hydroxide and purified water.

Appearance of the product and contents of the packaging:

Gelocatil is a transparent oral solution with a light amber tint presented in single-dose sachets.

The boxes are of 4 and 10 sachets.

Marketing Authorization Holder's Title:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Responsible for Manufacturing:

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)

Last Review Date of this Leaflet:February 2025

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/