GELOCATIL650 mgOral Solution

Paracetamol

Read the entire package insert carefully as it contains important information for you.

This medication can be purchased without a prescription. However, for the best results, it should be used with caution.

• Keep this package insert as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or if fever persists for more than 3 days or pain for more than 5 days, you should consult a doctor.

• If you consider any of the adverse effects you are experiencing to be severe, or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

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

Gelocatil is indicated in adults and adolescents over 14 years old.

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 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 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 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 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:

-Medication to prevent blood clots: 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 seizures: Barbiturates (used as hypnotics, sedatives, and anticonvulsants)

-Medications to lower blood cholesterol levels: (cholestyramine)

-Medications used to increase urine elimination (diuretics such as the furosemide group)

-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 (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with analytical tests:

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

Taking Gelocatil with food and drinks

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, etc. per day) may cause liver damage.

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

Use in children:

-Do not use in children under 14 years old.

Pregnancy

Consult your doctor or pharmacist before using any medication.

In case of need, 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 do 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 lactation 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-hydroxybenzoate of methyl (E-218), p-hydroxybenzoate of propyl (E-216), and sodium:

This medication contains 1300 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.

If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

This medication contains 1300 mg of sorbitol in each sachet.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or hereditary fructose intolerance (IHF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor or pharmacist before taking this medication.

You may experience allergic reactions (possibly delayed) because it contains p-hydroxybenzoate of methyl (E-218) and p-hydroxybenzoate of propyl (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 and adolescents over 14 years old (weight 64-65 kg):Take 1 tabletevery 4-6 hours as needed.Do not take more than 3 grams (4 tablets) 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 3 tablets of paracetamol in 24 hours, divided into 3 doses.

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

Take a maximum of 500 milligrams of paracetamol per dose.

Due to the dose, 650 milligrams 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, discontinue treatment and consult your doctor.

If you takemore 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 inflammation of the pancreas (pancreatitis).

If you have ingested an overdose, 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.

Incase of overdose or accidental ingestion, go to a medical center immediately or call the Toxicological 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). Severe skin reactions have been reported very rarely.

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

• 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 on the safety of this medication.

Keep out of the reach and sight 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. By doing so, you will help protect the environment.

Composition of Gelocatil:

Each sachet contains 650 milligrams of paracetamol.

The other components 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 package:

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

The boxes are of 4 and 12 sachets.

Holder of the marketing authorization:

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)

Date of the last review of this leaflet:February 2025

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