Gelocatil 1 g tablets

Package leaflet: Information for the user

Introduction

GELOCATIL 1 g Tablets

Paracetamol

Contents of the leaflet:

1. What Gelocatil 1 g Tablets are and what they are used for.
2. Before taking Gelocatil 1 g Tablets.
3. How to take Gelocatil 1 g Tablets.
4. Possible side effects.
5. How to store Gelocatil 1 g Tablets.
6. Further information.

1. What Gelocatil 1 g Tablets is and what it is used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), and in febrile conditions.

Gelocatil is indicated for adults.

2. Before taking Gelocatil

Do not take Gelocatil:

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

Take special care with Gelocatil:

• Do not take more medication than the recommended dose stated in section 3, "How to take Gelocatil 1 g Tablets".

• Avoid using this medicine simultaneously with other medicines containing paracetamol, such as cold and flu remedies, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

• Chronic alcoholics should take care not to exceed 2 grams of paracetamol in 24 hours.

• Patients with kidney, liver, heart, or lung diseases, or those with anaemia, should consult their doctor before taking this medicine.

• If you are receiving treatment with antiepileptic medicines, consult your doctor before taking this medicine, as concomitant use may reduce efficacy and increase the hepatotoxicity of paracetamol, especially with high-dose paracetamol regimens.

• Asthmatic patients who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

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

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these conditions when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Use of other medicines:

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, if you are taking any of the following medicines, dosage adjustments or discontinuation of treatment may be necessary:

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

Interference with laboratory tests:

If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking Gelocatil with food and drinks:

Taking this medicine with food does not affect its efficacy.

Use in children:

Do not use in individuals under 18 years of age.

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

If necessary, Gelocatil 1 g tablets may be used during pregnancy. You should use the lowest possible dose that relieves pain or fever and use it for the shortest possible time. Contact your doctor if pain or fever does not decrease or if you need to take the medicine more frequently.

Breast-feeding:

Consult your doctor or pharmacist before using any medicine.

Paracetamol passes into breast milk; therefore, women who are breast-feeding should consult their doctor or pharmacist before taking this medicine.

Driving and using machines:

The influence of paracetamol on the ability to drive and use machines is none or negligible.

Gelocatil contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially "sodium-free".

3. How to take Gelocatil

Follow these instructions unless your doctor has given you different advice. 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 tablets) in 24 hours.

Patients with liver disease: must consult their doctor before taking this medicine.

They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.

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

Patients with kidney disease: must consult their doctor before taking this medicine.

Take a maximum of 500 milligrams per dose.

Due to the dosage (1 gram of paracetamol), this medicine is not indicated for this patient group.

This medicine is taken orally.

The tablets should be swallowed whole or split in half, with a glass of liquid, preferably water.

The tablets are scored, which allows them to be split in half. The score line is only intended to help divide the tablet if you have difficulty swallowing it whole.

Always use the lowest effective dose.

The prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

Administration of this medicine should be based on the presence of pain or fever. As these symptoms subside, 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 new symptoms appear, you must stop treatment and consult your doctor.

If you have taken more Gelocatil than you should:

You must consult your doctor or pharmacist immediately.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and inflammation of the pancreas (pancreatitis).

If you have taken an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of taking the medicine.

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

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

4. Possible adverse effects

Like all medicines, Gelocatil may have adverse effects, although not everyone experiences them.

Rare adverse effects (occurring in between 1 and 10 out of every 10,000 people) are: malaise, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects (occurring in fewer than 1 out of every 10,000 people) are: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of severe skin reactions have also been reported.

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

Adverse effects with unknown frequency (cannot be estimated from the available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gelocatil 1 g Tablets

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Gelocatil:

Each tablet contains 1 gram of paracetamol as the active substance.

The other components (excipients) are magnesium stearate, povidone, anhydrous colloidal silica, potato starch, and pregelatinized corn starch.

Appearance of the product and contents of the pack:

Gelocatil is presented as tablets for oral administration.

The tablets are oblong, white, and bevelled-edged with a score line on one side.

Packs contain 4 and 10 tablets.

Marketing Authorization Holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

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 Vallès (Barcelona)

Local Representative:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona (Spain)

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/