GELOCATIL 650 mg TABLETS

Introduction

GELOCATIL 650 mg Tablets

Paracetamol

Contents of the prospectus:

1. What is Gelocatil 650 mg Tablets and what is it used for.
2. Before taking Gelocatil 650 mg Tablets.
3. How to take Gelocatil 650 mg Tablets.
4. Possible side effects.
5. Storage of Gelocatil 650 mg Tablets.
6. Additional information.

1. What is Gelocatil 650 mg Tablets and what is it used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of occasional mild or moderate pain, such as headache, dental, muscular (cramps) or back (lumbago) pain and in febrile states.

Gelocatil is indicated in adults and adolescents over 14 years of age.

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 that contain 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 that contains paracetamol without consulting a doctor.
• Chronic alcoholics should be careful not to take more than 2 grams of paracetamol in 24 hours.
• Patient 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 efficacy of paracetamol may be decreased and hepatotoxicity may be 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 diseases, such as severe renal failure 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 severe disease called metabolic acidosis (an anomaly in 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:

Inform 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:

• 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 convulsions: Barbiturics (used as hypnotics, sedatives, and anticonvulsants)
• Medications for lowering cholesterol levels in blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used for the treatment of gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used in the treatment of 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 test (including blood, urine, etc. ...), inform 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 efficacy.

Use in children:

• Do not use in adolescents under 14 years of age.

Pregnancy:

Consult your doctor or pharmacist before using any medication.

In case of necessity, Gelocatil 650mg Tablets 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 null or insignificant.

Gelocatil contains sodium

This medication contains less than 23 mg of sodium (1mmol) per tablet; this 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 and adolescents over 14 years of age (weight 64-65 kg): Take 1 tablet every 4-6 hours, as needed. Do not take more than 3 grams (4 tablets) in 24 hours.

Patient 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 intake.

They should not take more than 3 tablets in 24 hours, divided into 3 intakes.

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

Take a maximum of 500 milligrams per intake.

Due to the dose, 650 milligrams of paracetamol, the medication is not indicated for this group of patients.

This medication is taken orally.

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

The tablets are scored, which allows them to be broken in half. The score serves only to break the tablet if it is difficult to swallow whole.

Always use the lowest effective dose.

The use of high daily doses of paracetamol for prolonged periods of time should be avoided, 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 a doctor consulted.

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 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 more effective if started within 4 hours of ingestion of the medication.

Patient taking barbiturics 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 side effects

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

• Rare side effects that may occur (between 1 and 10 out of 10,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in blood. Very rare side effects that may occur (in less than 1 out of 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.

• Side effects of unknown frequency (cannot be estimated from available data): A severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gelocatil 650 mg Tablets

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE point of 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. Contents of the packaging and additional information

Composition of Gelocatil:

Each tablet contains 650 milligrams of paracetamol, as the active ingredient.

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 packaging:

Gelocatil is presented in tablets for oral administration.

The tablets are oblong, scored on one side, and white in color.

The boxes are of 4, 12, and 20 tablets.

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/