Gelocatil Plus 500 mg/65 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gelocatil Plus 500mg/65mg film-coated tablets

Paracetamol/Caffeine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

• You should consult a doctor if fever persists for more than 3 days or pain for more than 5 days (2 days in the case of sore throat).

Contents of the leaflet:

1. What Gelocatil Plus is and what it is used for.
2. What you need to know before taking Gelocatil Plus.
3. How to take Gelocatil Plus.
4. Possible adverse effects.
5. How to store Gelocatil Plus.
6. Contents of the pack and other information.

1. What Gelocatil Plus is and what it is used for

Gelocatil Plus tablets contain two active substances: Paracetamol and Caffeine.

• Paracetamol is effective in reducing pain and fever.

• Caffeine has a stimulating effect on the nervous system.

This medicine is used for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscle pain (muscle spasms), or back pain (lumbago), as well as in febrile conditions.

Gelocatil Plus is indicated for use in adults and adolescents over 16 years of age.

2. What you need to know before taking Gelocatil Plus

Do not take Gelocatil Plus:

• If you are allergic to paracetamol or caffeine or to any of the other ingredients of this medicine (listed in section 6).
• If you have heart disease.
• If you have severe hypertension.

Take special care with Gelocatil Plus:

• Do not take more than the recommended dose indicated in section 3, "How to take Gelocatil Plus".
• Avoid using this medicine simultaneously with other medicines containing paracetamol (e.g., 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 disease, or those with anemia, malnutrition, or dehydration should consult their doctor before taking this medicine.
• If you are being treated with antiepileptic drugs, 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.
• If you have cardiac arrhythmia, hyperthyroidism, or an anxiety syndrome, take this medicine with caution and only at low doses (maximum 2 tablets per day), or consult your doctor.
• If you have recently suffered a myocardial infarction, do not take this medicine until several weeks have passed since the event.
• If you have heart conditions or disorders (cardiac arrhythmia, myocardial ischemia, angina pectoris, etc.).
• If you are diabetic, be aware that caffeine may increase blood glucose levels.
• If you are allergic to xanthines (e.g., aminophylline, theophylline), you should not take this medicine, as you may also be allergic to caffeine.
• It is recommended to limit the use of other medicines and foods containing caffeine during treatment with this medicine.
• In individuals with sleep difficulties, it is recommended not to take this medicine in the hours before bedtime to avoid possible insomnia.
• During treatment with Gelocatil Plus, 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 have 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 circumstances when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, malaise (nausea), and vomiting.

Interference with laboratory tests:

If you are scheduled for any laboratory tests (including blood and urine tests), inform your doctor that you are taking this medicine, as it may alter test results.

Use of Gelocatil Plus with other medicines:

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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 to treat 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
• Medicines used to treat bronchial asthma: bronchodilators
• Medicines used in the recovery treatment of alcoholic patients: disulfiram
• Medicine used to treat anemia: iron. It is recommended to separate administration by at least 2 hours.
• Medicine used to correct heart rhythm disorders such as cardiac arrhythmias: mexiletine
• Medicines used to increase blood pressure: sympathomimetics
• Medicine used to treat diseases caused by thyroid deficiencies: thyroxine
• Medicines used to prevent pregnancy: oral contraceptives
• Medicines used to treat infections: quinolone antibiotics or erythromycin
• Medicines used to reduce symptoms of allergic reactions: antihistamines
• Medicine used for stomach acidity and stomach ulcers: cimetidine
• Medicine used in certain psychiatric conditions: lithium
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Taking Gelocatil Plus with food, drinks, and alcohol:

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

Limit consumption of beverages containing caffeine (coffee, tea, chocolate, and cola drinks) while taking this medicine.

Take this medicine after meals or with food.

Children and adolescents:

Do not use in children and adolescents under 16 years of age.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Paracetamol and caffeine pass into breast milk; therefore, women who are breastfeeding should consult their doctor or pharmacist before taking this medicine.

Driving and use of machines:

No effects on the ability to drive or operate machinery have been reported.

Gelocatil Plus contains azo dyes (carmoisine A (E-124) and sunset yellow FCF (E-110)) and sodium

This medicine may cause allergic reactions because it contains azo dyes (carmoisine A (E-124) and sunset yellow FCF (E-110)).

It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Gelocatil Plus

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Always use the lowest effective dose.

Adults and adolescents over 16 years of age:

The recommended dose is 1 tablet 1 to 4 times daily as needed. If necessary, 2 tablets may be taken in a single dose.

Do not exceed 3 grams in 24 hours (6 tablets), divided into 4 doses. Doses should be spaced at least 4 hours apart.

Avoid using high daily doses of paracetamol for prolonged periods, as this increases the risk of adverse effects such as liver damage.

This medicine should only be taken when pain or fever occurs. 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, stop treatment and consult your doctor.

For sore throat, do not use for more than 2 consecutive days without consulting your doctor.

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 must not take more than 4 tablets (2 g of paracetamol) in 24 hours, divided into 2 doses.

Patients with kidney disease: must consult their doctor before taking this medicine. The doctor will determine whether the minimum interval between doses should be 6 or 8 hours. The maximum dose per administration should be 500 mg of paracetamol (1 tablet).

This medicine is for oral use.

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

If you take more Gelocatil Plus than you should:

Consult your doctor or pharmacist immediately.

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

Symptoms of caffeine overdose are characterized by an initial phase of excitation, followed by dizziness, insomnia, vomiting, diarrhea, abdominal pain, and seizures.

If you have ingested an overdose, go immediately to a medical center even if you do not feel 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), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Due to the presence of paracetamol in this medicine, the following adverse effects may occur:

• Rare adverse effects (between 1 and 10 in every 10,000 people): malaise, low blood pressure (hypotension), and increased blood transaminase levels.

• Very rare adverse effects (in less than 1 in every 10,000 people): 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). Paracetamol may damage the liver when taken in high doses or during prolonged treatment. Very rare cases of severe skin reactions have been reported.

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

Due to the presence of caffeine in this medicine, the following adverse effects may occur, although their frequency cannot be established: insomnia, restlessness, nervousness, and headache. Nausea, vomiting, and stomach irritation have also been observed. In some cases, hyperglycaemia or hypoglycaemia (increased or decreased blood glucose) may also occur.

High doses of caffeine may cause palpitations, tachycardia, and increased blood pressure.

Treatment must be stopped immediately if the patient experiences episodes of dizziness or palpitations.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gelocatil Plus

Keep this medicine out of the sight and reach 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 must not be disposed of via wastewater or household waste. Instead, return any unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the package and other information

Composition of GelocatilPlus:

The active substances are: paracetamol and caffeine. Each tablet contains 500 mg of paracetamol and 65 mg of caffeine.

The other components (excipients) are: povidone, partially pregelatinized corn starch, microcrystalline cellulose, crospovidone, colloidal silicon dioxide, sodium stearyl fumarate, polyvinyl alcohol, polyethylene glycol, talc, carmine red A (E-124), titanium dioxide (E 171), and orange yellow S (E-110).

Appearance of the product and contents of the pack:

Gelocatil Plus is presented as round, biconvex, film-coated red tablets for oral administration. The packs contain 20 tablets.

Marketing Authorization Holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

Manufacturer responsible:

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 - Sant Cugat del Vallés (Barcelona)

Local Representative:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona (Spain)

Date of latest revision of the package 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/