GELOCATIL PLUS 500 mg/65 mg FILM-COATED TABLETS

2. What you need to know before taking Gelocatil Plus

Do not take Gelocatil Plus:

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

Be careful with Gelocatil Plus:

• Do not take more medication than recommended in section 3. How to take Gelocatil Plus.
• Concomitant use of this medication with other medications containing 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 containing paracetamol without consulting your doctor.
• Chronic alcoholics should be cautious not to take more than 2 grams of paracetamol in 24 hours.
• Patient with kidney, liver, heart, or lung disease, and patients with anemia or suffering from malnutrition or dehydration, 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 increased, especially with high doses of paracetamol.
• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• If you have a cardiac arrhythmia, have increased thyroid function, or suffer from an anxiety syndrome, take this medication with caution and at low doses (maximum 2 tablets per day) or consult your doctor.
• If you have recently suffered a myocardial infarction, do not take this medication until several weeks have passed since the incident.
• If you have suffered from heart disease (cardiac arrhythmia, myocardial ischemia, angina pectoris...),
• If you are diabetic, note that caffeine can increase blood sugar levels.
• If you are allergic to xanthines (aminophylline, theophylline...), you should not take this medication, as you may also be allergic to caffeine.
• It is recommended to limit the use of other medications and foods that contain caffeine when taking this medication.
• In people with sleep difficulties, it is recommended not to take this medication in the hours before bedtime to avoid possible insomnia.
• During treatment with Gelocatil Plus, inform your doctor immediately if:

If you have severe diseases, such as severe renal insufficiency 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 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.

Interference with analytical tests:

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

Use of Gelocatil Pluswith other medications:

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

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 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 cholesterol levels in blood: (cholestyramine)
• Medications used to increase urine elimination (loop diuretics such as furosemide)
• Medications used to treat gout (probenecid and sulfinpyrazone)
• Medications used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medications for bronchial asthma: bronchodilators.
• Medications used in the treatment of recovering alcoholics: disulfiram
• Medication for the treatment of anemia: iron. It is recommended to space out the intake by at least 2 hours.
• Medication used to correct heart rhythm disorders, such as arrhythmias: mexiletine.
• Medications used to increase blood pressure: sympathomimetics.
• Medication used to treat diseases caused by thyroid deficiencies: thyroxine.
• Medications used to prevent pregnancy: Oral contraceptives.
• Medications to treat infections: quinolone or erythromycin antibiotics.
• Medications used to reduce the symptoms of allergic reactions: antihistamines.
• Medication used for stomach acidity and stomach ulcers: cimetidine.
• Medication used in some psychiatric disorders: lithium.
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Gelocatil Plus with food, drinks, and alcohol:

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

Limit the consumption of beverages that contain caffeine (coffee, tea, chocolate, and cola drinks) while taking this medication.

Take this medication after meals or with some 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Paracetamol and caffeine pass into breast milk, so breastfeeding women should consult their doctor or pharmacist before taking this medication.

Driving and using machines:

No effects on the ability to drive and use machines have been described.

Gelocatil Plus contains azoic dyes (cochineal red A (E-124) and orange yellow S (E-110)) and sodium

This medication may cause allergic reactions because it contains azoic dyes (cochineal red A (E-124) and orange yellow S (E-110)).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

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

3. How to take Gelocatil Plus

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask 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 a day, as needed. If necessary, 2 tablets can be administered in a single dose.

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

High daily doses of paracetamol should be avoided during prolonged periods, 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 your doctor consulted.

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

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

They should take the prescribed amount of medication with a minimum interval of 8 hours between each dose.

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

Patient with kidney disease: before taking this medication, they must consult their doctor, who will indicate if the minimum interval between each administration should be 6 or 8 hours. They should take a maximum of 500 mg of paracetamol per dose (1 tablet).

This medication is administered orally.

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

If you take more Gelocatil Plus than you should:

Consult your doctor or pharmacist immediately.

The symptoms of paracetamol overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and pancreatitis (inflammation of the pancreas).

The symptoms of caffeine overdose are characterized by a first phase of excitement, followed by dizziness, insomnia, vomiting, diarrhea, abdominal pain, and convulsions.

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.

Treatment of overdose is most effective if started within 4 hours of ingestion of the medication.

Patient taking barbiturates 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 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, this medication can cause side effects, although not everyone will experience them.

Due to the presence of paracetamol in this medication, the following side effects may occur:

-Rare side effects (between 1 and 10 per 10,000 people): discomfort, low blood pressure (hypotension), and increased transaminase levels in blood.

-Very rare side effects (less than 1 in 10,000 people): 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). Paracetamol can damage the liver when taken in high doses or for prolonged periods. Very rare cases of severe skin reactions have been reported.

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

Due to the presence of caffeine in this medication, the following side effects may occur, for which the exact frequency cannot be established: insomnia, restlessness, and nervousness, and headache. Nausea, vomiting, and stomach irritation have also been observed. In some cases, hyperglycemia or hypoglycemia (increased or decreased glucose in blood) may also occur.

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

Treatment should be discontinued immediately if the patient experiences any episode of dizziness or palpitations.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Gelocatil Plus

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the pharmacy's SIGRE point. 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. Package contents and additional information

Composition of Gelocatil Plus:

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

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

Appearance of the product and package contents:

Gelocatil Plus is presented in film-coated, round, biconvex tablets of red color for oral administration. The boxes are of 20 tablets.

Marketing authorization holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Manufacturer:

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 - Sant Cugat del Vallés (Barcelona)

Date of the last revision of this leaflet: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/