Gelocatil Gripe with Pseudoephedrine Tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets

Paracetamol, pseudoephedrine and chlorpheniramine

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
• You should see a doctor if your condition worsens, does not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

Leaflet contents

1. What GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets are and what they are used for.
2. What you need to know before taking GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets.
3. How to take GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets.
4. Possible adverse effects.
5. How to store GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets.
6. Package contents and additional information.

1. What GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets are and what they are used for

GELOCATIL GRIPE CON PSEUDOEFEDRINA is a combination of paracetamol, pseudoephedrine, and chlorpheniramine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorpheniramine is an antihistamine that relieves nasal discharge.

Pseudoephedrine is a sympathomimetic that reduces nasal congestion.

It is indicated for the relief of symptoms of colds and flu accompanied by fever, mild to moderate pain, nasal congestion, and nasal discharge, in adults and adolescents aged 12 years and older.

You should consult a doctor if symptoms worsen, do not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

2. What you need to know before taking GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets

Do not take GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• If you have high blood pressure (hypertension).
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeat).
• If you are being treated with monoamine oxidase inhibitors (MAOIs) (such as certain antidepressant medicines, or medicines used to treat Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma, or medicines to increase heart rate).
• If you are being treated with beta-blockers (medicines for heart conditions or to treat arterial diseases) (see: Taking GELOCATIL FLU WITH PSEUDOEPHEDRINE with other medicines).
• If you have glaucoma (increased pressure in the eye).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris, cerebral hemorrhage).
• If you have severe liver or kidney disease.
• If you are in the first trimester of pregnancy.
• If you have very high blood pressure (severe hypertension) or uncontrolled hypertension not managed by your medication.
• If you have severe acute (sudden) or chronic (long-term) kidney disease, or kidney failure.
• Children under 12 years of age must not take this medicine.

There is a possibility of abuse of one of the active ingredients in Gelocatil Flu with Pseudoephedrine, pseudoephedrine. High doses of pseudoephedrine can be toxic. Continuous use may lead to tolerance and result in taking more Gelocatil Flu with Pseudoephedrine than the recommended dose to achieve the desired effect, which could increase the risk of overdose. The recommended maximum dose and treatment duration must not be exceeded (see section 3).

Warnings and precautions

Consult your doctor or pharmacist before starting to take GELOCATIL FLU WITH PSEUDOEPHEDRINE.

• Do not take more medicine than recommended in section 3, How to take GELOCATIL FLU WITH PSEUDOEPHEDRINE.

• Avoid using this medicine simultaneously with other medicines containing paracetamol, 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 take more than 4 tablets in 24 hours of GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets.

• The following patients should consult their doctor before taking this medicine:

• Patients with kidney, liver, heart, or lung diseases, and patients with anemia.

• Asthmatic patients who are sensitive to acetylsalicylic acid.

• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).

• Patients being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (stenosing peptic ulcer), pyloroduodenal obstruction (between the stomach and intestine), thyroid diseases, or patients sensitive to the sedative effects of certain medicines.

• If you are being treated with tricyclic antidepressants or medicines with similar effects and develop gastrointestinal problems, you must stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).

• If you are taking other products containing nasal decongestants, do not take this medicine.

• Treatment must be discontinued at least 24 hours before any surgical procedure.

• Concurrent use of cocaine with medicines containing pseudoephedrine may increase cardiovascular effects and the risk of adverse reactions.

• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).

• GELOCATIL FLU WITH PSEUDOEPHEDRINE may reduce blood flow to the optic nerve. If you experience sudden vision loss, stop taking GELOCATIL FLU WITH PSEUDOEPHEDRINE and contact your doctor or seek immediate medical attention. See section 4.

• Cases of reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported after using medicines containing pseudoephedrine. RPES and RCVS are rare conditions that may involve reduced blood flow to the brain. Stop using Gelocatil Flu with Pseudoephedrine immediately and seek immediate medical assistance if you experience symptoms that could indicate RPES or RCVS (for symptoms, see section 4, "Possible side effects").

• Sudden abdominal pain or rectal bleeding may occur with the use of Gelocatil Flu with Pseudoephedrine, due to inflammation of the colon (ischemic colitis). If these gastrointestinal symptoms occur, stop taking Gelocatil Flu with Pseudoephedrine and contact your doctor or seek immediate medical attention. See section 4.

During treatment with Gelocatil Flu with Pseudoephedrine, 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 in these situations when paracetamol is used at regular doses for prolonged periods or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulty with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Children and adolescents

This medicine is contraindicated in children and adolescents under 12 years of age.

Interference with laboratory tests:

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

This medicine may interfere with skin tests using allergens. It is recommended to stop taking this medicine at least 3 days before starting such tests and to inform your doctor.

Taking GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets 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 using any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Medicines to treat tuberculosis: (isoniazid, rifampicin).

• Medicines to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

• Medicine to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

• Medicines used to increase urine elimination (loop diuretics such as furosemide, or other diuretics), and other diuretics causing potassium loss (such as diuretics used to treat hypertension or others).

• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.

• Medicines used in the treatment of gout (probenecid and sulfinpyrazone).

• 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 disorder (called metabolic acidosis) requiring urgent treatment (see section 2).

• Medicines used to lower cholesterol levels in the blood: (cholestyramine).

• Medicines causing central nervous system depression (such as those used for insomnia or anxiety).

• Ototoxic medicines (which have the adverse effect of damaging the ear).

• Photosensitizing medicines (which, as an adverse effect, cause light allergy).

• Urinary acidifiers (ammonium chloride).

• Urinary alkalinizers (sodium bicarbonate, citrates).

• Inhalational anesthetics.

• Antidepressants (tricyclics and monoamine oxidase inhibitors). See section "Do not take GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets."

• Some medicines to lower blood pressure or promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine).

• Central nervous system stimulants (amphetamines, xanthines).

• Digitalis glycosides (used for heart conditions).

• Thyroid hormones (used for thyroid diseases).

• Levodopa (used to treat Parkinson's disease).

• Linezolid (used as an antibacterial agent).

• Nitrates (used to treat angina pectoris).

• Procarbazine (used to treat cancer).

• Selegiline (used to treat Parkinson's disease).

This medicine must not be used with other medicines intended to relieve nasal congestion.

Taking GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets with food, drinks, and alcohol

While being treated with this medicine, you must not consume alcoholic beverages, as they may increase the likelihood of adverse effects from this medicine.

In addition, using medicines containing paracetamol in patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy and breastfeeding

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

This medicine is contraindicated during the first trimester of pregnancy because it may cause intestinal and facial malformations in the newborn. It should also not be taken during the remainder of pregnancy unless your doctor considers it strictly necessary.

Women who are breastfeeding must not take this medicine, as it passes into breast milk and may cause adverse effects in the infant.

Driving and using machines

Gelocatil Flu with Pseudoephedrine may cause drowsiness, impairing mental and/or physical abilities. If you experience these effects, avoid driving or operating machinery.

Athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping control tests.

3. How to take GELOCATIL FLU WITH PSEUDOEPHEDRINE tablets

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

Recommended dose:

Adults and adolescents aged 12 years and older: The usual dose is 1 tablet (500 mg paracetamol) every 6–8 hours (3 or 4 times daily).

Do not exceed 3 grams of paracetamol in any 24-hour period (see section “Warnings and precautions”).

Patients with hepatic impairment: You must consult your doctor before taking this medicine.

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

Do not take more than 4 tablets in 24 hours.

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

Take a maximum of 1 tablet per dose.

Depending on your condition, your doctor will advise whether you should take the medicine at minimum intervals of 6 or 8 hours.

Use in children

This medicine is contraindicated in children and adolescents under 12 years of age.

Use in elderly patients

Elderly patients must not take this medicine without consulting a doctor, as they may be particularly susceptible to certain adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output due to the presence of phenylephrine and chlorphenamine. They may also be more likely to experience adverse effects such as dizziness, sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take:

Gelocatil Flu with Pseudoephedrine is an oral medicine.

The tablets should be taken with a glass of water or another liquid.

Administration should be based on the presence of symptoms. This medication should be discontinued as symptoms subside.

If fever persists for more than 3 days of treatment, or if pain or other symptoms persist for more than 5 days, worsen, or new symptoms appear, consult your doctor.

If you take more Gelocatil Flu with Pseudoephedrine tablets than you should

If you have taken an overdose, go immediately to a medical center even if you have no symptoms, as symptoms often do not appear until 3 days after the overdose, even in cases of severe poisoning.

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). Anxiety, fear, agitation, headache (which may indicate high blood pressure), seizures, insomnia (or excessive drowsiness), clumsiness, faintness, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (fast or irregular heartbeat), palpitations, reduced urine production. Metabolic acidosis (decreased blood alkaline reserve). With prolonged use, depletion of plasma volume (decreased blood volume) may occur.

In more severe cases, the following may occur: low blood potassium (hypokalaemia), mental disturbance with altered perception of reality (psychosis), seizures, coma, and hypertensive crises.

Overdose may also cause: coagulation disorders (blood clots and bleeding).

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

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 your doctor or the nearest hospital Emergency Department, or contact the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets can have adverse effects, although not everyone will experience them.

• The adverse effects that may occur most frequently are: Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2–3 days of treatment. Difficulty in facial movements, clumsiness, tremor, disturbances in sensation and tingling, dry mouth, loss of appetite, disturbances in taste or smell, gastrointestinal discomfort (which may decrease if the medicine is taken with food), nausea, vomiting, diarrhoea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision or other visual disturbances.

• The adverse effects that may occur less frequently (rare) are:

Malaise, low blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary oedema (increased fluid volume in the lungs), and cerebral haemorrhage (at high doses or in sensitive patients).

Nervous excitation (generally with high doses and more frequent in elderly patients and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even seizures. Other adverse effects that may occur less frequently are: rapid or irregular heartbeat (generally with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine or blood in stools within a few days of starting treatment, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorpheniramine. Blood disorders (changes in blood cell counts, such as agranulocytosis, leucopenia, aplastic anaemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat or fatigue; low or high blood pressure, oedema (swelling), ear disturbances, impotence, menstrual disorders.

• The adverse effects that may occur very rarely (very rare) are: Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

Paracetamol can damage the liver when taken at high doses or during prolonged treatment.

• Adverse effects for which frequency is unknown (cannot be estimated from available data) are: A serious illness that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2), serious conditions affecting the blood vessels in the brain known as reversible posterior encephalopathy syndrome (RPES) and reversible cerebral vasoconstriction syndrome (RCVS), anxiety, irritability, weakness, increased blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), narrowing of blood vessels (peripheral vasoconstriction), reduced cardiac performance especially in elderly patients and those with poor cerebral or coronary circulation, possible onset or worsening of heart disease, urinary retention, pallor, piloerection (goosebumps), increased blood sugar (hyperglycaemia), low potassium levels in the blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension), decreased blood flow to the optic nerve (ischaemic optic neuropathy), inflammation of the colon due to insufficient blood supply (ischaemic colitis). At high doses the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, reduction in blood volume may occur.

If seizures or hallucinations occur, stop taking this medicine immediately.

Stop using Gelocatil Gripe con Pseudoefedrina immediately and seek urgent medical attention if you experience symptoms that could be signs of reversible posterior encephalopathy syndrome (RPES) or reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden, severe headache
• malaise
• vomiting
• confusion
• seizures
• changes in vision

Reporting of adverse effects

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

5. Storage of GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets

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

GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets do not require any special storage conditions.

Do not use GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Gelocatil Gripe with Pseudoephedrine tablets

• Active substances: 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride (equivalent to 24.57 mg of pseudoephedrine), and 4 mg of chlorpheniramine maleate (equivalent to 2.81 mg of chlorpheniramine).
• Other components (excipients): microcrystalline cellulose, corn starch, povidone, talc, magnesium stearate, and purified water.

Presentation of the product and contents of the pack

Gelocatil Gripe with Pseudoephedrine is presented as white, round, scored tablets for oral administration. It is available in packs of 10 and 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 - Barcelona

Spain

Manufacturer:

FERRER INTERNACIONAL, S.A.

Buscallá, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

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 2026

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/