GELOCATIL GRIPE with PSEUDOEPhedrina COMPRESSES

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

GELOCATIL GRIPE CON PSEUDOEFEDRINA is an association of paracetamol, pseudoephedrine, and chlorphenamine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion.

Pseudoephedrine is a sympathomimetic that reduces nasal congestion.

It is indicated for the relief of symptoms of colds and flu that occur with fever, mild or moderate pain, congestion, and nasal secretion, for adults and adolescents from 12 years old.

You should consult your doctor if your condition worsens or does not improve, or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

2. What you need to know before starting to take GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets

Do not take GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• If you have high blood pressure.
• If you have hyperthyroidism.
• If you have diabetes mellitus.
• If you have tachycardia (rapid heartbeats).
• If you are being treated with a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or medications to accelerate heart rate).
• If you are being treated with beta-blocker medications (medications for the heart or to treat arterial diseases) (see: Taking GELOCATIL GRIPE CON PSEUDOEFEDRINA with other medications).
• If you have glaucoma (increased eye pressure).
• If you have a serious heart or artery disease (such as coronary artery disease or angina pectoris, cerebral hemorrhage).
• If you have a serious 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
• If you have severe kidney disease, acute (sudden) or chronic (long-term), or kidney failure
• Children under 12 years old cannot take this medication.

There is a possibility that one of the active ingredients in Gelocatil gripe con pseudoefedrina, pseudoephedrine, may be abused. Large doses of pseudoephedrine can be toxic. Continuous use can lead to tolerance and taking more Gelocatil gripe con pseudoefedrina than the recommended dose to achieve the desired effect, which could lead to an increased risk of overdose. Do not exceed the maximum recommended dose or treatment duration (see section 3)

Warnings and precautions

Consult your doctor or pharmacist before starting to take GELOCATIL GRIPE CON PSEUDOEFEDRINA.

• Do not take more medication than recommended in section 3. How to take GELOCATIL GRIPE CON PSEUDOEFEDRINA.
• Avoid simultaneous use of this medication with other medications that contain paracetamol, as high doses can lead to liver damage. Do not use more than one medication that contains paracetamol without consulting your doctor.
• In chronic alcoholics, caution should be taken not to take more than 4 tablets in 24 hours of GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets.
• The following patients should consult their doctor before taking this medication:

• Patients with kidney, liver, heart, or lung disease, and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patients sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patients being treated with medications for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patients sensitive to the sedative effects of some medications.
• If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, you should stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (stop of normal intestinal movements).
• If you are taking other products that contain nasal decongestants, you should not take this medication
• Treatment should be suspended at least 24 hours before surgery.
• The simultaneous use of cocaine with medications that contain pseudoephedrine can increase cardiovascular effects and the risk of side effects.
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia)

• With GELOCATIL GRIPE CON PSEUDOEFEDRINA, blood flow to the optic nerve may be reduced. If you experience sudden vision loss, stop taking GELOCATIL GRIPE CON PSEUDOEFEDRINA and contact your doctor or seek immediate medical attention. See section 4.
• There have been reports of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) after the use of medications that contain pseudoephedrine. PRES and RCVS are rare diseases that can involve reduced blood flow to the brain. Stop using Gelocatil Gripe con pseudoefedrina immediately and seek immediate medical attention if you experience symptoms that may be signs of PRES or RCVS (for symptoms, see section 4 "Possible side effects").

During treatment with Gelocatil gripe con pseudoefedrina, inform your doctor immediately if:

If you have serious diseases, such as severe kidney 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 disease called metabolic acidosis (a blood and fluid anomaly) 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. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Children and adolescents

This medication is contraindicated in children and adolescents under 12 years old.

Interference with laboratory tests:

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

This medication may interfere with skin tests that use allergens. It is recommended to suspend the use of this medication at least 3 days before starting the tests and inform the doctor.

Taking GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets with other medications

Inform your doctor or pharmacist that 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:

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

• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (that have ear damage as a side effect).
• Photosensitizing medications (that produce light allergy as a side effect).
• Urinary acidifiers (ammonium chloride).
• Urinary alkalizers (sodium bicarbonate, citrates).
• Inhalation anesthetics.
• Antidepressants (tricyclic and monoamine oxidase inhibitors). See section "Do not take GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets".
• Certain medications to lower blood pressure or to promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids like reserpine).
• Central nervous system stimulants (amphetamines, xanthines).
• Digitalis glycosides (used for the heart).
• Thyroid hormones (used for thyroid diseases).
• Levodopa (used to treat Parkinson's disease).
• Linezolid (used as an antibacterial).
• Nitrates (used to treat angina pectoris).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

Do not use with other medications to relieve nasal congestion.

Taking GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets with food, drinks, and alcohol

While being treated with this medication, you cannot consume alcoholic beverages, as it may increase the risk of side effects.

Additionally, the use of medications that contain paracetamol by patients who habitually consume alcohol (3 or more alcoholic beverages: beer, wine, liquor, ... per day) may cause liver damage.

Taking this medication 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 medication.

This medication is contraindicated in the first trimester of pregnancy because it may cause malformations in the intestine and face of the newborn. Additionally, it should not be taken during the rest of pregnancy unless your doctor considers it strictly necessary.

Breastfeeding women should not take this medication, as it passes into breast milk and may cause side effects in the baby.

Driving and using machines

Gelocatil Gripe con Pseudoefedrina may cause drowsiness, altering mental and/or physical ability. If you experience these effects, avoid driving vehicles or using machines.

Athletes

Athletes are informed that this medication contains a component that may result in a positive doping test.

3. How to take GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents from 12 years old: The usual dose is 1 tablet (500 mg of paracetamol) every 6-8 hours (3 or 4 times a day).

Do not take more than 3 grams of paracetamol every 24 hours (see section "Warnings and precautions").

Patients with liver failure: 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.

They cannot take more than 4 tablets in 24 hours.

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

Take a maximum of 1 tablet per dose.

According to their disease, their doctor will indicate if they should take their medication with a minimum interval of 6 or 8 hours.

Use in children

This medication is contraindicated in children and adolescents under 12 years old.

Use in elderly patients

Elderly patients cannot use this medication without consulting their doctor, as some side effects of the medication, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine, may affect them especially. They are also more likely to experience side 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 gripe con pseudoefedrina is a medication that is taken orally.

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

Administration is subject to the appearance of symptoms. As they disappear, this medication should be discontinued.

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

If you take more GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets than you should

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

Symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and pancreatitis. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense drowsiness), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkaline reserve). In prolonged use, it can cause plasma volume depletion (decrease in blood volume).

In more severe cases, it can cause: low potassium levels in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, and hypertensive crises.

Overdose can also cause: coagulation disorders (blood clots and hemorrhages).

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

Patients being treated 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 the doctor or the Emergency Service of the nearest hospital or consult the Toxicology Information Service (telephone: 91 562 04 20), indicating the medication and the amount ingested.

4. Possible Adverse Effects

Like all medications,GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets may have adverse effects, although not all people suffer from them.

• The adverse effects that may appear most frequently are: Mild drowsiness, dizziness, muscle weakness: these adverse effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and tingling, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus, sweating, blurred vision or other vision disorders.

• The adverse effects that may appear with low frequency (rare) are:

Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung fluid volume), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally with high doses and more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions. Other adverse effects that may appear with low frequency are: rapid or irregular heartbeats (generally with overdose), liver disorders (which may present with stomach pain or abdominal pain, dark urine, or blood in stools after a few days of starting treatment or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Alterations in blood (changes in the formula of blood cells, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), alterations in the ears, impotence, menstrual disorders.

• The adverse effects that may appear with very low frequency (very rare) are:Kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowish skin color), blood alterations (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 in prolonged treatments.

• The adverse effects whose frequency of appearance is not known (cannot be estimated from the available data) are: A serious disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2), severe diseases affecting the blood vessels of the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), anxiety, irritability, weakness, high blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), reduction of the caliber of blood vessels (peripheral vasoconstriction), reduction of heart performance that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, paleness, hair standing on end, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolism alteration), cold in the extremities (legs or arms), flushing, feeling of fainting (hypotension), decrease in blood flow to the optic nerve (ischemic optic neuropathy). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

In case of convulsions or hallucinations, stop taking this medication immediately.

Stop using Gelocatil gripe con pseudoefedrina immediately and seek urgent medical attention if you experience symptoms that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• sudden severe headache
• discomfort
• vomiting
• confusion
• convulsions
• changes in vision

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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets

Keep this medicationout of sight and reach of children.

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

Do not useGELOCATIL GRIPE CON PSEUDOEFEDRINA tablets 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 away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Gelocatil gripe con pseudoefedrina tablets

• As active ingredients: 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride (equivalent to 24.57 mg of pseudoephedrine), and 4 mg of chlorphenamine maleate (equivalent to 2.81 mg of chlorphenamine).
• The other components (excipients) are: microcrystalline cellulose, cornstarch, povidone, talc, magnesium stearate, and purified water.

Appearance of the Product and Package Contents

Gelocatil gripe con pseudoefedrina is presented in the form of round, white, scored tablets for oral administration. It is presented in packages of 10 and 20 tablets.

Marketing Authorization Holder and Manufacturer

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

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/