GELOCATIL GRIPE FORTE WITH PHENYLEPHRINE ORAL SOLUTION GRANULES

Introduction

Leaflet: Information for the user

Gelocatil flu forte with phenylephrine granules for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorphenamine maleate

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

Follow the administration instructions for the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult your doctor if your symptoms worsen or do not improve, or if the fever persists for more than 3 days or the pain or other symptoms persist for more than 5 days.

Contents of the leaflet

1. What Gelocatil flu forte with phenylephrine is and what it is used for
2. What you need to know before taking Gelocatil flu forte with phenylephrine
3. How to take Gelocatil flu forte with phenylephrine
4. Possible side effects
5. Storage of Gelocatil flu forte with phenylephrine
6. Package contents and additional information

1. What Gelocatil flu forte with phenylephrine is and what it is used for

This medicine is an association of paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is a pain reliever that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion.

Phenylephrine 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, in adults and adolescents over 15 years of age.

You should consult your doctor if your symptoms worsen or do 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 taking Gelocatil flu forte with phenylephrine

Do not take Gelocatil flu forte with phenylephrine

• If you are allergic to the active ingredients or to any of the other components of this medicine (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) (such as certain antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (medications used to treat asthma or 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 flu forte with phenylephrine with other medications).
• If you have glaucoma (increased eye pressure).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Gelocatil flu forte with phenylephrine.

• Do not take more than the recommended dose in section 3. How to take Gelocatil flu forte with phenylephrine.

• Avoid taking this medicine simultaneously with other medications that contain paracetamol, as high doses can cause liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor.

• Chronic alcoholics should be cautious not to take more than 3 sachets in 24 hours of Gelocatil flu forte with phenylephrine.

• Patients with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medicine.

• Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.

• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).

• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid diseases, patients sensitive to sedative effects of certain medications.

• If you are being treated with tricyclic antidepressants or medications with similar effects and you experience gastrointestinal problems, you should stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (stoppage of normal bowel movements).

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

During treatment with Gelocatil flu forte with phenylephrine, inform your doctor immediately if:

• You have severe diseases, 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 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. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling of discomfort (nausea) and vomiting.

Children and adolescents

This medicine should not be used in children and adolescents under 15 years of age.

Taking Gelocatil flu forte with phenylephrine with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take 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.

• Medications 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.

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

• Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). You should separate the intake of Gelocatil flu forte with phenylephrine and these medications by at least 15 days after finishing treatment.

• Medications used to treat migraines; medications taken for childbirth; medications taken to treat blood pressure or other diseases (alpha-adrenergic blocking medications).

• Alpha and beta-adrenergic blocking medications (such as labetalol and carvedilol) used for the heart or to treat arterial diseases.

• Medications for depression (tricyclic and tetracyclic antidepressants).

• General anesthetics.

• Antihypertensives (medications to lower blood pressure).

• Medications for the heart, such as cardiac glycosides, antiarrhythmics, and beta blockers.

• Medications containing thyroid hormones (used to treat thyroid diseases).

• Medications used for heart or digestive diseases (atropine sulfate).

• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety).

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

• Photosensitizing medications (which have the adverse effect of producing allergy to light).

• 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 undergo any diagnostic tests (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter the results.

Taking Gelocatil flu forte with phenylephrine with food, drinks, and alcohol

While taking this medicine, you should not consume alcoholic beverages, as it may increase the risk of side effects.

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

Taking this medicine with food does not affect its efficacy.

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 medicine.

This medicine should not be taken during pregnancy unless your doctor considers it strictly necessary.

Women who are breastfeeding should not take this medicine, as paracetamol and chlorphenamine pass into breast milk in small amounts, which may cause side effects in the baby.

Driving and using machines

This medicine may cause drowsiness, altering mental and/or physical ability. If you experience these effects, avoid driving vehicles or using machines.

Gelocatil flu forte with phenylephrine contains mannitol (E-421) and sodium

This medicine may produce a mild laxative effect because it contains mannitol.

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

3. How to take Gelocatil flu forte with phenylephrine

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

The intake of this medicine is subject to the appearance of symptoms. As they disappear, you should stop taking this medication.

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

The recommended dose is:

Adults and adolescents over 15 years of age: 1 sachet (650 mg of paracetamol) every 6-8 hours as needed.

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

Patient with liver failure: Before taking this medicine, they must consult their doctor.

These patients can only take 1 sachet every 8-12 hours as needed.

You should take the prescribed amount of medicine with a minimum interval of 8 hours between each intake.

Do not take more than 3 sachets in 24 hours, divided into 3 doses.

Patient with kidney failure: These patients should not take this medicine due to the paracetamol dose.

Use in children and adolescents

This medicine should not be administered to children and adolescents under 15 years of age due to the paracetamol dose.

Use in elderly patients

Elderly patients should not use this medicine without consulting their doctor, as they may be more susceptible to certain side effects, such as bradycardia (slow heart rate) or reduced cardiac output, due to the phenylephrine and chlorphenamine content. They may also be 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 this medicine

Gelocatil flu forte with phenylephrine is taken orally.

Dissolve the contents of the sachet completely in a little liquid, preferably in half a glass of water, and then drink.

Always take the lowest effective dose.

If you take more Gelocatil flu forte with phenylephrine 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 may not appear until 3 days after ingestion, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, confusion, restlessness, excitability, 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). Dry mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, reduced urine production. Metabolic acidosis (decrease in blood alkalinity). Prolonged use may cause plasma volume depletion (decrease in blood volume).

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

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

Patient being treated with barbiturates or chronic alcoholics may be more susceptible to paracetamol toxicity in case of overdose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Phone: 91 562 04 20, indicating the medication and the amount ingested.

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

During the period of use of the paracetamol, phenylephrine, and chlorphenamine association, the following adverse effects have been reported, whose frequency has not been established with precision:

• 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: Malaise, lowering of blood pressure (hypotension), and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally with high doses, and is 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: chest tightness, lung noises, rapid or irregular heartbeats (generally with overdose), liver disorders (which may present with stomach pain or abdominal pain, dark urine, 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. Blood disorders (changes in the blood cell formula, such as agranulocytosis, leukopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; lowering or rising 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 disorders (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 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), anxiety, irritability, weakness, difficulty breathing, 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 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 heart disease, urinary retention, paleness, hair standing on end, increased blood sugar (hyperglycemia), decreased potassium in the blood, metabolic acidosis (metabolism alteration), coldness in the extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, the following may occur: vomiting, palpitations, psychotic states with hallucinations; with prolonged use, a decrease in blood volume may occur.

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 Medicines: 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 Forte with Phenylephrine

Keep this medication out of sight and reach of children.

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.

No special storage conditions are required.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need at the SIGRE point in 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 Forte with Phenylephrine

Each sachet contains:

• As active ingredients: 650 mg of paracetamol, 15.58 mg of phenylephrine bitartrate (equivalent to 8.21 mg of phenylephrine), and 4 mg of chlorphenamine maleate (equivalent to 2.8 mg of chlorphenamine).
• The other components (excipients) are: Mannitol (E-421), sodium saccharin (E-954), anhydrous colloidal silica, orange flavor (containing maltodextrin, which is a corn starch derivative), and povidone.

Appearance of the Product and Package Contents

Gelocatil Gripe Forte with Phenylephrine is a white or yellowish-white granulate for oral solution with an orange flavor, presented in sachets packaged in cardboard boxes with 10 sachets.

Marketing Authorization Holder and Manufacturer

Holder

Ferrer Internacional S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

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/