Leaflet: information for the user

Gelocatil gripe forte with phenylephrine granulated for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorphenamine maleate

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those 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 any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if you worsen or if you 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.

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

2.What you need to knowbeforestarting to take Gelocatil gripe forte with phenylephrine

3.How to take Gelocatil gripe forte with phenylephrine

4.Possible side effects

5.Storage ofGelocatil gripe forte with phenylephrine

6.Contents of the pack and additional information

This medication is an association of acetaminophen, chlorphenamine, and phenylephrine.

Acetaminophen is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that alleviates nasal secretion.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated for the relief of symptoms of colds and flu that are accompanied by fever, mild or moderate pain, congestion, and nasal secretion, in adults and adolescents over 15 years old.

You should consult a doctor if it 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.

Do not take Gelocatil forte with phenylephrine if

-You are allergic to the active ingredients or 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 any monoamine oxidase inhibitor (MAOI) medication (such as certain 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 blood vessel diseases) (see: Taking Gelocatil forte with phenylephrine with other medications).

- If you have glaucoma (elevated eye pressure).

- If you have a severe heart or blood vessel disease (such as coronary artery disease or angina pectoris).

Warnings and precautions

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

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

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

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

• Consult your doctor before taking this medication:

• Patients with kidney, liver, heart, or lung diseases 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: benign prostatic hyperplasia, bronchial asthma, slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer disease (peptic ulcer stenosis), pyloric obstruction (between the stomach and intestine), 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 experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (detention of normal movements in a part of the intestine).

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

Inform your doctor immediately if you experience any of the following during treatment with Gelocatil forte with phenylephrine:

• If you have severe diseases, such as severe renal insufficiency or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, nausea, and vomiting.

Children and adolescents

This medication should not be used in children and adolescents under 15 years old.

Taking Gelocatil forte with phenylephrine with other medications

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or discontinue treatment:

• Medications for treating epilepsy: Antiepileptic drugs (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Medications for treating tuberculosis: (isoniazid, rifampicin).

• Medications for treating seizures 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 of the loop, such as furosemide, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for hypertension or others).

• Medications used to prevent nausea and vomiting (metoclopramide and domperidone).

• Medications used to treat gout (probencid and sulfinpyrazone).

• Medications used to treat high blood pressure and heart rhythm disorders (propranolol).

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

• Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). It is recommended to separate the intake of Gelocatil forte with phenylephrine and these medications for at least 15 days after completing treatment.

• Medications used to treat migraines; medications taken for childbirth; medications taken for hypertension, or other diseases (alpha-adrenergic blockers).

• Medications that block alpha and beta-adrenergic receptors (such as labetalol and carvedilol) used for the heart or to treat blood vessel diseases.

• Medications used to treat depression (tricyclic antidepressants and tetracyclic antidepressants).

• General anesthetics.

• Antihypertensives (medications to lower blood pressure).

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

• Ototoxic medications (that can damage the ear).

• Phototoxic medications (that, as an adverse effect, produce an allergy to light).

• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Interference with diagnostic tests

Inform your doctor if you are undergoing any diagnostic tests (including blood, urine, skin tests that use allergens, etc.) as this medication may alter the results.

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

While taking this medication, you should not consume alcoholic beverages, as it may potentiate the appearance of adverse effects of this medication.

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

The intake of this medication with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

Inform your doctor or pharmacist if you are pregnant, breastfeeding, or plan to become pregnant before using this medication.

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

Women breastfeeding should not take this medication, as paracetamol and chlorphenamine pass into breast milk in small amounts, potentially causing adverse effects in the baby.

Driving and operating machinery

This medication may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machinery.

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

This medication may cause a mild laxative effect due to the presence of mannitol.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor or pharmacist.

The taking of this medication is subject to the appearance of symptoms. As these disappear, this medication should be discontinued.

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

The recommended dose is:

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

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

Patients with liver insufficiency: Before taking this medication, you must consult your doctor.

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

You should take the amount of medication prescribed by your doctor with a minimum interval of 8 hours between each dose.

You should not take more than 3 tablets in 24 hours, divided into 3 doses.

Patients with renal insufficiency: These patients should not take this medication due to the paracetamol dose.

Use in children and adolescents

This medication should not be administered to children and adolescents under 15 years old due to the paracetamol dose.

Use in elderly patients

Elderly patients cannot use this medication without consulting their doctor

because they may be especially affected by some medication side effects such as the appearance of slow heartbeats (bradycardia) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine. They may also be more likely to present 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 medication

Gelocatil gripe forte with phenylephrine is taken orally.

Completely dissolve the contents of the tablet in a little liquid, preferably in a half glass of water, and then drink.

Always take the smallest effective dose.

If you take more Gelocatil gripe forte with phenylephrine than you should

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

The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, confusion, restlessness, excitement, yellowing of the skin and eyes (jaundice), abdominal painand inflammation of the pancreas (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 (this last 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 alkalinity reserve). In prolonged use, depletion of plasma volume (decrease in blood volume) may occur.

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

The treatment of an overdose is more effective if it is initiated within 4 hours of medication ingestion.

Patients undergoing barbiturate treatment or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• The side effects that may appear with low frequency (rare) are: Uncomfortable feeling, low blood pressure, and increased levels of transaminases in the blood. Myocardial infarction, ventricular arrhythmia (irregular heartbeats), pulmonary edema (increase in lung volume) and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (usually 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 side effects that may appear with low frequency are: chest tightness, lung noises, rapid or irregular heartbeats (usually with overdose), liver disturbances (which may present with stomach 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) with related chlorphenamine medications. Blood alterations (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), ear alterations, impotence, menstrual alterations.

• The side effects that may appear with very low frequency (very rare) are:Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood alterations (neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Very rarely, severe skin reactions have been reported.

Paracetamol can damage the liver when taken in high doses or with prolonged treatment.

• The side effects whose frequency of appearance is unknown (cannot be estimated from available data), are:A severe disease that can make the blood more acidic (designated metabolic acidosis) in patients with severe disease using paracetamol (see section 2),anxiety, irritability, weakness, difficulty breathing, high blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeats (severe bradycardia), peripheral vasoconstriction, reduced heart function that affects the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of heart disease, urinary retention, pallor, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disturbance), cold extremities (legs or arms), flushing, feeling of fainting (hypotension). With high doses, vomiting, palpitations, psychotic states with hallucinations may occur; with prolonged use, a decrease in blood volume may occur.

Reporting of side effects

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

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Gelocatil gripe forte with phenylephrine

Each sachet contains:

- As active principles: 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 aroma (containing maltodextrin, a derivative of cornstarch) and povidone.

Appearance of the product and contents of the packaging

Gelocatil gripe forte with phenylephrineis a white or light yellowish granulated oral solution with an orange flavor, presented in sachets that are packaged in cardboard boxes with 10 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder

Ferrer Internacional S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible for manufacturing

Laboratorios Alcalá Farma, S.L

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Date of the last review of this leaflet:February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/