Gelocatil Gripe Forte with Phenylephrine granules for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Gelocatil gripe forte with phenylephrine granules for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorphenamine maleate

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse.

• 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, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.
• You should consult your doctor if your condition worsens or does not improve, or if fever persists for more than 3 days or pain or other symptoms last longer than 5 days.

Contents of the leaflet

1. What Gelocatil gripe forte with phenylephrine is and what it is used for
2. What you need to know before taking Gelocatil gripe forte with phenylephrine
3. How to take Gelocatil gripe forte with phenylephrine
4. Possible side effects
5. How to store Gelocatil gripe forte with phenylephrine
6. Contents of the pack and other information

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

This medicine is a combination of paracetamol, chlorpheniramine and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorpheniramine is an antihistamine that relieves nasal discharge.

Phenylephrine 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 over 15 years of age.

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

2. What you need to know before starting to take Gelocatil gripe forte with phenylephrine

Do not take Gelocatil gripe forte with phenylephrine

• 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 inhibitor (MAOI) medicines (such as certain antidepressants 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 the heart or to treat arterial diseases) (see: Taking Gelocatil gripe forte with phenylephrine with other medicines).
• 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 gripe forte with phenylephrine.

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

• The simultaneous use of this medicine with other medicines containing paracetamol should be avoided, 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 3 sachets in 24 hours of Gelocatil gripe forte with phenylephrine.

• Patients should consult their doctor before taking this medicine if they have:

• Kidney, liver, heart, or lung diseases, or if they have anemia.

• Asthma and are sensitive to acetylsalicylic acid.

• Sensitivity (allergy) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).

• Patients who are 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 disorders, 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 should stop taking this medicine and consult your doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).

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

During treatment with Gelocatil gripe forte with phenylephrine, 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 have 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 over a prolonged period 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 must not be used in children and adolescents under 15 years of age.

Taking Gelocatil gripe forte with phenylephrine with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 output (loop diuretics such as furosemide, or other diuretics), and other diuretics that cause 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.

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

• Medicines used to treat depression, Parkinson's disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Gelocatil gripe forte with phenylephrine should be taken at least 15 days after stopping treatment with these medicines.

• Medicines used to treat migraine; medicines taken during childbirth; medicines used to treat blood pressure or other conditions (alpha-adrenergic blocking medicines).

• Alpha- and beta-adrenergic blocking medicines (such as labetalol and carvedilol) used for heart conditions or arterial diseases.

• Medicines to treat depression (tricyclic and tetracyclic antidepressants).

• General anesthetic medicines.

• Antihypertensives (medicines to lower blood pressure).

• Medicines used for the heart such as cardiac glycosides, antiarrhythmics, and beta-adrenergic blockers.

• Medicines containing thyroid hormones (used to treat thyroid disorders).

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

• Medicines that cause 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 allergy to light).

• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2).

Interference with diagnostic tests

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

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

While taking this medicine, you must not consume alcoholic beverages, as they may increase the risk of adverse effects of this medicine.

In addition, the use of medicines containing paracetamol by patients who regularly 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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.

Breastfeeding women should not take this medicine, as paracetamol and chlorpheniramine pass into breast milk in small amounts and may cause adverse effects in the infant.

Driving and using machines

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

Gelocatil gripe forte with phenylefrine 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; hence, it is essentially "sodium-free".

3. How to take Gelocatil gripe forte with phenylephrine

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

This medication should only be taken when symptoms are present. As symptoms subside, you should discontinue the treatment.

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

Recommended dose:

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

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

Patients with hepatic impairment: These patients must consult their doctor before taking this medicine.

Such patients may only take 1 sachet every 8–12 hours as needed.

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

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

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

Use in children and adolescents

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

Use in elderly patients

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

How to take this medicine

Gelocatil gripe forte with phenylephrine is taken orally.

Completely dissolve the contents of the sachet in a small amount of liquid, preferably half a glass of water, and then drink.

Always take the lowest effective dose.

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

If you have taken an overdose, you must go immediately to a medical center, even if there are 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, confusion, restlessness, excitability, yellowing of the skin and eyes (jaundice), abdominal pain, and inflammation of the pancreas (pancreatitis). Anxiety, fear, agitation, headache (which may be a sign of 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 (rapid or irregular heartbeats), palpitations, reduced urine output. Metabolic acidosis (decrease in the blood’s alkaline reserve). With prolonged use, plasma volume depletion (reduced blood volume) may occur.

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

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been reported during the use of the combination of paracetamol, phenylephrine and chlorphenamine, although their frequency has not been precisely established:

• The adverse effects that may occur more 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, drop in blood pressure (hypotension), and increased blood transaminase levels. Myocardial infarction, ventricular arrhythmia (irregular heartbeat), pulmonary edema (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally at high doses, and more common 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: chest tightness, lung sounds, rapid or irregular heartbeat (usually with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction, severe hypersensitivity reactions (cough, difficulty swallowing, rapid heartbeat, itching, swelling of the eyelids or around the eyes, face, tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medicines related to chlorphenamine. Blood disorders (changes in blood cell count, 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 infrequently (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 serious skin reactions have been reported.

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

• The adverse effects for which frequency of occurrence is unknown (cannot be estimated from available data) are: A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2), anxiety, irritability, weakness, difficulty breathing, increased blood pressure (hypertension, usually with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), very slow heartbeat (severe bradycardia), reduction in the diameter of blood vessels (peripheral vasoconstriction), reduced cardiac performance particularly affecting 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 (disturbance of metabolism), coldness in the extremities (legs or arms), flushing, feeling faint (hypotension). At 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 not listed in this leaflet. You can 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 forte with phenylephrine

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

Do not use this medicine after the expiry date stated on the container, after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Gelocatil Gripe Forte with phenylephrine

Each sachet contains:

• Active substances: 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).
• Other components (excipients): Mannitol (E-421), sodium saccharin (E-954), anhydrous colloidal silica, orange flavour (containing maltodextrin, which is a derivative of maize starch) and povidone.

Appearance of the medicine and contents of the pack

Gelocatil Gripe Forte with phenylephrine is a white or yellowish-white granulated preparation for oral solution with an orange flavour. It is supplied in sachets packed in cardboard boxes containing 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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)

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 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/