GELOGRIP POWDER FOR ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Gelogrip Powder for Oral Solution

Paracetamol, Phenylephrine, and Chlorphenamine

Contents of the Package Leaflet:

1. What is Gelogrip and what is it used for
2. What you need to know before you take Gelogrip
3. How to take Gelogrip
4. Possible side effects
5. Storage of Gelogrip
6. Contents of the pack and further information

1. What is Gelogrip and what is it used for

Gelogrip is an association of paracetamol, chlorphenamine, and phenylephrine.

Paracetamol is an analgesic that reduces pain and fever.

Chlorphenamine is an antihistamine that relieves nasal secretion.

Phenylephrine is a sympathomimetic that reduces nasal congestion.

It is indicated in adults for the treatment of symptoms of colds and flu that include fever, mild or moderate pain, congestion, and nasal secretion.

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.

2. What you need to know before you take Gelogrip

Do not takeGelogrip

• If you are allergic to the active substances or to any of the other components of this medicine (included 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 some antidepressants or medicines for Parkinson's disease).
• If you are being treated with sympathomimetic medicines (medicines used to treat asthma or to accelerate heart rate).
• If you are being treated with beta-blocker medicines (medicines for the heart or to treat arterial diseases) (see: Taking Gelogrip 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).
• If you have a serious liver or kidney disease.
• Patients under 18 years of age must not take this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Gelogrip.

• Do not take more than the recommended dose in section 3. How to take Gelogrip.
• Chronic alcoholics should not take more than 3 sachets in 24 hours of Gelogrip.
• While taking this medicine, you must not take other medicines that contain paracetamol because it could cause a paracetamol overdose that could damage the liver.

You should consult a doctor before taking this medicine:

• Patient with kidney, liver, heart, or lung disease and patients with anemia.
• Asthmatic patients sensitive to acetylsalicylic acid.
• Patient sensitive (allergic) to an antihistamine, because they may be sensitive to other antihistamines (such as chlorphenamine).
• Patient being treated with medicines for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, thyroid disease, patients sensitive to the sedative effects of some medicines.
• If you are being treated with tricyclic antidepressants or medicines with a similar effect and you experience gastrointestinal problems, you should stop taking this medicine and consult a doctor immediately, because you may develop paralytic ileus (stop of normal movements of a part of the intestine).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia)

During treatment with Gelogrip, inform your doctor immediately if:

• You have serious diseases, such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (an anomaly in the blood and fluids) 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 is contraindicated in patients under 18 years of age.

Taking Gelogrip with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, if you are using any of the following medicines, it may be necessary to modify the dose of some of them or to interrupt treatment:

• Medicines for treating epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).
• Medicines for treating tuberculosis: (isoniazid, rifampicin).
• Medicines for treating convulsions 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 that cause potassium loss (such as diuretics for treating hypertension or other conditions).
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone.
• Medicines used to treat gout (probenecid and sulfinpyrazone).
• Medicines used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.
• Medicines to lower cholesterol levels in the blood: (cholestyramine).
• Medicines used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). Gelogrip should be administered at least 15 days after finishing the treatment.
• Medicines used to treat migraines; medicines taken for childbirth; medicines taken to treat blood pressure or other diseases (alpha-adrenergic blocking agents).
• Alpha and beta-adrenergic blockers such as labetalol and carvedilol (used for the heart or to treat arterial diseases).
• Medicines for treating depression (tricyclic and tetracyclic antidepressants).
• General anesthetics.
• Antihypertensives (medicines to lower blood pressure).
• Medicines for the heart such as cardiac glycosides, antiarrhythmics, and beta-adrenergic blockers.
• Medicines containing thyroid hormones (used to treat thyroid diseases).
• Medicines used for heart or digestive diseases (atropine sulfate).
• Medicines that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medicines (that have the adverse effect of damaging the ear).
• Photosensitizing medicines (that have the adverse effect of causing light allergy).
• 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 test (including blood tests, urine tests, skin tests that use allergens, etc.), inform your doctor that you are taking/using this medicine, as it may alter the results.

Taking Gelogrip with food, drinks, and alcohol

While taking this medicine, you must not drink alcoholic beverages, as it may increase the appearance of adverse effects of this medicine.

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

Taking this medicine with food does not affect its efficacy.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

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

Driving and Using Machines

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

Gelogrip contains sucrose and sodium:

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should note that this medicine contains 3.994g of sucrose per sachet.

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

3. How to take Gelogrip

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

The recommended dose is:

Adults: 1 sachet every 6-8 hours as needed (three or four times a day). Do not take more than 4 sachets (4 grams of paracetamol) in 24 hours (one day).

Patient with liver failure: These patients can only take 1 sachet every 8-12 hours as needed. They should not take more than 2 sachets in 24 hours.

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

Use in Children

This medicine is contraindicated in patients under 18 years of age.

Use in Elderly Patients

Elderly patients must not use this medicine without consulting a doctor, as some adverse effects of the medicine, such as slow heartbeats (bradycardia) or reduced cardiac output, due to the content of phenylephrine and chlorphenamine, may especially affect them. They are also 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

Gelogrip sachets are 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 smallest effective dose.

Taking this medicine is subject to the appearance of symptoms. As they disappear, this medication should be suspended.

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 a doctor.

If you take moreGelogripthan you should

If you have ingested an overdose, you should go quickly to a medical center, even if there are 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 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).

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

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

Patient 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible Adverse Effects

Like all medications, Gelogripcan produce adverse effects, although not all people suffer from them.

During the period of use of the association of paracetamol, phenylephrine, and chlorphenamine, 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:

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: 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. 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 alterations.

• 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 may 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, 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 (alteration of metabolism), cold 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 Gelogrip

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.

Do not store at a temperature above 30°C.

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. Content of the Packaging and Additional Information

Composition ofGelogrip

Each sachet contains:

• As active ingredients: 1 gram of paracetamol, 10 mg of phenylephrine hydrochloride (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: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose, sodium cyclamate, orange flavor (containing maltodextrin and modified cornstarch).

Appearance of the Product and Content of the Packaging

Gelogripis a powder for oral solution. It is presented in sachets that are packaged in boxes of 10 units.

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/