Product Information for the User

GELOCATIL GRIPE CON PSEUDOEFEDRINA Tablets

Paracetamol, pseudoephedrine, and chlorphenamine

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

-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 or pharmacist, even if they are not listed in this leaflet.

-You should consult a doctor if you worsen, 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 GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets are and what they are used for.

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

3.How to take GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets.

4.Possible side effects.

5.Storage of GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets.

6.Contents of the pack and additional information.

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 are accompanied by fever, mild or moderate pain, congestion and nasal secretion, for adults and adolescents aged 12 years and over.

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 GRIPE CON PSEUDOEFEDRINA tablets

- 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 taking any monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).

- If you are taking sympathomimetic medications (medications used to treat asthma or medications to increase heart rate).

- If you are taking beta-blocker medications (medications for the heart or to treat blood vessel diseases) (see: Taking GELOCATIL GRIPE CON PSEUDOEFEDRINA with other medications).

- If you have glaucoma (elevated eye pressure).

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

- If you have severe liver or kidney disease.

- If you are in the first trimester of pregnancy.

- If you have severe high blood pressure or uncontrolled hypertension.

- If you have severe, acute, or chronic kidney disease, or kidney failure.

- Children under 12 years old cannot take this medication.

There is a possibility of abuse of one of the active ingredients in Gelocatil gripe con pseudoefedrina, pseudoefedrina. Large doses of pseudoefedrina can be toxic. Continuous use can cause tolerance and lead to taking more Gelocatil gripe con pseudoefedrina than the recommended dose to achieve the desired effect, which could increase the 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 taking this medication with other medications that contain paracetamol, as high doses can cause liver damage. Do not take more than one medication containing paracetamol without consulting your doctor.
• In chronic alcoholics, be careful not to take more than 4 tablets in 24 hours of GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets.
• 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 taking medications to treat: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (peptic ulcer stenosis), pyloroduodenal obstruction (between the stomach and the intestine), thyroid diseases, patients sensitive to the sedative effects of some medications.
• If you are taking tricyclic antidepressants or medications with a similar effect and experience gastrointestinal problems, stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (detention of normal intestinal movements).
• If you take other products containing nasal decongestants, do not take this medication.
• Stop treatment at least 24 hours before surgery.
• The simultaneous use of cocaine with pseudoefedrina-containing medications may increase cardiovascular effects and the risk of adverse effects.
• In case of glucose-6-phosphate dehydrogenase deficiency (G6PD) (may cause hemolytic anemia).

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

During treatment with Gelocatil gripe con pseudoefedrina, inform your doctor immediately 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 if you are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (anomaly in the blood and fluids) 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, somnolence, feeling unwell (nausea), and vomiting.

Children and adolescents

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

Interference with analytical tests:

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 stop taking this medication at least 3 days before starting the tests and inform your doctor.

Taking GELOCATIL GRIPE CON PSEUDOEFEDRINA with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may need to use 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 interrupt treatment:

• Medications for treating epilepsy: Antiepileptics (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 (arrhythmias): Propranolol.
• Flucloxacillin (antibiotic), due to a severe risk of fluid and blood anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).
• Medications to lower cholesterol levels in the blood: (cholestyramine).

• Medications that cause depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (that have as an adverse effect that damage the ear).
• Phototoxic medications (that, as an adverse effect, produce allergy to light).
• Urinary acidifiers (ammonium chloride).
• Urinary alkalinizers (sodium bicarbonate, citrates).
• Inhalation anesthetics.
• Tricyclic antidepressants or medications with a similar effect. See: Do not take GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets.
• Some medications to lower blood pressure or to promote urine elimination (such as beta-blockers, ACE inhibitors, rauwolfia alkaloids such as reserpine).
• Central nervous system stimulants (amphetamine, xanthines).
• Digitalis glycosides (used for the heart).
• Thyroid hormones (used for thyroid diseases).
• Levodopa (used for Parkinson's disease).
• Linezolid (used as an antibiotic).
• Nitrates (used for 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 with food, drinks, and alcohol

While taking this medication, do not consume alcoholic beverages, as it may increase the risk of adverse effects.

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 taking of this medication with food does not affect its efficacy.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Women breastfeeding should not take this medication, as it passes into breast milk and may cause adverse effects in the baby.

Driving and operating machinery

Gelocatil Gripe con Pseudoefedrina may cause drowsiness, affecting mental and/or physical ability. If you experience these effects, avoid driving vehicles or operating machinery.

Athletes

Inform athletes that this medication contains a component that may result in a positive analytical control test for doping.

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

The recommended dose is:

Adults and adolescents 12 years and older: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 paracetamolper 24 hours(see section “Warnings and precautions”).

Patients with liver insufficiency: before taking this medication, they must consult their doctor.

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

They cannot take more than 4 tablets in 24 hours.

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

Take a maximum of 1 tablet per dose.

Your doctor will indicate according to your disease whether you should take your 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 a 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 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 with pseudoephedrine is a medication taken orally.

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

The administration is subject to the appearance of symptoms. As these 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 with pseudoephedrine tablets than you should

If you have ingested an overdose, you should go quickly to a medical center, 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.

The symptoms of an overdose may be: dizziness, vomiting, loss of appetite, 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.

In more severe cases, it may occur: decrease in potassium in the blood (hypokalemia), mental disorder with altered perception of reality (psychosis), convulsions, coma, and hypertensive crisis.

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

bleeding).

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

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, go immediately to your doctor or the nearest hospital emergency service or consult the Toxicology Information Service (phone: 91 562 04 20), indicating the medication and the amount ingested.

Like all medicines, GELOCATIL GRIPE CON PSEUDOEFEDRINA tablets may have side effects, although not everyone will experience them.

• The side effects that may appear more frequently are:: Mild drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty moving the face, clumsiness, tremors, alterations in sensations and paresthesia, 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::

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

Nervous excitement (usually with high doses and 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: rapid or irregular heartbeats (usually with overdose), liver disorders (which may present with stomach pain or 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) with related chlorphenamine medications. To blood disorders (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:Renal diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (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 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 (known as metabolic acidosis) in patients with severe disease using paracetamol (see section 2), severe diseases affecting the blood vessels of the brain known as reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS), anxiety, irritability, weakness, 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 (bradycardia), reduction of blood vessel diameter (peripheral vasoconstriction), reduction of heart function affecting especially 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 disorder), cold extremities (legs or arms), flushing, feeling of fainting (hypotension), decreased blood flow to the optic nerve (ischemic optic neuropathy). With high doses, vomiting, palpitations, psychotic states with hallucinations may occur; in prolonged use, a decrease in blood volume may occur.

In the event 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 reversible posterior leukoencephalopathy syndrome (RPLS) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• Severe headache of sudden onset
• Discomfort
• Vomiting
• Confusion
• Convulsions
• Changes in vision

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 leaflet. You can also report them directly through the Spanish System for the 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 medication.

Keep this medicationout of the sight and reach of children.

GELCATIL FLU WITH PSEUDOEPHEDRINE tablets do not require special storage conditions.

Do not useGELCATIL FLU WITH PSEUDOEPHEDRINE tablets after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Gelocatil flu with pseudoephedrine tablets

-As active principles: 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 contents of the packaging

Gelocatil flu with pseudoephedrine is presented in the form of round, white, scored tablets for oral administration. It is presented in packs of 10 and 20 tablets.

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:

FERRER INTERNACIONAL, S.A.

Buscallá, 1-9

08173 Sant Cugat del Vallés (Barcelona)

Spain

Last review date of this leaflet: February 2025

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