Prospect: information for the user

TERMALGIN GRIPE650 mg / 15.58 mg / 4 mgoral granule solution

Paracetamol / Fenilefrina bitartrate / Chlorphenamine maleate

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

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor, pharmacist or nurse.

• Keep this prospect, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect.
• You should consult a doctor if you worsen, do not improve, or if fever persists for more than 3 days or pain or other symptoms persist for more than 5 days.

1.What isTERMALGIN GRIPEand what it is used for

2.What you need to knowbefore starting to takeTERMALGIN GRIPE

3.How to takeTERMALGIN GRIPE

4.Possible adverse effects

5.Storage ofTERMALGIN GRIPE

6.Contents of the package and additional informationl

It 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 and adolescents over 15 years old for the relief of symptoms of colds and flu that are accompanied by fever or mild to 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.

Do not take TERMALGIN GRIPE

• 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 some 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 arterial diseases) (see: Taking TERMALGIN GRIPE with other medications).
• If you have glaucoma (elevated eye pressure).
• If you have severe heart or arterial disease (such as coronary disease or angina pectoris).
• If you have severe liver or kidney disease.
• Children under 15 years old cannot take this medication.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take TERMALGIN GRIPE.

Do not take more medication than recommended in section 3: How to take TERMALGIN GRIPE.

Chronic alcoholics should be careful not to take more than 2g of paracetamol (3 packets) per day of TERMALGIN GRIPE.

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

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 antihistamines, as they may be sensitive to other antihistamines (such as chlorphenamine).

• Patients being treated for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer (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).

Inform your doctor immediately if you experience:

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, feeling unwell (nausea), and vomiting.

Children and adolescents

Not to be used in children under 15 years old.

Interference with laboratory tests:

Inform your doctor if you are taking/using this medication, as it may alter test results.

Taking TERMALGIN GRIPE with other medications

Inform your doctor or pharmacist if you are taking or have recently taken 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 epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

• Medications for tuberculosis: (isoniazid, rifampicin).

• Medications for 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 such as furosemide, or others), 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 (arritmias): Propanolol.

• 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)). It is necessary to separate the intake of TERMALGIN GRIPE and these medications for at least 15 days after completing treatment.

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

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

• Tricyclic antidepressants and tetracyclic antidepressants.

• General anesthetics.

• Anti-hypertensive medications.

• Medications used for the heart, such as cardiac glycosides, anti-arrhythmics, and beta-blockers.

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

• Medications used for heart or digestive diseases, such as 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 can cause an allergic reaction to light).

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

Taking TERMALGIN GRIPE with food, drinks, and alcohol

While taking this medication, do 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 habitually 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

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

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

This medication cannot be taken during breastfeeding, as it may cause 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.

TERMALGIN GRIPE 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 1 mmol of sodium (23 mg) per dose; it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. If you have any doubts, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and adolescents over 15 years:1 sachet every 6-8 hours as needed (3 or 4 sachets per day). Do not take more than 3 g of paracetamol (4 sachets) per 24 hours.

Patients with renal insufficiency:This medication cannot be administered to these patients, as it contains 650 mg of paracetamol and its pharmaceutical form is granulated. Since the maximum dose per intake for these patients is 500 mg, the sachet contents cannot be divided to obtain the appropriate dose.

Patients with liver insufficiency:In the case of liver insufficiency or Gilbert's syndrome, do not exceed 3 sachets per 24 hours and the minimum interval between doses will be 8 hours.

Use in children

This medication is contraindicatedin children and adolescents under 15 years.

Use in elderly patients

Older people 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 may also be more likely to experience side effects such as sedation, confusion, hypotension, or excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take

TERMALGIN GRIPE is taken orally.

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

Always take the smallest effective dose.

The taking of this medication is subject to the appearance of symptoms. As these disappear, treatment 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 symptoms appear, you should consult a doctor.

If you take more TERMALGIN GRIPE than you should

If you have ingested an overdose, you should go immediately to a medical center, even if you do not notice the 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), and abdominal pain. Anxiety, fear, agitation, headache (may be a symptom of high blood pressure), convulsions, insomnia (or intense somnolence), clumsiness, feeling of fainting, instability, confusion, irritability, tremors, anorexia; psychosis with hallucinations (this last one especially in children). Dryness of the mouth, nose, or throat. Effects such as high blood pressure, arrhythmias (rapid or irregular heartbeats), palpitations, decreased urine output, metabolic acidosis (decrease in blood alkalinity reserve). In cases of prolonged use, depletion of plasma volume (decrease in blood volume) may occur.

The treatment of an overdose is more effective if it is initiated within 4 hours of taking the overdose of the 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 a medical center 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 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, nasal and throat dryness, thickening of mucosities, sweating, blurred vision, or other visual disturbances.

• The side effectsthat 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 disorders (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 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 effectsthat may appear with very low frequency (very rare) are:Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar).

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

Very rarely, cases of skin reactions have been reported.

• The side effects whose frequency of appearance is unknown, are: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), peripheral vasoconstriction, reduced heart function that affects especially the elderly and patients with poor cerebral or coronary circulation, possible production or worsening of a heart disease, urinary retention, paleness, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disorder), coldness in the 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.

Unknown frequency (cannot be estimated from available data): A severe disease that may make the blood more acidic (denominated metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 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.

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

Composition of TERMALGIN GRIPE

Each blister pack 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, anhydrous colloidal silica, orange flavor (containing maltodextrin, a cornstarch derivative) and povidone.

Appearance of the product and contents of the packaging

TERMALGIN GRIPE is an orange-flavored, white or light yellowish granulated oral solution, presented in blister packs that are packaged in cardboard boxes with 10 blister packs.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Haleon Spain, S.A.

C/ Severo Ochoa, 2

28760 – Tres Cantos (Madrid)

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/