TERMALGIN GRIPE 650 MG/15.58 MG/4 MG ORAL SOLUTION GRANULES

2. What you need to know before taking TERMALGIN GRIPE

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 a monoamine oxidase inhibitor (MAOI) medication (such as some antidepressants or medications for Parkinson's disease).
• If you are being treated with sympathomimetic medications (used to treat asthma or to increase heart rate).
• If you are being treated with beta-blocker medications (for heart conditions or to treat artery diseases) (see: Taking TERMALGIN GRIPE with other medications).
• If you have glaucoma (increased eye pressure).
• If you have a severe heart or artery disease (such as coronary artery disease or angina pectoris).
• If you have a 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 than the recommended dose of medication as stated in section 3: How to take TERMALGIN GRIPE.

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

Avoid taking this medication simultaneously 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.

The following patients should consult their doctor before taking this medication:

• Patient with kidney, liver, heart, or lung diseases, and patients with anemia.

• Asthmatic patients sensitive to acetylsalicylic acid.

• Patient sensitive (allergic) to an antihistamine, as they may be sensitive to other antihistamines (such as chlorphenamine).

• Patient being treated with medications for: prostate hypertrophy, bronchial asthma, slow heartbeats, hypotension, cerebral arteriosclerosis, pancreatitis, peptic ulcer, pyloroduodenal obstruction, 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 you experience gastrointestinal problems, you should stop taking this medication and consult your doctor immediately, as you may develop paralytic ileus (stoppage of normal bowel movements).

During treatment with TERMALGIN GRIPE, inform your doctor immediately if:

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 (an anomaly in 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

Do not use in children under 15 years old.

Interference with Laboratory Tests

If you are going to have any laboratory tests (including blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the 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.

In particular, if you are using any of the following medications, 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 convulsions and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

• Medication to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).

• Medications used to increase urine production (diuretics such as furosemide, or others), and other diuretics that cause potassium loss (such as those used to treat hypertension).

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

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

• Medications used to treat high blood pressure and heart rhythm disorders (arrhythmias): Propranolol.

• 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)). You should separate the intake of TERMALGIN GRIPE and these medications by at least 15 days after finishing the treatment.

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

• Alpha and beta-adrenergic blocking medications (labetalol and carvedilol) used for the heart or to treat artery diseases.

• Medications for treating depression (tricyclic and tetracyclic antidepressants).

• General anesthetic medications.

• Antihypertensive medications (medications to lower blood pressure).

• Medications 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, such as atropine sulfate.

• Medications that depress the central nervous system (such as those used for insomnia or anxiety).

• Ototoxic medications (which can damage the ear as a side effect).

• Photosensitizing medications (which can cause light allergy as a side effect).

Flucloxacillin (antibiotic), due to a serious 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 being treated with this medication, you should not consume alcoholic beverages, as it may increase the risk of side effects.

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

Taking this medication with food does not affect its efficacy.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, 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 side effects in the baby.

Driving and Using Machines

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

TERMALGIN GRIPE Contains Mannitol (E-421) and Sodium

This medication may have a mild laxative effect because it contains mannitol.

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

3. How to Take TERMALGIN GRIPE

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

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

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

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

Use in Children

This medication is contraindicated in children and adolescents under 15 years old.

Use in Elderly Patients

Elderly people cannot use this medication without consulting their doctor, as they may be especially affected by some side effects of the medication, 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 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 contents of the sachet completely in a little liquid, preferably half a glass of water, and then drink.

Always take the smallest effective dose.

Treatment with this medication is subject to the appearance of symptoms. As they disappear, you should suspend treatment.

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 your doctor.

If You Take More TERMALGIN GRIPE Than You Should

If you have ingested an overdose, you should go to a medical center immediately, even if you do not notice symptoms, as they often do not appear until 3 days after ingestion, 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 (which can 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, decreased urine production, metabolic acidosis (decrease in blood alkaline reserve). In case of prolonged use, it can cause depletion of plasma volume (decrease in blood volume).

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

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, go to a medical center immediately or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

4. Possible Adverse Effects

Like all medications, this medication can produce adverse effects, although not all people suffer from them.

During the period of use 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 more 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 (increased fluid volume in the lungs), and cerebral hemorrhage (at high doses or in sensitive patients).

Nervous excitement (generally 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 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. 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), alterations in the ears, impotence, menstrual disorders.

• 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 disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

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

Very rare cases of skin reactions have been reported.

• The adverse effects whose frequency of appearance is not known are: Anxiety, irritability, weakness, 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, goosebumps, high blood sugar (hyperglycemia), low potassium in the blood, metabolic acidosis (metabolic disorder), 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.

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

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist or nurse, 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 TERMALGIN GRIPE

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.

No special storage conditions are required.

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications that 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 that you no longer need. This way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition of TERMALGIN GRIPE

Each sachet contains:

• As active ingredients: 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, which is a corn starch derivative) and povidone.

Appearance of the Product and Content of the Packaging

TERMALGIN GRIPE is a white or yellowish-white granulate for oral solution with an orange flavor, which is presented in sachets that are packaged in cardboard boxes with 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, 32nd floor,

28046 Madrid, 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/