Termalgine Gripe 650 mg/15.58 mg/4 mg granules for oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

TERMALGIN FLU 650 mg / 15.58 mg / 4 mg granules for oral solution

Paracetamol / Phenylephrine bitartrate / Chlorpheniramine maleate

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

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

• 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.
• 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.

Leaflet Contents

1. What TERMALGIN FLU is and what it is used for
2. What you need to know before taking TERMALGIN FLU
3. How to take TERMALGIN FLU
4. Possible adverse effects
5. How to store TERMALGIN FLU
6. Contents of the pack and other information

1. What TERMALGIN FLU is and what it is used for

It 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 in adults and adolescents over 15 years of age for the relief of symptoms of colds and flu accompanied by fever or mild to moderate pain, nasal congestion, and nasal discharge.

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

2. What you need to know before taking TERMALGIN FLU

Do not take TERMALGIN FLU

• 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 that increase heart rate).
• If you are being treated with beta-blockers (medicines for the heart or to treat arterial diseases) (see: Taking TERMALGIN FLU with other medicines).
• If you have glaucoma (increased intraocular pressure).
• If you have a serious heart or arterial disease (such as coronary artery disease or angina pectoris).
• If you have severe liver or kidney disease.
• Children under 15 years of age must not take this medicine.

Warnings and precautions

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

Do not take more medicine than the recommended dose stated in section 3: How to take TERMALGIN FLU.

Chronic alcoholics should take care not to exceed 2 g of paracetamol (3 sachets) per day of TERMALGIN FLU.

Concurrent 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.

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

• Patients with kidney, liver, heart, or lung disease, and patients with anemia.

• Asthmatic patients who are sensitive to acetylsalicylic acid.

• Patients who are sensitive (allergic) to an antihistamine, as they may also be sensitive to other antihistamines (such as chlorpheniramine).

• Patients being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), stenosing peptic ulcer, pyloroduodenal obstruction (between 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 experience gastrointestinal problems, you must stop taking this medicine and consult a doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).

During treatment with TERMALGIN FLU, 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 suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an imbalance 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

Do not use in individuals under 15 years of age.

Interference with laboratory tests:

If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.

Taking TERMALGIN FLU 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, dosage adjustments or discontinuation of treatment may be necessary:

• 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 elimination (loop diuretics such as furosemide or others), 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)). A minimum interval of 15 days must be maintained between stopping MAOI treatment and starting TERMALGIN FLU.

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

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

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

• General anesthetics.

• Antihypertensives (medicines to lower blood pressure).

• Medicines of the type cardiac glycosides, antiarrhythmics, and β-adrenergic blockers used for heart conditions.

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

• Medicines used for heart conditions or digestive disorders such as atropine sulfate.

• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).

• Ototoxic medicines (those with adverse effects damaging the ear).

• Photosensitizing medicines (those with adverse effects causing light allergy).

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

Taking TERMALGIN FLU with food, drinks, and alcohol

While being treated with this medicine, you must not consume alcoholic beverages, as this may increase the risk of adverse effects.

In addition, the use of medicines containing paracetamol in patients who habitually 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.

This medicine must not be taken during breastfeeding, as it may cause adverse effects in the infant.

Driving and use of machines

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

TERMALGIN FLU contains mannitol (E-421) and sodium

This medicine may cause a mild laxative effect due to its mannitol content.

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

3. How to take TERMALGIN FLU

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

Recommended dose:

Adults and adolescents over 15 years of age: 1 sachet every 6–8 hours as needed (3 or 4 sachets per day). Do not exceed 3 g of paracetamol (4 sachets) in any 24-hour period.

Patients with renal impairment: This medicine must not be administered to these patients because it contains 650 mg of paracetamol and its pharmaceutical form is granules. Since the maximum single dose for such patients is 500 mg, the contents of the sachet cannot be divided to achieve the appropriate dose.

Patients with hepatic impairment: In cases of hepatic impairment or Gilbert’s syndrome, do not exceed 3 sachets in 24 hours, and the minimum interval between doses must be 8 hours.

Use in children

This medicine is contraindicated in children and adolescents under 15 years of age.

Use in elderly patients

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

How to take

TERMALGIN FLU is taken orally.

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

Always take the lowest effective dose.

This medicine should only be taken when symptoms appear. As symptoms subside, treatment should be discontinued.

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

If you take more TERMALGIN FLU than you should

If you have ingested an overdose, go immediately to a medical center even if you do not feel 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, yellowing of the skin and eyes (jaundice), and abdominal pain. Anxiety, fear, agitation, headache (which may be a sign of high blood pressure), seizures, insomnia (or intense drowsiness), clumsiness, fainting sensation, 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 heartbeat), palpitations, reduced urine output, metabolic acidosis (reduction in the blood's alkaline reserve). With prolonged use, depletion of plasma volume (reduction in blood volume) may occur.

Treatment of overdose is most effective if initiated within 4 hours after ingestion.

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, go immediately to a medical center or call the Toxicology Information Service (Telephone 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 experiences them.

During the period of use of paracetamol, phenylephrine and chlorphenamine, the following adverse effects have been reported, whose frequency has not been accurately 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 excitation (generally with 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 (generally 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 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 counts, 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).

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

Cases of skin reactions have very rarely been reported.

• Adverse effects whose frequency of occurrence is unknown are: Anxiety, irritability, weakness, increase in blood pressure (hypertension, generally 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 blood, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). With high doses, vomiting, palpitations, and psychotic states with hallucinations may occur; with prolonged use, a decrease in blood volume may occur.

Frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who are using paracetamol (see section 2).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 TERMALGIN GRIPE

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

Do not use this medicine after the expiry date stated on the packaging, following EXP. The expiry date is 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 unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of TERMALGIN GRIPE

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 chlorpheniramine maleate (equivalent to 2.8 mg of chlorpheniramine).
• Other components (excipients): Mannitol (E-421), sodium saccharin, 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

TERMALGIN GRIPE is an oral granulate for solution, white or slightly yellowish-white in colour, with an orange flavour. It is supplied in sachets packed in cardboard cartons containing 10 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Haleon Spain, S.A.

Paseo de la Castellana, 259D, planta 32,

28046 Madrid, Spain

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid), Spain

Date of the most recent revision of this leaflet: February 2025

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