Friolgrip Descongestivo powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Friolgrip Decongestant Powder for oral solution

Paracetamol / Phenylephrine hydrochloride / Chlorpheniramine maleate

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult your doctor if you worsen, do not improve, if fever persists for more than 3 days, or if pain or other symptoms last longer than 5 days.

Contents of the leaflet

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

1. What Friolgrip Decongestant 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 12 years of age for the relief of symptoms of colds and flu associated with fever, mild to moderate pain, and nasal congestion and discharge.

You should consult your doctor if your condition worsens, does not improve, 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 Friolgrip Decongestant

Do not take Friolgrip Decongestant:

• If you are allergic to the active ingredients or to any of the 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 to increase heart rate).
• If you are being treated with beta-blockers (medicines for heart conditions or to treat arterial diseases) (see: Taking Friolgrip Decongestant with other medicines).
• If you have glaucoma (increased pressure in the eye).
• If you have a severe heart or arterial disease (such as coronary heart disease or angina pectoris).
• If you have severe liver or kidney disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Friolgrip Decongestant.

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

Avoid taking this medicine simultaneously with other medicines containing paracetamol, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.

Chronic alcoholics should take care not to take more than 3 sachets in 24 hours.

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 chlorphenamine).
• Patients who are being treated with medicines for: prostate enlargement, bronchial asthma, very slow heart rate, hypotension, cerebral arteriosclerosis, pancreatitis (inflammation of the pancreas), peptic ulcer (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 develop gastrointestinal problems, you must stop taking this medicine and consult a doctor immediately, as you may develop paralytic ileus (cessation of normal intestinal movements).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (which may cause hemolytic anemia).
• 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 abnormality 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, malaise (nausea), and vomiting.

Children and adolescents

Children under 12 years of age must not take this medicine, as the paracetamol dose cannot be adjusted appropriately for this population.

Interference with laboratory tests:

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

Taking Friolgrip Decongestant 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 taking 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 output (loop diuretics such as furosemide, or other diuretics), 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 to reduce blood cholesterol levels: (cholestyramine).
• Medicines used to treat depression, Parkinson’s disease, or other conditions (monoamine oxidase inhibitors (MAOIs)). Administration of medicines containing phenylephrine must be separated by at least 15 days after stopping MAOI treatment.
• Medicines used to treat migraine; medicines taken during childbirth; medicines taken to treat blood pressure or other conditions (alpha-adrenergic blocking medicines).
• Alpha- and beta-adrenergic blockers such as labetalol and carvedilol (used for heart conditions or to treat arterial diseases).
• Medicines to treat depression (tricyclic and tetracyclic antidepressants).

General anesthetics.

• Antihypertensives (medicines to lower blood pressure).
• Medicines used for the heart such as cardiac glycosides, antiarrhythmics, and β-adrenergic blockers.
• Medicines containing thyroid hormones (used to treat thyroid disorders).
• Medicines used for heart disease or digestive disorders (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 (antibiotic), due to a serious risk of blood and fluid imbalance (called metabolic acidosis) requiring urgent treatment (see section 2).

Taking Friolgrip Decongestant with food, drinks, and alcohol

While being treated with this medicine, do not consume alcoholic beverages, as they may increase the likelihood of adverse effects.

In addition, the use of medicines containing paracetamol by patients who regularly 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 and breastfeeding

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

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

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

Driving and using machines

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

Friolgrip Decongestant contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 3.994 grams of sucrose per sachet.

3. How to take Friolgrip Decongestant

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and adolescents over 12 years of age: Take 1 sachet every 6–8 hours (3 or 4 times daily). Do not take more than 4 sachets (equivalent to 2,600 mg of paracetamol) per day. Do not exceed 3 g of paracetamol in any 24-hour period (see section “Warnings and precautions”).

Patients with hepatic impairment: In cases of hepatic impairment, do not exceed 3 sachets per day, and the minimum interval between doses must be 8 hours.

Patients with renal impairment: This medicine is not indicated for this population due to the 650 mg dose of paracetamol.

Children: Children under 12 years of age must not take this medicine, as the dose of paracetamol cannot be adjusted appropriately for this population.

Use in elderly patients

Elderly patients must not use this medicine without consulting a doctor.

This is because 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 excitement, and may be more sensitive to effects such as dry mouth and urinary retention.

How to take

This medicine is taken orally.

Friolgrip Decongestant sachets are administered orally.

The contents of the sachet should be completely dissolved in a small amount of liquid, preferably half a glass of water.

Always take the lowest effective dose.

Treatment with this medicine should only be taken when symptoms are present. As symptoms improve, treatment should be discontinued.

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

If you take more Friolgrip Decongestant than you should

If you have taken an overdose, go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose has been ingested, 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, faintness, 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 output. Metabolic acidosis (decreased blood alkaline reserve). With prolonged use, plasma volume depletion (reduced blood volume) may occur. Paracetamol overdose may also cause: coagulation disorders (blood clots and hemorrhages).

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

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, Friolgrip Decongestant may cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported during the use of the combination of paracetamol, phenylephrine, and chlorphenamine, although their frequency has not been accurately established:

• 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, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucus secretions, sweating, blurred vision, or other visual disturbances.

• Adverse effects that may occur less frequently (rare):

Malaise, low 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 excitement (generally with high doses and more frequent 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 (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 heartbeat, itching, swelling of the eyelids or around the eyes, face, or tongue, breathing difficulties, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to drugs related to chlorphenamine. Blood disorders (changes in blood cell count, such as agranulocytosis, leucopenia, aplastic anemia, thrombocytopenia) with symptoms such as unusual bleeding, sore throat, or fatigue; low or high blood pressure, edema (swelling), ear disturbances, impotence, menstrual disorders.

• Adverse effects that may occur very rarely (very rare): Kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar).

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

Very rare cases of serious skin reactions have been reported.

• Adverse effects with unknown frequency: Anxiety, irritability, weakness, increased 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 blood vessel diameter (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 (hyperglycemia), decreased blood potassium levels, metabolic acidosis (metabolic disturbance), coldness in the extremities (legs or arms), flushing, feeling of faintness (hypotension). With high doses: vomiting, palpitations, psychotic states with hallucinations; with prolonged use: decreased blood volume. A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness using paracetamol (see section 2).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through 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 Friolgrip Decongestant

Keep out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging, which follows the term

EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This way, you will help protect the environment.

6. Package contents and other information

Composition of Friolgrip Decongestant

• The active substances are: paracetamol, phenylephrine hydrochloride and chlorpheniramine maleate. Each sachet of Friolgrip Decongestant contains: paracetamol 650 mg; phenylephrine hydrochloride 10 mg; chlorpheniramine maleate 4 mg.
• The other components (excipients) are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose, anhydrous sodium cyclamate, orange flavouring.

Appearance of the product and contents of the pack

White, homogeneous, water-dispersible powder for oral solution with an orange flavour. Friolgrip Decongestant is supplied in single-dose sachets, packed in boxes of 10 units.

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Manufacturer

Alcalá Farma, S.L.

Avenida de Madrid, 82,

28802 Alcalá de Henares (Spain)

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

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