FRIOLGRIP DECONGESTANT ORAL SOLUTION POWDER

Introduction

Package Leaflet: Information for the User

Friolgrip Decongestantpowderfor oral solution

Paracetamol / Phenylephrine hydrochloride / Chlorphenamine maleate

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

Follow the administration instructions of the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist even if they are side effects not listed in this leaflet. See section 4.
• You should consult your doctor if your symptoms worsen or 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.

Contents of the Package Leaflet

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

1. What is Friolgrip Decongestant and what is it used for

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 12 years for the symptomatic relief of symptoms of colds and flu that occur with fever, or mild or moderate pain, congestion, and nasal secretion.

You should consult your doctor if your symptoms worsen or 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.

2. What you need to know before taking Friolgrip Decongestant

Do not take Friolgrip Decongestant:

• If you are allergic to the active substances or to any of the components of this medicine (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) (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 artery diseases) (see: Taking Friolgrip Decongestantwith 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.

Warnings and precautions

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

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

Avoid taking this medicine 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.

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

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

• 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 being treated with tricyclic antidepressants or medications with similar effects and experience gastrointestinal problems, stop taking this medicine and consult a doctor immediately, as it may cause paralytic ileus (stop of normal movements of a part of the intestine).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia)
• If you have severe diseases, such as severe renal failure 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 serious disease called metabolic acidosis (an anomaly in the 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

Children under 12 years should not take this medicine, as the paracetamol dose cannot be adjusted for this population.

Interference with laboratory tests:

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

Taking Friolgrip Decongestant with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may 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 other diuretics), and other diuretics that produce potassium loss (such as diuretics for treating hypertension or other conditions).
• 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 to lower cholesterol levels in the blood: (cholestyramine).
• Medications used to treat depression, Parkinson's disease, or other diseases (monoamine oxidase inhibitors (MAOIs)). The administration of this medicine with phenylephrine should be separated by a minimum of 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 blockers such as labetalol and carvedilol (used for the heart or to treat artery diseases).
• Medications for treating depression (tricyclic and tetracyclic antidepressants).

General anesthetics.

• Antihypertensives (medications to lower blood pressure).
• Medications used 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 (atropine sulfate).
• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety).
• Ototoxic medications (which have the adverse effect of damaging the ear).
• Photosensitizing medications (which have the adverse effect of producing light allergy).
• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (called metabolic acidosis) that requires urgent treatment (see section 2).

Taking Friolgrip Decongestant with food, drinks, and alcohol

While being treated with this medicine, do not take alcoholic beverages, as it may enhance the appearance of side effects of this medicine.

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

This medicine cannot be used during breastfeeding, as it may produce side effects in the baby.

Driving and using machines

This medicine may cause drowsiness, altering mental and/or physical ability. If you notice these effects, avoid driving vehicles or using machines.

Friolgrip Decongestant contains sucrose.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

3. How to take Friolgrip Decongestant

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

Adults and adolescents over 12 years: Take 1 sachet every 6-8 hours (3 or 4 times a day). Do not take more than 4 sachets (equivalent to 2.6 g of paracetamol) per day. Do not take more than 3 g of paracetamol every 24 hours (see "Warnings and precautions" section).

Patient with liver failure: In case of liver failure, do not exceed 3 sachets, and the minimum interval between doses will be 8 hours.

Patient with kidney failure: This medicine is not indicated for this population due to the dose of 650 mg of paracetamol.

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

Use in elderly patients

Elderly people cannot use this medicine without consulting their doctor.

Because they may be especially affected by some side effects of the medicine, 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

This medicine is taken orally.

The sachets of Friolgrip Decongestant are administered orally.

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

Always take the smallest effective dose.

Taking this medicine is subject to the appearance of symptoms. As they 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 ones appear, consult your doctor.

If you take more Friolgrip Decongestant than you should

If you have ingested an overdose, go immediately to a medical center, 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 (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 (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 alkaline reserve). In prolonged use, it can cause depletion of plasma volume (decrease in blood volume). Paracetamol overdose can also cause: coagulation disorders (blood clots and bleeding).

Treatment of an overdose is more effective if started within 4 hours after taking the medicine.

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 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 produce adverse effects, although not all people suffer from them.

During the period of use of the association of paracetamol, phenylephrine, and chlorphenamine, the following adverse effects have been reported, whose frequency has not been established with precision:

• 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.

• 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 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 tension, 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 the eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-sensitivity (allergy) to medications related to chlorphenamine. Alterations in blood (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 alterations.

• 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 alterations (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 severe skin reactions have been reported.

• Adverse effects whose frequency of appearance is unknown 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. 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, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it 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.

Due to the content in

5. Conservation of Friolgrip Decongestant

Keep out of sight and reach of children.

Store below 30°C.

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.

Medicines 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. In this way, you will help protect the environment.

6. Content of the Packaging and Additional Information

Composition of Friolgrip Decongestant

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

Appearance of the Product and Content of the Packaging

Oral solution powder, white, homogeneous, dispersible in water, and with an orange flavor. Friolgrip Decongestant is presented in monodose sachets and packaged in boxes of 10 units.

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Alcalá Farma, S.L.

Avenida de Madrid, 82,

28802 Alcalá de Henares (Spain)

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/