FRIOLGRIP ANTITUSSIVE ORAL SOLUTION POWDER

Introduction

Leaflet: information for the user

Friolgrip antitussive powder for oral solution

Paracetamol + Dextromethorphan hydrobromide + Chlorpheniramine maleate

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

Follow the administration instructions for the medication 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 not listed in this leaflet. See section 4.
• You should consult your doctor or pharmacist 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 leaflet

1. What is Friolgrip Antitussive and what is it used for.
2. What you need to know before taking Friolgrip Antitussive
3. How to take Friolgrip Antitussive
4. Possible side effects
5. Storage of Friolgrip Antitussive
6. Package contents and additional information.

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

It is an association of paracetamol, chlorpheniramine, and dextromethorphan.

Paracetamol is an analgesic that reduces fever and relieves pain.

Chlorpheniramine is an antihistamine that relieves nasal congestion and sneezing.

Dextromethorphan is an antitussive that inhibits the cough reflex.

It is indicated in adults and adolescents over 14 years old for the relief of symptoms of colds and flu that occur with mild or moderate pain, fever, unproductive cough (irritative cough, nervous cough), 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 Antitussive

Do not takeFriolgrip Antitussive

• if you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6)
• if you have liver disease,
• if you have respiratory failure
• if you have asthma
• if you have a cough with abundant secretions
• If you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used to treat depression, such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See section on use of other medications).
• Patients under 14 years old cannot take this medication.

Warnings and precautions

This medication can cause dependence. Therefore, treatment should be short-term.

Consult your doctor or pharmacist before taking Friolgrip Antitussive:

• If you are taking other medications such as antidepressants or antipsychotics, Friolgrip Antitussive may interact with these medications and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
• In case of glucose-6-phosphate dehydrogenase (G6PD) deficiency (can cause hemolytic anemia)

• Do not take more medication than recommended in section 3. How to take Friolgrip Antitussive.

• Avoid simultaneous use of 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.

• Chronic alcoholics should be cautious not to take more than 2g of paracetamol per day, which is equivalent to a maximum of 3 sachets of Friolgrip Antitussive per day.

• Patients should consult their doctor before taking this medication:
  • Asthmatic patients sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
  • Patient with persistent or chronic cough, such as that caused by smoking
  • Patients with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition) who are sedated, debilitated, disabled, or bedridden.
  • Patient who are sensitive (allergic) to an antihistamine, because they may be sensitive to other antihistamines (such as chlorpheniramine).
  • Patient with kidney, liver, heart, or lung disease, and patients with anemia, should consult their doctor before taking this medication.
  • When being treated with any medication for epilepsy, consult your doctor before taking this medication, as the efficacy of paracetamol may be decreased and hepatotoxicity may be increased, especially with high doses of paracetamol.
  • Patient who have high blood pressure (hypertension), high eye pressure (glaucoma), any thyroid disease (hyperthyroidism), prostate disorders (prostatic hypertrophy), obstruction of the neck of the bladder (urinary bladder disease), or urinary retention, as well as acute asthma attacks, should consult their doctor before using this medication.
  • 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.

• This medication can cause sedation and drowsiness. Concomitant use with alcoholic beverages or barbituric medications (used as sleep inducers, sedatives, and anticonvulsants) or tranquilizers should be avoided.

Children and the elderly may experience a paradoxical reaction characterized by hyperexcitability (nervousness, restlessness).

The elderly may be more susceptible to experiencing dizziness, sedation, confusion, hypotension (low blood pressure), or dry mouth. These are side effects that may occur with chlorpheniramine.

Cases of abuse with medications containing dextromethorphan in adolescents have been reported, so this possibility should be taken into account, as serious side effects can occur (see section "If you take more Friolgrip Antitussive than you should").

Interference with analytical tests:

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

Taking Friolgrip Antitussive with other medications

Inform your doctor or pharmacist if you are taking, 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 (barbiturics), used as hypnotics, sedatives, and anticonvulsants.
• Medications that produce depression of the central nervous system (such as those used for insomnia or anxiety).
• Medications used to treat Parkinson's disease or other diseases (Monoamine oxidase inhibitors (MAOIs)).
• Medications used to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medications used to increase urine elimination (diuretics such as furosemide, or other diuretics), and other diuretics that produce potassium loss (such as diuretics for treating hypertension or other).
• 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 (hypertension) and heart rhythm disorders (arrhythmias) (propranolol, amiodarone, and quinidine).
• Medications used to lower cholesterol levels in the blood (cholestyramine).
• Medications that have ototoxic effects (damage to the ear).
• Medications that produce photosensitivity (photosensitizing medications).
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)
• Expectorant and mucolytic medications
• Medication used to treat mental disorders (haloperidol).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).

Do not take this medication during treatment or in the 2 weeks following treatment with the following medications, as it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Medications for treating depression: Monoamine oxidase inhibitors (MAOIs) (moclobemide, traniciprona), serotonin reuptake inhibitors (paroxetine, fluoxetine), or tranilcipromine.
• Medication used to quit smoking (bupropion)
• Medication used to treat infections (isoniazid)
• Medication used as an antibacterial (linezolid)
• Medication used to treat high blood pressure (pargyline)
• Medication used to treat cancer (procarbazine)
• Medication used to treat Parkinson's disease (selegiline)
• Medication used to treat obesity (sibutramine)

Taking Friolgrip Antitussive 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.

Do not take with grapefruit juice or bitter orange, as they may increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or 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 used during breastfeeding, as it may cause side effects in the baby.

Driving and using machines

This medication can cause drowsiness. If you experience drowsiness while taking this medication, avoid driving vehicles or using machines.

Friolgrip Antitussive contains sucrose

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

It may cause tooth decay.

3. How to take Friolgrip Antitussive

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

The recommended dose is:

Adults and adolescents over 14 years old:1 sachet every 6-8 hours as needed (3-4 sachets per day). Do not take more than 4 sachets per day (equivalent to 2.6g of paracetamol per day). Do not take more than 3g of paracetamol every 24 hours (see section "Warnings and precautions").

Patient with kidney disease:Cannot take this medication due to its content of paracetamol 650mg.

Patient with liver disease:In case of liver failure or Gilbert's syndrome, 1 sachet every 8 hours. Do not exceed 3 sachets/24 hours and the minimum interval between doses cannot be less than 8 hours.

Use in children and adolescents

This medication is contraindicated in children under 14 years old.

Use in elderly patients

Elderly patients cannot use this medication without consulting their doctor.

Because 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 chlorpheniramine. 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 medication is taken orally.

Tear the sachet and pour the contents into a glass, add hot water to half, and stir. Ingest once dissolved.

Always use the smallest effective dose.

Medication should be started when the first symptoms appear, and as they disappear, the medication should be discontinued.

You should consult your doctor if the fever persists for more than 3 days of treatment, the pain or other symptoms for more than 5 days, or if the symptoms worsen or new ones appear.

If you take more Friolgrip Antitussive than you should

If you take more Friolgrip Antitussive than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

As it contains paracetamol, it can cause liver damage when taken in higher doses than recommended or in prolonged treatments. Overdose can also cause: coagulation disorders (blood clots and bleeding). Treatment of paracetamol overdose is more effective if started within 4 hours after taking the overdose.

Patient taking barbiturics 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 (phone: 91.5620420), indicating the medication and the amount ingested.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

During the period of use of paracetamol, dextromethorphan, 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 medicine is administered with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dry 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. 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 pressure, lung noises, rapid or irregular heartbeats (tachycardia, generally with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction (cough, difficulty swallowing, rapid heartbeat, 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 alterations (changes in the blood cell formula, such as agranulocytosis, leucopenia, 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.

• The adverse effects that may appear with very low frequency (very rare) are: Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowish skin color), hypoglycemia (low blood sugar), severe skin reactions.

• The adverse effects whose frequency is not known are:

Mental confusion, high blood pressure (hypertension, generally with high doses and in sensitive patients), headache (with high doses and may be a symptom of hypertension), blurred vision, double vision, dry nose, dry throat, thickening of mucus, dry mouth, loss of appetite, alterations in taste and smell, gastrointestinal discomfort (nausea, vomiting, diarrhea, constipation, epigastric pain), sweating, urinary retention, and difficulty urinating.

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, 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 medicine.

5. Conservation of Friolgrip Antitussive

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine 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 medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition ofFriolgrip Antitussive:

-The active ingredients are: paracetamol, chlorphenamine maleate, and dextromethorphan hydrobromide.

Each sachet contains:

Paracetamol…………….650 mg

Chlorphenamine maleate……...4 mg

Dextromethorphan hydrobromide…..20 mg

-The other components (excipients) are: anhydrous colloidal silica, anhydrous citric acid, sodium saccharin, sucrose (3.873 mg/sachet), anhydrous sodium cyclamate, orange flavor.

Appearance of the Product and Package Contents

Box containing 10 sachets of powder for oral solution with orange flavor.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

Alcobendas, 28108, Madrid (Spain)

Manufacturer

ALCALA 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es