Leaflet: information for the user

Friolgrip antitussive powder for oral solution

Paracetamol + Dextromethorphan hydrobromide + Chlorphenamine maleate

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

Follow exactly the administration instructions for 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 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.

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

2. What you need to know before starting to take Friolgrip Antitussive

3. How to take Friolgrip AntitussiveFriolgrip Antitussive

4. Possible side effects

5. Storage of Friolgrip Antitussive

6. Contents of the pack and additional information.

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

Paracetamol is an analgesic that reduces fever and relieves pain.

Chlorphenamine is an antihistamine that alleviates 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 are accompanied by mild or moderate pain, fever, non-productive cough (irritative cough, nervous cough) and nasal discharge.

Consult a doctor if symptoms worsen or do not improve or if fever persists for more than 3 days or pain or other symptoms persist for more than 5 days.

Do not takeFriolgrip Antitusivo

- if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6)

- if you have liver disease

- if you have respiratory insufficiency

- if you have asthma cough

- if you have a cough accompanied by abundant secretions

- If you are taking or have taken within the last 2 weeks any monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other conditions, or other serotonin reuptake inhibitors used to treat depression such as fluoxetine and paroxetine; or also bupropion used to quit smoking or linezolid used as an antibiotic. (See section on use of other medications)

-Patients under 14 years old cannot take this medication.

Warnings and precautions

This medication may cause dependence. Therefore, treatment should be of short duration.

Consult your doctor or pharmacist before takingFriolgrip Antitusivo:

• If you are taking other medications such as antidepressants or antipsychotics, Friolgrip Antitusivo 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).
• In case of glucose-6-phosphate dehydrogenase deficiency (may cause hemolytic anemia)

- Do not take more medication than recommended in section 3. How to takeFriolgrip Antitusivo.

- Avoid taking this medication with other medications that contain paracetamol, as high doses may cause liver damage. Do not take more than one medication that contains paracetamol without consulting your doctor.

- Chronic alcoholics should be careful not to take more than 2g of paracetamol per day, which is equivalent to a maximum of 3 packets ofFriolgrip Antitusivoper day.

- Consult your doctor before taking this medication:

• Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medication.
• Patients with persistent or chronic cough, such as that caused by smoking
• Patients with atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition) who are sedated, weakened, incapacitated, or bedridden.
• Patients who are sensitive (allergic) to antihistamines, as they may be sensitive to other antihistamines (such as chlorphenamine).
• Patients with kidney, liver, heart, or lung diseases, and patients with anemia, should consult their doctor before taking this medication.
• When taking medication to treat epilepsy, consult your doctor before taking this medication, as when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially in high-dose treatments.
• Patients with high blood pressure, glaucoma, thyroid disease (hyperthyroidism), prostate enlargement (hypertrophy), urinary tract obstruction (urinary retention), 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 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 (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, somnolence, feeling unwell (nausea), and vomiting.

- This medication may cause sedation and somnolence. Avoid taking it with alcoholic beverages or barbiturates (used as hypnotics, sedatives, and anticonvulsants) or tranquilizers.

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

Older adults may be more susceptible to experiencing dizziness, sedation, confusion, hypotension (low blood pressure), or dry mouth. These are adverse effects that may appear with chlorphenamine.

Cases of abuse with medications containing dextromethorphan in adolescents have been reported, so this possibility should be taken into account, as it may cause severe adverse effects (see sectionif you take moreFriolgrip Antitusivothan you should).

Interference with laboratory tests:

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

Use ofFriolgrip Antitusivowith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

In particular, if you are using any of the following medications, as it may be necessary to modify the dose of some of them or interrupt treatment:

- Medications to treat epilepsy: Antiepileptics (lamotrigine, phenytoin, or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

- Medications to treat tuberculosis (isoniazid, rifampicin).

- Medications to treat seizures and depression (barbiturates), used as hypnotics, sedatives, and anticonvulsants.

- Medications that produce depression on the central nervous system (such as those used for insomnia or anxiety).

- Medications used to treat Parkinson's disease or other conditions (Monoamine oxidase inhibitors (MAOIs)).

- Medications used to prevent blood clotting: Oral anticoagulants (acenocoumarol, warfarin).

- Medications used to increase urine elimination (diuretics of the loop, such as those in the furosemide group, or other diuretics), and other diuretics that cause potassium loss (such as diuretics for hypertension or others).

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

- Medications used to treat gout (probencid and sulfinpyrazone).

- Medications used to treat high blood pressure and heart rhythm disorders (arritmias) (propranolol, amiodarone, and quinidine).

- Medications used to lower cholesterol levels in the blood (cholestyramine).

- Medications that have as an adverse effect that damage the ear (ototoxic).

- Medications that produce photosensitivity (photosensitizing medications).

- Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)

- Expectorants and mucolytics

- Medication used to treat mental disorders (haloperidol).

- Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that must receive 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 to treat depression: Monoamine oxidase inhibitors (MAOIs) (moclobemide, tranilcipromina), serotonin reuptake inhibitors (paroxetine, fluoxetine), or tranilcipromina.

- Medication used to quit smoking (bupropion)

- Medication used to treat infections (isoniazid)

- Medication used as an antibiotic (linezolid)

- Medication used to treat high blood pressure (pargilina)

- Medication used to treat cancer (procarbazine)

- Medication used to treat Parkinson's disease (selegiline)

- Medication used to treat obesity (sibutramine)

Use ofFriolgrip Antitusivowith food, drinks, and alcohol

While taking this medication, do not consume alcoholic beverages, as it may potentiate the appearance of adverse effects of this medication.

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

Do not take it with orange juice or bitter orange, as it may increase the adverse effects of this medication.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be 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 lactation, as it may cause adverse effects in the baby.

Driving and operating machinery

This medication may cause somnolence. If you experience somnolence during treatment with this medication, avoid driving vehicles or operating machinery.

Friolgrip Antitusivocontains saccharose

This medication contains saccharose. 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.

Follow exactly the administration instructions of the medication contained in this leaflet or those 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:1 tablet every 6-8 hours as needed (3-4 tablets a day). Do not take more than 4 tablets a day (equivalent to 2.6 g of paracetamol a day).Do not take more than 3 g of paracetamol every 24 hours (see section “Warnings and precautions”).

Patients with kidney diseases:They cannot take this medication due to its content of 650 mg paracetamol.

Patients with liver diseases:In case of liver insufficiency or Gilbert’s syndrome, 1 tablet every 8 hours. Do not exceed 3 tablets /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.

Use in elderly patients

Elderly patients cannot use this medication without consulting a doctor.

Because they may be especially affected by some adverse effects of the medication such as the appearance of slow heartbeats (bradycardia) or reduction of cardiac output, due to the content of chlorphenamine. They may also be more likely to present 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 medication is taken orally.

Rip the sachet and pour the contents of the same into a glass, add hot water up to the middle and stir. Take once dissolved.

Always use the lowest effective dose.

The medication should be initiated as soon as the first symptoms appear, as soon as they disappear, the medication should be discontinued.

Consult a 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 increase or new ones appear.

If you take moreFriolgrip Antitusivothan you should

If you take more Friolgrip Antitusivo than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, involuntary and rapid eye movements, cardiac disturbances (acceleration of heart rate), coordination disturbances, 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 may damage the liver when taken in higher doses than recommended or in prolonged treatments. Massive overdose may also cause: coagulation disorders (blood clots and hemorrhages). The treatment of paracetamol overdose is more effective if initiated within 4 hours of the overdose.

Patients undergoing barbiturate treatment 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 Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

During the period of use of paracetamol, dextromethorphan, and chlorphenamine, the following side effects have been reported, whose frequency has not been established with precision

- The side effects that may appear most frequently are:Mild drowsiness, dizziness, muscle weakness: these side effects may disappear after 2-3 days of treatment. Difficulty in facial movements, clumsiness, tremors, alterations in sensations and paresthesias, dry mouth, loss of appetite, alterations in taste or smell, gastrointestinal discomfort (which may decrease if the medication is taken with food), nausea, vomiting, diarrhea, constipation, stomach pain, urinary retention, dryness of the nose and throat, thickening of mucosities, sweating, blurred vision, or other visual disturbances.

- The side effects that may appear with low frequency (rare) are:Discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood. Nervous excitement (usually with high doses, and more frequent in the elderly and children), which may include symptoms such as: restlessness, insomnia, nervousness, and even convulsions.

Other side effects that may appear with low frequency are: chest pressure, lung noises, rapid or irregular heartbeats (tachycardia, usually with overdose), liver disorders (which may present with stomach or abdominal pain, dark urine, or other symptoms), allergic reaction (cough, difficulty swallowing, rapid heartbeats, itching, swelling of eyelids or around the eyes, face, tongue, difficulty breathing, etc.), photosensitivity (sensitivity to sunlight), cross-reactivity (allergy) with related chlorphenamine medications. 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), ear alterations, impotence, menstrual alterations.

-The side effects that may appear with very low frequency (very rare) are:Kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), hypoglycemia (low blood sugar), severe skin reactions.

-The side effects whose frequency is unknown are:

Confusion, high blood pressure (hypertension, usually 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, thickened 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 may make the blood more acidic (designated as metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment.

Composition ofFriolgrip Antitusivo:

-The active principles 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 contents of the packaging

Box containing 10 sachets of orange-flavored powder for oral solution.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108, Madrid (Spain)

Responsible for manufacturing

ALCALA FARMA, S.L.

Avenida de Madrid, 82

28802 (Alcalá de Henares) Spain

Last review date of this leaflet: February 2025

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es