Friolgrip antitussive powder for oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Friolgrip antitussive powder for oral solution

Paracetamol + Dextromethorphan hydrobromide + Chlorpheniramine maleate

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

Follow exactly the administration instructions 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 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 or pharmacist if you 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.

Leaflet contents

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

1. What Friolgrip Cough Suppressant is and what it is used for

It is a combination 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 a cough suppressant that inhibits the cough reflex.

It is indicated in adults and adolescents over 14 years of age for the relief of symptoms associated with colds and flu accompanied by mild to moderate pain, fever, non-productive cough (irritating cough, nervous cough) and nasal 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 more than 5 days.

2. What you need to know before taking Friolgrip Antitussive

Do not take Friolgrip Antitussive

• 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 any liver disease
• if you have respiratory insufficiency
• if you have asthmatic cough
• if you have cough with abundant secretions
• if you are currently being treated or have been treated within the previous 2 weeks with monoamine oxidase inhibitors (MAOIs) used to treat depression, Parkinson's disease, or other conditions, or with other serotonin reuptake inhibitors used for depression such as fluoxetine and paroxetine; or also with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine. (See section on use of other medicines.)
• Children under 14 years of age must not take this medicine.

Warnings and precautions

This medicine may cause dependence. Therefore, treatment should be short-term.

Consult your doctor or pharmacist before taking Friolgrip Antitussive:

• If you are taking other medicines such as antidepressants or antipsychotics, Friolgrip Antitussive may interact with these medicines 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 (G6PD) deficiency (may cause hemolytic anemia)

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

• Avoid simultaneous use of this medicine 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 2 g of paracetamol per day, equivalent to a maximum of 3 sachets of Friolgrip Antitussive per day.

• You should consult your doctor before taking this medicine:

  • Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
  • Patients with persistent or chronic cough, such as that caused by smoking
  • Patients with atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in childhood in individuals with hereditary predisposition to allergy) who are sedated, weakened, disabled, or bedridden.
  • Patients sensitive (allergic) to an antihistamine, 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 medicine.
  • When undergoing treatment with any medicine for epilepsy, consult your doctor before taking this medicine, as using them together may reduce efficacy and increase hepatotoxicity of paracetamol, especially with high-dose paracetamol treatments.
  • Patients with high blood pressure (hypertension), elevated eye pressure (glaucoma), thyroid disease (hyperthyroidism), prostate disorders (prostatic hypertrophy), bladder neck obstruction (urinary bladder disease), or urinary retention, as well as acute asthma attacks, should consult their doctor before using this medicine.
  • 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 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 difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

• This medicine may cause drowsiness and sedation. Avoid concomitant use with alcoholic beverages or barbiturate drugs (used as sleep inducers, sedatives, and anticonvulsants) or tranquilizers.

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

Elderly people may be more susceptible to dizziness, sedation, confusion, hypotension (low blood pressure), or dry mouth. These are adverse effects that may occur with chlorphenamine.

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section If you take more Friolgrip Antitussive than you should).

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 Friolgrip Antitussive with other medicines

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

In particular, if you are using any of the following medicines, dosage adjustment 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.
• Medicines that cause central nervous system depression (such as those used for insomnia or anxiety).
• Medicines used to treat Parkinson's disease or other conditions (monoamine oxidase inhibitors (MAOIs)).
• Medicines used to prevent blood clots: Oral anticoagulants (acenocoumarol, warfarin).
• Medicines used to increase urine elimination (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, amiodarone, and quinidine).
• Medicines used to lower blood cholesterol levels (cholestyramine).
• Medicines with adverse effects that damage the ear (ototoxic).
• Medicines that cause light sensitivity (photosensitizing medicines).
• Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib).
• Expectorant and mucolytic medicines.
• Medicine used to treat psychiatric disorders (haloperidol).
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) requiring urgent treatment (see section 2).

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

• Medicines for the treatment of depression: monoamine oxidase inhibitors (MAOIs) (moclobemide, tranilcipromine), serotonin reuptake inhibitors (paroxetine, fluoxetine), or tranilcipromine.
• Medicine used to stop smoking (bupropion)
• Medicine used for the treatment of infections (isoniazid)
• Medicine used as an antibacterial (linezolid)
• Medicine used to treat high blood pressure (pargyline)
• Medicine used for the treatment of cancer (procarbazine)
• Medicine used for the treatment of Parkinson's disease (selegiline)
• Medicine used for the treatment of obesity (sibutramine)

Taking Friolgrip Antitussive with food, drinks, and alcohol

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

In addition, the use of medicines containing paracetamol by patients who habitually consume alcohol (3 or more alcoholic drinks: beer, wine, liquor, etc., per day) may cause liver damage.

Do not take together with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.

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

Driving and use of machines

This medicine may cause drowsiness. If you feel drowsy during treatment with this medicine, avoid driving vehicles or operating machinery.

Friolgrip Antitussive contains sucrose

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

It may cause tooth decay.

3. How to take Friolgrip Antitussive

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

The recommended dose is:

Adults and adolescents over 14 years of age: 1 sachet every 6–8 hours as needed (3–4 sachets per day). Do not take more than 4 sachets per day (equivalent to 2,600 mg of paracetamol per day). Do not exceed 3 g of paracetamol in any 24-hour period (see section “Warnings and precautions”).

Patients with kidney disease: This medicine must not be taken due to its paracetamol content (650 mg).

Patients with liver disease: In cases of hepatic insufficiency or Gilbert’s syndrome, take 1 sachet every 8 hours. Do not exceed 3 sachets in 24 hours, and the minimum interval between doses must not be less than 8 hours.

Use in children and adolescents

This medicine is contraindicated in individuals under 14 years of age.

Use in elderly patients

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

This is because they may be particularly susceptible to certain adverse effects of the medicine, such as slow heart rate (bradycardia) or reduced cardiac output, due to the presence of chlorphenamine. 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

This medicine is taken orally.

Tear open the sachet and pour the contents into a glass. Add warm water up to half the glass and stir. Take once dissolved.

Always use the lowest effective dose.

Treatment should be started at the first onset of symptoms and discontinued as symptoms resolve.

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

If you take more Friolgrip Antitussive than you should

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

Other symptoms in cases of massive overdose may include coma, severe respiratory problems, and seizures.

Contact your doctor or go to hospital immediately if you experience any of these symptoms.

Because it contains paracetamol, this medicine may cause liver damage when taken in higher-than-recommended doses or during prolonged treatment. Overdose may also cause coagulation disorders (blood clots and hemorrhages). Treatment for paracetamol overdose is most effective if started within 4 hours of the overdose.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxic effects of a paracetamol overdose.

In case of overdose or accidental ingestion, seek immediate medical attention or call the Toxicology Information Service (telephone: 91.5620420), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

The following adverse effects have been reported during the period of use of paracetamol, dextromethorphan and chlorpheniramine, the frequency of which 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 vision disturbances.

• The adverse effects that may occur less frequently (rare) are: Malaise, drop in blood pressure (hypotension), and increased levels of transaminases in the blood. Nervous excitation (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 (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 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 chlorpheniramine. Blood disorders (changes in blood cell count, 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 disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), hypoglycaemia (low blood sugar), severe skin reactions.

• Adverse effects whose frequency is unknown are:

Mental confusion, increased 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, mucus thickening, dry mouth, loss of appetite, disturbances in taste and smell, gastrointestinal discomfort (nausea, vomiting, diarrhoea, constipation, epigastric pain), sweating, urinary retention and difficulty urinating.

A serious condition that may make the blood more acidic (called metabolic acidosis) in patients with severe illness who are 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 not listed in this leaflet. You may 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 Antitussive

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or in 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 medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Friolgrip Antitussive:

• The active substances 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 flavouring.

Appearance of the product and contents of the pack

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.
C/ Anabel Segura 11, Edificio Albatros B, 1st floor
Alcobendas, 28108, Madrid (Spain)

Manufacturer

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