Fritusil 3 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fritusil 3 mg/ml oral solution

Dextromethorphan hydrobromide

Read the entire 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 further 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 a doctor if symptoms worsen or do not improve after more than 7 days, or if they are accompanied by high fever, skin rash, or persistent headache.

Leaflet contents:

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

1. What Fritusil is and what it is used for

Dextromethorphan, the active ingredient in this medicine, is an antitussive that suppresses the cough reflex.

It is indicated for the symptomatic treatment of dry cough (non-productive cough), such as irritative cough or nervous cough, in adults and adolescents over 12 years of age.

You should consult a doctor if symptoms worsen or persist beyond 7 days of treatment, or if they are accompanied by high fever, skin rash, or persistent headache.

2. What you need to know before taking Fritusil

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

Do not take Fritusil:

• if you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6);
• if you have severe lung disease;
• if you have asthmatic cough;
• if you have a cough with abundant secretions;
• if you are being treated with a monoamine oxidase inhibitor (MAOI) medicine used for depression or Parkinson's disease (see section Taking Fritusil with other medicines).

Warnings and precautions

Talk to your doctor or pharmacist before taking Fritusil:

• if you have persistent or chronic cough, such as that caused by smoking;
• if you have liver disease;
• if you have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, beginning in childhood in individuals with hereditary predisposition to allergic conditions);
• if the patient is sedated, debilitated, or bedridden;
• if you are taking other medicines such as antidepressants or antipsychotics, Fritusil 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).

Children and adolescents

Do not administer to children under 12 years of age.

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 Fritusil than you should).

Taking Fritusil with other medicines

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

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

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine);

• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine);

• Bupropion (used to stop smoking);

• Isoniazid (used for infections);

• Haloperidol (used to treat psychiatric disorders);

• Central nervous system depressants (some used for mental illnesses, allergies, Parkinson's disease, etc.);

• Linezolid (used as an antibacterial);

• Pargyline (used to treat high blood pressure);

• Procarbazine (used to treat cancer);

• Selegiline (used for Parkinson's disease);

• Sibutramine (used to treat obesity);

• Tranylcypromine (used to treat depression).

If you are taking any of the following medicines, a dose adjustment or discontinuation of treatment may be necessary:

• Amiodarone and quinidine (used to treat heart arrhythmias);
• Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib);
• Expectorants and mucolytics.

Taking FRITUSIL with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as this may cause adverse reactions.

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

Pregnancy and breastfeeding

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

Driving and using machines

Rarely, during treatment, reduced reaction ability, drowsiness, or mild dizziness may occur. If you experience these symptoms, you should not drive or operate dangerous machinery.

Fritusil contains sucrose, carmine red A, ethanol, methyl parahydroxybenzoate, glycerol, sodium benzoate, and sodium

• This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 3.25 g of sucrose per 5 ml.
• This medicine may cause allergic-type reactions because it contains Carmine Red A (Ponceau 4R) (E-124).
• This medicine contains 202 mg of alcohol (ethanol) per dose unit (5% ethanol (alcohol)), equivalent to 5 ml of beer or 2.1 ml of wine.
• It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E 218).
• This medicine may cause headache, stomach discomfort, and diarrhea because it contains glycerol.
• This medicine contains 0.1 g of benzoic acid salt per volume unit, equivalent to 0.1 g/100 ml.
• This medicine contains less than 1 mmol of sodium (23 mg) per volume unit; hence, it is essentially “sodium-free”.

3. How to take Fritusil

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

The recommended dose is:

Adults and adolescents over 12 years of age: 5 ml (15 mg of dextromethorphan) measured with the graduated spoon provided, every 4 to 6 hours (as needed). Do not exceed 6 doses per day (30 ml of oral solution).

Patients with hepatic impairment: The dose should be reduced by half and must not exceed 4 doses per day under any circumstances.

Use in children

This medicine is indicated for patients over 12 years of age.

Fritusil is administered orally.

Take the measured amount directly from the graduated spoon.

If you take more Fritusil than you should:

You may experience: confusion, excitability, restlessness, nervousness, and irritability.

Very high doses may cause children to become drowsy, nervous, nauseous, vomit, or experience disturbances in gait.

If you take more Fritusil 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 problems, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose may include: coma, severe breathing difficulties, and seizures.

Cases of abuse have been reported with medications containing dextromethorphan, which may lead to serious adverse effects such as anxiety, panic, memory loss, tachycardia (increased heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil of the eye), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary and uncontrolled eye movements), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

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

In cases of overdose or accidental ingestion, seek immediate medical attention or call the Toxicology Information Service (Telephone 91 562 04 20), indicating the medication and the amount ingested.

If you forget to take Fritusil

Do not take a double dose to make up for missed doses. If necessary, resume taking the medicine in the same way as indicated in section 3. How to take Fritusil.

4. Possible adverse effects

Like all medicines, Fritusil may cause adverse effects, although not everyone experiences them.

During the period of dextromethorphan use, the following adverse effects have been observed, whose frequency cannot be precisely determined:

In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.

In rarer cases: mental confusion and headache.

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 Fritusil

No special storage conditions are required.

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

Do not use this medicine after the expiry date stated on the packaging after 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 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 pack and other information

Composition of Fritusil

• The active substance is dextromethorphan hydrobromide. Each ml contains 3 mg (equivalent to 2.2 milligrams of dextromethorphan).
• The other components (excipients) are: Sucrose, sodium saccharin (E-954), sodium benzoate (E-211), methyl parahydroxybenzoate (E-218), glycerol (E-422), menthol, ethanol (96%), strawberry flavour, carmine red A (E-124) and water.

Appearance of the product and contents of the pack

Fritusil is a red-transparent oral solution with strawberry odour and taste. It is supplied in a container containing 150 ml. It includes a graduated spoon.

Marketing Authorization Holder

Farline Comercializadora de Productos Farmacéuticos S.A.

C/ Sta. Engracia, 31

28010 Madrid, Spain

Manufacturer

ALCALÁ FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Date of the most recent review of this leaflet: September 2022

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