FRITUSIL 3 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Fritusil 3 mg/ml Oral Solution

Dextromethorphan Hydrobromide

Read this package leaflet carefully before starting to take this medicine, because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after more than 7 days or if they are accompanied by high fever, skin rash, or persistent headache.

Contents of the Package Leaflet:

1. What is Fritusil and what is it used for
2. What you need to know before taking Fritusil
3. How to take Fritusil
4. Possible side effects
5. Storage of Fritusil
6. Package Contents and Additional Information

1. What is Fritusil and what is it used for

Dextromethorphan, the active ingredient of this medicine, is a cough suppressant that inhibits the cough reflex.

It is indicated for the symptomatic treatment of cough forms that are not accompanied by expectoration (irritative cough, nervous cough) in adults and adolescents over 12 years old.

You should consult a doctor if your symptoms worsen or persist after 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 can cause dependence. Therefore, treatment should be short-term.

Do not take Fritusil:

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Fritusil:

• with persistent or chronic cough, such as that caused by smoking
• with liver disease
• 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)
• if the patient is sedated, weakened, 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Children and Adolescents

Do not administer to children under 12 years old.

There have been reports of abuse with medicines containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious side effects may occur (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 may need to take any other medicine.

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

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, traniciprona)
• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine)
• Bupropion (used to quit smoking)
• Isoniazid (used for infections)
• Haloperidol (used to treat mental disorders)

• Central nervous system depressant medicines (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 to treat Parkinson's disease)

• Sibutramine (used to treat obesity)
• Tranilcipromine (used to treat depression).

If you are using any of the following medicines, it may be necessary to modify the dose of one of them or interrupt treatment:

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

Taking Fritusil with food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment, as they may cause adverse reactions.

Do not take with grapefruit or bitter orange juice, as it 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 taking this medicine.

Driving and Using Machines

Rarely, during treatment, a decrease in reaction capacity or drowsiness and mild dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

Fritusil contains saccharose, cochineal red A, ethanol, methyl parahydroxybenzoate,glycerol, sodium benzoate, and sodium

• This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. Patients with diabetes mellitus should be aware that this medicine contains 3.25 g of saccharose per 5 ml.
• This medicine may cause allergic reactions because it contains Cochineal Red A (Ponceau 4R) (E-124). This medicine contains 202 mg of alcohol (ethanol) in each unit dose (5% ethanol), which is 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 upset, and diarrhea because it contains glycerol.
• This medicine contains 0.1 g of benzoic acid salt per unit volume, equivalent to 0.1 g/100 ml.
• This medicine contains less than 1 mmol of sodium (23 mg) per unit volume; i.e., it is essentially "sodium-free".

3. How to take Fritusil

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

The recommended dose is:

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

Patient with liver insufficiency: the dose should be reduced by half, not exceeding 4 daily doses in any case.

Use in Children

This medicine is indicated for children over 12 years old.

Fritusil is administered orally.

Take the measured amount directly from the graduated spoon.

If you take more Fritusil than you should:

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

Taking very high doses can cause children to become drowsy, nervous, nauseous, vomit, or have changes in their gait.

If you take more Fritusil than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, consciousness disorders, 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.

There have been cases of abuse with medicines containing dextromethorphan, which can cause serious side effects, such as anxiety, panic, memory loss, tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal upset, slurred speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

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

In cases 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.

If you forget to take Fritusil

Do not take a double dose to make up for forgotten doses. If necessary, take the medicine again as indicated in the section 3. How to take Fritusil

4. Possible side effects

Like all medicines, Fritusil can cause side effects, although not everyone gets them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency has not been established with certainty:

In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal upset, nausea, vomiting.

In rarer cases: mental confusion and headache.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Fritusil Composition

• The active ingredient is dextromethorphan hydrobromide. Each ml contains 3 mg (corresponding to 2.2 mg of dextromethorphan).
• The other components (excipients) are: Saccharose, Sodium Saccharin (E-954), Sodium Benzoate (E-211), Methyl Parahydroxybenzoate (E-218), Glycerol (E-422), Menthol, Ethanol (96%), Strawberry Flavor, Cochineal Red A (E-124), and Water.

Product Appearance and Package Contents

Fritusil is a red-transparent oral solution with a strawberry odor and flavor. It is presented in a 150 ml package. A graduated spoon is included.

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 last revision of this package leaflet:September 2022

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/