Leaflet: information for the user

Fritusil 3 mg/ml oral solution

Dextromethorphan hydrobromide

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

Follow exactly the administration instructions contained in this leaflet or those given 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 a doctor if the symptoms worsen or do not improve aftermore than 7 days or if they are accompanied by high fever, skin eruptions, or persistent headache

1. What Fritusil is and for what it is used

2. What you need to know before starting to take Fritusil

3. How to take Fritusil

4. Possible side effects

5. Storage of Fritusil

6. Contents of the pack and additional information

The dextromethorphan, active principle of this medication, is an antitussive that inhibits the cough reflex.

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

Consult a doctor if symptoms worsen or persist after 7 days of treatment, or if accompanied by high fever, skin eruptions or persistent headache.

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

Do not take Fritusil:

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

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, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition)
• if the patient is sedated, weakened, or bedridden.
• If you are taking other medications such as antidepressants or antipsychotics, Fritusil 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, hypertension, and exaggeration of 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 old.

Cases of abuse with dextromethorphan-containing medications have been described in adolescents, therefore this possibility should be taken into account, as it may cause severe adverse effects (see sectionIf you take more Fritusil than you should)

Use of Fritusil with other medications

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

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):

• monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease (moclobemide, tranylcypromine)
• serotonin reuptake inhibitors (paroxetine, fluoxetine)
• bupropion (used to quit smoking)
• isoniazid (used to treat infections)
• haloperidol (used to treat mental disorders)

• Central nervous system depressants (some used to treat 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)
• tranylcypromine (used to treat depression)

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

• amiodarone and quinidine (used to treat heart arrhythmias)
• anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)
• expectorants and mucolytics

Use of Fritusil with food, drinks, and alcohol

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

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

In rare cases, during treatment, you may experience a decrease in reaction time or mild dizziness and dizziness, so if you notice these symptoms, you should not drive or operate hazardous machinery.

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

• This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication. Patients with diabetes mellitus should be aware that this medication contains 3.25 g of saccharose per 5 ml.
• This medication may cause allergic reactions because it contains Red Cochineal A (Ponceau 4R) (E-124).
• This medication contains 202 mg of alcohol (ethanol) in each dose unit (5% ethanol (alcohol)), which is equivalent to 5 ml of beer or 2.1 ml of wine.
• This medication may cause delayed allergic reactions because it contains Parahydroxybenzoate of methyl (E 218)
• This medication may cause headaches, stomach discomfort, and diarrhea because it contains glycerol.
• This medication contains 0.1 g of sodium benzoate in each volume unit equivalent to 0.1 g/100 ml.
• This medication contains less than 1 mmol of sodium (23 mg) per volume unit; it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in 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 provided graduated spoon every 4 to 6 hours (as needed). Not exceeding 6 daily doses (30 ml of oral solution).

Patients with liver insufficiency: the dose must be reduced by half, not exceeding 4 daily doses.

Use in children

This medication is indicated for individuals 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.

High doses may cause children to experience drowsiness, nervousness, nausea, vomiting, or gait disturbances.

If you take more Fritusil than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (tachycardia), coordination disturbances, psychosis with visual hallucinations, and hyperexcitability.

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

Cases of abuse with dextromethorphan-containing medications have been reported, potentially leading to severe adverse effects, such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, mumbling speech, nystagmus (uncontrolled eye movement), fever, tachypnea (rapid breathing), cerebral damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

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

If you forgot to take Fritusil

Do not take a double dose to compensate for the missed doses. If necessary, take the medication in the same manner as indicated in the section3. How to take Fritusil

Like all medications, Fritusil may produce adverse effects, although not everyone will experience them.

During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency has not been established with precision:

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

In rare cases: mental confusion and headache.

Reporting Adverse Effects:

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

This product does not require special conditions for conservation.

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

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.

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

Composition of Fritusil

• The active principle is dextromethorphan hydrobromide.Each ml contains 3 mg (corresponding 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 flavor, Red Cochineal A (E-124) and Water.

Appearance of the product and contents of the packaging

Fritusil is a red-transparent oral solution, with a strawberry odor and taste. It is presented in a container that contains 150 ml. It includes a graduated spoon.

Holder of the marketing authorization

Farline Commercializer of Pharmaceutical Products S.A.

C/ Sta. Engracia, 31

28010 Madrid Spain

Responsible for manufacturing

ALCALÁ FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Last review date of this leaflet:September 2022

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