DEXTROMETHORPHAN FARMALIDER 10 mg ORAL SOLUTION

Introduction

Leaflet: Information for the user

DEXTROMETORFAN FARMALIDER 10 mg oral solution

Dextromethorphan Hydrobromide

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

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

• Keep this 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 side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens, or if you also have a high fever, skin rash, or persistent headache, or if it does not improve after 7 days of treatment.

Contents of the leaflet:

1. - What Dextromethorphan Farmalider is and what it is used for
2. - What you need to know before taking Dextromethorphan Farmalider
3. - How to take Dextromethorphan Farmalider
4. - Possible side effects
5. - Storage of Dextromethorphan Farmalider
6. - Contents of the package and additional information

1. What Dextromethorphan Farmalider is and what it is used for

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

It is indicated for the symptomatic treatment of cough that is not accompanied by expectoration (irritative cough, nervous cough) for adults and adolescents from 12 years of age. You should consult a doctor if it worsens or if it does not improve after 7 days of treatment.

2. What you need to know before taking Dextromethorphan Farmalider

Do not take Dextromethorphan Farmalider:

• If you are allergic (hypersensitive) to dextromethorphan or to any of the other components of this medication (listed in section 6).
• Children under 12 years of age cannot take this medication.
• 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 or have been treated during the 2 weeks prior to taking this medication with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used to treat depression, such as fluoxetine and paroxetine; or with bupropion, which is a medication used to quit smoking, or linezolid, which is an antibacterial medication (see section: Use of other medications).

Warnings and precautions

You should consult your doctor or pharmacist before starting to take Dextromethorphan Farmalider if you are a patient:

• with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• 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)
• who is sedated, weakened, or bedridden
• If you are taking other medications such as antidepressants or antipsychotics, Dextromethorphan Farmalider 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, arterial hypertension, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

This medication can cause dependence. Therefore, treatment should be short-term. There have been cases of abuse with medications containing dextromethorphan in adolescents; therefore, this possibility should be taken into account, as serious side effects can occur (see section: If you take more Dextromethorphan Farmalider than you should).

Children and adolescents

This medication can only be taken by adolescents from 12 years of age.

Taking Dextromethorphan Farmalider with other medications

Inform your doctor or pharmacist if you are taking or have recently taken 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 excitement, high blood pressure, and fever above 40°C (hyperpyrexia) may occur:

- Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranilcipromine)

• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine)
• Bupropion (used to quit smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson's disease)

Before starting to take this medication, you should consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or interrupt treatment:

• Amiodarone and quinidine (to treat heart arrhythmias)
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib)
• Central nervous system depressants (some of which are used to treat mental illnesses, allergies, Parkinson's disease, etc.)
• Expectorants and mucolytics (used to eliminate phlegm and mucus).

Taking Dextromethorphan Farmalider with food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment, as they may cause side effects.

Do not take with grapefruit or bitter orange juice, as they may increase the side effects of this medication.

The rest of the food and drinks do not affect the efficacy of the medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnant or breastfeeding women should not take this medication without consulting a doctor.

Driving and using machines

On rare occasions, during treatment, drowsiness and mild dizziness may occur; therefore, if you experience these symptoms, you should not drive vehicles or operate hazardous machinery.

Dextromethorphan Farmalider contains maltitol and amaranth

This medication contains maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains amaranth (E-123). It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Dextromethorphan Farmalider

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

The recommended dose is:

Adults and adolescents from 12 years of age:

- Take 1 to 2 sachets depending on the intensity of the cough, every 4-6 hours as needed. Do not exceed 6 doses in 24 hours.

- You can also take 3 sachets every 6 or 8 hours, if necessary. Do not exceed 4 doses in 24 hours.

Always use the lowest effective dose.

Use in children

This medication can only be taken by adolescents from 12 years of age.

How to take

Dextromethorphan Farmalider is taken orally.

Pour the contents of the sachet directly into the mouth or take it dissolved in a liquid, preferably water.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section: Taking Dextromethorphan Farmalider with food or drinks).

If it worsens, if the cough persists for more than 7 days of treatment, or if it is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more Dextromethorphan Farmalider than you should

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

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

Taking very high amounts of this medication can cause a state of stupor, hallucinations, nervousness, nausea, vomiting, or changes in gait in children.

There have been cases of abuse with medications 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 discomfort, 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.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service (telephone: 91.5620420), indicating the medication and the amount ingested.

4. Possible side effects

Like all medications, Dextromethorphan Farmalider can cause side effects, although not everyone experiences them.

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

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, 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 not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Dextromethorphan Farmalider

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

Store in the original packaging.

Do not use this medication after the expiration date shown on the packaging or on the sachet after CAD. The expiration date is the last day of the month indicated. Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at 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.

6. Contents of the package and additional information

Composition of Dextromethorphan Farmalider

• - Each sachet of oral solution contains 10 mg of dextromethorphan hydrobromide as the active ingredient.
• - The other components (excipients) are: sodium benzoate (E-211), anhydrous citric acid, liquid maltitol (E-965), sodium saccharin, propylene glycol, strawberry flavor, contramaro flavor, amaranth (E-123), and purified water.

Appearance of the product and contents of the package

This medication is a pink solution with a strawberry flavor.

It is presented in polyester-aluminum-polyethylene sachets with 5 ml of solution, contained in boxes of 12 or 24 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

FARMALIDER S.A.

C/ La Granja 1 28108-

Alcobendas- Madrid

Spain

Manufacturers

FARMASIERRA MANUFACTURING S.L.

Ctra. Irún, km 26,200.

San Sebastián de los Reyes

28709 Madrid

Spain

or

LABORATORIOS ALCALÁ FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares-Madrid

Spain

or

ZINEREO PHARMA, S.L.U.

A Relva, s/n.

36400 O Porriño – Pontevedra

Spain

Date of the last revision of this leaflet:October 2020

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/