DEXTROMETHORPHAN HYDROBROMIDE FARMALIDER 15 mg SOFT CAPSULES

Introduction

Package Leaflet: Information for the User

Dextromethorphan Hydrobromide Farmalider 15 mg Soft Capsules

Dextromethorphan Hydrobromide

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet:

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

1. What is Dextromethorphan Hydrobromide Farmalider 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 coughs that are 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 does not improve after 7 days of treatment.

2. What you need to know before taking Dextromethorphan Hydrobromide Farmalider

Do not take Dextromethorphan Hydrobromide Farmalider:

• If you are allergic (hypersensitive) to dextromethorphan or to any of the other components of this medicine (listed in section 6).
• Children under 12 years of age cannot take this medicine.
• 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 with any monoamine oxidase inhibitor (MAOI) medication used for the treatment of depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitor medications used for the treatment of depression, such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or linezolid, which is an antibacterial medication. (See section "Taking 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 due to 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).
• who is sedated, weakened, or bedridden.

There have been cases of abuse with medications containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious side effects can occur (see section: If you take more Dextromethorphan Farmalider than you should)

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

Children and Adolescents

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

Taking Dextromethorphan Hydrobromide with other medications

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

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

• Monoamine oxidase inhibitors (MAOIs) (moclobemide, tranilcipromine).
• Serotonin reuptake inhibitors (paroxetine, fluoxetine).
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).
• If you are taking other medications such as antidepressants or antipsychotics, Dextromethorphan Hydrobromide 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, high blood pressure, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Before starting to take this medicine, 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 Hydrobromide Farmalider with food, beverages, and alcohol

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

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

The rest of the food and beverages do not affect the efficacy of the 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.

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

Driving and Using Machines

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

Dextromethorphan Hydrobromide Farmalider contains Azorubine (E-122)

This medicine may cause allergic reactions because it contains Azorubine (E-122), which can cause allergic reactions. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

Dextromethorphan Hydrobromide Farmalider contains Sorbitol (E-420)

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Dextromethorphan Hydrobromide Farmalider

Follow exactly the administration instructions of the medicine contained in this 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 from 12 years of age:

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

• It can also be administered 2 capsules every 6-8 hours, if necessary. Do not exceed 4 doses in 24 hours.

Always use the lowest effective dose.

Use in Children

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

How to take

Dextromethorphan Hydrobromide Farmalider is taken orally.

Swallow the capsules with the help of a glass of 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 Hydrobromide Farmalider with food or beverages).

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 Hydrobromide Farmalider than you should

If you take more Dextromethorphan Hydrobromide Farmalider than recommended, you may notice: confusion, excitability, restlessness, nervousness, and irritability.

Taking very high doses of this medicine can cause children to enter a state of stupor, hallucinations, nervousness, nausea, vomiting, or changes in gait.

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

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

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service (phone: 91-5620420), indicating the medicine and the amount ingested.

4. Possible Side Effects

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

During the use of dextromethorphan, the following side effects have been observed, whose frequency could not be 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 Medicines and Health Products Agency's website www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dextromethorphan Hydrobromide Farmalider

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

Do not store at a temperature above 30°C.

Do not use this medicine after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dextromethorphan Hydrobromide Farmalider:

• Each capsule contains 15 mg of dextromethorphan hydrobromide as the active ingredient.
• The other components (excipients) are: propylene glycol, povidone, macrogol 400, purified water, gelatin, glycerol (E 422), sorbitol (E 420), d-sorbitol, azorubine (E 122), purified water.

Appearance of the Product and Package Contents

This medicine is soft capsules of red color. It is presented in packages of 12 capsules.

Marketing Authorization Holder

FARMALIDER, S.A.

C/La Granja, 1–

28108 Alcobendas, Madrid

Manufacturer:

FARMALIDER, S.A.

C/ Aragoneses, 2

28108 Alcobendas, Madrid

Date of the Last Revision of this Leaflet: November 2021

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