DEXTROMETHORPHAN CODRAMOL 10 mg LOZENGES HONEY-LEMON FLAVORED

Introduction

Package Leaflet: Information for the User

Dextromethorphan CODRAMOL 10 mg lozenges with honey-lemon flavor

Dextromethorphan hydrobromide

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

Follow the administration instructions for the medication 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.
• You should consult a doctor if your symptoms worsen, if they are accompanied by high fever, skin rash, or persistent headache, or if they do not improve after 7 days of treatment.

Contents of the Package Leaflet:

1. What is Dextromethorphan CODRAMOL and what is it used for
2. What you need to know before taking Dextromethorphan CODRAMOL
3. How to take Dextromethorphan CODRAMOL
4. Possible side effects
5. Storage of Dextromethorphan CODRAMOL
6. Package contents and additional information

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

Dextromethorphan, the active ingredient in 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 old.

You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

2. What you need to know before taking Codramol

Do not take Dextromethorphan CODRAMOL

• If you are allergic (hypersensitive) to dextromethorphan or any of the other components of this medication.
• Children under 12 years old 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 in the last 2 weeks 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 with linezolid, which is an antibacterial medication. (See section on use of other medications).

Warnings and precautions

• Patient groups that should consult a doctor before starting to take this medication:

• those with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• those with liver disease.
• those 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).
• those who are sedated, weakened, or bedridden.
• If you are taking other medications such as antidepressants or antipsychotics, Dextromethorphan Codramol 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 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 by adolescents, so this possibility should be taken into account, as serious side effects can occur (see section: If you take more Dextromethorphan CODRAMOL than you should).

Taking Dextromethorphan CODRAMOL with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use 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 CODRAMOL 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.

Pregnancy, breastfeeding, and fertility

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 their doctor.

Driving and using machines

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

Dextromethorphan CODRAMOL contains sucrose and glucose

This medication contains sucrose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Include the corresponding warnings in the package leaflet and all the excipients of mandatory declaration that the medication has.

Patients with diabetes mellitus should be aware that this medication contains 1.6 g of sucrose per lozenge.

3. How to take Dextromethorphan Codramol

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

Adults and adolescents from 12 years old: Dissolve 1 lozenge in the mouth when cough appears, up to a maximum of 2 lozenges every 4-6 hours as needed.

Do not exceed the dose of 12 lozenges (120 mg) in 24 hours, divided into several doses.

Always use the lowest effective dose.

Use in children

This medication is contraindicated in children under 12 years old.

How to take:

This medication is taken orally. Suck the lozenge slowly in the mouth until it is completely dissolved. Do not chew. Do not swallow.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section on taking Dextromethorphan CODRAMOL 10 mg with food or drinks).

If the cough worsens, if it 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 CODRAMOL than you should

If you take more Dextromethorphan Codramol 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 include: coma, severe respiratory problems, and convulsions.

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

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

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 (shallow and rapid 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 CODRAMOL can cause side effects, although not everyone will experience them.

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

• In some cases: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.
• In rarer cases: mental confusion and headache.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in the package leaflet.

5. Storage of Dextromethorphan Codramol

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

No special storage conditions are required. Keep in the original packaging.

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Dextromethorphan CODRAMOL

• The active ingredient is dextromethorphan. Each lozenge contains 10 mg of dextromethorphan hydrobromide.

• The other components (excipients) are cross-linked polyacrylic resin, liquid glucose, sucrose, sodium saccharin, citric acid monohydrate, sodium hydroxide, lemon flavor, and honey flavor.

Appearance of the product and package contents

This medication is presented in the form of honey-lemon flavored lozenges, which are round and yellow in color. It is available in packages containing 12 and 24 lozenges.

Marketing authorization holder

Farmalider, S.A.

C/La Granja, 1

28108 Alcobendas, Madrid

Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Date of the last revision of this package leaflet:April 2020

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