Label: Information for the User

Dextromethorphan CODRAMOL 10 mg Lozenges, Honey-Lemon Flavor

Dextromethorphan Hydrobromide

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

Follow exactly the administration instructions contained in this label or those given by your doctor or pharmacist.

• Keep this label, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.
• You should consult a doctor if your symptoms worsen, if symptoms are accompanied by high fever, skin eruptions, or persistent headache, or if you do not improve after 7 days of treatment.

The dextrometorfano, active ingredient of this medication, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of a cough that is not accompanied by expectoration (irritative cough, nervous cough). For adults and adolescents 12 years of age and older.

Consult a doctor if it worsens or does not improve after 7 days of treatment

Do not take Dextrometorfano CODRAMOL

• If you are allergic (hypersensitive) to dextrometorfano or to any of the other components of this medication
• Children under 12 years old cannot take this medication
• 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 or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, Parkinson's disease, or other diseases, as well as other medications that inhibit serotonin reuptake used for the treatment of depression such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication. (See the section on the use of other medications)

Warnings and precautions

- Patients with the following conditions should consult a doctor before starting to take this medication:

• Cough that persists or is chronic, such as that caused by tobacco. Especially in children, chronic cough could be an early symptom of asthma.
• Liver disease
• Atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition)
• Patients who are sedated, weakened, or bedridden.
• If you are taking other medications such as antidepressants or antipsychotics, Dextrometorfano 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 exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

This medication may cause dependence. Therefore, treatment should be of short duration. Cases of abuse with medications containing dextrometorfano by adolescents have been reported, therefore, this possibility should be taken into account, as it may result in severe adverse effects (see the section: If you take more Dextrometorfano CODRAMOL than you should).

Taking Dextrometorfano CODRAMOL with other medications

Inform your doctor or pharmacist if you are using, have used recently, 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 it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• MAOI antidepressants (moclobemide, tranilcipromine)
• SSRI 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 (used 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 mucus and phlegm)

Taking Dextrometorfano CODRAMOL with food, drinks, and alcohol

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

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

Driving and operating machinery

In rare cases, during treatment, drowsiness and dizziness may appear, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

Dextrometorfano CODRAMOL contains saccharose and glucose

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

Place the corresponding warnings on the prospectus and on 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 saccharose per lozenge.

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

Adults and adolescents 12 years and older: Dissolve 1 tablet in the mouth when coughing appears, up to a maximum of 2 tablets every 4-6 hours as needed.

Do not exceed a dose of 12 tablets (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.

How to take:

This medication is taken orally. Chew the tablet slowly in the mouth until it dissolves completely. Do not chew or swallow.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (See section Taking Dextrometorfano CODRAMOL 10 mg with food or drinks)

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

If you take more Dextrometorfano CODRAMOL than you should

If you take more Dextrometorfano Codramol 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 (accelerated heart rate), coordination disturbances, psychosis with visual hallucinations and hyperexcitability.

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

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

Taking very high doses of this medication may produce in children a state of drowsiness, nervousness, nausea, vomiting, or gait disturbances.

Cases of abuse with medications containing dextrometorfano have been reported, which may lead to severe adverse 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 disturbances, mumbling speech, nystagmus (uncontrolled and involuntary eye movements), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

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

Like all medications, Dextrometorfano CODRAMOL may produce adverse effects, although not all people will experience them.

During the period of use of dextrometorfano, 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.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in the prospectus.

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

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

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

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

Composition of Dextrometorfano CODRAMOL

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

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

Appearance of the product and contents of the packaging

This medicine is presented in the form of honey-lemon flavored lozenges, round and yellow in color. It is available in packaging containing 12 and 24 lozenges.

Holder of the marketing authorization

Farmalider, S.A.

C/La Granja, 1

28108 Alcobendas, Madrid

Spain

Responsible for manufacturing

Farmalider, S.A.

C/Aragoneses, 2

28108 Alcobendas, Madrid

Spain

Last review date of this leaflet:April 2020

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