Prospect: information for the user

DEXTROMETORFANO FARMALIDER 10 mg oral solution

Dextromethorphan hydrobromide

Read this prospect 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 prospect or those indicated by your doctor, pharmacist.

- Keep this prospect, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

- You should consult a doctor if you worsen, or if you also have high fever, skin eruptions or persistent headache, or if you do not improve after 7 days of treatment.

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

2. - What you need to know before starting to take Dextromethorphan Farmalider

3. - How to take Dextromethorphan Farmalider

4. - Possible adverse effects

5. - Conservation of Dextromethorphan Farmalider

6. - Contents of the package and additional information

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

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

Do not take Dextrometorfano Farmalider:

• If you are allergic (hypersensitive) to dextrometorfano or to any of the other components of this medication (listed in section 6).
• 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 serotonin reuptake inhibitors 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: Use of other medications).

Warnings and precautions

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

• with persistent or chronic cough, such as that caused by tobacco. Especially in children, chronic cough could be an early symptom of asthma.
• 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)
• who is sedated, weakened, or bedridden
• If you are taking other medications such as antidepressants or antipsychotics, Dextrometorfano 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, 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 in adolescents have been reported, so this possibility should be taken into account, as it may cause severe adverse effects (see section: If you take more Dextrometorfano Farmalider than you should).

Children and adolescents

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

Taking Dextrometorfano Farmalider with other medications

Inform your doctor or pharmacist if you are taking or 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 (MAOI) antidepressants (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)

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 Farmalider with food, drinks, and alcohol

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

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

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

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be 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 operating machinery

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

Dextrometorfano 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 him before taking this medication.

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

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.

The recommended dose is:

Adults and adolescents 12 years and older:

-Take 1 to 2 packets 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 packets 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 12 years and older

How to take

Dextrometorfano Farmalider is taken orally.

Empty the contents of the packet 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 Dextrometorfano 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 eruptions, or persistent headache, consult your doctor.

If you take more Dextrometorfano Farmalider than you should

If you take more Dextrometorfano Farmalider 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 cause in children a state of drowsiness, hallucinations, nervousness, nausea, vomiting, or gait disturbances.

There have been cases of abuse with medications containing dextrometorfano, which may appear with 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 discomfort, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), 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 Farmalider may produce adverse effects, although not all people may experience them.

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

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

- In less frequent occasions: 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.

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 label after CAD. The expiration date is the last day of the month indicated. Do not dispose of medications through drains or in the trash. Dispose of empty containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Dextrometorfano Farmalider

• −Each oral solution sachet 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, bitter almond flavor, amaranth (E-123) and purified water.

Appearance of the product and contents of the packaging

This medicine is a pink solution with a strawberry flavor.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FARMALIDER S.A.

C/ La Granja 1 28108-

Alcobendas- Madrid

Spain

Responsible for manufacturing

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

Last review date of this leaflet:October 2020

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