Dextromethorphan Farmalider 10 mg oral solution

Patient Information Leaflet

Introduction

Patient Information Leaflet

DEXTROMETHORPHAN FARMALIDER 10 mg oral solution

Dextromethorphan hydrobromide

Read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens, or if you develop high fever, skin rash, or persistent headache, or if you do not improve after 7 days of treatment.

Leaflet Contents:

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. • How to store Dextromethorphan Farmalider
6. • Contents of the pack and other information

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

Dextromethorphan, the active substance in this medicine, is an antitussive that suppresses the cough reflex.

It is indicated for the symptomatic treatment of dry cough (non-productive cough, such as irritative or nervous cough) in adults and adolescents aged 12 years and older. You should consult a doctor if symptoms worsen or do 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 medicine (listed in section 6).
• Children under 12 years of age must not take this medicine.
• If you have severe lung disease.
• If you have asthmatic cough.
• If you have a cough accompanied by abundant secretions.
• If you are currently taking or have taken within the previous 2 weeks any monoamine oxidase inhibitor (MAOI) medicines used to treat depression, Parkinson's disease, or other conditions, as well as other serotonin reuptake inhibitors used for depression such as fluoxetine and paroxetine; or bupropion, a medicine used to stop smoking, or linezolid, an antibacterial medicine (see section: Use with other medicines).

Warnings and precautions

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

• With persistent or chronic cough, such as that caused by smoking. In children especially, chronic cough may be an early symptom of asthma.
• With liver disease.
• With atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with hereditary predisposition to allergy).
• Who is sedated, debilitated, or bedridden.
• If you are taking other medicines such as antidepressants or antipsychotics, Dextromethorphan Farmalider may interact with these medicines 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 rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

This medicine may cause dependence. Therefore, treatment should be short-term. Cases of abuse have been reported with medicines containing dextromethorphan in adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section: If you take more Dextromethorphan Farmalider than you should).

Children and adolescents

This medicine may only be taken by adolescents aged 12 years and older.

Taking Dextromethorphan Farmalider with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take this medicine during treatment with, or within 2 weeks after treatment with, the following medicines, as it may cause excitation, high blood pressure, and fever above 40°C (hyperpyrexia):

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine)

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

Before starting this medicine, consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or interrupt treatment:

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

Taking Dextromethorphan Farmalider with food, drinks, and alcohol

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

Do not take together with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.

Other foods and drinks do not affect the effectiveness 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 must not take this medicine without first consulting a doctor.

Driving and use of machines

Rarely, drowsiness and mild dizziness may occur during treatment. If you experience these symptoms, you should not drive or operate dangerous machinery.

Dextromethorphan Farmalider contains maltitol and amaranth

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

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

3. How to take Dextromethorphan Farmalider

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents aged 12 years and older:

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

• Alternatively, 3 sachets may be taken 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 medicine is only suitable for adolescents aged 12 years and older.

How to take

Dextromethorphan Farmalider is taken orally.

Empty the contents of the sachet directly into the mouth, or dissolve it in a liquid, preferably water.

It may be taken with or without food.

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

If your symptoms worsen, if the cough persists for more than 7 days of treatment, or if it is accompanied by high fever, skin rashes, 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, disturbances of consciousness, rapid and involuntary eye movements, cardiac disorders (increased heart rate), coordination problems, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose may include: coma, severe breathing difficulties, and seizures.

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

Taking very high doses of this medicine may cause drowsiness, hallucinations, nervousness, nausea, vomiting, or disturbances in gait in children.

Cases of abuse have been reported with medications containing dextromethorphan, potentially leading to serious adverse effects such as: anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the eye pupil), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary, uncontrolled eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (loss of coordination), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

In case of overdose or accidental ingestion, contact your doctor or call the Toxicology Information Service (telephone: 91.5620420), stating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Dextrometorfano Farmalider may produce adverse effects, although not everyone will experience them.

During the period of dextromethorphan use, the following adverse effects have been observed, although their frequency cannot be precisely established:

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dextromethorphan Farmalider

Keep this medicine out of sight and reach of children.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the container or sachet after EXP. The expiry date refers to the last day of the month indicated. Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE point at your pharmacy.

If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dextromethorphan Farmalider

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

Nature of the product and contents of the pack

This medicine is a pink solution with a strawberry flavor.

It is presented in polyester-aluminum-polyethylene sachets containing 5 ml of solution, packed 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 most recent review of this leaflet: October 2020

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