DEXTROMETHORPHAN GEISER 10 mg LOZENGES

Introduction

Package Leaflet: Information for the User

Dextrometorfano Geiser 10 mg lozenges

Dextrometorfano hydrobromide

Read all of this leaflet carefully before you start taking this medicine because 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, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens, if the symptoms are accompanied by high fever, skin rash, or persistent headache, or if it does not improve after 7 days of treatment.

Contents of the package leaflet

1. What is Dextrometorfano Geiser and what is it used for
2. What you need to know before you start taking Dextrometorfano Geiser
3. How to take Dextrometorfano Geiser
4. Possible side effects
5. Storage of Dextrometorfano Geiser
6. Contents of the pack and further information

1. What is Dextrometorfano Geiser and what is it used for

The active substance of this medicine, dextromethorphan, 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 of age.

You should consult a doctor if it worsens or if it does not improve after 7 days of treatment.

2. What you need to know before you start taking Dextrometorfano Geiser

Do not takeDextrometorfano Geiser

• If you are allergic 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 asthma.
• 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 bupropion, which is a medicine used to quit smoking, or linezolid, which is an antibacterial medicine. (See section on use of other medicines).

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take this medicine if you are a patient:

• with persistent or chronic cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma.
• 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.
• if you are taking other medicines such as antidepressants or antipsychotics, Dextrometorfano Geiser 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

There have been cases of abuse with medicines containing dextromethorphan by adolescents, so this possibility should be taken into account, as serious side effects can occur (see section: If you take more Dextrometorfano Geiser than you should).

Children

Children under 12 years of age cannot take this medicine.

Other medicines andDextrometorfano Geiser

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

Do not take this medicine during treatment or in the 2 weeks following treatment with the following medicines, 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 medicine, consult your doctor if you are using any of the following medicines, 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 drugs (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).

TakingDextrometorfano Geiserwith food, drinksandalcohol

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 medicine.

The rest of the food and drinks do not affect the efficacy of the medicine.

Pregnancy, breastfeeding, and fertility

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

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

Dextrometorfano Geisercontains glucose, sucrose, and sodium

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

This medicine contains 1.18 g of glucose and 1.16 g of sucrose per lozenge, which should be taken into account in patients with diabetes mellitus.

This medicine contains less than 1 mmol of sodium (23 mg) per lozenge; it is essentially "sodium-free".

3. How to take Dextrometorfano Geiser

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.

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 medicine is contraindicated in children under 12 years of age.

How to take:

This medicine is taken orally. Suck the lozenge slowly in the mouth until it is completely dissolved.

Do not chew or swallow it.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section on taking Dextrometorfano Geiser with food, drinks, and alcohol).

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 moreDextrometorfano Geiserthan you should

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

Taking very high amounts of this medicine can cause children to become drowsy, nervous, nauseous, vomit, or have changes in their gait.

There have been cases of abuse with medicines 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 (rapid and shallow 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 medicine and the amount ingested.

4. Possible side effects

Like all medicines, Dextrometorfano Geiser can cause side effects, although not everyone gets them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency could not be established:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Dextrometorfano Geiser

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need in the pharmacy's SIGRE collection point. If in doubt, consult your pharmacist on how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6.

Composition of Dextrometorfano Geiser

• The active substance is dextromethorphan. Each lozenge contains 10 mg of dextromethorphan hydrobromide.
• The other components (excipients) are: sucrose, glucose syrup, sodium saccharin, citric acid monohydrate (E-330), and anise-licorice 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 blisters of 12 and 24 lozenges.

Marketing authorization holder

Geiser Pharma, S.L.

Camino de Labiano 45-B

31192 Mutilva Alta, Navarra

Spain

Manufacturers

Lozy’s Pharmaceuticals, S.L.

Campus Empresarial s/n

31795 Lekaroz, Navarra

Spain

or

Pierre Fabre Medicament Production.

Dietetique Et Pharmacie S.A.

Zone industrielle de la Coudette

32290 Aignan

France

Date of the last revision of this leaflet:February 2023

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