CINFATOS 10 mg LOZENGES

Introduction

Package Leaflet: Information for the User

cinfatós 10 mg lozenges

Dextromethorphan 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 doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or if you also have a 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 cinfatós and what is it used for
2. What you need to know before taking cinfatós
3. How to take cinfatós
4. Possible side effects
5. Storage of cinfatós
6. Contents of the pack and further information

1. What is cinfatós and what is it used for

Dextromethorphan, the active substance of this medicine, 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 taking cinfatós

This medicine can cause dependence. Therefore, treatment should be of short duration.

Do not take cinfatós

• If you are allergic to dextromethorphan or any of the other components of this medicine (listed in section 6).
• If you have a severe lung disease.
• If you have asthmatic cough.
• If you have cough accompanied by abundant secretions.
• If you are or have been treated during the 2 weeks prior to treatment with any monoamine oxidase inhibitor (MAOI) medication used to treat depression or Parkinson's disease or other diseases, as well as other serotonin reuptake inhibitor medications used to treat 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 section: Other medications and cinfatós).
• Children under 12 years of age cannot take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before taking cinfatós 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.

There have been reports of abuse with medications containing dextromethorphan in adolescents, so this possibility should be taken into account because serious side effects can occur (see section: If you take more cinfatós than you should).

Children

Children under 12 years of age cannot take this medicine due to the amount of dextromethorphan it contains.

There are other presentations more suitable for this age group.

Other medications and cinfatós

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not take this medicine 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 taking this medicine, you should consult your doctor if you are using any of the following medications because 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 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).

Taking cinfatós 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 medicine.

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

Pregnancy and breastfeeding

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 medicine.

Pregnant or breastfeeding women should not take this medicine without consulting their doctor.

Driving and using machines

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

cinfatós contains maltitol liquid (E-965) and sodium

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

It may have a mild laxative effect. Caloric value: 2.3 kcal/g of maltitol.

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

3. How to take cinfatós

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: take 1 or 2 lozenges (10-20 mg) every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

They can also be taken 3 lozenges (30 mg) every 6 or 8 hours, as needed. Do not exceed 4 doses in 24 hours.

The maximum amount that can be taken in 24 hours is 12 lozenges (120 mg) divided into several doses.

Always use the lowest effective dose.

Use in children

This medicine is contraindicated in children under 12 years of age due to the amount of dextromethorphan it contains.

How to take:

Buccopharyngeal use. Slowly dissolve the lozenge in the mouth. Do not chew. Do not swallow.

It is recommended to drink a glass of water after each dose and plenty of liquid throughout the day.

It can be taken with or without food. Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section: Taking cinfatós with food, drinks, and alcohol).

If the cough worsens or persists after 7 days of treatment or if it is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more cinfatós than you should

If you take more cinfatós than recommended, you may notice: confusion, excitability, restlessness, nervousness, and irritability.

Taking very high amounts of this medicine can cause children to become drowsy, have hallucinations, nervousness, nausea, vomiting, or changes in gait.

There have been cases of abuse with medications containing dextromethorphan, which can lead to serious side effects, such as anxiety, panic, memory loss, tachycardia (rapid heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, slurred speech, nystagmus (involuntary eye movement), fever, tachypnea (rapid breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

If you take more cinfatós than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, changes in consciousness, rapid involuntary eye movements, cardiac disorders (rapid 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take cinfatós

Do not take a double dose to make up for forgotten doses. If you have forgotten a dose, take it as soon as possible and continue with your usual schedule, as indicated in section 3. How to take cinfatós.

If you have any other doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the use of dextromethorphan, the following side effects have been observed, whose frequency has not been established with precision:

• 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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of cinfatós

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

Do not use this medicine after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of cinfatós

• The active substance is dextromethorphan hydrobromide. Each lozenge contains 10 mg of dextromethorphan hydrobromide.
• The other components (excipients) are: betacyclodextrin, gum arabic, sodium cyclamate, sodium saccharin, quinoline yellow (E-104), lemon flavor, honey flavor, levomenthol, anhydrous citric acid, maltitol liquid (E-965), liquid paraffin, and purified water.

Appearance of the product and contents of the pack

cinfatós 10 mg lozenges are presented in the form of cylindrical lozenges, yellow in color. Each pack contains 10 or 20 lozenges.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this leaflet:October 2019

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