Leaflet: information for the user

cinfatós 10 mg lozenges

Dextromethorphan hydrobromide

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any 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 you get worse or if you also have high fever, skin eruptions or persistent headache, or if you do not improve after 7 days of treatment.

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

It is indicated for the symptomatic treatment of a cough 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.

This medicine may 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 serious lung disease.
• If you have asthma.
• If you have a cough accompanied by abundant secretions.
• If you are or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression or 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 with linezolid, which is an antibacterial medication. (see section: Other medicines and cinfatós).
• Children under 12 years old cannot take this medicine.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfatósif you are a patient:

• with persistent or chronic cough, such as that due to 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, itching, 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, cinfatós 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).

Cases of abuse with dextromethorphan-containing medications have been described in adolescents, therefore this possibility should be taken into account as it may cause severe adverse effects (see section: If you take more cinfatós than you should).

Children

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

There are other presentations more suitable for this age group.

Other medicines and cinfatós

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

• MAOI antidepressants (moclobemide, tranylcypromine).
• 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 medicine, 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, allergy, Parkinson's disease, etc.).
• Expectorants and mucolytics (used to eliminate mucus and phlegm).

Taking cinfatós with food, drinks, and alcohol

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

Do not take it with orange or grapefruit juice, as it may increase the adverse 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, consult your doctor or pharmacist before using this medicine.

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

Driving and operating machinery

In rare cases, during treatment, you may experience mild drowsiness and dizziness, so if you notice these symptoms, you should not drive cars 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 him 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 tablet; it is essentially "sodium-free".

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 or 2 tablets (10-20 mg) every 4 hours as needed. Do not exceed 6 doses in 24 hours.

You can also take 3 tablets (30 mg) every 6 or 8 hours as needed. Do not exceed 4 doses in 24 hours.

The maximum amount you can take in 24 hours is 12 tablets (120 mg) divided into several doses.

Always use the lowest effective dose.

Use in children

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

How to take:

Oral disintegration. Dissolve the tablet slowly 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.

You can take it 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 is accompanied by high fever, skin eruptions, or persistent headache, consult your doctor.

If you take more cinfatós than you should

If you take morecinfatósthan recommended, you may notice: confusion, excitement, restlessness, nervousness, and irritability.

Taking very high amounts of this medication can cause in children a state of drowsiness, hallucinations, nervousness, nausea, vomiting, or gait disturbances.

There have been cases of abuse with medications containing dextromethorphan, which can lead to severe adverse effects, such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), 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 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, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (rapid 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.

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

If you forgot to take cinfatós

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

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

Like all medications, this medicationmay cause adverse effects, although not everyone will experience them.

During the period of use of dextromethorphan, 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 rarer instances: mental confusion and headache.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for 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.

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

Store in the original packaging.

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

Composition of cinfatós

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

Appearance of the product and content of the packaging

cinfatós 10 mg chewable tabletsare presented in the form of cylindrical chewable tablets, yellow lemon color. Each package contains 10 or 20 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:October 2019

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