Cinfatos 15 mg 20 comprimidos bucodispersables

What is cinfatós and what is it used for?
Dextromethorphan, the active ingredient in this medication, is an antitussive that inhibits the cough reflex.
It is indicated for the symptomatic treatment of cough that is not accompanied by expectoration (irritant cough, nervous cough) for adults and adolescents from 12 years of age.
You should consult a doctor if you get worse or if you do not improve after 7 days of treatment.

What you need to know before you start taking cinfatós
This medication can cause dependence. Therefore the treatment should be of short duration.

Do not take cinfatos if:
If you are allergic to dextromethorphan or any of the other ingredients of this medicine.
If you have a serious lung disease.
If you have an asthmatic cough.
If you have a cough accompanied by abundant secretions.
If you are or have been treated within the previous 2 weeks with any monoamine oxidase inhibitor (MAOI) medicines used to treat depression or Parkinson's disease or other diseases, as well as other serotonin reuptake inhibitor medicines used for the treatment of depression such as fluoxetine and paroxetine; or also with bupropion, which is a medicine used to stop smoking or with linezolid, which is an antibacterial medicine. (see section: Other medications and cinfatós).
Children under 12 years of age cannot take this medicine.
 
Warnings and precautions
Talk to your doctor or pharmacist before taking cinfatos if 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, crusting and peeling, which begins in childhood in individuals with a hereditary allergic predisposition),
who is sedated, weakened or bedridden.
- if you are taking other medications such as antidepressants or antipsychotics, cinfatos may interact with these medications and you may experience changes in your mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38º 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).
Cases of abuse with medications containing dextromethorphan have been described in adolescents, therefore this possibility should be taken into account because serious adverse effects may occur (see section: If you take more cinfatos than you should).

Children
Children under 12 years of age cannot take this medication because of the amount of dextromethorphan it contains.
There are other presentations more suitable for this age group.

Other medications and cinfatos
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine during treatment, or within 2 weeks after treatment, with the following medicines, as excitement, high blood pressure and fever higher than 40°C (hyperpyrexia) may occur:
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).
Before starting to take this medicine you should consult your doctor if you are using any of the following medicines because it may be necessary to modify the dose of any of them or stop treatment:
Amiodarone and quinidine (used to treat heart arrhythmias).
Anti-inflammatories (celecoxib, parecoxib or valdecoxib).
Central nervous system depressants (some of them used to treat: mental illness, allergy, 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, because they may cause adverse effects.
Do not take together with grapefruit or bitter orange juice because they may increase the adverse effects of this medication.
Other foods and drinks do not affect the effectiveness of the medicine.

Pregnancy and lactation
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant or breast-feeding women should not take this medication without consulting their doctor.

Driving and using machines
In rare cases, mild drowsiness and dizziness may occur during treatment, so if you notice these symptoms, you should not drive a car or operate dangerous machinery.

cinfatós contains liquid maltitol (E-965) and sodium
This medicine contains liquid maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
It may have a slight laxative effect. Caloric value: 2.3 kcal/g maltitol.
This medication contains less than 1 mmol sodium (23 mg) per pill; that is, essentially “sodium-free.”

How to take cinfatos
Exactly follow the medication administration instructions contained in this leaflet or as directed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:
Adults and adolescents from 12 years of age: take 1 or 2 pills (10-20 mg) every 4 hours if necessary. Do not exceed 6 doses in 24 hours.
You can also take 3 pills (30 mg) every 6 or 8 hours, as needed. Do not exceed 4 doses in 24 hours.
The maximum amount they can take in 24 hours is 12 pills (120 mg) divided into several doses.
Always use the lowest dose that is effective.

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

How to drink:
Oropharyngeal use. Slowly dissolve the tablet in the mouth. Don't chew it. Don't swallow it.
It is recommended to drink a glass of water after each dose and plenty of fluids during 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 your cough worsens or persists after 7 days of treatment or is accompanied by a high fever, skin rash, or persistent headache, consult your doctor.

If you take more cinfatos than you should
If you take more cinfatos than recommended you may notice: confusion, excitability, restlessness, nervousness and irritability.
Taking very high amounts of this medication can cause drowsiness, hallucinations, nervousness, nausea, vomiting or alterations in gait in children.
There have been cases of abuse with medications containing dextromethorphan, and serious adverse effects may appear, such as anxiety, panic, memory loss, tachycardia (accelerated heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis. (dilation of the pupil of the eye), agitation, vertigo, gastrointestinal discomfort, slurred speech, nystagmus (uncontrolled, involuntary movement of the eyes), fever, tachypnea (shallow, rapid breathing), brain damage, ataxia (uncoordinated movements), seizures , respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats) and death.
If you take more cinfatos than directed, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, involuntary and rapid eye movements, cardiac disorders (accelerated heart rate), disorders of coordination, psychosis with visual hallucinations and hyperexcitability.
Other symptoms in case of a massive overdose may include: coma, severe breathing problems and seizures.
Contact your doctor or hospital immediately if you experience any of the symptoms mentioned.
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

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

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

LEAFLET