Package Insert: Information for the User

Cinfatós 15 mg Bucodispersable Tablets

Dextromethorphan Hydrobromide

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment, or if your cough is accompanied by high fever, skin rash, or persistent headache.

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

It is indicated for the symptomatic treatment of 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.

Do not takeCinfatós:

-If you are allergic to dextromethorphan hydrobromide or any of the other components of this medication (listed in section 6).

-If you have asthma or a cough accompanied by abundant secretions.

-If you have chronic obstructive pulmonary disease (COPD) or another serious lung disease such as pneumonia.

-If you are being treated or have been treated in the past two weeks with any monoamine oxidase inhibitor (MAOI) used for the treatment of depression, selective serotonin reuptake inhibitors (SSRIs) used for the treatment of depression, bupropion used to quit smoking, linezolid used as an antibacterial, procainamide used to treat cancer, or selegiline used to treat Parkinson's disease.

• Children under 12 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeCinfatós.

This medication may cause dependence. Therefore, treatment should be of short duration.

You should consult your doctor before using this medication in the following cases:

• With persistent or chronic cough, such as that caused by smoking.
• With liver or kidney disease.
• With atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• Who are sedated, weakened, or bedridden
• With CYP2D6 polymorphism (genetic alteration affecting the activity of this liver enzyme).
• 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 high body temperature, increased heart rate, hypertension, and exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Concomitant use with alcohol should be avoided.

Cases of abuse with medications containing dextromethorphan in adolescents have been described, therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section “If you take moreCinfatósthan you should”). This product may also be addictive, so its use at high doses or for a prolonged period may cause mental and physical dependence. In patients with a tendency to abuse or dependence, it should only be administered under strict medical control and for short periods of time.

Children and adolescents

Do not use in children under 12 years old.

Other medications 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 medication during treatment, or in the two weeks following treatment, with the following medications, as it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• MAOIs (moclobemide, tranylcypromine).
• SSRIs (fluoxetine, sertraline, or paroxetine).
• Bupropion (used to quit smoking).
• Linezolid (used as an antibacterial).
• Procainamide (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

Before taking this medication, 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:

• Anti-inflammatory medications such as celecoxib, parecoxib, or valdecoxib.
• Medications used to treat heart arrhythmias such as amiodarone or quinidine.
• Medications used to eliminate phlegm and mucus such as acetylcysteine or guaifenesin.
• Central nervous system depressants (antihistamines, psychotropics, or medications for Parkinson's disease).
• CYP2D6 inhibitors such as haloperidol (used to treat mental illnesses).

Taking Cinfatós with food and drinks

Alcoholic beverages should be avoided during treatment with this medication, as dextromethorphan increases the effects of alcohol on the central nervous system and may cause changes in behavior and mood, memory problems, difficulty thinking clearly, difficulty with coordination and physical control.

Do not take this medication with orange or bitter lemon juice, as it may increase blood concentrations of dextromethorphan.

The rest of foods and drinks do not affect the efficacy of the medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medication.

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

Driving and operating machinery

In rare cases, during treatment, drowsiness and dizziness may appear, so if you notice these symptoms, you should not drive cars or operate hazardous machinery.

Cinfatós contains sodium

This medication contains less than 23 mg of sodium (1 mmol) 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. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents 12 years and older:1 tablet (15 mg of dextromethorphan hydrobromide) every 4 hours or 2 tablets (30 mg) every 6-8 hours depending on the severity of the cough. Do not take more than 8 tablets (120 mg) in 24 hours. Use the lowest effective dose.

Administration form

Oral route.

Place the tablet in the mouth, let it dissolve with saliva, and swallow. No need to take with water at the time of administration. Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section Taking Cinfatós with food and drinks)

If the patient worsens, the cough worsens or persists for more than 7 days, or is accompanied by high fever, skin eruptions, or persistent headache, consult the doctor.

Use in children

Do not administer to children under 12 years.

If taking more Cinfatós than you should

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 (accelerated 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.

High doses of this medication may cause in children a state of drowsiness or nervousness, nausea, vomiting, or gait disturbances.

There have been cases of abuse with dextromethorphan-containing medications in adolescents, which may lead to severe adverse effects, such as tachycardia (rapid heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, 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 heartbeats), and death.

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

In case of intoxication, appropriate treatments for symptoms will be applied, which may include intravenous naloxone injection and gastric lavage.

It may also increase serotonin syndrome.

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 the cough persists, restart treatment 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 medicationcan produce adverse effects, although not all people experience them.

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

• Immune system disorders: hypersensitivity and anaphylactic reaction, including symptoms such as asthma, skin rash, urticaria, edema, pruritus, and respiratory-cardiovascular difficulty.
• Psychiatric disorders: visual hallucinations and confusion. These effects are much more pronounced with overdose (see section If you take moreCinfatósthan you should).
• Nervous system disorders: drowsiness, dizziness, fatigue, involuntary muscle contractions, and less frequently mental confusion and headache.
• Vestibular and labyrinthine disorders: vertigo.
• Gastrointestinal disorders: nausea, vomiting, gastrointestinal discomfort such as stomach pain and constipation.
• Skin and subcutaneous tissue disorders: skin rash, urticaria, pruritus, erythema, and allergic dermatitis.

If you consider that any of the adverse effects you experience are severe, or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting 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 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 on the safety of this medication.

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

Store in the original packaging to protect it from light.

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.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the 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 buccal dispersible tablet contains 15 mg of dextromethorphan hydrobromide.

• The other components are: potassium carboxymethylcellulose, sucralose, sodium croscarmellose, microcrystalline cellulose, Avicel CE-15 (microcrystalline cellulose and guar gum), erythritol, orange flavor (comprising flavoring substances, corn-derived maltodextrin, and alpha-tocopherol (E-307)), sodium stearate fumarate, hydroxypropylcellulose, sodium citrate dihydrate, and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

Cinfatósis presented in the form of cylindrical, bicongcave tablets, white or off-white in color, in packaging containing 20 buccal dispersible tablets in a PVC-PVDC / Aluminum or Aluminum / Aluminum blister.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta.

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:March 2021

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