Label: information for the user

cinfatós 15 mg oral solution in sachets

Dextromethorphan hydrobromide

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

• Keep this label, 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 label. See section 4.
• You should consult a doctor if you worsen 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 medication may cause dependence. Therefore, treatment should be of short duration.

Do not take cinfatós

• If you are allergic to dextromethorphan or to any of the other components of this medication (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 and 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 medications and cinfatós).
• Children under 12 years old cannot take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfatós.

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

Especially, patients with persistent or chronic cough, such as that due to tobacco, should consult their doctor before using this medication. Especially in children, chronic cough could be an early symptom of asthma,

• with liver or kidney 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 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, 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 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 more cinfatós than you should). This medication 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 will only be administered under strict medical control and for short periods of time.

Children

Children under 12 years old cannot take this medication due to the amount of dextromethorphan contained in the package.

There are other presentations more suitable for this age group.

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 2 weeks following treatment, with the following medications, as it may cause excitement, high blood pressure, and high fever above 40°C (hyperpyrexia):

• MAOI antidepressants (moclobemide, tranylcypromine, clorgiline, iproniazid, and isocarboxazid).
• SSRI antidepressants (fluoxetine, sibutramine, sertraline, or paroxetine).
• 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 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:

• Amiodarone and quinidine (used to treat heart arrhythmias).
• Anti-inflammatory medications (celecoxib, parecoxib, or valdecoxib).
• CNS depressants (some of which are used to treat: mental illnesses, allergies, Parkinson's disease, etc.).
• Expectorants and mucolytics (used to eliminate phlegm and mucus).
• CYP2D6 inhibitors such as haloperidol (used to treat mental illnesses).

Taking cinfatós with food, drinks, and alcohol

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

Do not take it together with orange or grapefruit juice during treatment, as it may increase the adverse effects of this medication.

Pregnancy and lactation

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

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

Driving and operating machinery

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

cinfatós contains sorbitol(E-420).

This medication contains 3000 mg of sorbitol in each package.

Sorbitol is a source of fructose. If your doctor has told you (or your child) that you (or they) have an intolerance to certain sugars, or if you (or they) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child's doctor) before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

cinfatós contains ethanol

This medication contains 0.015% ethanol (alcohol), which corresponds to 1.12 mg/serving (7.5 ml).

cinfatós contains sodium benzoate (E-211).

This medication contains 26.25 mg of sodium benzoate in each package.

cinfatós contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per package; that is, 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: take 1 tablet (15 mg of dextromethorphan) every 4 hours. Do not exceed 6 doses in 24 hours,

You can also take 2 tablets (30 mg) every 6 or 8 hours, depending on the severity of the cough. Do not exceed 4 doses in 24 hours.

The maximum amount that can be taken in 24 hours is 8 tablets (120 mg) divided into several doses.Always use the lowest effective dose.

Use in children

Children under 12 years old cannot take this medication due to the amount of dextromethorphan contained in the tablet.

Administration form

cinfatósis taken orally.

Open the tablet and pour the contents directly into the mouth. 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 is accompanied by high fever, skin eruptions, or persistent headache, consult your doctor.

If you take 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.

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

There have been cases of abuse with medications containing dextromethorphan in adolescents, which may appear with severe adverse effects, such as tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, hallucinations, mumbling speech, nystagmus (involuntary and uncontrolled eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of intoxication, you will be treated with appropriate treatments for the symptoms, which may include intravenous naloxone injection and stomach lavage.

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 produce adverse effects, although not all people may experience them.

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

• Nervous System Disorders:drowsiness, dizziness, fatigue, involuntary muscle contractions, and less frequently, mental confusion and headache.
• Gastrointestinal Disorders:nausea, vomiting, gastrointestinal discomfort such as stomach pain, constipation.
• Vestibular and Labyrinthine Disorders:vertigo.
• Immune System Disorders:hypersensitivity and anaphylactic reaction, including symptoms such as: 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 more cinfatós than you should).
• Skin and Subcutaneous Tissue Disorders:skin rash, urticaria, pruritus, erythema, allergic dermatitis.

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 on 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.

This medication does notrequire special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat 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

• Each sachet contains 15 mg of dextromethorphan hydrobromide as the active ingredient.
• The other components (excipients) are: liquid non-crystallizing sorbitol 70% (E-420), sodium benzoate (E-211), sodium saccharin (E-954), citric acid monohydrate, orange flavor, 96% ethanol and purified water.

Appearance of the product and contents of the packaging

cinfatós is a transparent oral solution with an orange odor.

Each box of cinfatós contains 18 single-dose sachets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:December 2020

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