CINFATOS 15 mg ORALLY DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Cinfatós 15 mg Oral Dispersible Tablets

Dextromethorphan Hydrobromide

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

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, as 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 mentioned in this package leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days of treatment, or if the cough is accompanied by high fever, skin rash, or persistent headache.

Contents of the Package Leaflet

1. What Cinfatósis and what it is 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. Package Contents and Additional Information

1. What Cinfatós is and what it is used for

Dextromethorphan, the active ingredient 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 old.

You should consult a doctor if you worsen or do not improve after 7 days of treatment.

2. What you need to know before taking Cinfatós

Do not takeCinfatós:

• If you are allergic to dextromethorphan hydrobromide or to any of the other components of this medicine (listed in section 6).
• If you have asthmatic cough or cough accompanied by abundant secretions.
• If you have chronic obstructive pulmonary disease (COPD) or other severe lung disease such as pneumonia.
• If you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, serotonin reuptake inhibitors (SSRIs) used to treat depression, bupropion which is a medication used to quit smoking, linezolid which is an antibacterial medication, procarbazine which is a medication used to treat cancer, or selegiline which is used to treat Parkinson's disease.
  • Children under 12 years old cannot take this medicine.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Cinfatós.

This medicine can cause dependence. Therefore, treatment should be short-term.

Patient groups that should consult their doctor before using this medicine include:

• those with persistent or chronic cough, such as that caused by smoking.
• those with liver or kidney disease.
• those 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).
• those who are sedated, debilitated, or bedridden.
• those with CYP2D6 polymorphism (genetic alteration that affects the activity of this liver enzyme).
• if you are taking other medications such as antidepressants or antipsychotics, Cinfatósmay 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 exaggerated reflexes, muscle stiffness, 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 have been reported in adolescents, so this possibility should be taken into account, as serious side effects can occur (see "If you take more Cinfatósthan you should"). This product can also be addictive, so its use at high doses or for prolonged periods can lead to tolerance and 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 Medicines and Cinfatós

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

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) can occur:

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranilcipromine).
• Selective serotonin reuptake inhibitor (SSRI) antidepressants (fluoxetine, 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 taking this medicine, you should 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 for treating heart arrhythmias such as amiodarone or quinidine.
• Medications used to eliminate phlegm and mucus such as acetylcysteine or guaifenesin.
• Central Nervous System (CNS) 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 medicine, as dextromethorphan increases the effects of alcohol on the central nervous system, and changes in behavior and mood, memory problems, difficulty thinking clearly, difficulty with coordination and physical control can occur.

Do not take with grapefruit or bitter orange juice, as dextromethorphan blood levels may be elevated.

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

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

Driving and Using Machines

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

Cinfatós contains Sodium

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

3. How to Take Cinfatós

Follow exactly the administration instructions of the medicine contained in this package 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 old: 1 tablet (15 mg of dextromethorphan hydrobromide) every 4 hours or 2 tablets (30 mg) every 6-8 hours, depending on the intensity of the cough. Do not take more than 8 tablets (120 mg) in 24 hours. Always use the lowest effective dose.

Method of Administration

Oral route.

Place the tablet in the mouth, let it disperse with saliva, and swallow. It is not necessary 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 Cinfatóswith Food and Drinks").

If the patient worsens, the cough worsens, or persists for more than 7 days, or if it is accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.

Use in Children

Do not administer to children under 12 years old.

If you take more Cinfatós than you should

If you take more Cinfatósthan indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in case of massive overdose may be: coma, severe respiratory problems, and convulsions.

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

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

Contact your doctor or hospital immediately if you experience any of the mentioned symptoms.

In case of poisoning, you should receive treatment according to symptoms, which may include intravenous naloxone injection and stomach lavage.

It can also increase the 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 medicine and the amount ingested.

If you forget to take Cinfatós

Do not take a double dose to make up for forgotten 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 medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

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

• Immune system disorders: hypersensitivity and anaphylactic reaction, including symptoms such as asthma, skin rash, urticaria, edema, pruritus, and cardio-respiratory difficulty.
• Psychiatric disorders: visual hallucinations and confusion. These effects are much more pronounced with overdose (see "If you take more Cinfatósthan you should").
• Nervous system disorders: drowsiness, dizziness, fatigue, involuntary muscle contractions, and less frequently, mental confusion and headache.
• Ear and labyrinth 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 side effects you are experiencing is serious, or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) 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.

Store in the original packaging to protect it from light.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Cinfatós

• The active ingredient is dextromethorphan hydrobromide. Each oral dispersible tablet contains 15 mg of dextromethorphan hydrobromide.

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

Appearance of the Product and Package Contents

Cinfatósis presented in the form of cylindrical, biconcave, and white or off-white tablets in packages containing 20 oral dispersible tablets in PVC-PVDC/Aluminum or Aluminum/Aluminum blisters.

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 Package Leaflet:March 2021

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