CINFATOS 15 mg ORAL SOLUTION IN SACHETS

Introduction

Package Leaflet: Information for the User

cinfatós 15 mg oral solution in sachets

Dextromethorphan hydrobromide

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 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 your symptoms worsen or if you also have a high fever, skin rash, or persistent headache, or if you do not improve after 7 days of treatment.

Contents of the Package Leaflet

1. What is cinfatós and what is it 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. Contents of the pack and further information

1. What is cinfatós and what is it used for

The active ingredient of this medicine, dextromethorphan, 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 of age.

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

2. What you need to know before taking cinfatós

This medicine can 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 medicine (listed in section 6).
• If you have a severe lung disease.
• If you have asthma.
• If you have a cough with abundant secretions.
• If you are or have been treated during the last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication 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 bupropion, which is a medication used to quit smoking, or linezolid, which is an antibacterial medication. (See section: Other medicines and cinfatós).
• Children under 12 years of age 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 of short duration.

Especially, patients with the following conditions should consult their doctor before using this medicine:

• chronic or persistent cough, such as that caused by smoking. Especially in children, chronic cough could be an early symptom of asthma,
• liver or kidney disease,
• atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition),
• sedated, debilitated, or bedridden patients,
• CYP2D6 polymorphism (genetic alteration that affects the activity of this liver enzyme).

There have been reports of abuse with medications containing dextromethorphan in adolescents, which can cause serious side effects. This medicine can also be addictive, so its use at high doses or for a prolonged period can cause 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

Children under 12 years of age 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

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

Do not take this medicine during treatment or in the 2 weeks following treatment with the following medications, as it can cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• MAOIs (moclobemide, tranylcypromine, clorgyline, iproniazid, and isocarboxazid).
• Serotonin reuptake inhibitors (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 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:

• 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, 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 can cause side effects.

Do not take with grapefruit or orange juice during treatment, as they can increase the side effects of this 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 using this medicine.

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

Driving and using machines

Rarely, during treatment, drowsiness and mild dizziness may occur. If you experience these symptoms, do not drive vehicles or operate hazardous machinery.

cinfatós contains sorbitol(E-420).

This medicine contains 3000 mg of sorbitol in each sachet.

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

Sorbitol can cause gastrointestinal upset and a mild laxative effect.

cinfatós contains ethanol.

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

cinfatós contains sodium benzoate (E-211).

This medicine contains 26.25 mg of sodium benzoate in each sachet.

cinfatós contains sodium.

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

3. How to take cinfatós

Follow exactly the administration instructions of the medicine contained in this 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 of age: take 1 sachet (15 mg of dextromethorphan) every 4 hours. Do not exceed 6 doses in 24 hours.

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

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

Use in children

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

Method of administration

cinfatós is taken orally.

Open the sachet and pour the contents directly into the mouth. It is recommended to drink a glass of water after each dose and plenty of liquid during the day.

It can be taken with or without food.

Do not take with grapefruit or 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 a high fever, skin rash, 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, muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid 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.

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

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

In case of poisoning, you should receive treatment according to 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 medicine and the amount ingested.

If you forget to take cinfatós

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

4. Possible side effects

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

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

• Nervous system disorders: drowsiness, dizziness, fatigue, involuntary muscle contractions, and more rarely mental confusion and headache.
• Gastrointestinal disorders: nausea, vomiting, gastrointestinal upset such as stomach pain, constipation.
• Ear and labyrinth disorders: vertigo.
• Immune system disorders: hypersensitivity and anaphylactic reaction including symptoms such as skin rash, urticaria, edema, itching, and cardio-respiratory 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, itching, erythema, allergic dermatitis.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: 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.

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

This medicine does not require special storage conditions.

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

6. Contents of the pack and further information

Composition of cinfatós

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

Appearance of the product and contents of the pack

cinfatós is a clear oral solution with an orange flavor.

Each box of cinfatós contains 18 single-dose sachets.

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 leaflet:December 2020

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