Cinfatos Antitussive 15 mg orodispersible tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfatós antitussive flas 15 mg orodispersible tablets

Dextromethorphan hydrobromide

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as advised 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 any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this 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.

Leaflet contents

1. What cinfatós antitussive flas is and what it is used for
2. What you need to know before taking cinfatós antitussive flas
3. How to take cinfatós antitussive flas
4. Possible adverse effects
5. Storage of cinfatós antitussive flas
6. Contents of the pack and other information

1. What cinfatós antitusivo flas is and what it is used for

Dextromethorphan, the active substance in this medicine, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of dry cough (non-productive cough, irritative cough, nervous cough) in adults and adolescents from 12 years of age.

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

2. What you need to know before taking cinfatós antitussive flas

Do not take cinfatós antitussive flas:

• 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 with abundant secretions.
• If you have chronic obstructive pulmonary disease (COPD) or another serious lung disease such as pneumonia.
• If you are currently taking or have taken within the previous 2 weeks any monoamine oxidase inhibitor (MAOI) medicines used to treat depression, serotonin reuptake inhibitor (SSRI) medicines used for depression, bupropion (a medicine used to stop smoking), linezolid (an antibacterial medicine), procarbazine (a medicine used to treat cancer), or selegiline (used to treat Parkinson's disease).
  • Children under 12 years of age must not take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking cinfatós antitussive flas.

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

Patients should consult their doctor before using this medicine if they:

• Have persistent or chronic cough, such as that caused by smoking.
• Have liver or kidney disease.
• Have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in childhood in individuals with hereditary predisposition to allergic reactions).
• Are sedated, weakened, or bedridden.
• Have CYP2D6 polymorphism (a genetic alteration affecting the activity of this liver enzyme).
• Are taking other medicines such as antidepressants or antipsychotics; cinfatós antitussive flas may interact with these medicines 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, high blood pressure, exaggerated 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 of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section “If you take more cinfatós antitussive flas than you should”). This product may also be addictive, so its use at high doses or for prolonged periods may 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 supervision and for short periods of time.

Children and adolescents

Do not use in children under 12 years of age.

Other medicines and cinfatós antitussive flas

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

Do not take this medicine during treatment with, or within 2 weeks after treatment with, the following medicines, as this may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

• Monoamine oxidase inhibitor antidepressants (moclobemide, tranylcypromine).
• Selective serotonin reuptake inhibitor antidepressants (fluoxetine, sertraline, or paroxetine).
• Bupropion (used to stop smoking).
• Linezolid (used as an antibacterial).
• Procarbazine (used to treat cancer).
• Selegiline (used to treat Parkinson's disease).

Before taking this medicine, consult your doctor if you are taking any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

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

Taking cinfatós antitussive flas with food and drinks

Alcoholic beverages should be avoided during treatment with this medicine because dextromethorphan increases the effects of alcohol on the central nervous system, which may lead to changes in behavior and mood, memory problems, difficulty thinking clearly, and impaired coordination and physical control.

Do not take with grapefruit juice or bitter orange juice, as this may increase blood levels of dextromethorphan.

Other foods and drinks do not affect the effectiveness 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 women or those who are breastfeeding should not take this medicine without first consulting a doctor.

Driving and using machines

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

cinfatós antitussive flas contains sodium

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

3. How to take cinfatós antitusivo flas

Follow exactly the dosage instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Recommended dose:

• Adults and adolescents aged 12 years and older: 1 tablet (15 mg 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. Always use the lowest effective dose.

Method of administration

Oral use.

Place the tablet in the mouth, allow it to disperse with saliva, and then swallow. It is not necessary to take it with water at the time of administration. Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section Taking cinfatós antitusivo flas with food and drinks).

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

Use in children

Do not administer to children under 12 years of age.

If you take more cinfatós antitusivo flas than you should

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

Other symptoms in cases of massive overdose may include: coma, severe breathing problems, and seizures.

Taking very high doses of this medicine may cause drowsiness or nervousness, nausea, vomiting, or disturbances in walking in children.

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

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

In case of poisoning, appropriate treatments for the symptoms should be administered, which may include intravenous naloxone injection and gastric lavage.

Serotonin syndrome may also be increased.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take cinfatós antitusivo flas

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 antitusivo flas.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed during the period of dextromethorphan use, although their frequency cannot be precisely determined:

• 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 in cases of overdose (see section "If you take more cinfatós antitussive flas than you should").
• Nervous system disorders: somnolence, dizziness, fatigue, involuntary muscle contractions, and more rarely 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 any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinfatós antitussive flas

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

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the package, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of cinfatós antitussive flas

• The active substance is dextromethorphan hydrobromide. Each orodispersible tablet contains 15 mg of dextromethorphan hydrobromide.

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

Appearance of the product and contents of the container

cinfatós antitussive flas is presented as cylindrical, biconvex, white or almost white tablets, in packs containing 20 orodispersible 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 most recent review of this leaflet: March 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85817/P_85817.html

QR code: https://cima.aemps.es/cima/dochtml/p/85817/P_85817.html