Cinfatos Antitussive 10 mg lozenges

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

cinfatós antitussive 10 mg lozenges

Dextromethorphan hydrobromide

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens, or if you develop high fever, skin rash, persistent headache, or if you do not improve after 7 days of treatment.

Contents of the leaflet

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

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

Dextromethorphan, the active ingredient in this medicine, is an antitussive that suppresses the cough reflex.

It is indicated for the symptomatic treatment of dry cough not accompanied by expectoration (irritant cough, nervous cough) in adults and adolescents aged 12 years and older.

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

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

Do not take cinfatós antitussive

• If you are allergic to dextromethorphan or to any of the other ingredients of this medicine (listed in section 6).
• If you have a serious lung disease.
• If you have asthmatic cough.
• If you have a cough with abundant secretions.
• If you are currently or have been treated within the previous 2 weeks with a monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson's disease or other conditions, or with other serotonin reuptake inhibitors used to treat depression such as fluoxetine and paroxetine; or with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial medicine. (See section: Other medicines and cinfatós antitussive).
• Children under 12 years of age must not take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking cinfatós antitussive if you are a patient:

• With persistent or chronic cough, such as that caused by smoking. Particularly in children, chronic cough may be an early sign of asthma.
• With liver disease.
• With atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, beginning in infancy in individuals with hereditary allergic predisposition).
• Who is sedated, weakened, or bedridden.
• If you are taking other medicines such as antidepressants or antipsychotics, cinfatós antitussive 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).

Cases of abuse of medicines containing dextromethorphan in adolescents have been reported; therefore, this possibility should be considered, as it may lead to serious adverse effects (see section: If you take more cinfatós antitussive than you should).

Children

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

Other formulations more suitable for this age group are available.

Other medicines and cinfatós antitussive

Inform 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 it may cause excitation, high blood pressure, and fever above 40°C (hyperpyrexia):

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

Before starting 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:

• Amiodarone and quinidine (used to treat heart arrhythmias).
• Anti-inflammatory drugs (celecoxib, parecoxib, or valdecoxib).
• Central nervous system depressants (some of which are used to treat: mental disorders, allergies, Parkinson's disease, etc.).
• Expectorants and mucolytics (used to eliminate phlegm and mucus).

Taking cinfatós antitussive with food, drinks, and alcohol

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

Do not take together with grapefruit juice or bitter orange juice, as they may increase the adverse effects of this medicine.

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 using this medicine.

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

Driving and operating machinery

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

cinfatós antitussive contains maltitol liquid (E-965) and sodium

This medicine contains liquid maltitol (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

It may have a mild laxative effect. Calorific value: 2.3 kcal/g of maltitol.

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

3. How to take cinfatós antitussive

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults and adolescents aged 12 years and older: Take 1 or 2 tablets (10–20 mg) every 4 hours as needed. Do not exceed 6 doses in 24 hours.

Alternatively, 3 tablets (30 mg) may be taken every 6 to 8 hours as needed. Do not exceed 4 doses in 24 hours.

The maximum daily dose is 12 tablets (120 mg), divided into several doses.

Always use the lowest effective dose.

Use in children

This medicine is contraindicated in children under 12 years of age due to the amount of dextromethorphan it contains.

How to take:

Buccopharyngeal use. Allow the tablet to dissolve slowly in the mouth. Do not chew or swallow it.

It is recommended to drink a glass of water after each dose and plenty of fluids throughout the day.

The tablet may be taken with or without food. Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section: Taking cinfatós antitussive with food, drinks, and alcohol).

If cough worsens or persists beyond 7 days of treatment, or if it is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more cinfatós antitussive than you should

If you take more cinfatós antitussive than recommended, you may experience: confusion, excitability, restlessness, nervousness, and irritability.

Taking very high doses of this medicine may cause children to become drowsy, hallucinate, become nervous, nauseous, vomit, or experience disturbances in walking.

Cases of abuse have occurred with medicines containing dextromethorphan, potentially causing serious adverse effects such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (dilation of the pupil), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary, uncontrolled eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

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

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

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

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

If you forget to take cinfatós antitussive

Do not take a double dose to make up for missed doses. If you forget a dose, take it as soon as possible and then continue with your usual dosing schedule, as indicated in section 3. How to take cinfatós.

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.

During the period of use of dextromethorphan, the following adverse effects have been observed, whose frequency cannot be precisely determined:

• In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting.
• More rarely: mental confusion and headache.

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

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

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

Store in the original packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of cinfatós antitussive

• The active substance is dextromethorphan hydrobromide. Each tablet contains 10 mg of dextromethorphan hydrobromide.
• The other components (excipients) are: betadex (beta-cyclodextrin), gum arabic, sodium cyclamate, sodium saccharin, quinoline yellow (E-104), lime flavor, honey flavor, levomenthol, anhydrous citric acid, maltitol liquid (E-965), liquid paraffin, and purified water.

Appearance of the product and contents of the package

cinfatós antitussive 10 mg lozenges are presented as cylindrical yellow lemon-colored lozenges for sucking. Each package contains 10 or 20 lozenges.

Only certain package sizes may be marketed.

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: October 2019

Detailed and up-to-date 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/64797/P_64797.html

QR code to: https://cima.aemps.es/cima/dochtml/p/64797/P_64797.html