Cinfatos Expectorante 2 mg/ml + 20 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfatós expectorant 2 mg/ml + 20 mg/ml oral solution

dextromethorphan hydrobromide/guaifenesin

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

Follow exactly the instructions for use provided in this leaflet or those 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 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 you worsen or do not improve after 7 days of treatment.

Leaflet contents

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

1. What is Cinfatós Expectorant and what is it used for

It is a medicine that contains dextromethorphan hydrobromide, which is an antitussive, and guaifenesin, which is an expectorant.

It is indicated for the relief of cough and for facilitating the expulsion of excess mucus and phlegm in colds and flu in adults and children aged 6 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 expectorant

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

Do not take cinfatós expectorant

• If you are allergic to guaifenesin, dextromethorphan hydrobromide, or any of the other ingredients of this medicine (listed in section 6).
• If you have asthma.
• If you have a cough with large amounts of mucus and phlegm.
• If you have a serious lung disease.
• If you are currently taking or have taken within the last 2 weeks any monoamine oxidase inhibitor (MAOI) medicine used to treat depression, Parkinson's disease, or other conditions (see section "Taking cinfatós expectorant with other medicines").
• If you have fructose intolerance (see section on important information about some of the ingredients of cinfatós expectorant).

Warnings and precautions

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

• With liver disease.
• With atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary predisposition to allergy).
• If you are taking other medicines such as antidepressants or antipsychotics, cinfatós expectorant 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).

Patients with persistent or chronic cough, such as that due to smoking, or who are sedated, weakened, or bedridden, should not take this medicine.

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents. This may lead to serious adverse effects (see section "If you take more cinfatós expectorant than you should").

Interference with diagnostic tests

If you are due to have any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), tell your doctor that you are taking this medicine, as it may alter test results.

Other medicines and cinfatós expectorant

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

Note that these instructions may also apply to medicines taken previously or that may be taken in the future.

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

• Medicines used to treat depression such as monoamine oxidase inhibitor antidepressants (MAOIs) (moclobemide, tranylcypromine) and 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).

If you are taking any of the following medicines, it may be necessary to adjust the dose or discontinue treatment:

• Amiodarone and quinidine (to treat heart arrhythmias).
• Anti-inflammatory medicines (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 clear mucus and phlegm).
• Haloperidol (an antipsychotic).

Taking cinfatós expectorant with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment with this medicine, as it may cause adverse reactions.

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

Pregnancy and breastfeeding

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

Driving and use of machines

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

cinfatós expectorant contains sorbitol (E-420), sodium benzoate (E-211), and sodium

This medicine contains 399.98 mg of sorbitol (E-420) in each ml.

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

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains 3.5 mg of sodium benzoate (E-211) in each ml.

This medicine contains less than 1 mmol of sodium (23 mg) per ml; therefore, it is essentially “sodium-free”.

3. How to take cinfatós expectorant

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: 5 ml or 10 ml every 4–6 hours as needed. Maximum 60 ml / 24 hours.

Use in children

Children aged 6 to 12 years: 2.5 ml or 5 ml every 4–6 hours as needed. Maximum 30 ml / 24 hours.

Serious adverse effects may occur in children in case of overdose, including neurological disturbances. Caregivers must not exceed the recommended dose.

Children aged 2 to 6 years: Other formulations more suitable for this population are available. Administration should only occur under medical supervision due to the risk of paradoxical central nervous system (CNS) stimulation.

Children under 2 years of age: Contraindicated.

Patients with hepatic impairment: The dose should be reduced by half of the recommended dose for each population group, and must not exceed 4 doses per day.

This medicine is for oral use.

How to take:

Measure the required amount of medication using the dosing cup provided with the bottle. After use, wash the dosing cup.

It is recommended to drink a glass of water after each dose and to maintain adequate fluid intake throughout the day. The medicine 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 expectorant with food, drinks and alcohol").

Consult a doctor if symptoms worsen, or if you develop high fever, skin rash, or persistent headache, or if there is no improvement after 7 days of treatment.

If you take more cinfatós expectorant than you should

If you have taken more cinfatós expectorant than recommended, you may experience: confusion, excitability, restlessness, nervousness, irritability, nausea, and vomiting.

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

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

If you take more cinfatós expectorant than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances in consciousness, involuntary and rapid eye movements, cardiac disorders (increased heart rate), lack of coordination, 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 go to the 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 telephone number 91 562 04 20, indicating the name of the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

During the period of use of dextromethorphan and guaifenesin, the following adverse effects have been observed, for which the frequency could not be established accurately:

• In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting, headache, and skin itching (urticaria).
• In rarer cases: mental confusion.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of cinfatós expectorant

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is 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 Point located at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of cinfatós expectorant

• The active substances are dextromethorphan hydrobromide and guaifenesin. Each ml of oral solution contains 2 mg of dextromethorphan hydrobromide and 20 mg of guaifenesin.

• The other components (excipients) are: sodium saccharin, non-crystallizable liquid sorbitol (E-420), povidone, sodium benzoate (E-211), citric acid monohydrate, orange flavor, and purified water.

Appearance of the product and contents of the pack

cinfatós expectorant is a transparent, slightly colored oral solution with a characteristic odor.

The medicine is supplied in a topaz glass bottle fitted with a metal cap with Pilfer Proof seal, or in a topaz polyethylene terephthalate (PET) bottle fitted with a polypropylene cap, containing 125 ml or 200 ml of oral solution.

Each pack includes a dosing cup graduated from 2.5 ml to 15 ml.

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 medicine 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 may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/60898/P_60898.html

QR code to: https://cima.aemps.es/cima/dochtml/p/60898/P_60898.html