Label: information for the user

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

Dextromethorphan hydrobromide/Guaifenesin

Read this label 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 label or those indicated by your doctor or pharmacist

• Keep this label, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

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

It is indicated for the relief of cough and to facilitate the expulsion of excess mucus and phlegm in colds and flu for adults and children aged 6 years and older.

Consult a doctor if symptoms worsen or do not improve after 7 days of treatment.

This medication may cause dependence. Therefore, treatment should be of short duration.

Do not take cinfatós expectorant

• If you are allergic to guaifenesin, dextromethorphan hydrobromide, or any of the other components of this medication (listed in section 6).
• If you have asthma.
• If you have a persistent or chronic cough, such as that caused by smoking or that is due to being bedridden.
• If you have a serious lung disease.
• If you are being treated or have been treated in the past two weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression or Parkinson's disease or other conditions (see section Taking cinfatós expectorant with other medications).
• If you have fructose intolerance (see section Important information about one of the components of cinfatós expectorant).

Warnings and precautions

Consult your doctor or pharmacist before starting to takecinfatós expectorantif you are a patient:

• with liver disease
• with atopic dermatitis (inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition).
• If you are taking other medications such as antidepressants or antipsychotics, cinfatós expectorant may interact with these medications and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, high blood pressure, and 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 caused by smoking or that are bedridden, should not take this medication.

Cases of abuse with dextromethorphan-containing medications have been reported in adolescents. This can cause severe adverse effects (see section If you take more cinfatós expectorant than you should).

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.) inform your doctor that you are taking this medication, as it may alter the results.

Other medications and cinfatós expectorant

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

These instructions may also apply to medications that have been used before or may be used afterwards.

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

• Medications used to treat depression, such as monoamine oxidase inhibitors (MAOIs) (moclobemide, tranylcypromine) and selective serotonin reuptake inhibitors (paroxetine, fluoxetine)
• Bupropion (used to quit 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 medications, it may be necessary to modify the dose of one or both of them or to discontinue 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 mucus and phlegm)
• Haloperidol (antipsychotic)

Taking cinfatós expectorant with food, drinks, and alcohol

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

Do not take this medication with orange or grapefruit juice, as it may increase the adverse effects of this medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

In rare cases, during treatment, drowsiness and dizziness may occur, so if you experience these symptoms, you should not drive cars or operate hazardous machinery.

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

This medication contains 399.98 mg of sorbitol (E-420) per ml.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a condition where you cannot digest certain sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication contains 3.5 mg of sodium benzoate (E-211) per ml.

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 12 years and older: 5 ml or 10 ml, every 4-6 hours as needed. Maximum 60 ml / 24 hours.

Use in children

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

Severe adverse effects may occur in children in case of overdose, including neurological alterations. Caregivers should not exceed the recommended dose.

Children 2 to 6 years: There are other presentations more suitable for this population. Administer only under medical supervision, due to the risk of paradoxical stimulation of the CNS.

Children under 2 years: Contraindicated

Patients with liver insufficiency: The dose should be reduced to half of the recommended dose for each population, not exceeding 4 daily doses.

This medication is taken orally.

How to take:

Measure the amount of medication to take with 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 abundant liquid throughout the day. It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or with alcoholic beverages (see section Taking cinfatós expectorant with food, drinks, and alcohol).

Consult a doctor if it worsens, or if you also have high fever, skin eruptions, or persistent headache or if you do not improve after 7 days of treatment.

If you take more cinfatós expectorant than you should

If you have taken more cinfatós expectorantthan you should, you may notice: confusion, excitement, restlessness, nervousness, irritability, nausea, and vomiting.

Taking very high doses of this medication may cause in children a state of drowsiness, nervousness, nausea, vomiting, or alterations in gait.

Cases of abuse with medications containing dextromethorphan in adolescents have been reported, which may lead to severe adverse effects, such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), 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, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (rapid heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

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

Immediately contact your doctor or hospital if you experience any of the mentioned symptoms.

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 medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

During the period of use of dextromethorphan and guaifenesin, the following adverse effects have been observed, whose frequency has not been established with precision:

• In some cases, the following have occurred: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting, headache, and skin itching (urticaria).
• In rare cases: mental confusion.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Cinfa Expectorant Composition

• The active principles are dextromethorphan hydrobromide and guaifenesin. Each milliliter 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.

Product appearance and packaging contents

Cinfa Expectorant is a transparent, slightly colored oral solution with a characteristic odor.

The medication is presented in a amber glass bottle with a metal cap and Pilfer Proof closure or a polycarbonate bottle with a polypropylene cap, containing 125 ml or 200 ml of oral solution.

Each package is provided with a dosing cup with a graduation ranging from 2.5 ml to 15 ml.

Marketing authorization holder and manufacturer:

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:October 2019

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/