Label: information for the user

cinfatós expectorant 10 mg + 100 mg oral solution in sachets

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 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 any 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 you worsen or if you also have high fever, skin eruptions, or persistent headache, or if you do 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 it worsens or does not improve after 7 days of treatment.

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

Do not take cinfatós expectorant

• If you are allergic to dextromethorphan hydrobromide, guaifenesin, or any of the other components of this medicine (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 or debilitated.
• 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) used to treat depression or Parkinson's disease or other diseases (see section Taking cinfatós expectorant with other medicines).
• 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 take cinfatós expectorant if you are a patient:

Patients with persistent or chronic cough, such as that caused by smoking or that are due to being bedridden or debilitated, should not take this medicine.

Cases of abuse with dextromethorphan-containing medicines have been reported in adolescents. This may 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, urine, or skin tests that use allergens, etc.) inform your doctor that you are taking this medicine, as it may alter the results.

Other medicines and cinfatós expectorant

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

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

Do not take this medicine during treatment, or in the two weeks following treatment, with the following medicines, as it may cause excitement, high blood pressure, and a body temperature higher than 40°C (hyperpyrexia):

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

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 this medicine with orange or grapefruit juice, as it may increase the adverse effects of this medicine.

Pregnancy and lactation

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

Driving and operating machinery

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

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

This medicine contains 1999.9 mg of sorbitol (E-420) in each sachet.

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) suffer from intolerance to certain sugars, or 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 may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains 17.50 mg of sodium benzoate (E-211) in each sachet.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; that is, 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:1-2 packets, every 4-6 hours as needed. Maximum 12 packets per 24 hours.

Use in children

Children 6 to 12 years:1 packet every 4-6 hours as needed. Maximum 6 packets per 24 hours.

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.

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

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.

Open the packet and pour the contents directly into the mouth. 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 morecinfatós expectorantthan you should, you may notice: confusion, excitement, restlessness, nervousness, irritability, nausea, and vomiting.

The intake of very high amounts 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 have been reported in adolescents, 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 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, consciousness disorders, involuntary and rapid eye movements, cardiac disorders (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:

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear 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 about 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 package 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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of cinfatós expectorant

The active principles are dextromethorphan hydrobromide and guaifenesin. Each sachet contains 10 mg of dextromethorphan hydrobromide and 100 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 aroma, and purified water.

Appearance of the product and contents of the packaging

cinfatós expectorant is a transparent, slightly colored oral solution with an orange aroma.

Each box of cinfatós expectorant contains 18 sachets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:October 2019

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