CINFATOS EXPECTORANT 2 mg/ml + 20 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

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

dextromethorphan hydrobromide/guaifenesin

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days of treatment.

Contents of the Package Leaflet

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

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

It is a medicine that contains dextromethorphan hydrobromide, which is a cough suppressant, 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 from 6 years of age.

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

2. What you need to know before you start taking cinfatós expectorant

This medicine can 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 medicine (listed in section 6).
• If you have asthma.
• If you have a cough with a large amount of mucus and phlegm.
• If you have a severe lung disease.
• If you are being treated or have been treated in the last 2 weeks with a monoamine oxidase inhibitor (MAOI) medicine used to treat depression or Parkinson's disease or other diseases (see section on taking cinfatós expectorant with other medicines).
• If you have fructose intolerance (see section on important information about some of the components of cinfatós expectorant).

Warnings and precautions

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

• with liver disease
• with atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and scaling, which begins in childhood in individuals with a hereditary allergic predisposition).
• 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, hypertension, and exaggerated reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

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

There have been cases of abuse with medicines containing dextromethorphan by adolescents. This can cause serious side effects (see section on if you take more cinfatós expectorant than you should).

Interference with laboratory tests

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

Other medicines and cinfatós expectorant

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

Note that these instructions may also apply to medicines that have been used before or may be used after.

Do not take this medicine during treatment or in the 2 weeks following treatment with 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 inhibitors (MAOIs) (moclobemide, tranilcipromine) 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 using any of the following medicines, it may be necessary to modify the dose of one of them or interrupt treatment:

• Amiodarone and quinidine (for treating heart arrhythmias)
• Anti-inflammatory drugs (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 medicine because it may cause adverse reactions.

Do not take with grapefruit or bitter orange juice because they may increase the adverse effects of this 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.

Driving and using machines

Rarely, during treatment, drowsiness and dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate hazardous machinery.

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

This medicine 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 an intolerance to certain sugars, or you 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 upset and a mild laxative effect.

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

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

3. How to take cinfatós expectorant

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

The recommended dose is:

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

Use in children

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

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

Children from 2 to 6 years: other presentations are more suitable for this population. Administer only under medical supervision due to the risk of paradoxical stimulation of the central nervous system.

Children under 2 years: contraindicated

Patient with liver failure: the dose should be reduced to half of the recommended dose for each population, not exceeding 4 daily doses in any case.

This medicine is taken orally.

How to take:

Measure the amount of medicine to be taken with the measuring cup that comes with the bottle. After use, wash the measuring cup.

It is recommended to drink a glass of water after each dose and plenty of 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 on taking cinfatós expectorant with food, drinks, and alcohol).

You should consult a doctor if your symptoms worsen, or if you also have high fever, skin rash, 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 expectorant than you should, you may notice: confusion, excitability, restlessness, nervousness, irritability, nausea, and vomiting.

Taking very high doses of this medicine can cause children to become drowsy, nervous, nauseous, vomit, or have changes in their gait.

There have been cases of abuse with medicines containing dextromethorphan in adolescents, which can cause serious side effects, such as anxiety, panic, memory loss, tachycardia (rapid heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal upset, slurred speech, nystagmus (involuntary and uncontrolled eye movements), fever, tachypnea (shallow and rapid breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), 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, changes in consciousness, rapid and involuntary eye movements, cardiac disorders (rapid heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

During the use of dextromethorphan and guaifenesin, the following side effects have been observed, whose frequency cannot be established with precision:

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es. By reporting side effects, you can contribute to providing 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 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 should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of cinfatós expectorant

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

• The other ingredients (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 pack contents

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

The medicine comes in a brown glass bottle with a metal cap with a Pilfer Proof closure or a brown polyethylene terephthalate bottle with a polypropylene cap, containing 125 ml or 200 ml of oral solution.

Each pack comes with a measuring cup with graduations ranging 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 last revision of this leaflet:October 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can 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