Cinfatos Expectorante 10 mg + 100 mg oral solution in sachets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

cinfatós expectorant 10 mg + 100 mg oral solution in sachets

dextromethorphan hydrobromide/guaifenesin

Read the entire 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 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or if you also have high fever, skin rashes, or persistent headache, or if you 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. Storage of 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 a cough suppressant, and guaifenesin, which is an expectorant.

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

You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.

2. What you need to know before starting to take cinfatós expectorant

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

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 cough with a large amount of mucus and phlegm.
• If you have a serious lung disease.
• If you are currently being treated or have been treated within the previous 2 weeks with a monoamine oxidase inhibitor (MAOI) 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 components 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, crusting, 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, as 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 caused by smoking, or who are sedated, weakened, or bedridden should not take this medicine.

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

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (including blood or urine tests, skin tests using allergens, etc.), inform 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 (used to treat heart arrhythmias).
• Anti-inflammatory medicines (celecoxib, parecoxib, or valdecoxib).
• Central nervous system depressants (some used to treat: mental disorders, allergies, Parkinson's disease, etc.).
• Expectorants and mucolytics (used to eliminate 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 plan 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 1999.9 mg of sorbitol (E-420) in each sachet.

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 disorder 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; hence, 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: 1-2 sachets every 4-6 hours as needed. Maximum 12 sachets every 24 hours.

Use in children

Children aged 6 to 12 years: 1 sachet every 4-6 hours as needed. Maximum 6 sachets every 24 hours.

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.

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

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 in no case should exceed 4 doses per day.

This medicine is taken orally.

Open the sachet and pour the contents directly into the mouth. It is recommended to drink a glass of water after each dose and to maintain abundant fluid intake throughout the day.

It 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 also 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 amounts 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, 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 of consciousness, involuntary and rapid 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 respiratory problems, and seizures.

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

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

4. Possible adverse effects

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

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

• In some cases: drowsiness, 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 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 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 sachet after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 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 flavor, and purified water.

Appearance of the product and contents of the pack

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

Each cinfatós expectorant pack contains 18 sachets.

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 information on this medicinal product 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78985/P_78985.html

QR code to: https://cima.aemps.es/cima/dochtml/p/78985/P_78985.html