BRONCOMEDICAL with Sulfoguaiacol 2mg/ml + 10mg/ml Syrup

Introduction

Package Leaflet: Information for the Patient

Broncomedical with Sulfoguayacol

2 mg/ml + 10 mg/ml

Syrup

Dextromethorphan hydrobromide / Potassium sulfoguayacolate.

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package 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, pharmacist, or nurse, even if they are not listed in this package leaflet.
• You should consult a doctor if your symptoms worsen or improve after 7 days, or if they are accompanied by high fever, skin rash, or persistent headache.

Package Leaflet Contents

1. What is Broncomedical with Sulfoguayacol and what is it used for
2. What you need to know before taking Broncomedical with Sulfoguayacol
3. How to take Broncomedical with Sulfoguayacol
4. Possible side effects
5. Storage of Broncomedical with Sulfoguayacol
6. Package contents and additional information

1. What is Broncomedical with Sulfoguayacol and what is it used for

It is indicated for the relief of cough and to facilitate the expulsion of excess mucus and phlegm in adults and children from 6 years old.

Dextromethorphan is a cough suppressant that inhibits the cough reflex. Sulfoguayacolate is an expectorant that facilitates the elimination of mucus.

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

2. What you need to know before taking Broncomedical with Sulfoguayacol

This medication can cause dependence. Therefore, treatment should be short-term.

Do not takeBroncomedical with Sulfoguayacol

• if you are allergic to dextromethorphan, sulfoguayacol, or any of the other components of this medication (listed in section 6)
• if you have a severe lung disease (respiratory failure)
• if you have asthma
• if you have a cough with abundant secretions
• if you have a persistent or chronic cough, such as that caused by smoking or emphysema
• if you are being treated or have been treated in the last 2 weeks with a monoamine oxidase inhibitor (MAOI) medication used to treat depression or Parkinson's disease or other conditions (see section: "Use of other medications")
• in children under 6 years old
• if the patient is sedated, weakened, or bedridden.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Broncomedical with Sulfoguayacol

• if the cough persists for more than a week or is accompanied by high fever, skin rash, or persistent headache
• if you have liver disease
• if you have atopic dermatitis (an 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 medications such as antidepressants or antipsychotics, Broncomedical with Sulfoguayacol may interact with these medications 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).

There have been reports of abuse with medications containing dextromethorphan in adolescents, so this possibility should be taken into account, as serious side effects can occur (see section: "If you take more Broncomedical with Sulfoguayacol than you should").

Children and adolescents

Do not use in children under 6 years old.

Use ofBroncomedical with Sulfoguayacolwith other medications

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

Do not take this medication during treatment or in the 2 weeks following treatment with the following medications, as excitement, high blood pressure, and fever above 40°C (hyperpyrexia) may occur:

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranilcipromine)
• Serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine)
• Bupropion (used to quit smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson's disease)
• Sibutramine (used to treat obesity)

If you are using any of the following medications, it may be necessary to modify the dose of one of them or interrupt treatment:

• Amiodarone and quinidine (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 (used to treat mental disorders) may increase the side effects of dextromethorphan.

TakingBroncomedical with Sulfoguayacolwith food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment, as they may cause side effects.

Do not take with grapefruit or bitter orange juice, as they may increase the side effects of this medication.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant, do not use Broncomedical with Sulfoguayacol unless your doctor considers it absolutely necessary for your treatment.

This medication is excreted in breast milk, so breastfeeding should be suspended or the administration of this medication avoided.

Important for women

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. Taking the medication during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and using machines

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

Important information about some of the components ofBroncomedical with Sulfoguayacol

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 3 g of sucrose per 5 ml.

3. How to take Broncomedical with Sulfoguayacol

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and children over 12 years old: Take 5 ml to 10 ml every 6 hours. Depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

The maximum amount that can be taken in 24 hours is 60 ml, divided into several doses.

Children from 6 to 12 years old: Take 2.5 ml to 5 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

The maximum amount that can be taken in 24 hours is 30 ml, divided into several doses.

Always use the lowest effective dose.

In patients with liver disease, the dose should be reduced by half, not exceeding 4 daily doses in any case.

Guidelines for correct administration

Broncomedical with Sulfoguayacol is taken orally.

A measuring cup is included in the package. This way, you can measure the amount of medication to take according to the information mentioned above.

Shake before use.

To open, press and turn the cap at the same time.

Pour the exact dose into the measuring cup.

It can be taken with or without food.

Do not take with grapefruit or bitter orange juice or alcoholic beverages (see section: "Taking Broncomedical with Sulfoguayacol with food or drinks").

If the cough worsens, if it persists after 7 days of treatment, or is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

Use in children and adolescents

Do not administer to children under 6 years old.

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

If you take moreBroncomedical with Sulfoguayacolthan you should

If you take more Broncomedical with Sulfoguayacol than recommended, you may notice: confusion, excitability, restlessness, nervousness, and irritability.

If you take more Broncomedical with Sulfoguayacol than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid involuntary eye movements, cardiac disorders (accelerated 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.

Taking very high amounts of this medication can cause children to enter a state of stupor, hallucinations, nervousness, nausea, vomiting, or changes in gait.

There have been cases of abuse with medications containing dextromethorphan, which can cause serious side effects, such as anxiety, panic, memory loss, tachycardia (accelerated heart rate), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, vertigo, gastrointestinal discomfort, slurred speech, nystagmus (involuntary eye movement), fever, tachypnea (rapid shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of overdose or improper use, consult your doctor, pharmacist, or nurse immediately or call the Toxicology Information Service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Broncomedical with Sulfoguayacol

Do not take a double dose to make up for forgotten doses. If necessary, restart treatment as indicated in section 3, "How to take Broncomedical with Sulfoguayacol".

If you stop treatment with Broncomedical with Sulfoguayacol

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Broncomedical with Sulfoguayacol can cause side effects, although not everyone will experience them.

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

• In some cases, the following have occurred: drowsiness, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting
• In rarer cases: mental confusion and headache.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

5. Storage of Broncomedical with Sulfoguayacol

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

Do not use this medication after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in the original package.

Once the package is opened, it should not be used after 6 months.

Medications should not be thrown away in drains or trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofBroncomedical with Sulfoguayacol

• The active ingredients are Dextromethorphan hydrobromide and Potassium sulfoguayacolate.
• The other components (excipients) are sucrose, sodium saccharin, peppermint flavor, pineapple flavor, caramel (E-150), and purified water.

Appearance of the product and package contents

Broncomedical with Sulfoguayacol is a clear solution that comes in a topaz polyethylene bottle containing 180 ml of product and a 15 ml measuring cup.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical, S.A.

Pol. Ind. Las Quemadas, Parcela 87

14014 - Córdoba.

Manufacturer

Laboratorio Generfarma, S.L.

Ronda Isaac Peral, 6 (Parque Tecnológico)

46980 – Paterna. Valencia.

or

Seid, S.A.

Ctra. Sabadell-Granollers, km. 15

08185 Lliçà de Vall (Barcelona)

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70, Pol. Industrial Urtinsa II

28923- Alcorcón (Madrid)

This package leaflet was approved in October 2023

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