BRONCOMEDICAL with Guaifenesin 10 mg/100 mg ORAL SOLUTION

Introduction

Leaflet: Information for the User

BRONCOMEDICAL with Guaifenesina10 mg/100 mg Oral Solution

Dextromethorphan, hydrobromide/Guaifenesina

Read the entire leaflet carefully because it contains important information for you.

This medication can be purchased without a prescription. Nevertheless, to obtain the best results, it should be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If the symptoms worsen, if they persist for more than 7 days, or if during treatment you notice skin rashes, high fever, or persistent headache, you should stop treatment and consult a doctor.
• If you consider that any of the adverse effects you are experiencing is serious, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Leaflet:

1. What is BRONCOMEDICAL with Guaifenesina and what is it used for
2. Before taking BRONCOMEDICAL with Guaifenesina
3. How to take BRONCOMEDICAL with Guaifenesina
4. Possible side effects
5. Storage of BRONCOMEDICAL with Guaifenesina
6. Additional information

1. What is BRONCOMEDICAL with Guaifenesina and what is it used for

It is a medication that contains dextromethorphan hydrobromide, which is a cough suppressant, and guaifenesina, 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.

2. Before taking BRONCOMEDICAL with Guaifenesina

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

Do not takeBRONCOMEDICAL with Guaifenesina

• If you are allergic (hypersensitive) to guaifenesina or dextromethorphan hydrobromide, or to any of the other components of the medication
• 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 any monoamine oxidase inhibitor (MAOI) medication used to treat depression or Parkinson's disease or other diseases (see section on Use of other medications)
• If you have fructose intolerance (see section on Important information about some of the components of BRONCOMEDICAL with Guaifenesina)

Be careful withBRONCOMEDICAL with Guaifenesina

Patients with the following conditions should consult their doctor before using this medication:

• Liver disease
• 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 medications such as antidepressants or antipsychotics, BRONCOMEDICAL with Guaifenesina 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).

Patients with persistent or chronic cough, such as those due to smoking or who are sedated, debilitated, or bedridden, should not take this medication.

There have been cases of abuse with medications containing dextromethorphan by adolescents.

This can cause serious adverse effects (see section on If you take more BRONCOMEDICAL with Guaifenesina than you should).

Interference with analytical tests

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

Do not take this medication during treatment or in the 2 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, 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)
• 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 (antipsychotic)

TakingBRONCOMEDICAL with Guaifenesinawith food and drinks

Alcoholic beverages should not be consumed during treatment, as they may cause adverse reactions.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Important for women

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

Pregnant and breastfeeding women should not take this medication without consulting their doctor.

Driving and using machines

Rarely, during treatment, a decrease in reaction capacity or drowsiness and mild dizziness may occur, so if you notice these symptoms, you should not drive vehicles or operate machines.

Important information about some of the components ofBRONCOMEDICAL with Guaifenesina

This medication may be harmful to people with phenylketonuria because it contains aspartame (E-951), which is a source of phenylalanine.

This medication contains sorbitol (E-420). If your doctor has told you that you have an intolerance to certain sugars (such as fructose), consult with them before taking this medication.

3. How to take BRONCOMEDICAL with Guaifenesina

Follow these instructions unless your doctor has given you different ones. Consult your doctor or pharmacist if you have doubts.

The normal dose is:

Adults: Take 1 sachet every 6 hours. If necessary, it can be taken every 4 hours. If it is not enough, 2 sachets can be taken every 4-6 hours as needed. In any case, the maximum amount of medication that can be taken in 24 hours is 12 sachets, divided into at least 6 doses.

Use in children:

Children between 6 and 12 years old: Take 1 sachet every 6 hours. If necessary, it can be taken every 4 hours.

The maximum amount of medication that can be taken in 24 hours is 6 sachets, divided into at least 6 doses.

Children under 6 years old: This medication is contraindicated in children under 6 years old.

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

How to take:

This medication is taken orally.

The oral solution can be taken directly from the sachet.

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 BRONCOMEDICAL with Guaifenesina with food or drinks).

If the symptoms worsen, if they persist for more than 7 days, or if during treatment you notice skin rashes, high fever, or persistent headache, you should stop treatment and consult a doctor.

If you take moreBRONCOMEDICAL with Guaifenesinathan you should

If you take more BRONCOMEDICAL with Guaifenesina than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disorders of consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, psychosis with visual hallucinations, and hyperexcitability.

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

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

Taking very high doses of this medication can cause children to become drowsy, nervous, nauseous, vomit, or have gait disturbances.

There have been cases of abuse with medications containing dextromethorphan, which can cause serious adverse 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 and uncontrolled eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), convulsions, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicology Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

If you forget to takeBRONCOMEDICAL with Guaifenesina

If you forget to take BRONCOMEDICAL with Guaifenesina and the symptoms continue, do not take a double dose to make up for the forgotten dose. If necessary, take the medication again as indicated in section 3. HOW TO TAKE BRONCOMEDICAL with Guaifenesina.

4. Possible side effects

Like all medications, BRONCOMEDICAL with Guaifenesina can have side effects, although not everyone experiences them.

During the use of dextromethorphan and guaifenesina, the following side 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 rarer cases: mental confusion.

If you consider that any of the side effects you are experiencing is serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of BRONCOMEDICAL with Guaifenesina

Keep out of the reach and sight of children.

Do not use this medication after the expiration date shown on the packaging after CAD.

The expiration date is the last day of the month indicated.

No special storage conditions are required

Medications should not be thrown away through the sewage system or in the trash. Deposit the packaging and medications you no longer need in the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. ADDITIONAL INFORMATION

Composition ofBRONCOMEDICALwith Guaifenesina

Each sachet (5 ml of oral solution) contains:

• As active ingredients: dextromethorphan hydrobromide 10 mg and guaifenesina 100 mg.
• Other components (excipients) are: Povidone, sodium benzoate (E-211), anhydrous citric acid, strawberry flavor (with cornstarch and propylene glycol), sorbitol (E-420) 2.875 mg, aspartame (E-951) 35 mg, and purified water.

Appearance of the product and packaging content

Packaging with 20 sachets of clear yellow oral solution with a strawberry flavor.

Marketing authorization holder and manufacturer

Marketing authorization holder

Medical, S.A.

Pol. Ind. Las Quemadas, Parcela 87 14014 - Córdoba.

SPAIN

Manufacturer

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid).

SPAIN

This leaflet was approved in June 2023

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