Prospect: information for the patient

Broncomedical with Sulfoguayacol

2 mg/ml + 10 mg/ml

Syrup

Dextromethorphan hydrobromide / Potassium sulfoguaiacolate.

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor, pharmacist, or nurse.

• Keep this prospect, 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 or nurse, even if they do not appear in this prospect.
• You should consult a doctor if they worsen or improve after 7 days, or if they are accompanied by high fever, skin eruptions, or persistent headache.

1. What it isBroncomedical with Sulfoguayacoland for what it is used

2. What you need to know before starting to takeBroncomedical with Sulfoguayacol

3. How to takeBroncomedical with Sulfoguayacol

4. Possible adverse effects

5. Conservation ofBroncomedical with Sulfoguayacol

6. Contents of the package and additional information

This is indicated for the relief of cough and to facilitate the expulsion of excess mucus and phlegm in adults and children aged 6 years and above.

Dextromethorphan is an antitussive that inhibits the cough reflex. Sulfoguaiacolate is an expectorant that facilitates the elimination of mucus.

You should consult your doctor if it worsens or does not improve after 7 days.

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

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 serious lung disease (respiratory insufficiency)
• if you have asthma cough
• if you have a cough accompanied by abundant secretions
• if you have persistent or chronic cough caused by smoking or emphysema
• if you are being treated or have been treated in the past 2 weeks with any 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 or pharmacist or nurse before starting to takeBroncomedical with Sulfoguayacol

• if the cough persists for more than a week or is accompanied by high fever, skin eruptions, or persistent headache
• if you have liver disease
• if you have atopic dermatitis (inflammatory skin disease characterized by erythema, itching, exudation, crusts, and desquamation, which begins in childhood in individuals with 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 exaggeration of reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhea).

Cases of abuse with dextromethorphan-containing medications have been described in adolescents, therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section: “If you take more Broncomedical with Sulfoguayacol than you should”).

Children and adolescents

Not to be used in children under 6 years old.

Use ofBroncomedical with Sulfoguayacolwith other medications

Inform your doctor or pharmacist if you are using or have used recently 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 it may cause excitement, high blood pressure, and fever above 40°C (hyperpyrexia):

- Monoamine oxidase inhibitors (MAOIs) antidepressants (moclobemide, tranylcypromine)

- Serotonin reuptake inhibitors 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 taking any of the following medications, it may be necessary to modify the dose of one of them or discontinue treatment:

- Amiodarone and quinidine (used 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 adverse effects of dextromethorphan.

TakingBroncomedical with Sulfoguayacolwith food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as it may cause adverse effects.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be 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, therefore, it is recommended to suspend breastfeeding or avoid administering this medication.

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 may be hazardous to the embryo or fetus and should be monitored by your doctor.

Driving and operating machinery

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

Important information about some of the components ofBroncomedical with Sulfoguayacol

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

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

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

The recommended dose is:

Adults and children over 12 years: 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: 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 to half, not exceeding 4 daily doses.

Guidelines for correct administration

Broncomedical with Sulfoguayacol is taken orally.

A dosing cup is included in the packaging. This way, you can measure the amount of medication to be taken 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 dosing cup.

It can be taken with or without food.

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

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

Use in children and adolescents

Do not administer to children under 6 years.

Severe adverse effects may occur in children in case of overdose, including neurological alterations. 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, altered consciousness, involuntary and rapid eye movements, cardiac disturbances (accelerated heart rate), coordination disturbances, 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.

Taking very high amounts of this medication can cause in children a state of drowsiness, hallucinations, nervousness, nausea, vomiting, or gait disturbances.

Cases of abuse with medications containing dextromethorphan have been reported, which can lead to severe adverse 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 discomfort, mumbling speech, nystagmus (uncontrolled and involuntary eye movement), fever, tachypnea (rapid and shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeats), and death.

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

If you forgot to take Broncomedical with Sulfoguayacol

Do not take a double dose to compensate for the missed doses. If necessary, restart treatment according to the section 3. "How to take Bronco Medical".

If you interrupt treatment with Broncomedical with Sulfoguayacol

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

Like all medications, Broncomedical with Sulfoguayacol may produce adverse effects, although not all people will experience them.

During the period of dextromethorphan use, the following adverse effects have been observed, but their frequency could not be established with precision:

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

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

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Once the packaging is opened, do not use it after 6 months.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition ofBroncomedical with Sulfoguayacol

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

Appearance of the product and content of the packaging

Broncomedical with Sulfoguayacol is a transparent solution of a certain color presented in a polyethylene terephthalate bottle containing 180 ml of product and a 15 ml measuring cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Medical, S.A.

Pol. Ind.Las Quemadas, Parcela 87

14014 - Córdoba.

Responsible for manufacturing

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 leaflet was approved in October 2023

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