Broncomedical with sulfoguaiacol 2 mg/ml + 10 mg/ml syrup

Patient Information Leaflet

Introduction

Patient Information Leaflet

Broncomedical with Sulfoguaiacol

2 mg/ml + 10 mg/ml

Oral Solution

Dextromethorphan hydrobromide / Potassium guaiacolsulfonate

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.
• You should consult a doctor if your condition worsens or if symptoms improve after 7 days, or if they are accompanied by high fever, skin rash, or persistent headache.

Leaflet Contents

1. What Broncomedical with Sulfoguaiacol is and what it is used for
2. What you need to know before taking Broncomedical with Sulfoguaiacol
3. How to take Broncomedical with Sulfoguaiacol
4. Possible side effects
5. How to store Broncomedical with Sulfoguaiacol
6. Contents of the pack and other information

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

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

Dextromethorphan is a cough suppressant that inhibits the cough reflex. Guaiacolsulfonate is an expectorant that facilitates the removal of mucus.

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

2. What you need to know before starting to take Broncomedical with Guaiacolsulfonate

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

Do not take Broncomedical with Guaiacolsulfonate

• if you are allergic to dextromethorphan, guaiacolsulfonate, or any of the other ingredients of this medicine (listed in section 6)
• if you have a severe lung disease (respiratory failure)
• if you have asthmatic cough
• if you have cough accompanied by abundant secretions
• if you have persistent or chronic cough such as that caused by smoking or emphysema
• if you are currently receiving, or have received within the previous 2 weeks, treatment with a monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other conditions (see section: "Use of other medicines")
• in children under 6 years of age
• if the patient is sedated, weakened, or bedridden.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Broncomedical with Guaiacolsulfonate

• if your cough persists for more than one 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, 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, Broncomedical with Guaiacolsulfonate 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).

Cases of abuse of medicines containing dextromethorphan have been reported in adolescents; therefore, this possibility should be considered, as serious adverse effects may occur (see section: "If you take more Broncomedical with Guaiacolsulfonate than you should").

Children and adolescents

Do not use in children under 6 years of age.

Taking Broncomedical with Guaiacolsulfonate with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Do not take this medicine during treatment, or within 2 weeks after treatment, with the following medicines, as it may cause excitation, high blood pressure, and fever above 40°C (hyperpyrexia):

• Monoamine oxidase inhibitor (MAOI) antidepressants (moclobemide, tranylcypromine)
• 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)
• Sibutramine (used to treat obesity)

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 of which are used to treat: mental disorders, allergies, Parkinson's disease, etc.)
• Expectorants and mucolytics (used to help eliminate phlegm and mucus)
• Haloperidol (used to treat mental disorders), which may increase the adverse effects of dextromethorphan.

Taking Broncomedical with Guaiacolsulfonate with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

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

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

This medicine is excreted in breast milk; therefore, it is recommended to discontinue breastfeeding or avoid administering this medicine.

Important for women

If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking this medicine during pregnancy may be harmful to the embryo or fetus and must be monitored by your doctor.

Driving and using machines

Rarely, drowsiness and mild dizziness may occur during treatment. If you experience these symptoms, you should not drive or operate dangerous machinery.

Important information about some of the ingredients of Broncomedical with Guaiacolsulfonate

This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult with your doctor before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 3 g of sucrose per 5 ml.

3. How to take Broncomedical with Sulfoguayacol

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Recommended dose:

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

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

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

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

Always use the lowest effective dose.

In patients with hepatic impairment, the dose should be reduced by half, and under no circumstances should the dose exceed 4 daily administrations.

Instructions for correct administration

Broncomedical with Sulfoguayacol is taken orally.

A dosing cup is included in the package, allowing you to measure the exact amount of medication to take according to the information above.

Shake well before use.

To open, press down and twist the cap simultaneously.

Pour the exact dose into the dosing cup.

Can be taken with or without food.

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

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

Use in children and adolescents

Do not administer to children under 6 years of age.

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

If you take more Broncomedical with Sulfoguayacol than you should

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

If you take more than the recommended amount, 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 problems, 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 hospital immediately if you experience any of the symptoms listed above.

Taking very high amounts of this medicine may cause children to become drowsy, experience hallucinations, nervousness, nausea, vomiting, or disturbances in gait.

Cases of abuse have occurred with medications containing dextromethorphan, potentially leading to serious adverse effects such as anxiety, panic, memory loss, tachycardia (rapid heartbeat), lethargy, hypertension or hypotension (high or low blood pressure), mydriasis (pupil dilation), agitation, dizziness, gastrointestinal discomfort, slurred speech, nystagmus (involuntary, uncontrolled eye movements), fever, tachypnea (rapid, shallow breathing), brain damage, ataxia (uncoordinated movements), seizures, respiratory depression, loss of consciousness, arrhythmias (irregular heartbeat), and death.

In case of overdose or inappropriate use, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses. If necessary, restart treatment as indicated in section 3, “How to take Broncomedical”.

If you stop treatment with Broncomedical with Sulfoguayacol

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Broncomedical with Sulfoguaiacol may produce adverse effects, although not everyone will experience them.

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

• In some cases: somnolence, dizziness, vertigo, constipation, gastrointestinal discomfort, nausea, vomiting
• In rarer cases: mental confusion and headache.

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

5. Storage of Broncomedical with Sulfoguaiacol

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

After opening the container, do not use beyond 6 months.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to a pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Package contents and other information

Composition of Broncomedical with Sulfoguayacol

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

Appearance of the product and contents of the container

Broncomedical with Sulfoguayacol is a transparent coloured solution supplied in a 180 ml amber polyethylene bottle and includes a 15 ml dosing cup.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Medical, S.A.

Pol. Ind. Las Quemadas, Parcela 87

14014 - Córdoba, Spain

Manufacturer

Laboratorio Generfarma, S.L.

Ronda Isaac Peral, 6 (Parque Tecnológico)

46980 – Paterna, Valencia, Spain

or

Seid, S.A.

Ctra. Sabadell-Granollers, km. 15

08185 Lliçà de Vall (Barcelona), Spain

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

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

28923- Alcorcón (Madrid), Spain

This leaflet was approved in October 2023

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