Prospect: Information for the User

Bisolvon Antitusivo 2 mg/ml Syrup

Dextromethorphan hydrobromide

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 or pharmacist.

• 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,even if they are not listed in this prospect. See section 4
• You should consult a doctor if it worsens or does not improve after 5 days.

The dextromethorphan, active ingredient of this medication, is an antitussive that inhibits the cough reflex.

It is indicated for the symptomatic treatment of forms of cough not accompanied by expectoration (irritative cough, nervous cough) in adults and children aged 2 years and above.

Consult a doctor if it worsens or does not improve after 5 days of treatment

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

Do not take Bisolvon Antitusivo:

• If you are allergic to dextromethorphan or any of the other components of this medication(listed in section 6).
• Children under 2 years old cannot take this medication.

• If you have bronchial asthma.
• If you have chronic obstructive pulmonary disease (COPD).
• If you have pneumonia.
• If you have respiratory failure.
• If you have respiratory depression.
• If you are breastfeeding.

• If you have a cough accompanied by abundant secretions (for example in patients with diseases such as bronchiectasis (a lung disease where the bronchi are dilated and filled with pus) or cystic fibrosis).
• If you are being treated or have been treated in the past 2 weeks with any monoamine oxidase inhibitor (MAOI) used to treat depression, Parkinson's disease, or other diseases, as well as other serotonin reuptake inhibitors used to treat depression such as fluoxetine and paroxetine; or also with bupropion, which is a medication used to quit smoking, or with linezolid, which is an antibacterial medication.

Warnings and precautions

Consult your doctor before starting to take Bisolvon Antitusivo

• If you have persistent or chronic cough.
• If you are taking serotoninergic medications (different from MAOIs) such as serotonin reuptake inhibitors or tricyclic antidepressants (see section Other medications and Bisolvon Antitusivo).
• In patients with neurological diseases associated with a significantly reduced cough reflex (such as stroke, Parkinson's disease, and dementia), treatment with Bisolvon Antitusivo should be administered with special caution and only after carefully evaluating the benefit-risk (see section Other medications and Bisolvon Antitusivo).
• If you have liver or kidney disease.
• If you have atopic dermatitis (an inflammatory skin disease characterized by erythema, pruritus, exudation, crusts, and desquamation, which begins in childhood in individuals with hereditary allergic predisposition) and/or mastocytosis(an increase in mast cells in the blood).
• If you are sedated, debilitated, or bedridden.
• Dextromethorphan has a mild addictive potential. Its prolonged use (for example, if the recommended duration is exceeded) may produce mental and physical dependence. Individuals with a tendency to abuse or dependence should only take it under strict medical supervision and for short periods of time. Patients should not exceed the recommended dose or duration of treatment.
• Cases of abuse with medications containing dextromethorphan have been reported, especially in adolescents and young adults, as well as in patients with a history of substance or psychoactive substance abuse, therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section If you take more Bisolvon Antitusivo than you should).

• It is recommended to have a doctor or pharmacist supervise the treatment of children between 2 and 12 years old.
• If you are taking other medications such as antidepressants or antipsychotics, Bisolvon Antitusivo may interact with these medications and you may experience changes in your mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, hypertension, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

Other medications and Bisolvon Antitusivo

Inform your doctor or pharmacist if you are using, 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 a fever higher than 40°C (hyperpyrexia):

• MAOIs (moclobemide, tranilcipromina)
• SSRIs (paroxetine, fluoxetine)
• Bupropion (used to quit smoking)
• Linezolid (used as an antibacterial)
• Procarbazina (used to treat cancer)
• Selegilina (used to treat Parkinson's disease)
• Terbinafina (used as an antifungal)

Before taking this medication, consult your doctor if you are using any of the following medications, as it may be necessary to modify the dose of one of them or discontinue treatment:

• Medications to treat heart arrhythmias such as Amiodarona, Quinidina, Flecainida, and Propafenona.
• Anti-inflammatory medications such as celecoxib, parecoxib, or valdecoxib.
• Depressants of the central nervous system used to treat mental illnesses, allergies, Parkinson's disease.
• Expectorants and mucolytics, especially if you have a chest disease such as bronchiectasis (a lung disease where the bronchi are dilated and filled with pus) or cystic fibrosis.
• Medications used to treat psychosis (mental states in which there is a loss of contact with reality) such as Haloperidol and Tioridazina.
• Medications used to treat HIV such as Ritonavir.
• Herbal medications such as Berberina.
• Medications used to treat hyperparathyroidism such as Cinacalcet.
• Antifungal medications such as Terbinafina.
• Medications used to treat stomach acid such as Cimetidina.

Taking Bisolvon Antitusivo with food, drinks, and alcohol:

Do not consume alcoholic beverages during treatment, as it may increase the risk of adverse effects.

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

Pregnancy, lactation, and fertility

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

Bisolvon Antitusivo contains propylene glycol. If you are pregnant or breastfeeding,

do not take this medication unless recommended by your doctor, as it may cause respiratory depression in infants.

Your doctor may perform additional checks while you are taking this medication.

Driving and operating machinery:

During treatment, you may experience a decrease in reaction time or drowsiness and dizziness, even at the recommended doses, so if you notice these symptoms, you should not drive or operate machinery.

Bisolvon Antitusivo contains maltitol, propylene glycol, methyl parahydroxybenzoate, and sodium:

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

This medication contains 66.08 mg of propylene glycol per ml. If you are pregnant or breastfeeding, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication. If you have liver or kidney disease, do not take this medication unless recommended by your doctor. Your doctor may perform additional checks while you are taking this medication. If the child is under 5 years old, consult your doctor or pharmacist, especially if other medications containing propylene glycol or alcohol have been administered.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218).

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.Do not exceed the recommended dose or the duration of treatment indicated. Cases of dextromethorphan abuse have been reported, even in children and adolescents.

The recommended dose is:

Adults and adolescents 12 years and older:take 5 to 10 ml, depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

You can also take 15 ml every 6 or 8 hours if necessary.

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

Use in children

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

Children 6-11 years:take 2.5 to 5 ml depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

You can also take 7.5 ml every 6 or 8 hours if necessary.

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

Children 2-5 years:take 1.25 to 2.5 ml depending on the intensity of the cough, every 4 hours if necessary. Do not exceed 6 doses in 24 hours.

You can also take 3.75 ml (2.5 ml + 1.25 ml) every 6 or 8 hours if necessary. The maximum amount that can be taken in 24 hours is 15 ml divided into several doses.

Children under 2 years:

This medication is contraindicated in children under 2 years.

How to take:

This medication is taken orally.

A measuring cup is included in the box to measure the amount of medication to be taken.

Drink the medication directly from the measuring cup and wash it after each use.

You can take it with or without food.

Do not take with orange or bitter lemon juice or with alcoholic beverages (See section Taking Bisolvon Antitusivo with food, drinks, and alcohol).

If it worsens or persists for more than 5 days of treatment, or if accompanied by high fever, skin eruptions, or persistent headache, consult your doctor.

If you take more Bisolvon Antitusivo than you should:

If you think you have taken too much Bisolvon Antitusivo, seek medical help immediately.

If you take more Bisolvon Antitusivo than recommended, you may notice, especially in children and adolescents or in case of abuse: nausea, vomiting, gastrointestinal discomfort, dizziness, fatigue, drowsiness, and hallucinations. Additionally, restlessness and excitement can turn into agitation with increasing overdose. Furthermore, symptoms such as decreased concentration and consciousness up to coma as a sign of severe poisoning, mood changes such as dysphoria and euphoria, confused speech, loss of balance, psychotic disorders such as disorientation and delirium up to confused or paranoid states, increased muscle tone, ataxia (uncoordinated movements), dysarthria, nystagmus (uncontrolled and involuntary eye movements), and visual disturbances, as well as respiratory depression, changes in blood pressure (high or low tension), and tachycardia (rapid heart rate) may occur.

Dextromethorphan may increase the risk of serotonin syndrome, and this risk is increased in cases of overdose, especially when taken with other serotoninergic agents.

Cases of death due to overdose have been reported when taking dextromethorphan with other drugs (combined poisoning).

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

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

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

In case of overdose or accidental ingestion, contact your doctor or call the Toxicological Information Service (phone 91.5620420), indicating the medication and the amount ingested. Naloxone may be used as an antagonist.

If you forgot to take Bisolvon Antitusivo:

If you forgot to take Bisolvon Antitusivo and symptoms persist, do not take a double dose to compensate for the missed dose. If necessary, resume the medication in the same way as indicated in the section 3. How to take Bisolvon Antitusivo.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Very common adverse effects: may affect more than 1 in 10 patients

• dizziness

Rare adverse effects: may affect up to 1 in 1,000 patients

• excitement
• decreased appetite

Adverse effects of unknown frequency (cannot be estimated from available data)

• itching (urticaria)
• skin rash (erythema, urticaria, fixed drug eruption)
• drug addiction
• respiratory difficulties (bronchospasm)
• hallucinations
• confusion
• drowsiness
• allergic reactions (hypersensitivity, including anaphylactic reaction)
• swelling of the face and lips (angioedema)
• difficulty speaking and eye spasms (nystagmus)
• muscle tension disorder (dystonia), especially in children
• sensation of spinning (vertigo)
• lethargy
• vomiting
• constipation
• fatigue
• dilated pupils (mydriasis)

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not freeze.

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.

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

Composition of Bisolvon Antitusivo

• The active ingredient is dextromethorphan hydrobromide. Each ml of syrup contains

2 mg of dextromethorphan hydrobromide.

?The other components (excipients) are: sodium saccharin, liquid maltitol (E965), propylene glycol (E1520), vanilla flavor, apricot flavor, methyl parahydroxybenzoate (E218) and purified water.

Appearance of the product and contents of the packaging

Bisolvon Antitusivo is a syrup with an apricot and vanilla scent.

It is presented in a 200 ml packaging with a dosing cup.

Holder of the marketing authorization:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing:

DELPHARM REIMS, S.A.S.

10, Rue Colonel Charbonneaux

51100 Reims

France

Last review date of this leaflet: March 2024

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