Bisolvon Antitussive 2 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bisolvon Cough Syrup 2 mg/ml

Dextromethorphan hydrobromide

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, 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 adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

Leaflet contents

1. What Bisolvon Cough Syrup is and what it is used for
2. What you need to know before taking Bisolvon Cough Syrup
3. How to take Bisolvon Cough Syrup
4. Possible adverse effects
5. How to store Bisolvon Cough Syrup
6. Contents of the pack and other information

1. What Bisolvon Cough Syrup is and what it is used for

Dextromethorphan, the active ingredient in this medicine, is a cough suppressant that inhibits the cough reflex.

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

You should consult a doctor if symptoms worsen or do not improve after 5 days of treatment.

2. What you need to know before taking Bisolvon Cough Syrup

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

Do not take Bisolvon Cough Syrup:

• If you are allergic to dextromethorphan or any of the other ingredients of this medicine (listed in section 6).

• Children under 2 years of age must not take this medicine.

• If you have bronchial asthma.

• If you have chronic obstructive pulmonary disease (COPD).

• If you have pneumonia.

• If you have respiratory insufficiency.

• If you have respiratory depression.

• If you are breastfeeding.

• If you have a cough accompanied by abundant secretions (e.g., in patients with conditions such as bronchiectasis (a lung disease where the bronchi are dilated and filled with pus) or cystic fibrosis).

• If you are currently being treated or have been treated within the previous 2 weeks with monoamine oxidase inhibitors (MAOIs) used for depression, Parkinson’s disease, or other conditions, as well as other serotonin reuptake inhibitors used for depression such as fluoxetine and paroxetine; or with bupropion, a medicine used to stop smoking, or with linezolid, an antibacterial agent. (See section "Other medicines and Bisolvon Cough Syrup").

Warnings and precautions

Consult your doctor before starting to take Bisolvon Cough Syrup:

• If you have a persistent or chronic cough.
• If you are taking serotonergic medicines (other than MAOIs), such as serotonin reuptake inhibitors or tricyclic antidepressants (see section "Other medicines and Bisolvon Cough Syrup").
• In patients with neurological disorders associated with markedly reduced cough reflex (such as stroke, Parkinson’s disease, and dementia), treatment with Bisolvon Cough Syrup should be administered with special caution and only after careful benefit-risk assessment (see section "Other medicines and Bisolvon Cough Syrup").
• If you have liver or kidney disease.
• If you have atopic dermatitis (an inflammatory skin disease characterized by erythema, itching, exudation, crusting, and scaling, which begins in infancy in individuals with hereditary predisposition to allergy) and/or mastocytosis (increased number of mast cells in blood).
• If you are sedated, weakened, or bedridden.
• Dextromethorphan has a low potential for addiction. Prolonged use (e.g., exceeding the recommended duration) may lead to tolerance or mental and physical dependence. Individuals with a history of substance abuse or dependence should only take this medicine under strict medical supervision and for short periods. Patients must not exceed the recommended dose or treatment duration.
• Cases of abuse have been reported with medicines containing dextromethorphan, particularly among adolescents and young adults, as well as in patients with a history of drug or psychoactive substance abuse. This possibility should therefore be considered, as it may lead to serious adverse effects (see section: "If you take more Bisolvon Cough Syrup than you should").
• Medical or pharmacist supervision is recommended when treating children aged between 2 and 12 years.
• If you are taking other medicines such as antidepressants or antipsychotics, Bisolvon Cough Syrup may interact with them, possibly causing 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, diarrhea).

Other medicines and Bisolvon Cough Syrup

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

• Monoamine oxidase inhibitor antidepressants (MAOIs) (moclobemide, tranylcypromine)
• Serotonin reuptake inhibitor antidepressants (SSRIs) (paroxetine, fluoxetine)
• Bupropion (used to stop smoking)
• Linezolid (used as an antibacterial)
• Procarbazine (used to treat cancer)
• Selegiline (used to treat Parkinson’s disease)
• Terbinafine (used as an antifungal)

Before taking this medicine, consult your doctor if you are using any of the following medicines, as it may be necessary to adjust the dose or discontinue treatment:

• Medicines for treating heart arrhythmias such as amiodarone, quinidine, flecainide, and propafenone.
• Anti-inflammatory medicines such as celecoxib, parecoxib, or valdecoxib.
• Central nervous system depressants used to treat mental illnesses, allergies, or Parkinson’s disease.
• Medicines used to expel phlegm and mucus, such as expectorants and mucolytics, especially if you have a chest condition such as bronchiectasis (a lung disease where the bronchi are dilated and filled with pus) or cystic fibrosis.
• Medicines for treating psychosis (mental states involving loss of contact with reality) such as haloperidol and thioridazine.
• Medicines for treating HIV such as ritonavir.
• Herbal medicines such as berberine.
• Medicines for treating hyperparathyroidism such as cinacalcet.
• Antifungal medicines such as terbinafine.
• Medicines for treating stomach acidity such as cimetidine.

Taking Bisolvon Cough Syrup with food, drinks, and alcohol:

Do not consume alcoholic beverages during treatment, as this may increase the occurrence of 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.

Bisolvon Cough Syrup contains propylene glycol. If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor, as it may cause slow and shallow breathing (respiratory depression) in infants.

Your doctor may perform additional check-ups while you are taking this medicine.

Driving and using machines:

During treatment, reduced reaction ability, drowsiness, and mild dizziness may occur, even when taken at the recommended dose. If you experience these symptoms, you should not drive or operate machinery.

Bisolvon Cough Syrup contains maltitol, propylene glycol, methylparahydroxybenzoate, and sodium:

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

This medicine contains 66.08 mg of propylene glycol per ml. If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine. If you have liver or kidney insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may perform additional check-ups while you are taking this medicine. If the child is under 5 years of age, consult your doctor or pharmacist, especially if they have been given other medicines containing propylene glycol or alcohol.

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

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

3. How to take Bisolvon Cough Syrup

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

The recommended dose is:

Adults and adolescents aged 12 years and over: Take 5 to 10 ml, depending on the severity of cough, every 4 hours if needed. Do not exceed 6 doses in 24 hours.

Alternatively, 15 ml may be taken every 6 or 8 hours if needed.

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

Use in children

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

Children aged 6–11 years: Take 2.5 to 5 ml, depending on the severity of cough, every 4 hours if needed. Do not exceed 6 doses in 24 hours.

Alternatively, 7.5 ml may be taken every 6 or 8 hours if needed.

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

Children aged 2–5 years: Take 1.25 to 2.5 ml, depending on the severity of cough, every 4 hours if needed. Do not exceed 6 doses in 24 hours.

Alternatively, 3.75 ml (one 2.5 ml measure plus one 1.25 ml measure) may be taken every 6 or 8 hours if needed. The maximum amount that can be taken in 24 hours is 15 ml, divided into several doses.

Children under 2 years of age:

This medicine is contraindicated in children under 2 years of age.

How to take:

This medicine is taken orally.

A graduated dosing cup is included in the package to help measure the correct amount of medicine.

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

The medicine may be taken with or without food.

Do not take with grapefruit juice or bitter orange juice, or with alcoholic beverages (see section "Taking Bisolvon Cough Syrup with food, drinks and alcohol").

If your symptoms worsen or if cough persists for more than 5 days of treatment, or if accompanied by high fever, skin rash, or persistent headache, consult your doctor.

If you take more Bisolvon Cough Syrup than you should:

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

If you take more Bisolvon Cough Syrup than recommended, you may experience, especially in children and adolescents or in cases of abuse: nausea, vomiting, gastrointestinal discomfort, dizziness, fatigue, drowsiness, and hallucinations. Restlessness and excitability may progress to agitation as the overdose increases. Additionally, symptoms such as decreased concentration and level of consciousness up to coma (as a sign of severe intoxication), mood changes such as dysphoria and euphoria, confused speech, loss of balance, psychotic disorders such as disorientation and delusions up to states of confusion or paranoia, increased muscle tone, ataxia (uncoordinated movements), dysarthria, nystagmus (involuntary, rapid eye movements), and visual disturbances may occur. Respiratory depression, changes in blood pressure (high or low), and tachycardia (increased heart rate) may also occur.

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

Cases of death due to overdose have been reported when dextromethorphan was taken with other drugs (combined intoxication).

If you take more Bisolvon Cough Syrup than indicated, 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 disorders, psychosis with visual hallucinations, and hyperexcitability.

Other symptoms in cases of massive overdose may include: coma, severe breathing problems, and seizures.

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

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

If you forget to take Bisolvon Cough Syrup:

If you forget to take Bisolvon Cough Syrup and symptoms persist, do not take a double dose to make up for the missed dose. If necessary, resume taking the medicine as indicated in section 3. How to take Bisolvon Cough Syrup.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• dizziness

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

• excitation
• decreased appetite

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

• itching (urticaria)
• skin rash (erythema, rash, fixed drug eruption)
• medication dependence
• breathing difficulties (bronchospasm)
• hallucinations
• confusion
• somnolence
• 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)
• dizziness
• vomiting
• constipation
• fatigue
• dilated pupils (mydriasis)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it involves possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bisolvon Cough Syrup

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not freeze.

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

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bisolvon Antitussive

• The active substance 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 flavour, apricot flavour, methyl parahydroxybenzoate (E218) and purified water.

Appearance of the product and contents of the pack

Bisolvon Antitussive is a syrup with an apricot and vanilla odour.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona,

Spain

Manufacturer:

DELPHARM REIMS, S.A.S.

10, Rue Colonel Charbonneaux

51100 Reims

France

Date of the most recent review of this leaflet: November 2025

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/57174/P_57174.html

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