Bisolvon Antitussive Compositum 3 mg/ml + 1.5 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Bisolvon Antitussive Compositum 3 mg/ml + 1.5 mg/ml oral solution

dextromethorphan hydrobromide / diphenhydramine hydrochloride

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

Always follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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 any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.
• If symptoms worsen or persist for more than 5 days, or if they are accompanied by high fever, skin rash, or persistent headache, you must consult your doctor.

Contents of the leaflet

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

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

It is a cough suppressant medication.

It is indicated for the symptomatic treatment of dry cough (irritative cough, nervous cough) not accompanied by sputum production, associated with colds and influenza-like conditions in adults and children over 6 years of age.

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 Antitussive Compositum

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

Do not take Bisolvon Antitussive Compositum

• if you are allergic to dextromethorphan, diphenhydramine, or any of the other components of this medicine (listed in section 6).
• if you are currently being treated or have been treated in the previous 2 weeks with monoamine oxidase inhibitors (MAOIs) used to treat depression, serotonin reuptake inhibitors used to treat depression, bupropion (a medicine used to stop smoking), linezolid (an antibacterial medicine), procarbazine (a medicine used to treat cancer), or selegiline (used to treat Parkinson's disease).
• if you have bronchial asthma.
• if you have COPD (chronic obstructive pulmonary disease).
• if you have pneumonia.
• children under 6 years of age must not take this medicine.
• if you have a serious lung disease.
• if you have respiratory depression.
• if you have a heart condition.
• women who are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Bisolvon Antitussive Compositum.

• If you are taking other medicines such as antidepressants or antipsychotics, Bisolvon Antitussive Compositum 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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

This medicine must not be taken by people being treated with central nervous system depressants or with monoamine oxidase inhibitor (MAOI) antidepressants (see section "Other medicines and Bisolvon Antitussive Compositum").

Patients should consult their doctor before using this medicine if they:

• have persistent or chronic cough.
• have productive cough (cough accompanied by abundant sputum).
• have used the medicine for a prolonged period, as tolerance and dependence on the medicine may develop. Patients must not exceed the recommended dose or duration of treatment.
• cases of abuse have been reported with medicines containing dextromethorphan in adolescents and children; therefore, this possibility should be considered, as serious adverse effects may occur (see section "If you take more Bisolvon Antitussive Compositum than you should").
• have a tendency to abuse or dependence and/or psychiatric disorders.
• have liver or kidney disease.
• have atopic dermatitis or mastocytosis.
• are being treated with selective serotonin reuptake inhibitors (SSRIs) used to treat depression and anxiety, or tricyclic antidepressants.
• are sedated, weakened, or bedridden.
• have prostate enlargement, bladder obstruction, or urinary retention, or low potassium levels in the blood.
• have increased intraocular pressure (glaucoma), hyperthyroidism, cardiovascular diseases, high blood pressure (hypertension), intestinal obstruction, or urinary retention, or stomach ulcer.
• are being treated with medicines toxic to the ear.
• diphenhydramine may increase sensitivity to sunlight.

Children and adolescents

• Children under 6 years of age must not take this medicine except under medical advice.
• Medical supervision is recommended for children aged 6 to 12 years.
• Serious adverse effects, including neurological disturbances, may occur in children in case of overdose. Caregivers must not exceed the recommended dose.

Other medicines and Bisolvon Antitussive Compositum

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 excitement, high blood pressure, and fever above 40°C (hyperpyrexia), or increase the effects of diphenhydramine:

• Monoamine oxidase inhibitor antidepressants
• Selective serotonin reuptake inhibitor antidepressants (paroxetine, fluoxetine)
• Bupropion (used to stop smoking)
• Isoniazid (used for infections)
• Linezolid (used as an antibacterial)
• Moclobemide or tranylcypromine (used to treat depression)
• Pargyline (used to treat high blood pressure)
• Procarbazine (used to treat cancer)
• Medicines for Parkinson's disease, such as selegiline
• Neuroleptics

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 to treat heart arrhythmias such as amiodarone or quinidine.
• Anti-inflammatory medicines such as celecoxib, parecoxib, or valdecoxib.
• Medicines used to remove mucus and phlegm such as expectorants or mucolytics.
• Concomitant administration with metoprolol (for the treatment of serious heart conditions).
• Medicines acting on the central nervous system.

Concomitant administration with medicines that inhibit Cytochrome P450 2D6, including medicines such as amiodarone, quinidine (medicines to treat heart arrhythmias), fluoxetine, paroxetine (selective serotonin reuptake inhibitor antidepressants), haloperidol (used as an antipsychotic), propafenone (used for arrhythmias), thioridazine (used as an antipsychotic), cimetidine (to treat peptic ulcer), ritonavir (medicine to treat AIDS), berberine, bupropion (used to stop smoking), cinacalcet (to treat secondary hyperparathyroidism), flecainide (to treat arrhythmias), and terbinafine (treatment of fungal infections).

The use of antihypertensives together with this medicine may increase fatigue.

The sedative effect of medicines used to treat Parkinson's disease, tricyclic antidepressants, MAOIs, neuroleptics, hypnotics, anxiolytics, barbiturates, antipsychotics, and opioid analgesics may be enhanced.

Signs of injury caused by ototoxic medicines such as aminoglycoside antibiotics may be masked.

Interference with diagnostic tests

If you are scheduled to undergo any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Bisolvon Antitussive Compositum with food, drinks, and alcohol

Do not consume alcoholic beverages during treatment, as adverse reactions may occur.

It is not recommended to take this medicine together with grapefruit juice or bitter orange juice.

Pregnancy, breastfeeding, and fertility

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

Dextromethorphan and diphenhydramine should only be taken during pregnancy after careful evaluation by your doctor or pharmacist.

This medicine must not be taken during breastfeeding (see section "Do not take Bisolvon Antitussive Compositum").

No effect of this medicine on fertility has been observed.

Driving and using machines

This medicine may cause mild drowsiness or dizziness and may impair reaction ability, even when taken at the recommended dose. Therefore, your ability to drive or operate dangerous machinery during treatment may be affected.

This risk increases when taken in combination with alcohol or other medicines that may themselves impair reaction ability.

Bisolvon Antitussive Compositum contains sorbitol (E 420), amaranth (E 123), sodium benzoate (E 211), and propylene glycol (E 1520)

This medicine contains sorbitol (E 420). This medicine contains 500.15 mg of sorbitol per ml. Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which the body cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine may cause allergic-type reactions because it contains amaranth (E 123).

This medicine contains 2 mg of sodium benzoate (E 211) per ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains 50 mg of propylene glycol (E 1520) per ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, particularly if the baby has been given other medicines containing propylene glycol or alcohol.

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

3. How to take Bisolvon Antitussive Compositum

Follow exactly the dosing instructions provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

If you think you have taken too much Bisolvon Antitussive Compositum, seek medical help immediately. It is recommended to take this medicine with food and to drink plenty of water during treatment. Cases of abuse of diphenhydramine and dextromethorphan have been reported, including in children and adults.

Recommended dose:

Adults and adolescents aged 12 years and older:

Take one 5 ml dose every 4 to 8 hours. Maximum daily dose: 120 mg of dextromethorphan hydrobromide and 60 mg of diphenhydramine hydrochloride (40 ml). Do not exceed 6 doses per day.

Use in children

Children aged 6 to 11 years:

Take one 2.5 ml dose every 4 to 8 hours. Maximum daily dose: 60 mg of dextromethorphan hydrobromide and 30 mg of diphenhydramine hydrochloride (20 ml). Do not exceed 6 doses per day.

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

Children under 6 years:

This medicine is contraindicated in children under 6 years of age.

Method of administration

Bisolvon Antitussive Compositum is administered orally. Open the child-resistant cap by pressing down and turning the cap to the left. Use the dosing cup provided in the cap.

For nighttime cough, it is advisable to take this medicine before going to bed.

If cough worsens, persists for more than 5 days, or is accompanied by high fever, skin rash, or persistent headache, consult your doctor.

The duration of treatment should not exceed 5 days without medical supervision.

If you take more Bisolvon Antitussive Compositum than you should

Due to dextromethorphan:

In case of overdose, the most common signs—especially in children, adolescents, or cases of abuse—are nausea, vomiting, and gastrointestinal disturbances, dizziness, fatigue, drowsiness, and hallucinations. Restlessness and excitability may occur, which, with increasing overdose, may lead to agitation.

Additional symptoms may include difficulty concentrating, loss of consciousness, coma (in cases of severe intoxication), mood changes, psychotic disorders such as disorientation and delusions, up to states of confusion or paranoia, increased muscle tone, ataxia (uncoordinated movements), dysarthria, nystagmus (involuntary and uncontrollable eye movements), visual disturbances, as well as respiratory depression, hypertension or hypotension (high or low blood pressure), and tachycardia (rapid heartbeat).

Serotonin syndrome may also be increased.

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

If you take more Bisolvon Antitussive Compositum than recommended, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, disturbances of consciousness, rapid and involuntary 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 breathing difficulties, and seizures.

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

Due to diphenhydramine:

In case of overdose, symptoms include dryness of mucous membranes, urinary retention, reduced peristalsis, mydriasis (pupil dilation), skin flushing, hyperthermia, drowsiness, tachycardia, hallucinations, and seizures.

Symptoms of central nervous system depression and stimulation, as well as hypotension, have also been reported.

Accidental ingestion of very high doses may cause more severe symptoms in children than those described 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.

If you forget to take Bisolvon Antitussive Compositum

Do not take a double dose to make up for missed doses. If symptoms persist, restart treatment as indicated in section 3.

4. Possible adverse effects

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

The following adverse effects have been observed during the period of use of dextromethorphan and diphenhydramine:

Very common: dizziness and somnolence.

Common: mental confusion, gastrointestinal discomfort (nausea, vomiting, and constipation), and fatigue.

Uncommon: blurred vision, dry mouth, and difficulty urinating, more likely in elderly patients.

Very rare: increased intraocular pressure, blood disorders, allergic reactions, for example affecting the skin.

Frequency not known: hallucinations, drug dependence, allergic reactions such as anaphylactic reaction, angioedema, bronchospasm, urticaria, skin reactions such as erythema with pruritus, headache, vertigo, slurred speech, nystagmus, dystonia, fixed drug eruption, atopic dermatitis, paradoxical reactions, and photosensitivity following intense sun exposure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Expectorant Compositum

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.

Do not use more than 6 months after first opening the container.

Store below 30 °C. Do not freeze.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please 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 Compositum

• The active substances are dextromethorphan hydrobromide and diphenhydramine hydrochloride. Each ml contains 3 mg of dextromethorphan hydrobromide and 1.5 mg of diphenhydramine hydrochloride.

• The other components (excipients) are: sodium benzoate (E211), citric acid monohydrate, sodium hydroxide, hydroxyethylcellulose, propylene glycol, raspberry flavour, amaranth (E123), glycerol (E422), sorbitol (E420), purified water.

Appearance of the product and contents of the pack

Bisolvon Antitussive Compositum is a clear, translucent red solution.

It is supplied in colourless glass bottles with child-resistant screw caps containing 200 ml of solution and a dosing cup marked with the following measurements: 1.25 ml, 2.5 ml and 5 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona,

Spain

Manufacturer:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

or

Opella Healthcare Italy, S.r.l.

Viale Europa 11, 21040

Origgio (Va)

Italy

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

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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/69543/P_69543.html