Prospect: information for the user

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

dextromethorphan hydrobromide / diphenhydramine hydrochloride

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.
• If symptoms worsen or persist after 5 days, or if they are accompanied by high fever, skin eruptions, or persistent headache, you must consult your doctor.

1. What is Bisolvon Antitusivo Compositum and for what it is used

2. What you need to know before starting to take Bisolvon Antitusivo Compositum

3. How to take Bisolvon Antitusivo Compositum

4. Possible adverse effects

5. Storage of Bisolvon Antitusivo Compositum

6. Contents of the package and additional informationl

It is an antitussive medication.

It is indicated for the symptomatic treatment of forms of cough that are not accompanied by expectoration (irritative cough, nervous cough) in colds and flu-like processes in adults and children over 6 years old.

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 takeBisolvon Antitusivo Compositum

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bisolvon Antitusivo Compositum.

• If you are taking other medications such as antidepressants or antipsychotics, Bisolvon Antitusivo Compositum 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, high blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhea).

Do not take this medication if you are taking central nervous system depressants or MAOIs (see section Other medications and Bisolvon Antitusivo Compositum).

You should consult your doctor before using this medication if you have:

• chronic or persistent cough.
• productive cough (cough accompanied by abundant mucus).
• long-term use, as tolerance and dependence to the medication may develop. Patients should not exceed the recommended dose or duration of treatment.
• cases of abuse with medications containing dextromethorphan in adolescents and children have been reported, therefore, this possibility should be taken into account, as it may cause severe adverse effects (see section If you take moreBisolvon Antitusivo Compositumthan you should).
• patients with a tendency to abuse or dependence and/or psychiatric diseases.
• liver and kidney disease.
• atopic dermatitis and mastocytosis.
• selective serotonin reuptake inhibitors (SSRIs) used to treat depression and anxiety, or tricyclic antidepressants.
• sedated, weakened, or bedridden patients.
• prostatic hypertrophy, urinary obstruction, or urinary retention, low potassium levels in the blood.
• increased intraocular pressure (glaucoma), hyperthyroidism, cardiovascular diseases, high blood pressure (hypertension), intestinal obstruction, or urinary retention, stomach ulcers.
• medications toxic to the ear.
• diphenhydramine may increase sensitivity to sunlight.

Children and adolescents

• children under 6 years old cannot take this medication except under medical advice.
• it is recommended to have a healthcare professional supervise children aged 6 to 12 years.
• severe adverse effects may occur in children in case of overdose, including neurological alterations. Caregivers should not exceed the recommended dose.

Other medications and Bisolvon Antitusivo Compositum

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take 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), or increase the effects of diphenhydramine:

• MAOIs
• SSRIs (paroxetine, fluoxetine)
• bupropion (used for smoking cessation)
• 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)
• selegiline (used for Parkinson's disease treatment)
• neuroleptics

Before taking this medication, you should 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 interrupt treatment:

• medications used to treat heart arrhythmias such as amiodarone or quinidine.
• anti-inflammatory medications such as celecoxib, parecoxib, or valdecoxib.
• expectorants or mucolytics used to eliminate mucus and phlegm.
• concomitant administration with metoprolol (for the treatment of severe heart disease).
• medications that act on the central nervous system.

Concomitant administration with medications that inhibit CYP2D6, including medications such as amiodarone, quinidine (medications used to treat heart arrhythmias), fluoxetine, paroxetine (SSRIs), haloperidol (used as an antipsychotic), propafenone (used for arrhythmias), thioridazine (used as an antipsychotic), cimetidine (used to treat stomach ulcers), ritonavir (used to treat HIV/AIDS), berberine, bupropion (used to quit smoking), cinacalcet (used to treat secondary hyperparathyroidism), flecainide (used to treat arrhythmias), and terbinafine (used to treat fungal infections).

The use of antihypertensives concomitantly with this medication may increase fatigue.

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

The signs of ototoxicity caused by medications such as aminoglycoside antibiotics may be masked.

Interference with analytical tests

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

TakingBisolvon Antitusivo Compositumwith food, drinks, and alcohol

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

Do not take it concomitantly with orange or grapefruit juice.

Pregnancy, lactation, and fertility

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

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

This medication should not be taken during lactation (see section Do not takeBisolvon Antitusivo Compositum).

This medication has not been observed to affect fertility.

Driving and operating machinery

This medication may cause mild drowsiness or dizziness and alter your reaction time, even at the recommended doses. Therefore, your ability to drive or operate hazardous machinery during treatment may be affected.

Thisrisk is increased when taken in combination with alcohol or other medications that may affect your reaction time on their own.

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

This medication contains sorbitol (E 420). This medication contains 500.15 mg of sorbitol in each ml. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medication may cause allergic reactions because it contains amaranth (E 123).

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

This medication contains 50 mg of propylene glycol (E 1520) in each ml. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

This medication contains less than 1 mmol of sodium (23 mg) 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. In case of doubt, ask your doctor or pharmacist.

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

The recommended dose is:

Adults and adolescents 12 years and older:

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

Use in children

Children 6 to 11 years:

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

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

Children under 6 years:

This medication is contraindicated in children under 6 years.

Administration form

Bisolvon Antitusivo Compositum is administered orally,by opening the child-resistant closure of the bottle by pressing down and turning the cap to the left,using the dosing cup included in the cap.

In case of nocturnal cough, it is recommended to administer this medication before bedtime.

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

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

If you take moreBisolvon Antitusivo Compositumthan you should

Due to dextromethorphan:

If an overdose has been taken, the most frequent signs, especially in children and adolescents or in cases of abuse, are: nausea, vomiting, and gastrointestinal disturbances, dizziness, fatigue, drowsiness, and hallucinations. Restlessness and excitement that with increasing overdose can trigger agitation.

Additionally, symptoms such as concentration disturbances and loss of consciousness, coma (in cases of severe poisoning), changes in mood, psychotic disorders such as disorientation and delirium up to states of confusion or paranoia, increased muscle tone, ataxia (uncoordinated movements), dysarthria, nystagmus (uncontrolled and involuntary eye movements) and visual disturbances, as well as respiratory depression, hypertension or hypotension, and tachycardia (accelerated heart rate) may appear.

Serotonin syndrome may also increase.

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

If you take more Bisolvon Antitusivo Compositum than indicated, you may experience the following symptoms: nausea and vomiting, involuntary muscle contractions, agitation, confusion, drowsiness, consciousness disturbances, 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 convulsions.

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

Due to diphenhydramine:

If an overdose has been taken, the signsare dryness of mucous membranes, urinary retention, reduced peristalsis, mydriasis (pupil dilation), skin erythema, hyperthermia, somnolence, tachycardia, hallucinations, and convulsions.

Symptoms of depression and stimulation of the central nervous system and hypotension have also been described.

Accidental intake of very high doses may produce in children more severe symptoms than those described above.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicological Information Service (phone: 91.5620420), indicating the medication and the amount ingested.

If you forgot to takeBisolvon Antitusivo Compositum

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

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

During the period of use of dextromethorphan and diphenhydramine, the following adverse effects have been observed:

Very common: dizziness and drowsiness.

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 on the skin.

Frequency unknown: hallucinations, medication dependence, allergic reactions such as anaphylactic reactions, angioedema, bronchospasm, urticaria, skin reactions such as erythema with pruritus, headache, vertigo, slurred speech, nystagmus, dystonia, fixed drug eruption, atopic dermatitis, and paradoxical reactions and sensitivity to sunlight after intense sun exposure.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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.

Do not use after 6 months of opening the packaging for the first time.

Store below 30°C. Do not freeze.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofBisolvon Antitusivo Compositum

• The active principles 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 flavor, amaranth (E123), glycerol (E422), sorbitol (E420), purified water.

Appearance of the product and contents of the packaging

Bisolvon Antitusivo Compositumis a clear, transparent red-colored solution.

It is presented in colorless glass bottles with a child-resistant plastic screw cap containing 200 ml of solution and a measuring cup marked with the following measurements: 1.25 ml, 2.5 ml, and 5 ml.

Holder of the marketing authorization:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

Responsible for manufacturing:

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

Last review date of this leaflet:June 2024

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69543/P_69543.html