BISOLVON ANTITUSSIVE COMPOSITUM 3 mg/ml + 1.5 mg/ml ORAL SOLUTION

2. What you need to know before taking Bisolvon Antitusivo Compositum

This medication can cause dependence. Therefore, treatment should be short-term.

Do not takeBisolvon Antitusivo Compositum

• if you are allergic to dextromethorphan, diphenhydramine, or any of the other components of this medication (included in section 6).
• if you are being treated or have been treated in the last 2 weeks with any monoamine oxidase inhibitor (MAOI) medication used to treat depression, serotonin reuptake inhibitor medications used to treat depression, bupropion which is a medication used to quit smoking, linezolid which is an antibacterial medication, procarbazine which is a medication used to treat cancer, or selegiline which is used to treat Parkinson's disease.
• if you have bronchial asthma.
• if you have COPD.
• if you have pneumonia.
• children under 6 years old cannot take this medication.
• if you have a severe lung disease.
• if you have respiratory depression.
• if you have a heart problem.
• breastfeeding women.

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 stiffness, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, and diarrhea).

People undergoing treatment with central nervous system depressants or monoamine oxidase inhibitor (MAOI) antidepressants should not take this medication (see section Other medications and Bisolvon Antitusivo Compositum).

Patients should consult their doctor before using this medication:

• with persistent or chronic cough.
• with productive cough (cough accompanied by abundant expectoration).
• after prolonged use, as tolerance and dependence on the medication may develop. Patients should not exceed the recommended dose or duration of treatment.
• there have been cases of abuse with medications containing dextromethorphan in adolescents and children, so this possibility should be taken into account, as serious side effects may occur (see section If you take more Bisolvon Antitusivo Compositum than you should).
• in patients with a tendency to abuse or dependence and/or with psychiatric illnesses.
• with liver and kidney disease.
• with atopic dermatitis and mastocytosis.
• under treatment with selective serotonin reuptake inhibitors (SSRIs) used to treat depression and anxiety, or tricyclic antidepressants.
• who are sedated, debilitated, or bedridden.
• with prostate hypertrophy, bladder obstruction, or urinary retention, low potassium levels in the blood.
• with increased eye pressure (glaucoma), hyperthyroidism, cardiovascular diseases, high blood pressure (hypertension), intestinal obstruction, or urinary retention, stomach ulcers.
• under treatment with ototoxic medications.
• diphenhydramine may increase sensitivity to sunlight.

Children and adolescents

• children under 6 years old cannot take this medication except under medical advice.
• supervision by a healthcare professional is recommended in children between 6 and 12 years old.
• serious side effects can occur in children in case of overdose, including neurological alterations. Caregivers should not exceed the recommended dose.

Other medications and Bisolvon Antitusivo Compositum

Tell your doctor or pharmacist if you are taking or have recently taken 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 excitement, high blood pressure, and fever above 40°C (hyperpyrexia) may occur or the effects of diphenhydramine may increase:

• Monoamine oxidase inhibitor (MAOI) antidepressants
• Selective serotonin reuptake inhibitor (SSRI) antidepressants (paroxetine, fluoxetine)
• Bupropion (used to quit 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)
• Medications for Parkinson's disease, such as selegiline
• 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 to treat heart arrhythmias such as amiodarone or quinidine.
• Anti-inflammatory medications such as celecoxib, parecoxib, or valdecoxib.
• Medications used to eliminate phlegm and mucus such as expectorants or mucolytics.
• Concomitant administration with metoprolol (for the treatment of serious heart diseases).
• Medications that act on the central nervous system.

Concomitant administration with medications that inhibit Cytochrome P450 2D6, which include medications such as amiodarone, quinidine (medications to treat heart arrhythmias), fluoxetine, paroxetine (SSRI antidepressants), haloperidol (used as an antipsychotic), propafenone (used for arrhythmias), thioridazine (used as an antipsychotic), cimetidine (for the treatment of peptic ulcers), ritonavir (medication for the treatment of AIDS), berberine, bupropion (used to quit smoking), cinacalcet (to treat secondary hyperparathyroidism), flecainide (for the treatment of arrhythmias), and terbinafine (treatment of fungal infections).

The use of antihypertensives in combination with this medication may increase fatigue.

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

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

Interference with analytical tests

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

TakingBisolvon Antitusivo Compositumwith food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment because adverse reactions may occur.

It is not recommended to take it together with grapefruit 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 medication.

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

This medication should not be taken during breastfeeding (see section Do not take Bisolvon Antitusivo Compositum).

No effect on fertility has been observed with this medication.

Driving and using machines

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

This risk increases when taken in combination with alcohol or other medications that may affect reaction capacity by themselves.

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 per ml. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol may cause gastrointestinal upset 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) per 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) per ml. If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications that contain propylene glycol or alcohol.

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

3. How to take Bisolvon Antitusivo Compositum

Follow the administration instructions for the medication contained in this leaflet or as indicated by your doctor or pharmacist exactly. 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 diphenhydramine and dextromethorphan have been reported, including cases in children and adults.

The recommended dose is:

Adults and adolescents from 12 years old:

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

Use in children

Children between 6 and 11 years old:

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

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

Children under 6 years old:

This medication is contraindicated in children under 6 years old.

Method of administration

Bisolvon Antitusivo Compositum is administered orally, 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, if it persists for more than 5 days, or if it is accompanied by high fever, skin rash, or persistent headache, you should consult a doctor.

The duration of treatment 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 disorders, dizziness, fatigue, somnolence, and hallucinations. Restlessness and excitability that with increased overdose can trigger agitation.

Additionally, symptoms such as changes in concentration and loss of consciousness, coma (in cases of severe poisoning), changes in mood, psychotic disorders such as disorientation and delirium up to confused or paranoid states, increased muscle tone, ataxia (uncoordinated movements), dysarthria, nystagmus (involuntary and uncontrolled eye movement), and vision alteration, as well as respiratory depression, hypertension or hypotension (high or low blood pressure), and tachycardia (accelerated heart rate) may also appear.

The serotonin syndrome may also increase.

Deaths from 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, somnolence, changes in consciousness, rapid and involuntary eye movements, cardiac disorders (accelerated heart rate), coordination disorders, 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 signs are dryness of membranes, urinary retention, reduced peristalsis, mydriasis (pupil dilation), skin redness, hyperthermia, somnolence, tachycardia, hallucinations, and convulsions.

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

Accidental ingestion of very high doses can produce in children aggravated symptoms compared to those described above.

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

If you forget to takeBisolvon Antitusivo Compositum

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

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

Very common: dizziness and somnolence.

Common: mental confusion, gastrointestinal disorders (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 not known: hallucinations, dependence on the medication, allergic reactions such as anaphylactic reaction, angioedema, bronchospasm, urticaria, skin reactions such as erythema with itching, headache, vertigo, confused speech, nystagmus, dystonia, fixed drug eruption, atopic dermatitis, and paradoxical reactions, and sensitivity to sunlight after intense sun exposure.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medications: www.notificaram.es.

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

5. Storage of Bisolvon Antitusivo Compositum

Keep this medication out of 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.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition ofBisolvon Antitusivo Compositum

• The active ingredients 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 Container Content

Bisolvon Antitusivo Compositum is a clear, translucent red 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 measures 1.25 ml, 2.5 ml, and 5 ml.

Marketing Authorization Holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 – Barcelona

Spain

Sanofi Group

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 Last Revision of this Leaflet:June 2024

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

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