Bisolvon cough sedative 10, 5 mg 20 gummy tablets

Bisolvon cough sedative 10.5 mg 20 gummies is an antitussive medicine specifically formulated for the symptomatic treatment of dry and irritative cough in adults and adolescents. Each gummie contains dextromethorphan hydrobromide (10.5 mg), an active ingredient known for its effectiveness in calming cough by acting directly on the cough center in the brain, thus reducing the cough stimulus without compromising breathing.

Bisolvon gummy lozenges are easy to take, they dissolve slowly in the mouth and are characterized by a pleasant honey and lime aroma , making cough treatment more pleasant even when away from home. The formulation is sugar-free , also suitable for those who follow controlled diets. The product is indicated for adults and adolescents over 12 years of age and represents an effective solution for dry cough at night or persistent, often associated with irritation of the airways.

Bisolvon cough sedative 10.5 mg is available in a pack of 20 gummy lozenges , ideal for a complete treatment cycle. Thanks to its targeted action, it helps to quickly soothe dry cough and improve the quality of sleep and daily life.

ACTIVE INGREDIENTS

Active ingredients contained in Bisolvon cough sedative 10.5 mg 20 gummy lozenges - What is the active ingredient in Bisolvon cough sedative 10.5 mg 20 gummy lozenges?

Bisolvon cough sedative 10.5 mg gummy lozenges 1 gummy lozenge contains: active ingredient: dextromethorphan hydrobromide 10.5 mg. Excipient with known effect: liquid maltitol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Bisolvon cough sedative 10.5 mg 20 gummy lozenges - What does Bisolvon cough sedative 10.5 mg 20 gummy lozenges contain?

Excipients: acacia, betadex, anhydrous citric acid, honey flavouring, lime flavouring, levomenthol, liquid paraffin, quinoline yellow, sodium saccharin, liquid maltitol, sodium cyclamate, purified water.

DIRECTIONS

Therapeutic indications Bisolvon cough sedative 10.5 mg 20 gummy lozenges - Why is Bisolvon cough sedative 10.5 mg 20 gummy lozenges used? What is it used for?

Symptomatic treatment of dry cough.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Bisolvon cough sedative 10.5 mg 20 gummy lozenges - When should Bisolvon cough sedative 10.5 mg 20 gummy lozenges not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Bronchial asthma, COPD (chronic obstructive pulmonary disease), pneumonia, lung infection, difficulty breathing, respiratory failure, respiratory depression, cardiovascular disease, hypertension, hyperthyroidism, glaucoma, prostatic hypertrophy, gastrointestinal and urogenital tract stenosis, epilepsy, severe liver disease. First trimester of pregnancy and breastfeeding (see section 4.6). Children and adolescents under 12 years of age. Do not use at the same time or within two weeks of MAO inhibitor antidepressants (see section 4.5).

DOSAGE

Quantity and method of taking Bisolvon cough sedative 10.5 mg 20 gummy lozenges - How to take Bisolvon cough sedative 10.5 mg 20 gummy lozenges?

Adults and adolescents over 12 years: The recommended dose is 1-2 gummy lozenges (equivalent to 10.5 - 21 mg of dextromethorphan hydrobromide) to dissolve in the mouth up to 6 times a day, if necessary, with an interval of at least 4 hours. The maximum daily dose is 126 mg. Do not exceed the maximum daily dose. Bisolvon cough sedative is contraindicated in children and adolescents under 12 years of age (see section 4.3). The maximum duration of treatment is 5 days.

CONSERVATION

Storage Bisolvon cough sedative 10.5 mg 20 gummy lozenges - How is Bisolvon cough sedative 10.5 mg 20 gummy lozenges stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Bisolvon cough sedative 10.5 mg 20 gummy lozenges - About Bisolvon cough sedative 10.5 mg 20 gummy lozenges it is important to know that:

Dextromethorphan may be slightly addictive. With prolonged use (e.g. exceeding the recommended treatment period), patients may develop tolerance to the drug, as well as mental and physical dependence. Patients with a tendency to abuse or dependence should take Bisolvon cough sedative for short periods and be carefully monitored. Cases of abuse and dependence on dextromethorphan have been reported. Particular caution is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse. Bisolvon cough sedative should be used with caution in patients taking serotonergic drugs (other than MAO inhibitors), such as selective serotonin reuptake inhibitors (SSRIs) (e.g. fluoxetine, paroxetine) or tricyclic antidepressant drugs (see section 4.5). There is limited information on the use of dextromethorphan in patients with impaired hepatic or renal function. Therefore, Bisolvon cough sedative should be administered with caution in such patients, especially in patients with severe renal impairment. Due to the potential release of histamine, the use of Bisolvon cough sedative in cases of mastocytosis is not recommended. A chronic cough may be an early symptom of asthma and therefore Bisolvon cough sedative is not indicated for the suppression of chronic cough, particularly in children. In cases of productive cough, with a significant production of mucus (e.g. in patients with diseases such as bronchiectasis and cystic fibrosis) or in patients with neurological diseases associated with a marked reduction of the cough reflex (such as stroke, Parkinson's disease and dementia), the treatment of Bisolvon cough sedative as a cough suppressant should be administered with particular caution and after a careful risk-benefit assessment (see section 4.5). Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. Approximately 10% of the population is a slow metaboliser of CYP2D6. Exaggerated and/or prolonged effects of dextromethorphan may occur in poor metabolisers and patients with concomitant use of CYP2D6 inhibitors. Caution is therefore required in patients who are poor metabolisers of CYP2D6 or who use CYP2D6 inhibitors (see also section 4.5). Risk from concomitant use of sedative medicinal products such as benzodiazepines or related medicinal products: Concomitant use of Bisolvon cough sedative and sedative medicinal products such as benzodiazepines or related medicinal products may result in sedation, respiratory depression, coma and death. Due to these risks, concomitant prescribing with these sedative medicinal products should be limited to patients for whom alternative treatment options are not possible. If a decision is made to prescribe Bisolvon cough sedative together with sedative medicinal products, the lowest effective dose should be used and the duration of treatment should be as short as possible (see also general dose recommendations in section 4.2). Patients should be monitored closely for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and their caregivers (where applicable) so that they are aware of these symptoms (see section 4.5). Serotonin syndrome Serotonergic effects, including the development of a potentially life-threatening serotonin syndrome, have been reported for dextromethorphan with concomitant administration of serotonergic agents, such as selective serotonin reuptake inhibitors (SSRIs), drugs which impair metabolism of serotonin (including monoamine oxidase inhibitors [MAOIs]) and CYP2D6 inhibitors. Serotonin syndrome may include mental status changes, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms. If serotonin syndrome is suspected, treatment with Bisolvon Cough Sedative should be discontinued. Important information about some of the excipients The maximum recommended daily dose of Bisolvon Cough Sedative contains 10.2 g of liquid maltitol. It may have a mild laxative effect. The caloric value of maltitol is 2.3 kcal/g. Patients with rare hereditary problems of fructose intolerance should not take this medicine. This medicinal product contains less than 1 mmol sodium (23 mg) per lozenge, i.e. essentially “sodium-free”. Alcohol intake during treatment is not recommended. Dextromethorphan potentiates the inhibitory effect of alcohol on the central nervous system (see section 4.5).

INTERACTIONS

Interactions Bisolvon cough sedative 10.5 mg 20 gummy lozenges - Which medicines or foods can modify the effect of Bisolvon cough sedative 10.5 mg 20 gummy lozenges?

Dextromethorphan has weak serotonergic properties. Dextromethorphan may therefore lead to an increased risk of serotonergic toxicity (serotonin syndrome), especially when taken together with other serotonergic agents, such as MAO inhibitors or SSRIs or tricyclic antidepressants. Especially pre-treatment or concomitant treatment with drugs that impair serotonin metabolism, such as antidepressants of the MAO inhibitor type, may lead to the development of a serotonin syndrome with the following characteristic symptoms: neuromuscular hyperactivity (e.g. tremor, clonic jerk, myoclonus, increased reflex response and pyramidal rigidity), autonomic hyperactivity (e.g. diaphoresis, fever, tachycardia, tachypnoea, mydriasis) and altered mental status (e.g. agitation, excitation, confusion) (see section 4.3 (MAO inhibitor drugs) and 4.4). Concomitant administration of drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or alcohol intake, may lead to additive effects. Other sedative drugs such as benzodiazepines or related drugs: Concomitant use of opioids with sedative drugs such as benzodiazepines or related drugs increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use should be limited (see section 4.4). CYP2D6 inhibitors Dextromethorphan is metabolised by CYP2D6 and has extensive first-pass metabolism. Concomitant use of potent inhibitors of the CYP2D6 enzyme may increase dextromethorphan concentrations in the body to levels many times higher than normal. This increases the patient's risk of toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea, and respiratory depression) and the development of serotonin syndrome. Potent inhibitors of CYP2D6 are fluoxetine, paroxetine, quinidine, and terbinafine. When used concomitantly with quinidine, plasma concentrations of dextromethorphan are increased up to 20-fold, resulting in increased central nervous system adverse effects of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine, thioridazine, cimetidine, ritonavir, and berberine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is necessary, the patient should be monitored and the dose of dextromethorphan may need to be reduced. Even if they are no longer taken at the moment, such effects may occur if these medicines have been taken recently. If dextromethorphan is used in combination with secretolytics in patients with pre-existing respiratory tract diseases, such as cystic fibrosis and bronchiectasis, suffering from mucus hypersecretion, the reduction of the cough reflex can lead to a serious accumulation of mucus, therefore in case of irritating cough with a considerable mucus production, treatment with dextromethorphan should be administered with particular caution and after a careful risk-benefit assessment.

SIDE EFFECTS

Like all medicines, Bisolvon cough sedative 10.5 mg 20 gummy lozenges can cause side effects - What are the side effects of Bisolvon cough sedative 10.5 mg 20 gummy lozenges?

Adverse reactions are listed below by system organ class and frequency, using the following categories: Very common ≥ 1/10 Common ≥ 1/100, < 1/10 Uncommon ≥ 1/1,000, < 1/100 Rare ≥ 1/10,000, < 1/1,000 Very rare < 1/10,000 Not known Frequency cannot be estimated from the available data. Immune system disorders : Not known: hypersensitivity reactions including anaphylactic reaction, angioedema, urticaria, fixed drug eruption, bronchospasm. Psychiatric disorders : Common: confusional state Very rare: hallucinations, abuse and dependence. Nervous system disorders : Very common: somnolence, dizziness. Common: vertigo. Not known: dysarthria, nystagmus, dystonia especially in children. Gastrointestinal disorders : Common: nausea, vomiting, gastrointestinal disturbances, constipation and decreased appetite. Skin and subcutaneous tissue disorders : Not known: erythema, rash, pruritus. General disorders and administration site conditions : Common: fatigue. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Overdose Bisolvon cough sedative 10.5 mg 20 gummy lozenges - What are the risks of Bisolvon cough sedative 10.5 mg 20 gummy lozenges in case of overdose?

Symptoms and signs Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability. In case of massive overdose, the following symptoms may be observed: coma, respiratory depression, convulsions. Dextromethorphan may lead to an increased risk of serotonin syndrome, a risk that is increased in case of overdose, especially in case of concomitant intake of other serotonergic agents. Cases of fatal outcomes have been reported with combined overdose of dextromethorphan and other drugs (combination poisoning). Management Activated charcoal may be administered to asymptomatic patients who have ingested dextromethorphan overdoses within the previous hour. For patients who have ingested dextromethorphan and are sedated or comatose, naloxone may be considered in doses usual for the treatment of opioid overdose. Benzodiazepines may be used for seizures and benzodiazepines and external cooling measures for serotonin syndrome hyperthermia.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Bisolvon cough sedative 10.5 mg 20 gummy lozenges.

Pregnancy The results of epidemiological studies on a limited population sample have not indicated an increase in the frequency of malformations in children who were exposed to dextromethorphan during the prenatal period. However, these studies do not adequately document the timing and duration of treatment with dextromethorphan. Non-clinical studies on reproductive toxicity do not indicate a potential risk for dextromethorphan for humans (see section 5.3). Bisolvon cough sedative should not be used during the first three months of pregnancy (see section 4.3); furthermore, since the administration of high doses of dextromethorphan, even for short periods, can cause respiratory depression in newborns, in the following months the drug should be administered only in case of real need and after a careful evaluation of the benefits and risks. Breastfeeding Since the excretion of the drug in breast milk is not known and a respiratory depression effect on the infant cannot be excluded, Bisolvon cough sedative is contraindicated during breastfeeding (see section 4.3). Fertility Based on available non-clinical experience, no effects on fertility have been reported following the use of dextromethorphan (see section 5.3).

DRIVING AND USE OF MACHINERY

Taking Bisolvon cough sedative 10.5 mg 20 gummy lozenges before driving or using machines - Does Bisolvon cough sedative 10.5 mg 20 gummy lozenges affect driving or using machines?

Bisolvon cough sedative may cause drowsiness or dizziness and alter reaction times, therefore the ability to drive vehicles and use machinery may be reduced. These effects are accentuated in the case of concomitant intake of alcohol or other medicines that can reduce reaction times. Those who may drive vehicles or perform operations that require integrity of the degree of alertness must be warned of this.