GOLASEPT 20 ML OF SEDATIVE

GOLASEPT SEDATIVE TOSSE 15 MG/ML ORAL GOCCE DECELOPMENT

active ingredients

1 ml of solution contains: active ingredient: dextromethtorphan bromirate 15 mg (1 ml corresponds to 40 drops) Excipients with known effects: sorbitol, benzoate sodium and ethanol. For the full list of excipients see paragraph 6.1

Excellent

Liquid sodium, glycerol, monohydrate citric acid, benzoate sodium, vanillin, ethanol, sodium saccharin, purified water.

Therapeutic indications

Bromidated dextromethtorphan is indicated for the symptomatic treatment of dry cough.

Contraindications

- Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1; - bronchial asthma, BPCO (chronic obstructivebroncopneumopathy), pneumonia, difficulty breathing, respiratory depression; - cardiovascular disease, hypertension; - hyperthyroidism; - diabetes; - glaucoma; - prostate hypertrophy; - stenosis of gastroenteric and urogenital apparatus; - epilepsy; - severe liver disease; - children under the age of 12; - do not use at the same time or in the two weeks following antidepressant inhibition drugs of MAO; - first trimester of pregnancy, nursing (see paragraph 4.6).

Population

Adults and teenagers (from 12 to 18 years) The generally recommended dose range varies from 10 mg (about 27 drops) to 20 mg (about 53 drops) every 6 hours. The maximum dose reached in 24 hours is 80 mg (about 213 drops). Pediatric population Children up to 12 years Destrometorphan bromirate should not be used.

Conservation

Store in the original packaging to protect the medicine from light.

Warnings

Treatment with bromitted dextromethtorphan should not be protracted over 5 - 7 days. In the absence of a therapeutic response within a few days, the doctor must reevaluate the situation. The bromitted dextrometorphan can give assuefation. As a result of prolonged use, patients may develop tolerance to the medicinal product, as well as mental and physical dependence (see paragraph 4.8). Patients with a tendency to abuse or dependence should take bromidated dextromethtorphan drops for short periods and under strict control of the doctor. Cases of detachment and detachment were reported. It is recommended to pay special attention to teenagers and young adults as well as patients with a history of drug abuse or psychoactive substances. Chronic cough may be an early symptom of asthma and then bromirate dextromethtorphan is not indicated for the suppression of chronic or persistent cough (e.g. smoke, emphysema, asthma, etc.). Bromidated dextromethtorphan should be given with particular caution and only on medical advice in case the cough is accompanied by other symptoms such as: fever, rash, headache, nausea and vomiting. The medicine should not be taken in case of cough accompanied by abundant secretion. In case of irritating cough with a remarkable production of mucus, the treatment with bromirate dextromethtorphan should be administered with particular caution and only on medical advice after careful assessment of the risk-benefit. During therapy with bromirate dextromethtorphan it is not advisable to use alcohol (see paragraph 4.5). Administer with caution and only after a careful assessment of the risk-beneficio rightmetorphan bromirate in patients with cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostate hypertrophy, stenosis of the gastroenteric and urogenital apparatus, epilepsy, altered liver function, in subjects who are taking antidepressant drugs, such as drugs. The rightmetorphan is metabolized by the liver cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population slowly metabolizes CYP2D6. In slow metabolizers and patients with concomitant use of CYP2D6 inhibitors, exaggerated and/or prolonged effects of dextromethtorphan may occur. It is therefore necessary to pay attention to CYP2D6 slow metabolizer patients or to use CYP2D6 inhibitors (see also paragraph 4.5). Risk from concomitant use of sedative medicines such as benzodiazepines or medicines related to them Concomitant use of Golasept sedative cough 15 mg/ml oral drops, solution and sedative medicines such as benzodiazepines or related medicines may result in sedation, respiratory depression, coma and death.Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible.If a decision is made to prescribe Golasept sedative cough 15 mg/ml oral drops, solution concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.Patients should be carefully assessed for signs and symptoms of respiratory depression and sedation.In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to pay attention to 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) [monoamine oxidase inhibitors, MAOI]) 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 Golasept Cough Sedative should be discontinued. Important information about some of the excipients: This medicinal product contains 3 mg of alcohol (ethanol) per dose of 10 mg equivalent to 27 drops and 24 mg per maximum daily dose.The amount per maximum daily dose of this medicinal product is equivalent to less than 1 ml of beer.The small amount of alcohol in this medicinal product will not produce any relevant effects.This medicinal product contains 67.5 mg of sorbitol per dose of 10 mg equivalent to 27 drops and 540 mg per maximum daily dose.The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet should be taken into account.The sorbitol content in medicinal products for oral use may alter the bioavailability of other concomitantly administered medicinal products for oral use.Patients with hereditary fructose intolerance should not be given this medicinal product.This medicinal product contains 3.35 mg of sodium benzoate per dose of 10 mg equivalent to 27 drops and 26.8 mg per maximum daily dose.This medicinal product contains less than 1 mmol sodium (23 mg) per maximum daily dose, that is to say essentially ‘sodium-free’.

Interactions

MAO inhibitor drugs Concurrent administration of bromirate dextromethtorphan with MAO inhibitor drugs is contraindicated. In addition, you should not take bromidated dextromethtorphan drops in the 2 weeks following the treatment with MAO inhibitor drugs. The association of these drugs can, in fact, induce the development of a serotoninergic syndrome characterized by the following symptoms: nausea, hypotension, neuromuscular hyperactivity (tremity, clonic spasm, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, midriasis) and altered mental state (acting, excitement, confusion), until arriving at cardiac arrest and death. Linezolid and sibutramine Cases of serotonin syndrome have also been reported following concomitant administration of dextromethorphan hydrobromide with linezolid or sibutramine. Central nervous system inhibitors Concurrent administration of bromirate dextromethtorphan with drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or with alcohol intake, can lead to additive effects on the central nervous system. Cytochrome inhibitors CYP2D6 The dextromethtorphan is metabolized by the CYP2D6 and has a wide metabolism of the first step. Concurrent use of powerful CYP2D6 enzyme inhibitors can increase the concentrations of dextromethtorphan in the body at many times higher than normal value. This increases the risk for the patient of toxic effects of dextromethtorphan (acting, confusion, tremor, insomnia, diarrhea and respiratory depression) and of development of serotonin syndrome. Powerful inhibitors of CYP2D6 are fluoxetine, paroxetine, chinidine and terbinaphine. In use in conjunction with chinidine, plasma concentrations of dextromethtorphan have increased up to 20 times, resulting in increased adverse effects on the central nervous system of the agent. Also amiodarone, flecainide and propafenone, sertralin, bupropion, methadone, cinacalcet, aloperidol, perfenazine and thiodazine have similar effects on the metabolism of the dextromethtorphan. If the concomitant use of CYP2D6 inhibitors and dextromethtorphans is necessary, the patient must be monitored and it may be necessary to reduce the dose of dextromethtorphan. It should be taken into account that this effect can occur even if the inhibition drug of the cytochrome CYP2D6 has recently taken place and not necessarily in a contemporary way to the drops of bromirate dextromethorphan. Other drugs that inhibit cytochrome P450-2D6 are cimetidine and ritonavir. Secretolithic drugs If the bromidrate dextromethtorphan is used in combination with secretolithic drugs, the reduction of cough reflex can lead to a severe accumulation of mucus. Sedative medicines such as benzodiazepines or medicines related to them: Concomitant use of opioids with sedative medicinal products 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 combined treatment should be limited (see section 4.4). Grapefruit juice Grapefruit juice can increase absorption, bioavailability and elimination of bromirate dextromethtorphan, resulting in increased toxicity or decrease in its effect.

Effects

Below are the undesirable effects of the bromidrate dextromethtorphan organized according to the organic system classification MedDRA. No sufficient data is available to determine the frequency of all the individual effects listed. Diseases of the nervous system: Sleeplessness, fatigue, nistagm, dystonia, dizziness, mental stunnel and dark language. Serotoninergic syndrome, characterized by: nausea, hypotension, neuromuscular hyperactivity (tremity, chlonic spasm, myoclonus, increased reflex response and stiffness of pyramidal origin), hyperactivity of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, midriasis) and altered mental state (agitation, excitement, confusion), to the death of cardiac arrest and. Psychiatric disorders: Psychosis, hallucinations. Psychic addiction; the dextromethtorphan has a low risk of abuse and dependence. However, cases of psychic dependence (non-physical) and cases of abuse were reported due to the euphoric effect caused by the substance. Immune system disorders: Anaphylactic and anaphylactic reactions. Systemic pathologies and conditions for administration: Hyperpyressia and hyperthermia. Disorders of metabolism and nutrition: Diabetes mellitus. Gastrointestinal diseases: Nausea, vomiting, gastrointestinal disorders and appetite reduction. Pathologies of skin and subcutaneous tissue: Allergic skin reactions and rashes. Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address: www.agenziafarmaco.gov.it/content/come-segnalareuna-sospetta-reazione-avversa.

Overdosing

Symptoms and signs: Dextromethorphan overdose may be associated with nausea, vomiting, dystonia, agitation, mental confusion, drowsiness, stupor, nystagmus, cardiotoxicity (tachycardia, abnormal ECG including QTc prolongation), ataxia, toxic psychosis with visual hallucinations, hyperexcitability and dizziness, increased muscle tone, hypotension.In case of massive overdose, the following symptoms may be observed: coma, urinary retention, respiratory depression and convulsions. Management: Active carbon can be administered to asymptomatic patients who ingested overdose of dextromethtorphan in the previous hour. In case of need to use intensive medical care (in particular intubation, ventilation). Precautions may be required to safeguard heat loss and replenish liquids. The intravenous administration of naloxone can antagonize the effects of dextromethtorphan on the central nervous system, especially respiratory depression. For patients who have ingested the rightmetorphan and are sedated or comatose, naloxone can be considered, in the usual doses for the treatment of overdose from opioids. Benzodiazepines can be used for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome. If necessary, it is recommended to carry out the gastric lavender. Do not administer hemetics at central action.

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 hydrobromide during the prenatal period.However, these studies do not adequately document the timing and duration of treatment with dextromethorphan hydrobromide.Reproductive toxicity studies in animals do not indicate a potential risk for humans for dextromethorphan hydrobromide (see section 5.3).Dextromethorphan hydrobromide should not be used during the first three months of pregnancy;furthermore, since the administration of high doses of dextromethorphan hydrobromide, 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.Since the excretion of the drug in breast milk is not known and a respiratory depression effect on the newborn cannot be excluded, dextromethorphan hydrobromide is contraindicated during breastfeeding.

Source: Farmadati