PREPARED FOODS FOR INFANTS AND YOUNG CHILDREN SELLA 20

PREPARED FOODS FOR INFANTS AND YOUNG CHILDREN SELLA

active ingredients

Destrometorfano bromidrato Sella 7,65 mg chewing tablets One tablet contains Active Ingredient: Rightometorphan bromirate 7,65 mg Excipient with known effects: sorbitol Destrometorfano bromidrato Sella 30 mg/10 ml syrup 10 ml syrup contains Active Ingredient: rightmetorphan bromirate 30 mg Excipients with known effects: sucrose, methyl parahydroxybenzoate Destrometorphan bromidrate Sella 15 mg/ml oral drops, solution 1 ml solution contains Active Ingredient: dextromethtorphan bromirate 15 mg (1 ml corresponds to 20 drops) Excipient with known effects: methyl parahydroxybenzoate For the full list of excipients, see paragraph 6.1.

Excellent

Destrometorfano bromidrato Sella 7,65 mg chewing tablets Sorbitol (E420) Rice starch Magnesium trisilicate Magnesium stearate Aroma mint Destrometorfano bromidrato Sella 30 mg/10 ml syrup Sodium benzoate (E211) Citric acid monohydrate Saccarosio Metile parahydroxybenzoate (E218) raspberry aroma Purified water Destrometorphan bromidrate Sella 15 mg/ml oral drops, solution Glicerol Metile parahydroxybenzoate (E218) 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; - 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 12 years of age; - 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

Destrometorfano bromidrato Sella 7,65 mg chewing tablets Adults and teenagers (from 12 to 18 years) The generally recommended dose range varies from 1 tablet to 3 tablets every 6 hours. The maximum dose reached in 24 hours is 10-11 tablets. Children up to 12 years Destrometorfano bromidrato should not be used. Destrometorfano bromidrato Sella 30 mg/10 ml syrup Adults and teenagers (from 12 to 18 years) The generally recommended dose range varies from 10 mg (a coffee spoon corresponding to about 3 ml) to 20 mg (2 teaspoons of coffee corresponding altogether to about 6 ml) every 6 hours. The maximum dose reached in 24 hours is 80 mg. Children up to 12 years Destrometorfano bromidrato should not be used. Destrometorphan bromidrate Sella 15 mg/ml oral drops, solution Adults and teenagers (from 12 to 18 years) The generally recommended dose range varies from 10 mg (about 14 drops) to 20 mg (about 28 drops) every 6 hours. The maximum dose reached in 24 hours is 80 mg (about 110 drops). Children up to 12 years Destrometorfano bromidrato should not be used. The duration of treatment with this medicine should not exceed 5-7 days.

Conservation

Store in well closed packaging, sheltered from moisture and 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). Cases of abuse have been reported and dependence from the right-hand side. 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 therefore 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 must be carried out 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 diseases, 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 dextromethtorphan is metabolized by the hepatic cytochrome P450 2D6 (CYP2D6). 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). Serotonin Syndrome Serotoninergic effects, including the development of a potentially lethal serotonin syndrome, have been reported for dextromethtorphan with concomitant administration of serotonininergic agents, such as selective inhibitors of serotonin reuptake (selective serotonin reuptake inhibitors, SSRIs), drugs that alter serotonin metabolism (including monoamine inhibitors) [monoamine oxidase inhibitors, MAOI]) and CYP2D6 inhibitors. Serotonin syndrome may include changes in mental state, autonomic instability, neuromuscular abnormalities and/or gastrointestinal symptoms. If you suspect a serotonin syndrome, the treatment with Destrometorfano bromidrato Sella must be stopped. Avoid taking grapefruit juice during treatment with this medicine because an increase in the toxic effects or a decrease in the effect can occur. Avoid taking alcohol during treatment with this medicine (see paragraph 4.5). Risk from the concomitant use of sedative medicines such as benzodiazepines or medicinal products related to them Concurrent use of Destrometorfano bromidrato Sella and sedative medicines such as benzodiazepines or medicines related to them can cause sedation, respiratory depression, coma and death. Due to these risks, the concomitant prescription with these sedative medicines must be reserved to patients for whom alternative therapeutic options are not possible. If you decide to prescribe Destrometorfano bromidrato Sella in conjunction with sedative medicines, you must use the lowest effective dose possible and the duration of treatment must be as short as possible. Patients should be carefully monitored for signs and symptoms of respiratory depression and sedation. In this regard, it is strongly recommended to inform patients and people who take care of these symptoms (see paragraph 4.5). Destrometorfano bromidrato Sella 7,65 mg chewing tablets This medicine contains 640 mg of sorbitol per dose. Sorbitol is a source of fructose. Patients suffering from rare hereditary problems of fructose intolerance should not take this medicine. The additive effect of co-administration of medicinal products containing sorbitol (or fructose) and the daily intake of sorbitol (or fructose) with the diet must be considered. The content of sorbitol in oral medicines may change the bioavailability of other oral medications co- administered. It can cause gastrointestinal problems and have a slight laxative effect. Destrometorfano bromidrato Sella 30 mg/10 ml syrup This medicine contains 3 g sucrose (sugar) per dose. To consider in people with diabetes mellitus. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption, or isomaltase sucrasis failure, should not take this medicine. This medicine contains parahydroxybenzoate methyl (E218) which can cause allergic reactions (also delayed). This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘without sodium’. This medicine contains 9 mg of benzoate salt per dose. This medicine contains methyl parahydroxybenzoate which can cause allergic reactions (also delayed). Destrometorphan bromidrate Sella 15 mg/ml oral drops, solution This medicine contains parahydroxybenzoate methyl (E218) which can cause allergic reactions (also delayed).

Interactions

MAO inhibitor drugs Concurrent administration of bromirate dextromethtorphan with MAO inhibitor drugs is contraindicated. In addition, you should not take bromidated dextromethtorphan tablets in the two weeks following the treatment with MAO inhibitor drugs. The association with these drugs can, in fact, induce the development of a serotoninergic syndrome characterized by the following symptoms: nausea, hypotension, neuromuscular hyperactivity (tremity, clonic spasm, myoclonic, 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 Serotoninergic syndrome cases have been reported also following the concomitant administration of the bromidrate dextromethtorphan with linezolid and 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 P4502D6 (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, thiodazine, cimetidine and ritonavir have similar effects on the metabolism of the rightmetorphan. 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. 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. Grapefruit juice Grapefruit juice can increase absorption, bioavailability and elimination of bromirate dextromethtorphan, resulting in increased toxicity and decrease in its effect. Sedative medicines such as benzodiazepines or medicines related to them Concurrent use of opioids with sedative medicines such as benzodiazepines or related to them increases the risk of sedation, respiratory depression, coma and death due to the additional depressive effect on SNC. The dose and duration of the concurrent treatment must be limited (see paragraph 4.4).

Effects

Below are the undesirable effects of bromidrate dextromethtorphan organized according to the organic systematic 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, myoclonic, 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. Metabolism and nutrition disorders Diabetes mellitus. Gastrointestinal diseases Nausea, vomiting, gastrointestinal disorders and appetite reduction. Pathologies of skin and subcutaneous tissue Skin allergic 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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Symptoms and signs: The overdose of dextromethtorphan can be associated with nausea, vomiting, dystonia, agitation, confusion, drowsiness, astonishment, nistagm, cardiotoxicity (tachycardia, abnormal ECG including the extension of the QTc range), ataxia, toxic psychosis with visual hallucinations, hypereccitability. In case of massive overdose, the following symptoms can be observed: coma, respiratory depression, seizures. In extreme cases, urinary retention and respiratory depression may occur. Management: Active carbon can be administered to asymptomatic patients who ingested overdose of dextromethtorphan in the previous hour. For patients who have ingested dextromethtorphan and are sedated or comatose, naloxone can be considered, in the usual doses for the treatment of opioid overdose. Benzodiazepines can be used for convulsions and benzodiazepines and external cooling measures for hyperthermia from serotonin syndrome. 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 the bromidated dextrogen on the central nervous system, in particular respiratory depression. If necessary, it is recommended to carry out the gastric lavender. Do not administer hemetics at central action.

Pregnancy

The results of epidemiological studies on a limited sample of population did not indicate an increase in the frequency of malformations in children who were exposed to bromirate dextrometorphan during the prenatal period. However, these studies do not adequately document the period and duration of treatment with bromidrate dextromethtorphan. Reproductive toxicity studies on animals do not indicate a potential risk for man for the bromide (see paragraph 5.3). Destrometorphan bromidrate should not be used during the first three months of pregnancy; moreover, since the administration of high doses of bromirate dextromethtorphan, even for short periods, may cause respiratory depression in infants, in the following months the drug must be administered only in case of actual need and after careful evaluation of benefits and risks.

Food

Since it is not known the excretion of the drug in breast milk and cannot be excluded an effect of respiratory depression on the newborn, dextrometorphan bromirate is contraindicated during breastfeeding.

Source: Farmadati