Vicks Cough Sedative 1.33mg/ml Honey Flavored Syrup 180ml

NAME
VICKS SEDATIVE COUGH, 1.33 MG / ML SYRUP

PHARMACOTHERAPEUTIC CATEGORY
Prepare for coughs and colds.

ACTIVE PRINCIPLES
Dextromethorphan hydrobromide.

EXCIPIENTS
Sucrose, sodium saccharin, propylene glycol, 96 percent ethanol, carmellose sodium, sodium citrate, anhydrous citric acid, honey flavoring (containing honey), verbena flavoring, sodium benzoate, polyethylene oxide, menthoxypropanediol, polyoxystearate 40, purified water.

INDICATIONS
Cough suppressant.

CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity to the active substance, to structurally similar compounds, or to any of the excipients listed. Do not use at the same time and in the two weeks following therapy with MAO inhibiting antidepressant drugs. Asthmabronchial, COPD (chronic obstructive pulmonary disease), pneumonia, respiratory distress, respiratory depression, cardiovascular disease, hypertension, hyperthyroidism, diabetes, glaucoma, prostatic hypertrophy, stenosis of the gastrointestinal and urogenital tract, epilepsy, severe liver disease. Do not administer to children under the age of 12 years. Pregnancy, especially in the first trimester, breastfeeding.

DOSAGE
Adults and adolescents over 12 years: 15 ml (equivalent to 3 teaspoons of coffee). These doses can be repeated every 6 hours, up to 4 times a day. Do not exceed the recommended dose. Children up to 12 years: dextromethorphan should not be used.

STORAGE
Store at a temperature not exceeding 25 degrees C.

WARNINGS
Treatment with dextromethorphan should not be continued beyond 5-7 days. If there is no therapeutic response within a few days, the physician should reassess the situation. Dextromethorphan can be addictive. Following prolonged use, patients may develop tolerance to the drug, as well as mental and physical dependence. Cases of dextromethorphan abuse have been reported. Particular care is recommended with adolescents and young adults, as well as with patients with a history of drug or psychoactive substance abuse. Dextromethorphan is metabolised by hepatic cytochrome P450 2D6. The activity of this enzyme is genetically determined. About 10% of the population metabolise CYP2D6 slowly. Exaggerated and / or prolonged effects of dextromethorphan may occur in poor metabolisers and patients with concomitant use of CYP2D6 inhibitors. Therefore, caution should be exercised in patients who are poor CYP2D6 metabolisers or who use CYP2D6 inhibitors. Chronic cough can be an early symptom of asthma and therefore dextromethorphan is not indicated for the suppression of chronic or persistent cough (e.g. due to smoking, emphysema, asthma, etc.), dextromethorphan should be administered with particular caution and only on medical advice if the cough is accompanied by other symptoms such as: fever, rash, headache, nausea and vomiting. In case of an irritating cough with considerable mucus production, treatment with dextromethorphan should be administered with particular caution and only on medical advice after a careful risk-benefit assessment. Administer with caution in subjects with impaired hepatic or renal function, especially in patients with severe impairment. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This medicine contains about 5.5 g of sucrose per 15 ml of syrup (equal to 3 teaspoons). To be taken into consideration in people with diabetes mellitus or low-calorie diets. This medicine contains 5.3 vol% ethanol (alcohol), eg. up to 208.3 mg per 5 ml dose (equal to 1 teaspoon), equivalent to 5.3 ml of beer, 2.2 ml of wine. It can be harmful to alcoholics. To be taken into consideration in pregnant or lactating women, in children and in high-risk groups such as people with liver disease or epilepsy. This medicine contains 1.3 mmol (or 30 mg) sodium per 15 ml dose (equal to 3 teaspoons). To be taken into consideration in people with impaired renal function or who follow a low sodium diet. It is not advisable to take alcohol during therapy.

INTERACTIONS
MAO inhibitor drugs: concomitant administration of dextromethorphan with MAO inhibitor drugs is contraindicated. Also, dextromethorphan should not be administered during or in the two weeks following administration of monoamine oxidase inhibitor drugs. The association of these drugs can, in fact, induce the development of a serotonin syndrome characterized by the following symptoms: nausea, hypotension, neuromuscular hyperactivity (tremor, clonic spasm, myoclonus, increased reflex response and rigidity of pyramidal origin), hyperactivity 'of the autonomic nervous system (diaphoresis, fever, tachycardia, tachypnea, mydriasis) and altered mental status (agitation, excitement, confusion), up to cardiac arrest and death. Linezolid and sibutramine: cases of serotonin syndrome have also been reported following concomitant administration of dextromethorphan with linezolid or sibutramine CYP2D6 inhibitors: dextromethorphan is metabolised by CYP2D6 and has extensive first pass metabolism. Concomitant use of potent inhibitors of the CYP2D6 enzyme can increase dextromethorphan concentrations in the body to levels several times the normal value. This increases the patient's risk of the toxic effects of dextromethorphan (agitation, confusion, tremor, insomnia, diarrhea and respiratory depression) and of developing serotonin syndrome. Potent inhibitors of CYP2D6 are fluoxetine, paroxetine, quinidine and terbinafine. In concomitant use with quinidine, plasma concentrations of dextromethorphan are increased up to 20-fold, resulting in increased adverse effects on the central nervous system of the agent. Amiodarone, flecainide and propafenone, sertraline, bupropion, methadone, cinacalcet, haloperidol, perphenazine and thioridazine also have similar effects on the metabolism of dextromethorphan. If concomitant use of CYP2D6 inhibitors and dextromethorphan is required, the patient should be monitored and the dextromethorphan dose may need to be reduced. Central nervous system inhibitory drugs: concomitant administration of dextromethorphan with drugs with an inhibitory effect on the central nervous system such as hypnotics, sedatives or anxiolytics, or with the intake of alcohol, can lead to additive effects on the central nervous system. Secretolytic drugs: if dextromethorphan is used in combination with secretolytic drugs, the reduction of the cough reflex can lead to a severe accumulation of mucus. Grapefruit juice: grapefruit juice can increase the absorption, bioavailability and elimination of dextromethorphan, with a consequent increase in its toxicity and decrease in its effect.

SIDE EFFECTS
Adverse reactions are listed below by system organ class and frequency, according to 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 (cannot be estimated from the available data). Disorders of the immune system. Not known: hypersensitivity reactions' including anaphylactic reaction, angioedema, urticaria, pruritus, rash and erythema. Metabolism and nutrition disorders. Not known: diabetes mellitus. Psychiatric disorders. Very rare: hallucinations; not known: psychosis. Nervous system disorders. Common: dizziness. Rare: somnolence. Gastrointestinal disorders. Common: nausea, vomiting, gastrointestinal upset and decreased appetite. Skin and subcutaneous tissue disorders. Rare: skin rashes. General disorders and administration site conditions. Common: fatigue; not known: hyperpyrexia. There have been reports of dependence and abuse with dextromethorphan. The reporting of suspected adverse reactions that occur after the authorization of the drug is important, as it allows continuous monitoring of the benefit / risk ratio of the drug.

PREGNANCY AND BREASTFEEDING
The results of epidemiological studies on a limited sample of the population did not indicate 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 period and duration of treatment with dextromethorphan. Reproductive toxicity studies on animals do not indicate a potential risk to humans for dextromethorphan. Dextromethorphan should not be used during the first three months of pregnancy; moreover, since the administration of high doses of dextromethorphan, even for short periods, can cause respiratory depression in newborns, in the following months the drug must be administered only in case of real need and after a careful evaluation of the benefits and risks. Since excretion of the drug in breast milk is not known and a respiratory depressive effect on the newborn cannot be excluded, dextromethorphan is contraindicated during breastfeeding.