SEKI SCIR FL 200ML 3.54MG/ML

SEKI 3.54 MG/ML DISCOVER

active ingredients

SEKI 3.54 mg/ml syrup 100 ml contain: active ingredient: cloperastina fendizoato 354 mg equal to cloperastina 180 mg excipients with known effects: ethanol 30 mg, methyl-para-hydroxybenzoate 122 mg, propyl-para-hydroxybenzoate 18 mg, propylene glycol 230,4 mg, sucrose 45 mg. For the full list of excipients, see paragraph 6.1.

Excellent

SEKI 3.54 mg/ml syrup microcrystalline cellulose, sodium carmellose, polyoxidyl-40-stearate, sucrose, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate, banana essence (containing ethanol, glycol propylene), purified water.

Therapeutic indications

Cough sedative.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. For the absence of studies in early childhood, the medicine is contraindicated in children under 2 years.

Population

Daily dose: ADULTS: 2 cups (Adults) of the dispenser included in the package; a “Adulti” notch corresponds to 7.5 ml syrup) in the evening at the time of bedtime; a drink in the morning, a drink in the afternoon. CHILDREN: After two years: two glasses (tacca "Bambini" of the dispenser included in the package; a “Bambini” notch corresponds to 3,75 ml syrup) the evening before the night rest; a drink in the morning, a drink in the afternoon. Duration of treatment: 7 days. If you do not notice appreciable results you should consult your doctor.

Conservation

Store at a temperature below 30°C.

Warnings

Caution is recommended in patients with intraocular hypertension, prostate hypertrophy or bladder obstruction. Important information about some excipients Ethanol (contained in banana aroma) This medicine contains 0,0011 ml of alcohol (ethanol) in each dose of 3.75 ml (touch “Children”) and 0,0022 ml of alcohol (ethanol) in each dose of 7.5 ml (touch “Adults”). The amount in a dose of this medicine is equivalent to less than 1 ml of beer or 1 of wine. The small amount of alcohol in this medicine will not produce significant effects. Parahydroxybenzos This medicine contains methyl-para-hydroxybenzoate (E218) and propyl-para-hydroxybenzoate (E216) which can cause allergic reactions (also delayed). Propilene Glicole (contained in banana aroma) This medicine contains 8.6 mg of glycol propylene in 3.75 ml (Tools) and 17, 3 mg of glycol propylene in 7.5 ml (tools). Sucrose This medicine contains 1,687 g sucrose per dose of 3,75 ml (tacca “Bambini”) and 3,375 g sucrose per dose of 7, 5 ml (tacca “Adulti”). To consider in people with diabetes mellitus. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption or isomaltase sucrasis failure should not take this medicine. Sodium This medicine contains less than 1 mmol (23mg) of sodium per dose, i.e. essentially ‘without sodium’.

Interactions

Although the central secondary effects of cloperastina are reduced, the drug can interact with both depressive and stimulating substances of the central nervous system. No human interaction studies have been conducted. It is not recommended, both in adult patients and in children, the concomitant use of Seki with: - Alcohol; - Antihistamines; - Anticholinergics; - Sedatives. It is not known if in pediatric age the extent of the above interactions is similar to that in adulthood. There is no information about any interaction of the drug with laboratory tests. Information on the interaction of cloperastina with food is not available, so it is not recommended to take it during meals.

Effects

Below is a table on the frequency of unwanted effects: Frequency: very common (≥ 1/10); common (≥ 1/100, Organ-systematic classification Adverse reactions Not common (≥1/1.000; Rare (≥1/10.000; Very rare ( Not known Immune system disorders       Anaphylactic reaction Diseases of the nervous system Sleep, dry mouth       Skin and subcutaneous tissue pathologies       Erythema urticaria Pediatry Clinical studies and post-marketing surveillance with cloperastina have not shown significant differences in nature, frequency, severity and reversibility of adverse reactions between adult and pediatric population. 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

Adults No case of savradosage was reported in adults treated with Seki. Children A case of overdose was reported in a child who took a dose of 40 ml of Seki syrup. No associated adverse reactions have been reported. The patient was treated with two tablespoons of activated carbon. Treatment of overdose Gastric washing is useful if practiced within a short time by ingestion of the drug. The patient must be kept quiet to minimize every sign of central subsistence: in this case the use of benzodiazepines can be useful.

Pregnancy

Information on the use of pregnant Seki is not available. Although toxicity studies carried out during pregnancy in animals have not evidenced teratogenic activity and fetotoxicity, it is good prudential norm not to take the drug in the first months of pregnancy and in the further period only in case of actual need under the direct control of the doctor.

Food

It is not known whether the medicinal product and/or its metabolites are excreted in breast milk; since the risk for infants cannot be excluded, Seki should not be used during breastfeeding.

Source: Farmadati