SEKI OS GTT 25ML 35,4MG/ML

SEKI

active ingredients

SEKI 10 mg coated tablets One tablet contains: active ingredient: cloperastina hydrochloride mg 10; excipient with known effect: sucrose 38,07 mg.SEKI 35.4 mg/ml oral drops, suspension 100 ml contain: active ingredient: cloperastina fendizoato 3,54 g equal to cloperastina 1,8 g; excipients with known effects: sucrose 14 g, methyl-para-hydroxybenzoate 0.2 g. 1 drop (equivalent to 0.05 ml) contains 1,8 mg of cloperastina fendizoate equal to 0.9 mg of cloperastina. SEKI children 4,4 mg chewing tablets One tablet contains: active ingredient: cloperastina fendizoato mg 4,4; excipient with known effect: sucrose 36.8 mg. For the full list of excipients, see paragraph 6.1

Excellent

SEKI 10 mg coated tablets microcrystalline cellulose, silica, talc, magnesium stearate, ipromellose, povidone, macrogol 4000, sucrose, magnesium carbonate, titanium dioxide, erythrosine (E127). SEKI 35.4 mg/ml oral drops, suspension polyoxyethylene stearate, silica, methyl-para-hydroxybenzoate, sucrose, banana aroma, purified water. SEKI children 4,4 mg chewable tablets sucrose, mannitol, microcrystalline cellulose, starch, methylcellulose, magnesium stearate, talc, strawberry essence.

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: Covered tablets: 2 tablets in the evening at bedtime; 1 tablet in the morning, 1 tablet in the afternoon, preferably between meals. Drops: 30 drops in the evening before bedtime, 15 drops in the morning, 15 drops in the afternoon. CHILDREN aged 2 years: Chewable tablets: up to 7 years: 2 tablets in the evening at the time of bedtime; one tablet in the morning; one tablet in the afternoon. After 7 years: 4-6 tablets in the evening at the time of bedtime; 2-3 tablets in the morning; 2-3 tablets in the afternoon. Drops: 14 drops in the evening before bedtime, 8 drops in the morning, 8 drops in the afternoon. Duration of treatment: 7 days. If you do not notice appreciable results you should consult your doctor.

Conservation

Chewable drops and tablets: this medicine does not require any particular condition of conservation. Covered tablets: keep at a temperature below 25°C.

Warnings

Caution is recommended in patients with intraocular hypertension, prostate hypertrophy or bladder obstruction. Important information about some excipients Parahydroxybenzos Drops contain methyl-para-hydroxybenzoate (E218) which can cause allergic reactions (also delayed). Sucrose - coated tablets contain 38.07 mg of sucrose per dose; - chewable tablets contain about 36.8 mg of sucrose per dose; - the drops contain about 140 mg of sucrose per ml. Patients with rare hereditary problems of fructose intolerance, glucose-galactosis mal absorption or isomaltase sucrasis failure, should not take this medicine. In the case of diabetic subjects or following hypocaloric dietary regimes it is to be borne in mind that the preparation contains sugar.

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