Seki Syrup Bottle 200ml 3.54 mg/ml

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Cough suppressant.

ACTIVE INGREDIENTS

SEKI 3.54 mg/ml syrup 100 ml contain: active ingredient: cloperastine phendizoate 354 mg equal to cloperastine 180 mg excipients with known effects: ethanol 30 mg, methyl parahydroxybenzoate 122 mg, propyl parahydroxybenzoate 18 mg, propylene glycol 230.4 mg, sucrose 45 mg For the full list of excipients, see section 6.1

EXCIPIENTS

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

CONTRAINDICATIONS AND SIDE EFFECTS

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

DOSAGE

Daily dose: ADULTS: 2 small glasses ("Adults" mark on the dispenser included in the package; one "Adults" mark corresponds to 7.5 ml of syrup) in the evening at bedtime; a drink in the morning, a drink in the afternoon. CHILDREN: After two years: two small glasses ("Children" mark on the dispenser included in the package; one "Children" mark corresponds to 3.75 ml of syrup) in the evening before bedtime; a drink in the morning, a drink in the afternoon. Duration of treatment: 7 days. If you do not notice appreciable results, it is advisable to consult your doctor.

CONSERVATION

Store below 30°C.

WARNINGS

Caution is advised when using it in patients suffering from intraocular hypertension, prostatic hypertrophy or bladder obstruction. Important information about some excipients Ethanol (contained in banana flavour) This medicine contains 0.0011 ml of alcohol (ethanol) in each 3.75 ml dose (marked “Children”) and 0.0022 ml of alcohol (ethanol) in each 7.5 ml dose (marked “Adults”). The amount in one 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 any noticeable effects. Parahydroxybenzoates This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed). Propylene Glycol (contained in banana flavour) This medicine contains 8.6 mg of propylene glycol in 3.75 ml (mark “Children”) and 17.3 mg of propylene glycol in 7.5 ml (mark “Adults”). Sucrose This medicine contains 1.687 g of sucrose per 3.75 ml dose (mark “Children”) and 3.375 g of sucrose per 7.5 ml dose (mark “Adults”). To be taken into consideration in people suffering from diabetes mellitus. Patients suffering from rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase isomaltase insufficiency should not take this medicine. Sodium This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially 'sodium-free'.

INTERACTIONS

Although the central side effects of cloperastine are reduced, the medicine can interact with both central nervous system depressants and stimulants. No interaction studies have been conducted on humans. The concomitant use of Seki with: - alcohol, - antihistamines, - anticholinergics, - sedatives is not recommended, both in adult patients and in children. It is not known whether in pediatric age the extent of the interactions reported above is similar to that in adulthood. There is no information regarding any interactions of the drug with laboratory tests. No information is available regarding the interaction of cloperastine with food, therefore its intake during meals is not recommended.

SIDE EFFECTS

Below is a table relating to the frequency of side effects: Frequency: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1000, < 1/100); rare (≥ 1/10000, < 1/1000); very rare (< 1/10000), not known (frequency cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

System organ class - Adverse reactions: Uncommon (≥1/1,000; <1/100). Rare (≥1/10,000; <1/1,000). Very rare (<1/10,000). Not known.

Immune system disorders - Anaphylactic/anaphylactoid reaction.

Nervous system disorders - Adverse reactions: Drowsiness, dry mouth.

Skin and subcutaneous tissue disorders - Urticaria Erythema.

Pediatrics Clinical studies and post-marketing surveillance with cloperastine have not shown any relevant differences in the nature, frequency, severity and reversibility of adverse reactions between adult and pediatric populations. Reporting of suspected adverse reactions. Reporting suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit/risk balance of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

OVERDOSE

Adults No cases of overdose have been reported in adults treated with Seki. Children One case of overdose has been reported in a child who took a dose of 40 ml of Seki syrup. No associated adverse reactions were reported. The patient was treated with two tablespoons of activated charcoal. Treatment of overdose Gastric lavage is useful if performed within a short time of ingesting the drug. The patient must be kept calm to minimize any sign of central overexcitation: in this case the use of benzodiazepines can be useful.

PREGNANCY AND BREASTFEEDING

Pregnancy There is no information available regarding the use of Seki during pregnancy. Although toxicity studies carried out during pregnancy in animals have not shown teratogenic activity and foetotoxicity, it is good prudential practice not to take the drug in the first months of pregnancy and in the subsequent period only in case of actual need under the direct supervision of a doctor. Breastfeeding It is not known whether the medicinal product and/or its metabolites are excreted in breast milk; Since the risk to the infant cannot be excluded, Seki must not be used during breastfeeding.

EFFECTS ON DRIVING ABILITY

Since the product can, although rarely, cause drowsiness, those who may drive vehicles or carry out operations requiring a high degree of vigilance must be warned of this.