Seki Syrup Bottle 200ml 3.54 mg/ml

In compliance with article 118 "authorization of advertising to the public" of the legislative decree of 24 April 2006, number 219

INDICATIONS

Cough suppressant.

CONTRAINDICATIONS

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.

WARNINGS AND PRECAUTIONS FOR USE

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.

Organ-systemic classification | 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 | Not known: Anaphylactic/anaphylactoid reaction

Nervous system disorders | Uncommon (≥1/1,000; <1/100): Drowsiness, dry mouth

Skin and subcutaneous tissue disorders | Not known: 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.