Seki 35, 4 mg/ml 25 ml oral drops suspension

Seki 35.4 mg/ml 25 ml oral drops suspension is an antitussive drug specifically formulated for the treatment of dry and persistent cough . Thanks to its active ingredient, cloperastine fendizoate , Seki acts directly on the cough centers, helping to calm the urge to cough and relieve the itchy throat that often accompanies non-productive coughs. The formulation in oral drops suspension makes the product particularly practical and suitable for both adults and children over 2 years of age, allowing precise and personalized dosing based on individual needs.

The 25 ml bottle of Seki is ideal for home use and ensures quick and easy administration. The presence of banana flavour makes the suspension pleasant even for the little ones. Seki 35.4 mg/ml is indicated as a cough sedative and represents an effective solution for those looking for a cough medicine that acts quickly and in a targeted manner. Its antitussive action helps improve the quality of sleep and daily well-being, reducing the discomfort associated with dry cough. Seki is a reference product among oral medicines against cough, thanks to the proven efficacy of cloperastine and its tolerability.

ACTIVE INGREDIENTS

Active substances contained in Seki 35.4 mg/ml 25 ml oral drops suspension - What is the active substance of Seki 35.4 mg/ml 25 ml oral drops suspension?

SEKI 10 mg coated tablets One tablet contains: active ingredient : cloperastine hydrochloride 10 mg; excipient with known effect : sucrose 38.07 mg. SEKI 35.4 mg/ml oral drops, suspension 100 ml contain: active ingredient : cloperastine fendizoate 3.54 g equivalent to cloperastine 1.8 g; excipients with known effect : sucrose 14 g, methyl-para-hydroxybenzoate 0.2 g. 1 drop (equivalent to 0.05 ml) contains 1.8 mg of cloperastine fendizoate equivalent to 0.9 mg of cloperastine. SEKI children 4.4 mg chewable tablets One tablet contains: active ingredient : cloperastine fendizoate 4.4 mg; excipient with known effect : sucrose 36.8 mg. For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Seki 35.4 mg/ml 25 ml oral drops suspension - What does Seki 35.4 mg/ml 25 ml oral drops suspension contain?

SEKI 10 mg coated tablets microcrystalline cellulose, silica, talc, magnesium stearate, hypromellose, 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 flavour, purified water. SEKI children 4.4 mg chewable tablets sucrose, mannitol, microcrystalline cellulose, starch, methylcellulose, magnesium stearate, talc, strawberry essence.

DIRECTIONS

Therapeutic indications Seki 35.4 mg/ml 25 ml oral drops suspension - Why is Seki 35.4 mg/ml 25 ml oral drops suspension used? What is it used for?

Cough suppressant.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Seki 35.4 mg/ml 25 ml oral drops suspension - When should Seki 35.4 mg/ml 25 ml oral drops suspension not be used?

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

DOSAGE

Quantity and method of taking Seki 35.4 mg/ml 25 ml oral drops suspension - How to take Seki 35.4 mg/ml 25 ml oral drops suspension?

Daily dose : ADULTS: Coated 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 at bedtime, 15 drops in the morning, 15 drops in the afternoon. CHILDREN over 2 years of age: Chewable tablets : up to 7 years of age: 2 tablets in the evening at bedtime; one tablet in the morning; one tablet in the afternoon. After 7 years of age: 4-6 tablets in the evening at bedtime; 2-3 tablets in the morning; 2-3 tablets in the afternoon. Drops : 14 drops in the evening at bedtime, 8 drops in the morning, 8 drops in the afternoon. Duration of treatment: 7 days. If no appreciable results are seen, it is advisable to consult your doctor.

CONSERVATION

Storage Seki 35.4 mg/ml 25 ml oral drops suspension - How should Seki 35.4 mg/ml 25 ml oral drops suspension be stored?

Drops and chewable tablets: This medicine does not require any special storage conditions. Coated tablets: Store below 25°C.

WARNINGS

Warnings Seki 35.4 mg/ml 25 ml oral drops suspension - About Seki 35.4 mg/ml 25 ml oral drops suspension it is important to know that:

Caution is advised when using in patients with intraocular hypertension, prostatic hypertrophy or bladder obstruction. Important information about some of the excipients Parahydroxybenzoates The drops contain methyl-parahydroxybenzoate (E218) which may cause allergic reactions (possibly delayed). Sucrose - the coated tablets contain 38.07 mg of sucrose per dose; - the chewable tablets contain approximately 36.8 mg of sucrose per dose; - the drops contain approximately 140 mg of sucrose per ml. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. In the case of diabetics or those on a low-calorie diet, it should be taken into account that the preparation contains sugar.

INTERACTIONS

Interactions Seki 35.4 mg/ml 25 ml oral drops suspension - Which medicines or foods can modify the effect of Seki 35.4 mg/ml 25 ml oral drops suspension?

Although the central side effects of cloperastine are reduced, the medicinal product may interact with both central nervous system depressants and stimulants. No interaction studies have been conducted in humans. It is not recommended, both in adults and children, the concomitant use of Seki with: - alcohol; - antihistamines; - anticholinergics; - sedatives. It is not known whether the extent of the interactions reported above is similar in children to that in adults. There is no information on any interactions of the drug with laboratory tests. There is no information on the interaction of cloperastine with food, therefore it is not recommended to take it during meals.

SIDE EFFECTS

Like all medicines, Seki 35.4 mg/ml 25 ml oral drops suspension can cause side effects - What are the side effects of Seki 35.4 mg/ml 25 ml oral drops suspension?

The following table shows the frequency of adverse reactions: 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, adverse reactions are presented in decreasing order of seriousness.

Organ-system 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				Anaphylactic/anaphylactoid reaction
Nervous system disorders	Drowsiness, dry mouth
Skin and subcutaneous tissue disorders				Urticaria Erythema

Pediatrics Clinical studies and post-marketing surveillance with cloperastine have not shown any significant differences in the nature, frequency, severity and reversibility of adverse reactions between the adult and pediatric populations. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product. 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

Overdose Seki 35.4 mg/ml 25 ml oral drops suspension - What are the risks of Seki 35.4 mg/ml 25 ml oral drops suspension in case of 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 spoonfuls of activated charcoal. Treatment of overdose Gastric lavage is useful if performed shortly after ingestion of the drug. The patient should be kept calm to minimise any signs of central overexcitation: in this case the use of benzodiazepines may be useful.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Seki 35.4 mg/ml 25 ml oral drops suspension.

Pregnancy There is no information available on 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 practice to avoid taking the drug during the first months of pregnancy and in the subsequent period only in case of real 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 a risk to the infant cannot be excluded, Seki should not be used during breastfeeding.

DRIVING AND USE OF MACHINERY

Taking Seki 35.4 mg/ml 25 ml oral drops suspension before driving or using machines - Does Seki 35.4 mg/ml 25 ml oral drops suspension affect driving or using machines?

Since the product may, although rarely, cause drowsiness, those who may drive vehicles or perform operations requiring a high level of alertness must be warned of this.