Descrizione Clinica
CLOEL "708 MG/100 ML SOSPENSION ORAL
active ingredients
100 ml of suspension contain: Cloperastina fendizoato mg 708 (equal to cloperastina Hydrochloride mg 400). Excipients with known effects: methyl para-hydroxybenzoate, propile para-hydroxybenzoate. For the full list of excipients, see paragraph 6.1.Excellent
Gomma xantana, Macrogol stearato, Xilitolo, Metile para-hydroxybenzoato, Propile para-hydroxybenzoato, Banana aroma, Sodium hydroxide, 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. Generally contraindicated in pregnancy (see "Use during pregnancy and nursing").Population
Adults: 5 ml three times a day. Pediatric population: between 2 and 4 years: 2 ml twice a day; between 4 and 7 years: 3 ml twice a day; between 7 and 15 years: 5 ml twice a day. Duration of treatment: 7 days. If you do not notice appreciable results you should consult your doctor. A 2-3-5 ml calibrated measles are attached to the package.Conservation
This medicine does not require any special condition of conservation.Warnings
Cloel 708 mg/100 ml Oral suspension contains parabens such as methyl para-hydroxybenzoate and propile para-hydroxybenzoate that can cause allergic reactions (also delayed). Caution is recommended in patients with intraocular hypertension, prostate hypertrophy or bladder obstruction. Keep out of sight and reach of children. Precautions for use: Shake well before use. Important information about some excipients Cloel 708 mg/100 ml Oral suspension contains parabens such as methyl para-hydroxybenzoate and propile para-hydroxybenzoate that can cause allergic reactions (also delayed). This medicine contains less than 1mmol (23mg) of sodium per dose of 5ml, 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. The simultaneous intake of sedatives or antihistamines, as well as alcohol ingestion, can enhance the unwanted effects of the drug.Effects
Undesirable effects are classified by systems and organs and by freqence. The frequencies are defined as: very common (≥ 1/10); common (≥ 1/100, 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: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.Overdosing
In case of overdose, please do gastric washing within a short time and keep the patient quiet by minimizing any central overexcitation; possibly use benzodiazepines.Pregnancy Although toxicity studies carried out during pregnancy in animals have not evidenced teratogenic activity and fetal toxicity, the risk of harmful effects on the fetus as a result of taking cloperastina cannot be excluded. For precautionary purposes, it is preferable to avoid the use of Cloel during pregnancy.
Source: Farmadati
