200 ml - oral suspension
Each 100 ml of suspension contains
L-Cloperastine fendizoate 708 mg
PHARMACEUTICAL FORM
200 ml oral suspension.
CLINICAL PARTICULARS
Therapeutic indications
Sedative for coughs.
Dosage and administration method
Adults: 5 ml three times per day.
Children: from 2 to 4 years: 2 ml twice per day;
from 4 to 7 years: 3 ml twice per day;
from 7 to 15 years: 5 ml twice per day. A measuring cup marked at 2-3-5 ml is provided in the packaging.
Counter-indications
Hypersensitivity to one of the product components.
Due to a lack of studies in the 0 to 2 year age band we recommend against using the
medicine on young infants.
It is generally not recommended during pregnancy.
Special warnings and use precautions
Special warnings None.
Special precautions for use None.
Interactions with other medicines and other forms of interaction
Even if the secondary central effects of the levocloperastine are significantly reduced, the medicine may interact with both depressant and stimulant substances of the central nervous system.
The possibility of strengthening the effect of substances with an antihistamine/antiserotoninic action and to a lesser extent of myo-relaxants such as papaverine should be considered.
Pregnancy and weaning
Whilst toxicity studies performed during pregnancy on animals have not highlighted any teratogenic activity and foetal toxicity, it is prudentially good practice not to take the medicine during the initial months of pregnancy and in the later period only in the case of effective necessity under the direct control of a doctor.
Effects on the ability to drive and use machinery
At the therapeutic doses, the medicine does not induce sedation and does not interfere with the ability to drive vehicles or to use machinery.
Undesired effects
No signs or symptoms that can be connected to a central effect of the sedative or stimulating types have been found at therapeutic doses.
Overdose
In the case of overdose, we recommend performing the normal procedures (gastro-washing, activated carbon,
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmaco-therapeutic group: cough sedative.
Action mechanism:
selective inhibiting action on the cough bulbar centre;
sedative action on the peripheral stimuli that induce the cough reflex, by inhibiting the inflammatory process mediators and an anti broncho-spasm effect.
Pharmacokinetic properties
The product is absorbed through the intestine and is principally excreted in urine, in a mainly degraded form.
The maximum plasma peak is reached in 90-120 minutes, with a successive broad distribution in the tissue regions and above all in the lungs.
PHARMACEUTICAL PARTICULARS
List of excipients
Xantan gum, polyoxyethyl stearate, Xylitol, Methyl p-hydroxybenzoate, Propyl p-hydroxybenzoate, Banana aroma, deionized water.
Incompatibilities None.
Shelf-life 5 years.
Special precautions for storage None.
Nature and contents of container
Glass bottle with a child-proof stopper and seal, containing suspension with a fruit flavour and a sweet, pleasant taste.