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[COMPOSITION]
Each capsules contains cetirizine hydrochloride 10 mg.
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[PACKAGING]
Box containing 6 capsules for oral use.
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| [PROPERTIES] |
In experimental animals, ÒÁάÍ×®
has been shown to be an anti-H1 agent devoid of any significant
anticholinergic or antiserotonin effects. At pharmacologically
active doses, it induces neither sedation nor behavioural changes.
This may be explained by the fact that ÒÁάÍ×® does
not cross the blood-brain barrier.
It was shown in human pharmacology studies that ÒÁάÍ×®will
inhibit certain effects produced by exogenous histamine. This
activity appears rapidly. ÒÁάÍ×® also inhibits
the effects produced by endogenous histamine released in vivo
by an agent such as 48/80.Finally, it inhibits the cutaneous
reaction induced by VIP (vasoactive lntestinal polypeptide)
and substance P, neuropeptides which are believed to take part
in the allergic reaction.
ÒÁάÍ×® markedly reduces bronchial hyperreactivity
to histamine in the asthmatic patient. It also reduces the allergic
reaction induced by specific allergens. These effects are obtained
without any central effects being demonstrated either by psychometric
tests or by a quantified EEG.
Peak blood levels of the order of 339.3¡À23.8ng/ml micrograms/ml
are reached between forty and sixty minutes after administration
of a 10 mg dose of ÒÁάÍ×®. Its plasma half-life
is approximately 8.7¡À1.5 hours. |
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[INDICATION]
Symptomatic treatment of seasonal rhinitis and conjunctivitis,
perennial allergic rhinitis as well as pruritus and urticaria
of allergic origin. |
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[Dosage and Directions for use]
Adults and children of 12 years and older.
In most cases, the recommended dose is one 10mg tablet daily. |
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[CONTRADINDACTIONS]
Are contraindicated in patients with a history of hypersensitivity
to any of the constituents. |
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[Side Effects]
When is administered at recommended doses any side effects that
may occur, such as agitation, dry mouth, drowsiness, or headache,
do not differ significantly from placebo. |
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[Pregnancy and Lactation]
Teratology studies in animal have not demonstrated any special
adverse effects. As a precaution,
However, ÒÁάÍ×® should not be administered to pregnant
women during the first three months of pregnancy, nor should
women who are breastfeeding take the drug. |
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[Driving or Operating Machinery]
Studies in healthy volunteers on 20 or 25 mg/day have not revealed
effects on alertness or reaction time. Patient should be advised,
however, to take care not to exceed the recommended dose. |
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[Drug Interaction]
To date, there are no known interactions with other drugs.
Nevertheless, should be advised, however, to take care not to
exceed the recommended dose. |
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 [OVERDOSAGE]
Drowsiness can be a symptom of overdosage, occurring from administration
of 50 mg of as a single does.
To date, there is no specific antidote. In the case of massive
overdosage, gastric lavage should be performed as soon as possible.
Usual supportive measures should be provided and routine observations
carried out regularly.
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[STORAGE]
Store below 25oC in a dry place. |
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[STABILITY]
The expiry date on the package, found after the mention "EXP."
should not have been exceeded.
The information provided in this leaflet is limited; further
information can be obtained from other sources, including
doctors and pharmacists.
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