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Respiratory System

Rolinoz (Tablets / Oral Drops)
(Cetirizine)



CONTENT:
Tablets. Tablet contains cetirizine dihydrochloride 10 mg.
Oral drops. 1 ml of the preparation contains cetirizine dihydrochloride 10 mg.
 
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMICS. Rolinoz - selective blocator of peripheral histamine H1-receptors, metabolite of hydroxyzine. It has the anti-histamine and anti-allergic effects. The drug prevents the development and relives the course of allergic reactions, has antipruritic and antiexudative effects.
It influences on the early stage of allergic reactions, as well as reduces the migration of inflammatory cells; supresses the mediators discharge, participating in the late allergic reaction. It reduces the capillary permeability, prevents the development of tissue edema, release the smooth muscles spasm. It eliminates the skin reaction on the histamine injection, offending allergens, as well as on the cooling (at cold urticaria). It reduces histamine bronchoconstruction at the bronchial asthma of the light course. It practically does not have sedative effect at the application with the recommended doses and does not have anticholinergic and anti-serotonin actions. PHARMACOKINETICS. The preparation is quickly absorbed from the gastro-intestinal tract. The absorption is 70%. The maximum concentration is reached in 1 hour after the application. The elimination half-life is about 7-10 h.
It is metabolized in liver in minimum amounts with the development of non-active metabolite and is removed unchanged predominantly through the kidneys.
 
THERAPEUTIC INDICATIONS:
- year-round and seasonal allergic rhinitis (as symptomatic therapy);
- pollinosis;
- urticaria (including chronic and idiopatic);
- dermatoses with itch (including atopic dermatitis, neurodermatitis);
- allergic conjunctivitis;
- chronic eczema;
- complex therapy of bronchial asthma.
 
CONTRAINDICATIONS:
- hypersensitivity to the drug components or to hydroxyzine;
- children under 2 years;
- pregnancy.
 
SIDE EFFECTS:
The preparation is usually well tolerated. Side effects appear rarely and have transient character.
From the digestive system: dry mouth, dyspepsia.
From the central nervous system (CNS): headache, drowsiness, dizziness, migraine.
Allergic reactions: skin rash, angioneurotic edema, urticaria, skin itch.
 
DOSAGE AND ADMINISTRATION:
The oral application of Rolinoz is made independently on the meal, taking with sufficient quantity of liquid.
Children from 2 to 6 years: 2.5 mg (5 drops) 2 times per day or 5 mg (10 drops) 1 time per day.
Children from 6 to 12 years: 10 mg (20 drops or 1 tablet) 1 time per day or 5 mg (10 drops or tablet) in the morning and in the evening.
Adults and teenagers (12+ years): the daily dose of 10 mg (20 drops or 1 tablet).
For older patients (on condition of normal kidneys function): the dose of Rolinoz should not be reduced.
For patients with moderate and heavy kidneys dysfunction: the dose of preparation should be to be half from usual.
 
PACKAGING:
10 tablets in a blister.
2 blisters in carton box together with enclosed leaflet.
Oral drops in dark glass vial of 20 ml. The vial is provided with a dropper and a childproof closure system.
1 vial in carton box together with enclosed leaflet.
 
 
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