APPLICATION INSTRUCTION
ALER NEO

GENERIC NAME: Cetirizine.
DRUG FORM: Coated tablets.
PHARMACOLOGICAL GROUP: Antihistamine, H1 histamine receptor blocker.
COMPOSITION:
Active substance: Cetirizine dihydrochloride – 10mg;
Aiding substances: Lactose monohydrate, corn starch, carboxymethylcellulose, calcium stearate, talc, sugar, magnesium carbonate, polyvinylpyrrolidone, titanium dioxide, aerosil.
PHARMACOLOGICAL OPERATION:
Pharmacodynamics: “Aler Neo” represents II generation antihistamine, H1 histamine receptors’ selective blocker. The preparation doesn’t reveal anticholinergic and antiserotonin properties. It doesn’t get into hematoencephalic barrier, in therapeutic doses almost has no sedative effect and doesn’t cause drowsiness. It has antipruritic and antiexudative action. Has impact on early histaminedependent stage of allergic reactions, oppresses excretion of the mediators, participating in the late stage of allergic reaction. Reduces conductivity of capillaries, removes a spasm of smooth muscles, reduces migration of eosinophil, neutrophil and basophile in reply to allergen introduction, disturbs edema of tissues. The preparation blocks development of skin reactions by introduction of histamine and specific allergens.
The therapeutic effect reveals in 20 minutes after preparation reception (among 50% of patients) or after 1-2 hours (among 95% of patients) and remains within 24 hours. Restoration of skin reactivity toward histamine happens within 3 days. During treatment tolerance doesn’t develop toward preparation.
Pharmacokinetics: Cetirizine is quickly and well absorbed in the gastrointestinal tract (not less than 70%). Preparation intake together with food has no impact on absorption quality, however slightly decreases absorption speed. The considerable part of Cetirizine (93%) relates to blood plasma proteins. The maximum concentration of the preparation in plasma (0.3 mkg/ml) is reached in 30-60 minutes after reception, and stable concentration – after three days. Cetirizine practically doesn’t metabolize in the liver. About 60% is excreted unchanged form through kidneys. The system clearance makes up 54ml/min. Half-life makes up 10 hours for adults, among children from 6 to 12 years – 6 hours and from 2 to 5 years – 5 hours.
In case of kidneys’ function disorder (clearance lower than 11-31 ml/min.) and patients being on a dialysis, the period of half-life increases by 3 times, and the clearance decreases by 70%. At long reception, accumulation in an organism isn’t noted.
INDICATION:IT IS USED IN COMPLEX THERAPY, AS AN AID MEAN:
· Seasonal and chronic allergic rhinitis;
· Allergic conjunctivitis;
· Pollinosis;
· Nettle-rash (including chronic idiopathic nettle-rash);
· Angioedema;
· Dermatoses proceeding with an itch;
· Complex therapy of chronic eczema, atopic dermatitis, bronchial asthma;
· Various allergic diseases.
CONTRAINDICATIONS:
· Hypersensitivity toward compound components or hydroxyzinum.
· Pregnancy;
· Lactation period;
· Children’s age up to 2 years;
· Serious renal illnesses;
ORDER OF INTAKE AND DOSAGE: Peroral intake with enough amount of water, preferably in the evening. Regular intake is recommended one and the same time. Preparation intake doesn’t depend on food intake.
In adults and adolescents over 12 years is recommended 1 pill one time in a day (in the evening).
Children from 6 to 12 years:
· Children less than 30kg: 1/2 pill in the evening;
· Children more than 30kg: 1pill in the evening, or 1/2 pill 2 times in a day (in the morning and in the evening);
Children from 2 to 6 years: 1/4 pill 1-2 times in a day; maximal round-the-clock dose is 5mg.
At time of renal insufficiency, also patients being on hemodialysis – the recommended dose should be reduced twice.
At time of liver function disorder, dosage selection is individual. Dosage correction isn’t necessary for elderly, in case of normal function of kidney. Treatment course duration is individual and includes 2-4 weeks.
At time of seasonal allergic rhinitis treatment course duration is 3-6 weeks. Children over 6 years – 2-4 weeks, at short-term influence of allergen – 1 week.
SIDE EFFECTS: “Aler Neo” is well transferred. Side-effects revealed in the period of treatment, have easy and moderate temper and don’t demand treatment termination.
At reception of “Aler Neo” there may reveal following side-effects:
From the side of central nervous system: poorly expressed headache, dizziness, feeling of weakness, the increased nervous excitability, drowsiness.
From the side of cardiovascular system: very seldom – tachycardia.
From the side of digestion system: mouth dryness, change of flavouring feeling, dyspepsia, nausea, diarrhea, constipation, pain in the abdominal cavity;
Allergic reactions: rash on skin, angioneurotic edema, itch;
SPECIAL INSTRUCTIONS: It is necessary to be careful and reduce preparation dosage to those patients who has liver and/or kidneys function insufficiency, and also to the patients, being on hemodialysis.
In elderly, Cetirizine excretion is slowed down and in frequent cases it is necessary to correct a dosage.
Efficiency and safety of the preparation isn’t studied among children less than 2 years.
PREGNANCY AND LACTATION: Use of preparation during pregnancy is contraindicated. Cetirizine gets into the mother’s milk, so it is necessary to stop chest feeding during treatment.
INTERACTION WITH OTHER MEDICINES OR OTHER SORT INTERACTION: When using together with teophilin, the general clearance of Cetirizine decreases by 16% (teophilin kinetics doesn’t change). It isn’t recommended to use “Aler Neo” together with central nervous system suppressing preparations. It can be disguised at simultaneous reception together with ototoxic influence preparations (for example, gentamycin), such symptoms, as dizziness and noise in ears.
OVERDOSE:
Symptoms: Drowsiness, weakness, headaches, tachycardia, excitability, urination delay.
Treatment: Treatment is symptomatic, a specific antidote doesn’t exist, hemodialysis is inefficient, gastric lavage is carried out, intake activated charcoal.
INFLUENCE ON ABILITY OF DRIVING CARS AND OTHER VEHICLE: In case of reception recommended dose – 10 mg, the preparation has no impact on ability if driving cars and other vehicle. However, it is expedient to refrain from the activity, demanding concentration of attention and fast psychomotor reactions.
PACKAGE: 20 tablets on a polyvinylchloride blister, 1 blister in the cardboard box.
STORAGE CONDITIONS: Store on 15-25ºC temperature in a dry, protected from light place and keep away from children.
In case of visual defects and expiry of validity date, the preparation can not be used.
ORDER OF ISSUE: II group of a pharmaceutical product, issued with prescription form # 3
VALIDITY: 3 years.
MANUFACTURER: Ltd “Neopharmi”.

12th km. David Agmashenebeli alley. Tbilisi. Georgia
Tel/Fax: +995 (32) 259-64-46, 259-57-90.