La-Son tablets film-coated

Država: Armenija

Jezik: engleski

Izvor: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivni sastojci:

hydroxyzine (hydroxyzine hydrochloride)

Dostupno od:

Arpimed LLC

ATC koda:

N05BB01

INN (International ime):

hydroxyzine (hydroxyzine hydrochloride)

Doziranje:

25mg

Farmaceutski oblik:

tablets film-coated

Jedinice u paketu:

(20/2x10/) in blister

Tip recepta:

Prescription

Status autorizacije:

Registered

Datum autorizacije:

2023-07-21

Svojstava lijeka

SUMMARY PRODUCT CHARACTERISTIC
LA-SON
25 MG FILM-COATED TABLETS
1. NAME OF THE MEDICINAL PRODUCT -
La-Son 25 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
_ACTIVE INGREDIENT:_
Hydroxyzine hydrochloride – 25 mg;
_For a full list of excipients, see section 6.1. _
_ _
3. PHARMACEUTICAL FORM
White biconvex oval scored film-coated tablets.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
La-Son is indicated to assist in the management of anxiety in adults.
La-Son is indicated for the management of pruritus associated with
acute and chronic urticaria,
including cholinergic and physical types, and atopic and contact
dermatitis in adults and children.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
La-Son should be used at the lowest effective dose and for the
shortest possible duration.
In adults and children over 40 kg in weight, the maximum daily dose is
100 mg per day.
_Anxiety _
_ADULTS _
50-100mg daily in divided doses
_ _
_Pruritus _
_ADULTS _
Starting dose of 25mg at night increasing as necessary to 25mg three
or four times daily.
_ _
_ELDERLY _
In the elderly, the maximum daily dose is 50 mg per day (see section
4.4). A reduced dose is advised.
This is due to a possible increase in the volume of distribution,
prolonged action and the possible effect
of age-related changes on pharmacologic functions; including hepatic
metabolism and renal excretion
(see Section 5.2 'Pharmacokinetic properties')
_PAEDIATRIC POPULATION _
FOR TREATING ITCHING IN CHILDREN
This product is not recommended for children under 6 years of age. In
children up to 40 kg in weight,
other appropriate strengths and dosage forms containing hydroxyzine
should be administered.
_ _
For children over 6 years, starting at 15-25mg and increasing to
50-100mg daily in divided doses
adjusted according to the child's weight.
As with all medications, the dosage should be adjusted according to
the patient's response to therapy.
_HEPATIC IMPAIRMENT _
The total daily dose should be reduced by 33%. Use in