LOSARTAN POTASSIUM JUBILANT 50MG FILM COATED TABLETS

Χώρα: Κύπρος

Γλώσσα: Ελληνικά

Πηγή: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας

Δραστική ουσία:

LOSARTAN POTASSIUM

Διαθέσιμο από:

JUBILANT PHARMACEUTICALS NV (0000007886) AXXES BUSINESS PARK, GULDENSPORENPARK 22, BLOCK C, MERELBEKE, 9820

Φαρμακολογική κατηγορία (ATC):

C09CA01

INN (Διεθνής Όνομα):

LOSARTAN

Δοσολογία:

50MG

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

LOSARTAN POTASSIUM (8000001451) 50MG

Οδός χορήγησης:

ORAL USE

Τρόπος διάθεσης:

Εθνική Διαδικασία

Θεραπευτική περιοχή:

LOSARTAN

Περίληψη προϊόντος:

Νομικό καθεστώς: Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 28 TABS IN BLISTER(S) (300029902) 28 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 56 TABS IN BLISTER(S) (300029905) 56 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται; PACK WITH 98 TABS IN BLISTER(S) (300029907) 98 TABLET - Εγκεκριμένο - Με Ιατρική Συνταγή που Επαναλαμβάνεται

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Losartan potassium Jubilant 50 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg losartan potassium
Excipients:
Each Losartan potassium 50 mg film-coated tablet contains 25 mg
lactose.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Losartan potassium Jubilant 50 mg film-coated tablets are white to
off-white, oval shaped, film-coated
tablets, debossed with “J” on one side and “50” on the other
side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
• Treatment of essential hypertension
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Hypertension
The usual initial and maintenance dose is 50 mg once daily for most
patients. The maximal
antihypertensive effect is attained 3-6 weeks after initiation of
therapy. Some patients may receive an
additional benefit by increasing the dose to 100 mg losartan once
daily (in the morning). Losartan
potassium may be administered with other antihypertensive agents,
especially with diuretics (e.g.
hydrochlorothiazide) (see section 4.3, 4.4, 4.5 and 5.1).
Paediatric hypertension
There are limited data on the efficacy and safety of losartan in
children and adolescents aged 6-18
years old for the treatment of hypertension (see 5.1: Pharmacodynamic
properties). Limited
pharmacokinetic data are available in hypertensive children above one
month of age (see 5.2:
Pharmacokinetic properties).
For patients who can swallow tablets, the recommended dose is 25 mg
once daily in patients >20 to
<50 kg. In exceptional cases the dose can be increased to a maximum of
50 mg once daily. Dosage
should be adjusted according to blood pressure response.
In patients >50 kg, the usual dose is 50 mg once daily. In exceptional
cases the dose can be adjusted to
a maximum of 100 mg once daily. Doses above 1.4 mg/ kg (or in excess
of 100 mg) daily have not
been studied in paediatric patients.
Losartan is not recommended for use in childre