Verospiron 50mg capsules

Riik: Armeenia

keel: inglise

Allikas: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Toimeaine:

spironolactone

Saadav alates:

Gedeon Richter PLC

ATC kood:

C03DA01

INN (Rahvusvaheline Nimetus):

spironolactone

Annus:

50mg

Ravimvorm:

capsules

Ühikuid pakis:

(30/3x10/) in blister

Retsepti tüüp:

Prescription

Volitamisolek:

Registered

Loa andmise kuupäev:

2019-11-27

Toote omadused

24054-55-56/55/09.
31820-21-22/41/09.
OGYI/16866-1/2010
OGYI/16867-1/2010
OGYI/16868-1/2010
1.
NAME OF THE MEDICINAL PRODUCT
VEROSPIRON 25 MG TABLETS
VEROSPIRON 50 MG CAPSULES, HARD
VEROSPIRON 100 MG CAPSULES, HARD
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Verospiron 25 mg tablets _
Each tablet contains 25.0 mg spironolactone. The preparation also
contains 146.0 mg lactose
monohydrate in each tablet.
_Verospiron 50 mg capsules, hard _
Each capsule, hard contains 50.0 mg spironolactone. The 50 mg capsule
also contains 127.5 mg
lactose monohydrate in each capsule.
_Verospiron 100 mg capsules, hard _
Each capsule, hard contains 100 mg spironolactone. The 100 mg capsule
also contains 255.0 mg
lactose monohydrate in each capsule.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
_Verospiron 25 mg tablets _
Almost white, round, flat, bevelled edged tablets with a
characteristic mercaptane-like odour, having
an imprinting VEROSPIRON on the one side.
_Verospiron 50 mg capsules, hard _
Filling: 225 mg white or almost white granules.
Hard gelatine capsules, size No. 3.
Upper part: yellow, opaque.
Lower part: white, opaque.
_Verospiron 100 mg capsules, hard _
Filling: 450 mg white or almost white granules.
Hard gelatine capsules, size No. 0.
Upper part: orange, opaque.
Lower part: yellow, opaque.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
–
_In congestive heart failure_ when the patient is not responsive to,
or is intolerant of other
therapeutic measures, or the effect of other diuretics has to be
potentiated.
–
_Essential hypertension_, mainly in case of hypokalaemia, usually in
combination with other
antihypertensive drugs.
–
In cirrhosis of the liver accompanied by oedema and/or ascites.
–
For the treatment of primary hyperaldosteronism.
–
In case of oedema in nephrotic syndrome.
–
For the treatment of hypokalaemia when the patient cannot receive any
other therapy.
RenBin002279_1
129/901
2
–
Prevention of hypokalaemia in patients taking digitalis when other
measures are cons