Dvella tablets

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

ulipristal (ulipristal acetate)

Disponibil de la:

Laboratorios Leon Farma S.A.

Codul ATC:

G03AD02

INN (nume internaţional):

ulipristal (ulipristal acetate)

Dozare:

30mg

Forma farmaceutică:

tablets

Unități în pachet:

(1) in blister

Tip de prescriptie medicala:

OTC

Statutul autorizaţiei:

Registered

Data de autorizare:

2018-05-07

Caracteristicilor produsului

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dvella 30 mg tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 30 mg ulipristal acetate.
Excipients with known effect:
Each tablet contains 237 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
White to marble creamy, round curved tablet of 9mm diameter engraved
with
_“еllа”_
on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Emergency contraception within 120 hours (5 days) of unprotected
sexual intercourse or contraceptive
failure.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment consists of one tablet to be taken orally as soon as
possible, but no later than 120 hours
(5 days) after unprotected intercourse or contraceptive failure.
Dvella can be taken at any time during the menstrual cycle.
If vomiting occurs within 3 hours of Dvella intake, another tablet
should be taken.
If a woman’s menstrual period is late or in case of symptoms of
pregnancy, pregnancy should be excluded
before Dvella is administered.
Special populations
_ _
_Renal impairment_
No dose adjustment is necessary.
_Hepatic impairment _
In the absence of specific studies, no alternate dose recommendations
for Dvella can be made.
_Severe hepatic impairment_
In the absence of specific studies, Dvella is not recommended.
_Paediatric population _
There is no relevant use of Dvella for children of prepubertal age in
the indication emergency contraception
_._
Adolescents: Dvella is suitable for any woman of child bearing age,
including adolescents. No differences in
safety or efficacy have been shown compared to adult women aged 18 and
older (see section 5.1).
3
Method of administration
Oral use.
The tablet can be taken with or without food.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Dvella is for occasional use only. It should in no insta