Endofemine 2 mg Tablett

Country: Sweden

Language: Swedish

Source: Läkemedelsverket (Medical Products Agency)

Active ingredient:

dienogest

Available from:

Mylan AB

ATC code:

G03DB08

INN (International Name):

dienogest

Dosage:

2 mg

Pharmaceutical form:

Tablett

Composition:

laktosmonohydrat Hjälpämne; dienogest 2 mg Aktiv substans

Prescription type:

Receptbelagt

Product summary:

Förpacknings: Blister, 1 x 28 tabletter (kalenderförpackning); Blister, 3 x 28 tabletter (kalenderförpackning); Blister, 6 x 28 tabletter (kalenderförpackning)

Authorization status:

Avregistrerad

Authorization date:

2019-03-15

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Endofemine 2 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dienogest
Excipient with known effect: each tablet contains 60.9 mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White, round, tablets with a diameter of 5 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of endometriosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology: _
The dosage of is one tablet daily without any break,
taken preferably at
the same time each day with some liquid as needed. The tablet can be
taken with or without
food.
Tablets must be taken continuously without regard to vaginal bleeding.
When a pack is finished
the next one should be started without interruption.
There is no experience with treatment >15 months in
patients with
endometriosis.
Treatment can be started on any day of the menstrual cycle.
Any hormonal contraception needs to be stopped prior to initiation of
.
If contraception is required, non-hormonal methods of contraception
should be used (e.g.
barrier method).
_Management of missed tablets: _
2
The efficacy of may be reduced in the event of missed
tablets, vomiting
and/or diarrhea (if occuring within 3-4 hours after tablet taking). In
the event of one or more
missed tablets, the woman should take one tablet only, as soon as she
remembers, and should
then continue the next day at her usual time. A tablet not absorbed
due to vomiting or diarrhea
should likewise be replaced by one tablet.
_ADDITIONAL INFORMATION ON SPECIAL POPULATIONS _
_Paediatric population: _
is not indicated in children prior to menarche.
The safety and efficacy of dienogest was investigated in an
uncontrolled clinical trial over 12
months
in
111
adolescent
women
(12-<18)
with
clinically
suspected
or
confirmed
endometriosis (see sections 4.4 and 5.1).
_Geriatric population: _
There is no relevant