Desogestrel Mylan 0,075 mg, tabletten

Šalis: Nyderlandai

kalba: olandų

Šaltinis: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Veiklioji medžiaga:

DESOGESTREL 0,075 mg/stuk

Prieinama:

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN

ATC kodas:

G03AC09

INN (Tarptautinis Pavadinimas):

DESOGESTREL 0,075 mg/stuk

Vaisto forma:

Tablet

Sudėtis:

AARDAPPELZETMEEL ; LACTOSE 0-WATER ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551) ; STEARINEZUUR (E 570) ; TOCOFEROL, DL-ALFA (E 307),

Vartojimo būdas:

Oraal gebruik

Gydymo sritis:

Desogestrel

Produkto santrauka:

Hulpstoffen: AARDAPPELZETMEEL; LACTOSE 0-WATER; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551); STEARINEZUUR (E 570); TOCOFEROL, DL-ALFA (E 307);

Leidimo data:

2018-04-25

Pakuotės lapelis

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE USER
DESOGESTREL MYLAN 75 MICROGRAMS TABLETS
desogestrel
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Desogestrel Mylan is and what it is used for
2.
What you need to know before you take
3.
How to take Desogestrel Mylan Possible side effects
4.
How to store Desogestrel Mylan Contents of the pack and other
information
1.
WHAT DESOGESTREL MYLAN IS AND WHAT IT IS USED FOR
•
Desogestrel Mylan is used to prevent pregnancy.
•
There are 2 main kinds of hormone contraceptive:
-
The combined pill, “THE PILL”, which contains 2 types of female
sex hormone (an oestrogen and
a progestogen).
-
The progestogen-only pill, POP, which doesn’t contain an oestrogen.
•
Desogestrel Mylan is a progestogen-only-pill (POP).
•
Desogestrel Mylan contains a small amount of one type of female sex
hormone, the progestogen
DESOGESTREL.
•
Most POPs work primarily by preventing the sperm cells from entering
the womb but they do not
always prevent the egg cell from ripening, which is the main way that
combined pills work.
•
Desogestrel is different from most POPs in having a dose that in most
cases prevents the egg cell
from ripening. As a result, desogestrel is a highly effective
contraceptive.
•
In contrast to the combined pill, Desogestrel Mylan can be used by
women who do not tolerate
oestrogens and by women who are breast feeding.
•
A disadvantage is that vaginal bleeding may occur at irregular
intervals during the use of Desogestrel

Prekės savybės

1.
NAME OF THE MEDICINAL PRODUCT
Desogestrel Mylan 0,075 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 75 micrograms desogestrel.
Excipient(s) with known effect
58.22 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Round, white to off-white, uncoated, biconvex tablets with
approximately 5 mm of diameter and
debossed ‘152’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral Contraception.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To achieve contraceptive effectiveness, desogestrel must be used as
directed (see 'How to take
desogestrel' and 'How to start desogestrel').
Special populations
_Renal impairment _
No clinical studies have been performed in patients with renal
impairment.
_Hepatic impairment _
No clinical studies have been performed in patients with hepatic
insufficiency. Since the metabolism
of steroid hormones might be impaired in patients with severe hepatic
disease, the use of desogestrel
in these women is not indicated as long as liver function values have
not returned to normal (see
section 4.3).
_Paediatric population _
The safety and efficacy of desogestrel in adolescents below 18 years
has not been established. No data
are available.
Method of administration
Oral use
HOW TO TAKE DESOGESTREL
Tablets must be taken every day at about the same time so that the
interval between two tablets is
always 24 hours. The first tablet should be taken on the first day of
menstrual bleeding. Thereafter one
tablet each day is to be taken continuously, without taking any notice
of possible bleeding. A new
blister is started directly the day after the previous one.
HOW TO START DESOGESTREL.
_No preceding hormonal contraceptive use [in the past month] _
Tablet-taking has to start on day 1 of the woman's natural cycle (day
1 is the first day of her menstrual
bleeding). Starting on days 2-5 is allowed, but during the first cycle
a barrier method is recommended
for the first 7 days of tablet-taking.
_Following fir