Dienogest Hormosan 2 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

DIENOGEST

Beschikbaar vanaf:

Hormosan Pharma GmbH

ATC-code:

G03DB08

INN (Algemene Internationale Benaming):

DIENOGEST

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; KATOENZAADOLIE, GEHYDREERD ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Dienogest

Autorisatie datum:

2019-10-17

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIENOGEST HORMOSAN 2 MG FILMOMHULDE TABLETTEN
dienogest
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 Dienogest Hormosan is and what it is used for
2.
What you need to know before you take Dienogest Hormosan
3.
How to take Dienogest Hormosan
4.
Possible side effects
5.
How to store Dienogest Hormosan
6.
Contents of the pack and other information
1.
WHAT DIENOGEST HORMOSAN IS AND WHAT IT IS USED FOR
Dienogest Hormosan is a preparation for the treatment of endometriosis
(painful symptoms due to
displaced tissue of the lining of the womb). Dienogest Hormosan
contains a hormone, the progestogen
dienogest.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIENOGEST HORMOSAN
_ _
DO NOT TAKE DIENOGEST HORMOSAN IF YOU:
-
are suffering from a BLOOD CLOT (thromboembolic disorder) in your
veins. This may occur, for
example, in the blood vessels of the legs (deep vein thrombosis) or
the lungs (pulmonary
embolism). See also “Dienogest Hormosan and venous blood clots”
below
-
have or have ever had a SEVERE ARTERIAL DISEASE, including
cardiovascular disease, such as a
heart attack, stroke or heart disease which causes a reduced blood
supply (angina pectoris). See
also "Dienogest Hormosan and arterial blood clots" below
-
have DIABETES with blood vessel damage
-
have or have ever had SEVERE LIVER DISEASE (and your liver function
values have not returned to
normal). Symptoms of liver disease may be yellowing of the skin and/or
itching of the whole
body
-
have or have ever h

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dienogest Hormosan 2 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dienogest
Excipient with known effect:
Each tablet contains 54.3 mg lactose (as monohydrate).
Each tablet contains 0.2 mg sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex film-coated tablets with a embossed “2” on
one side and an approximate
diameter and thickness of 6.1 mm and 2.7 mm, respectively.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of endometriosis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration:_
For oral use.
_Posology: _
_ _
The dosage of Dienogest Hormosan 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
Dienogest
Hormosan
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
Dienogest Hormosan. If
contraception
is
required,
non-hormonal
methods
of
contraception
should
be
used
(e.g.
barrier
method).
_Management of missed tablets: _
_ _
The efficacy of Dienogest Hormosan may be reduced in the event of
missed tablets, vomiting and/or
diarrhea (if occurring 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: _
_ _
Dienogest Hormosan is not indicated in children prior to menarche. Th