Endodien 2 mg filmomhulde tabletten

Land: Holland

Sprog: hollandsk

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

Aktiv bestanddel:

DIENOGEST 2 mg/stuk

Tilgængelig fra:

Farmitalia s.r.l. Viale A. De Gasperi 165/B 95127 CATANIA (ITALIË)

ATC-kode:

G03DB08

INN (International Name):

DIENOGEST 2 mg/stuk

Lægemiddelform:

Filmomhulde tablet

Sammensætning:

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), HYPROLOSE (E 463) ; HYPROMELLOSE (E 464) ; KATOENZAADOLIE, GEHYDREERD ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; NATRIUMZETMEELGLYCOLAAT (E468) ; POVIDON K 30 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Indgivelsesvej:

Oraal gebruik

Terapeutisk område:

Dienogest

Autorisation dato:

2018-12-24

Indlægsseddel

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Endodien 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 Endodien is and what it is used for
2.
What you need to know before you take Endodien
3.
How to take Endodien
4.
Possible side effects
5.
How to store Endodien
6.
Contents of the pack and other information
1.
WHAT ENDODIEN IS AND WHAT IT IS USED FOR
Endodien is a preparation for the treatment of endometriosis (painful
symptoms due to displaced tissue
of the lining of the womb). Endodien contains a hormone, the
progestogen dienogest.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENDODIEN
_ _
DO NOT TAKE ENDODIEN 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 “Endodien 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 "Endodien 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 had a BENIGN OR MALIGNANT LIVER TUMOUR
-
suffer or have ever suffered, or if it is suspected that you

Produktets egenskaber

SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
Endodien 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 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: _
_ _
The efficacy of 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: _
_ _
is not indicated in children prior to menarche. The
safety and efficacy of

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