Tubanis 2 mg filmomhulde tabletten

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

DIENOGEST 2 mg/stuk

Tersedia dari:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

Kode ATC:

G03DB08

INN (Nama Internasional):

DIENOGEST 2 mg/stuk

Bentuk farmasi:

Filmomhulde tablet

Komposisi:

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)

Rute administrasi :

Oraal gebruik

Area terapi:

Dienogest

Tanggal Otorisasi:

2018-12-24

Selebaran informasi

B. PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
Tubanis 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 Tubanis is and what it is used for
2.
What you need to know before you take Tubanis
3.
How to take Tubanis
4.
Possible side effects
5.
How to store Tubanis
6.
Contents of the pack and other information
1.
WHAT TUBANIS IS AND WHAT IT IS USED FOR
Tubanis is a preparation for the treatment of endometriosis (painful
symptoms due to displaced tissue
of the lining of the womb). Tubanis contains a hormone, the
progestogen dienogest.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TUBANIS
_ _
DO NOT TAKE TUBANIS 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 “Tubanis 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 "Tubanis 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 suffer
from

Karakteristik produk

SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAME OF THE MEDICINAL PRODUCT
Tubanis 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