Dienogest Stragen 2 mg film-coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Dienogest

Διαθέσιμο από:

G&G Pharmaceutical (Netherlands) B.V.

Φαρμακολογική κατηγορία (ATC):

G03DB; G03DB08

INN (Διεθνής Όνομα):

Dienogest

Δοσολογία:

2 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Θεραπευτική περιοχή:

Pregnadien derivatives; dienogest

Ημερομηνία της άδειας:

2019-06-28

Φύλλο οδηγιών χρήσης

1
0001_A5
PACKAGE LEAFLET: INFORMATION FOR THE
USER
DIENOGEST STRAGEN 2 MG FILM-COATED TABLETS
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 Stragen is and what it is used
for
2.
What you need to know before you take
Dienogest Stragen
3.
How to take
Dienogest Stragen
4.
Possible side
effects
5.
How to store
Dienogest Stragen
6.
Contents of the pack and other
information
1. WHAT DIENOGEST STRAGEN IS AND WHAT IT IS USED
FOR
Dienogest Stragen is a medicine used for the treatment of
endometriosis (painful symptoms due to displaced
tissue of
the
lining of the womb). Dienogest Stragen contains a hormone, the
progestogen
Dienogest
Stragen.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DIENOGEST STRAGEN
DO NOT TAKE DIENOGEST STRAGEN 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 Stragen 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 Stragen 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
o

Αρχείο Π.Χ.Π.

Health△Products△Regulatory△Authority
18△October△2023
CRN00DVYJ
Page△1△of△10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dienogest△Stragen△2△mg△film-coated△tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each△tablet△contains△2△mg△dienogest
For△the△full△list△of△excipients,△see△section△6.1.
3 PHARMACEUTICAL FORM
Film-coated△Tablets
White,△round,△7.1△mm△wide△and△3.4△mm△high
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment△of△endometriosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
The△dosage△of△Dienogest△Stragen△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.
Treatment△can△be△started△on△any△day△of△the△menstrual△cycle.
Any△hormonal△contraception△needs△to△be△stopped△prior△to△initiation△of△Dienogest△Stragen.△If△contraception△is△required,△
non-hormonal△methods△of△contraception△should△be△used△(e.g.△barrier△method).
_Management of missed tablets:_
The△efficacy△of△Dienogest△Stragen△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_
_Paediatricpopulation:_
D