Dienogest Stragen 2 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dienogest

Available from:

Stragen Nordic A/S

ATC code:

G03DB; G03DB08

INN (International Name):

Dienogest

Dosage:

2 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Pregnadien derivatives; dienogest

Authorization date:

2019-06-28

Patient Information leaflet

1
06660
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
of the

Summary of Product characteristics

Health△Products△Regulatory△Authority
04△July△2019
CRN008LN4
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.
There△is△no△experience△with△Dienogest△Stragen△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△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△
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