Zafrilla 2mg tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Dienogest

から入手可能:

Gedeon Richter Plc

ATCコード:

G03DB08

INN（国際名）:

Dienogest

投薬量:

2 milligram(s)

医薬品形態:

Tablet

治療領域:

dienogest

認証ステータス:

Marketed

承認日:

2019-04-12

情報リーフレット

UTAS-3
PIL_180x250_180x500
2019.07.02.
180 × 500 /180 × 250 mm
/Page1
HORVÁTH Győző
Zafrilla 2mg
IE
2021.04.28.
K-30808-1.1
-
v_01
P Black
Helvetica Neue LT Com (9 pt [10,8 pt])
-
-
Mucius Scaevola Kft.
KOBOLÁK Fanni
What is in this leaflet
1. What Zafrilla is and what it is used for
2. What you need to know before you take Zafrilla
3. How to take Zafrilla
4. Possible side effects
5. How to store Zafrilla
6. Contents of the pack and other information
1. What Zafrilla is and what it is used for
Zafrilla is a preparation for the treatment of endometriosis (painful
symptoms due to displaced tissue of the lining of the womb). Zafrilla
contains a hormone, the progestogen dienogest.
2. What you need to know before you take Zafrilla
Do not take Zafrilla:
– 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 _“Zafrilla and venous blood clots”_ below;
– if you 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 _“Zafrilla and arterial blood clots”_ below;
– if you have diabetes with blood vessel damage;
– if you 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;
– if you have or have ever had a benign or malignant liver tumour;
– if you suffer or have ever suffered, or if it is suspected that
you
suffer from a malignant sex-hormone dependent tumour such as
cancer of the breast or the genital organs;
– if you have any unexplained vaginal bleeding;
– if you are allergic (hypersensitive) to dienogest or any of the
other ingredients of this medicine (listed in section 6).
If any of these conditions appear for the first time while using
Zafrilla,
stop taking it a

製品の特徴

Health Products Regulatory Authority
10 January 2023
CRN00D714
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zafrilla 2mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dienogest.
Excipient with known effect: each tablet contains 62.80 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White or almost white, round, flat, bevelled-edge tablets, engraved
with "G 93" on one side and with "RG" on the other side.
The diameter of the tablets is 7 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of endometriosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage of Zafrilla 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
Zafrilla. If contraception is required, non-hormonal
methods of contraception should be used (e.g. barrier method).
_Management of missed tablets_
The efficacy of Zafrilla may be reduced in the event of missed
tablets, vomiting and/or diarrhoea (if occuring 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 diarrhoea
should likewise be replaced by one tablet.
_ADDITIONAL INFORMATION ON SPECIAL POPULATIONS_
_Paediatric population_
Zafrilla is not indicated in children prior to menarche.
The safety and efficacy of dienogest 2 mg tablet was investigated in
an uncontrolled clinical trial over 12 months in 111
adolescent women (12 ‑ <18) with clinically suspected or confirmed
endometriosis (se