Dienogest León Farma 2 mg Tablett

Land: Zweden

Taal: Zweeds

Bron: Läkemedelsverket (Medical Products Agency)

Werkstoffen:

dienogest

Beschikbaar vanaf:

Laboratorios Leon Farma S.A.

ATC-code:

G03DB08

INN (Algemene Internationale Benaming):

dienogest

Dosering:

2 mg

farmaceutische vorm:

Tablett

Samenstelling:

laktosmonohydrat Hjälpämne; dienogest 2 mg Aktiv substans

Prescription-type:

Receptbelagt

Product samenvatting:

Förpacknings: Blister, 1 x 28 tabletter (kalenderförpackning); Blister, 3 x 28 tabletter (kalenderförpackning); Blister, 6 x 28 tabletter (kalenderförpackning)

Autorisatie-status:

Godkänd

Autorisatie datum:

2019-06-07

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIENOGEST LEÓN FARMA 2 MG 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. Do not pass it on to
others. It may harm them, even
if their symptoms 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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
is a preparation for the treatment of endometriosis
(painful symptoms
due to displaced tissue of the lining of the womb).
contains a hormone,
the progestogen dienogest.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE 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
_“ 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
_" 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
�

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dienogest León Farma 2 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dienogest
Excipient with known effect: each tablet contains 60.9 mg lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Tablet
White, round, tablets with a diameter of 5 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of endometriosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_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.
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 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 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 dienogest was investigated in an
uncontrolled clinical trial over 12
months in 111 adolescent women (12-<18) with clinically suspected or
confirmed endometriosis
(see sections 4.4 and 5.1).
_Geriatric population:_
There is no relevant indication for use of in the
Geriatric population.
_Patients with hepatic impa