Desogestrel Rowex 75 microgram Film-coated tablets

Country: Malta

Tungumál: enska

Heimild: Medicines Authority

Fáanlegur frá:

Rowex Ltd Newtown Bantry, Co. Cork, , Ireland

ATC númer:

G03AC09

INN (Alþjóðlegt nafn):

DESOGESTREL 75 µg

Lyfjaform:

FILM-COATED TABLET

Samsetning:

DESOGESTREL 75 µg

Gerð lyfseðils:

POM

Lækningarsvæði:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

Leyfisstaða:

Authorised

Leyfisdagur:

2024-03-11

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DESOGESTREL ROWEX 75 MICROGRAM FILM-COATED TABLETS
DESOGESTREL_ _
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 Desogestrel Rowex is and what it is used for
2. What you need to know before you take Desogestrel Rowex
3. How to take Desogestrel Rowex
4. Possible side effects
5. How to store Desogestrel Rowex
6. Contents of the pack and other information
1. WHAT DESOGESTREL ROWEX IS AND WHAT IT IS USED FOR
_ _
•
Desogestrel Rowex is used to prevent pregnancy.
•
There are 2 main kinds of hormone contraceptive.
-
The combined pill, "The Pill", which contains 2 types of female sex
hormone, an oestrogen
and a progestogen,
-
The progestogen-only pill, POP, which doesn't contain an oestrogen.
•
Desogestrel Rowex is a progestogen-only-pill (POP).
•
Desogestrel Rowex contains a small amount of one type of female sex
hormone, the progestogen
DESOGESTREL
.
•
Most POPs work primarily by preventing the sperm cells from entering
the womb but do not
always prevent the egg cell from ripening, which is the main way that
combined pills work.
•
Desogestrel Rowex is different from most POPs in having a dose that in
most cases prevents the
egg cell from ripening. As a result, Desogestrel Rowex is a highly
effective contraceptive.
•
In contrast to the combined pill, Desogestrel Rowex can be used by
women who do not tolerate
oestrogens and by women who are breast-feeding.
•
A disadvantage is that vaginal bleeding may occur at irregular
intervals during the u

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Desogestrel Rowex 75 microgram Film-coated tablets
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 micrograms desogestrel
Excipient(s) with known effects:
51.3 mg lactose (as mononhydrate)
0.03 mg soya-bean oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, plain, white film-coated tablets with a diameter of 5 mm
approximately and a thickness of 2.9
mm approximately.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contraception.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
To achieve contraceptive effectiveness, Desogestrel Rowex must be used
as directed (see 'How to take
Desogestrel Rowex and 'How to start Desogestrel Rowex).
Special populations
_Renal impairment_
No clinical studies have been performed in patients with renal
impairment.
_Hepatic impairment_
No clinical studies have been performed in patients with hepatic
insufficiency. Since the metabolism
of steroid hormones might be impaired in patients with severe hepatic
disease, the use of Desogestrel
Rowex in these women is not indicated as long as liver function values
have not returned to normal
(see section 4.3).
_Paediatric population_
The safety and efficacy of desogestrel in adolescents below 18 years
has not been established. No data
are available.
Method of administration
Oral use
HOW TO TAKE DESOGESTREL ROWEX
Tablets must be taken every day at about the same time so that the
interval between two tablets always
is 24 hours. The first tablet should be taken on the first day of
menstrual bleeding. Thereafter one
tablet each day is to be taken continuously, without taking any notice
on possible bleeding. A new
blister is started directly the day after the previous one.
HOW TO START DESOGESTREL ROWEX
_No preceding hormonal contraceptive use [in the past month] _
Tablet taking has to start on day 1 of the woman’s natural cycle
(day 1 is the first day of her menstrual
bleeding).
Starting