Desogestrel Rowex 75 microgram Film-coated Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Desogestrel

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

G03AC; G03AC09

INN (International Name):

Desogestrel

Dosering :

75 microgram(s)

Legemiddelform:

Film-coated tablet

Administreringsrute:

oral use

Enheter i pakken:

pack sizes 1x28, 3x28, 6x28 and 13x28

Resept typen:

Product subject to prescription which may be renewed (B)

Produsert av:

Salutas Pharma GmbH

Terapeutisk gruppe:

: hormonal contraceptives for systemic use

Terapeutisk område:

Progestogens; desogestrel

Indikasjoner:

Contraception

Autorisasjon status:

Marketed

Autorisasjon dato:

2015-10-02

Informasjon til brukeren

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
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 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 use of
Desogestrel Rowex. You also m

Preparatomtale

Health Products Regulatory Authority
08 October 2020
CRN009XVM
Page 1 of 9
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 microgram 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.
Health Products Regulatory Authority
08 October 2020
CRN009XVM
Page 2 of 9
HOW TO START DESOGESTREL ROWEX
_No preceding hormonal contraceptive use [i