ISANIVA

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DESOGESTREL MICRONIZED

Available from:

Actavis Group PTC ehf

ATC code:

G03AC09

INN (International Name):

DESOGESTREL MICRONIZED

Dosage:

75 Microgram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

desogestrel

Authorization status:

Not Marketed

Authorization date:

2013-09-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ISANIVA 75 MICROGRAM FILM-COATED TABLETS
DESOGESTREL
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, or pharmacist,
or nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It is not
suitable for all women, so you should not give it to anyone else as it
may harm them.
•
If you get any side effects, talk to your doctor, or pharmacist, or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Isaniva is and what it is used for
2.
What you need to known before you
take Isaniva
3.
How to take Isaniva
4.
Possible side effects
5.
How to store Isaniva
6.
Contents of the pack and other
information
1.
WHAT ISANIVA IS AND WHAT IT IS USED FOR
•
Isaniva contains a small amount of one
type
of
female
sex
hormone,
the
progestogen desogestrel.
•
Isaniva 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
or
mini-pill,
which
doesn't
contain
an
oestrogen.
•
Isaniva is a progestogen-only-pill (POP),
or a mini-pill.
•
Most POPs or minipills 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.
•
Isaniva is different from other mini-pills
in
having
a
dose
that
in
most
cases
prevents the egg cell from ripening. As a
result,
Isaniva
is
a
highly
effective
contraceptive.
•
In contrast to the combined pill, Isaniva
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 Isaniva. On the othe

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Isaniva 75 microgram film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 microgram of desogestrel
Excipients with known effect:
Lactose monohydrate 55.07 mg, soybean oil (maximum 0.026 mg).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Oral contraception
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
HOW TO TAKE ISANIVA
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 ISANIVA
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 on days 2-5 is allowed, but during the first cycle a barrier
method is recommended for the first 7 days of tablet-
taking.
Following first-trimester abortion:
After first-trimester abortion it is recommended to start immediately.
In that case there is no need to use an additional
method of contraception.
Following delivery or second-trimester abortion:
Contraceptive treatment with Isaniva after delivery can be initiated
before the menstruations have returned. If more
than 21 days have elapsed pregnancy ought to be ruled out and an
additional method of contraception should be used
for the first week.
For additional information for breastfeeding women see section 4.6.
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