Feanolla 75microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Desogestrel

Available from:

Lupin Healthcare (UK) Ltd

ATC code:

G03AC09

INN (International Name):

Desogestrel

Dosage:

75microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030201; GTIN: 8901107023119

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
FEANOLLA 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,
pharmacist or Family Planning Nurse.
•
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,
pharmacist
or
Family
Planning
Nurse.
This
includes any possible side effects not listed in this
leaflet.
WHAT IS IN THIS LEAFLET
1.
What Feanolla is and what it is used for
2.
What you need to know before you take Feanolla
3.
How to take Feanolla
4.
Possible side effects
5.
How to store Feanolla
6.
Contents of the pack and other information
1. WHAT FEANOLLA IS AND WHAT IT IS USED FOR
•
Feanolla 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.
•
Feanolla is a progestogen-only-pill
(POP),
or
a
MINI-PILL.
•
Feanolla contains a small
amount
of
one type
of
female
sex
hormone,
the
progestogen
DESOGESTREL.
•
Most
POPs
or
minipills
work
primarily
by
preventing the
sperm cells
from entering the
womb but
they do not
always prevent
the egg
cell
from ripening,
which is the main way that
combined pills work.
•
Feanolla is different from other mini-pills in having
a dose that
in most
cases prevents the egg cell
from ripening.
As a result,
Feanolla is a highly
effective contraceptive.
•
In contrast to the combined pill,
Feanolla 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 Feanolla. On
the other hand

Summary of Product characteristics

OBJECT 1
FEANOLLA 75 MICROGRAM FILM COATED TABLET
Summary of Product Characteristics Updated 07-Oct-2015 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Feanolla 75 microgram film coated tablet
2. Qualitative and quantitative composition
One film-coated tablet contains 75 micrograms desogestrel
_Excipients:_
Each tablet contains 66.45 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White round, biconvex, film-coated tablet, plain on both the sides.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception
4.2 Posology and method of administration
4.2.1 HOW TO TAKE FEANOLLA
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.
_Paediatric population _
The safety and efficacy of desogestrel in adolescents below 18 years
has not yet been established. No data
are available.
4.2.2 HOW TO START FEANOLLA
_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 Feanolla 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 breast