Aidulan 20microgram/75microgram tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Gestodene; Ethinylestradiol

Available from:

Lupin Healthcare (UK) Ltd

ATC code:

G03AA10

INN (International Name):

Gestodene; Ethinylestradiol

Dosage:

75microgram ; 20microgram

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07030100; GTIN: 8901107025298

Patient Information leaflet

1
_Version 4, 02/2016 _
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
AIDULAN 20 / 75 MICROGRAMS FILM-COATED TABLETS
ETHINYLESTRADIOL / GESTODENE
_ _
IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES
(CHCS):
•
They are one of the most reliable reversible methods of contraception
if used correctly
•
They slightly increase the risk of having a blood clot in the veins
and arteries, especially in the first
year or when restarting a combined hormonal contraceptive following a
break of 4 or more weeks
•
Please be alert and see your doctor if you think you may have symptoms
of a blood clot (see
section 2 “Blood clots”)
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.
WHAT IS IN THIS LEAFLET
1.
What Aidulan 20/75 Tablets are and what they are used for
2.
What you need to know before you take Aidulan 20/75 Tablets
3.
How to take Aidulan 20/75 Tablets
4.
Possible side effects
5.
How to store Aidulan 20/75 Tablets
6.
Contents of the pack and other information
1.
WHAT
AIDULAN 20/75 TABLETS ARE AND WHAT IT IS USED FOR
Aidulan 20/75
is a combined oral contraceptive and belongs to a group of medicines
which is
frequently called “the Pill”. It contains two types of hormone: an
oestrogen, named ethinylestradiol
and a progestogen type, named gestodene. These hormones stop the ovary
from releasing an egg each
month (ovulation). They also thicken the fluid (mucus) at the neck of
the womb (cervix) making it
more difficult for the sperm to reach the egg, and alter the lining of
the womb to make it less likely to
accept a fer

Summary of Product characteristics

OBJECT 1
AIDULAN 20/75 MICROGRAM FILM-COATED TABLETS
Summary of Product Characteristics Updated 14-Aug-2017 | Lupin
Healthcare (UK) Ltd
1. Name of the medicinal product
Aidulan 20/75 microgram film-coated tablets
2. Qualitative and quantitative composition
Each tablet contains:
Ethinylestradiol 20 micrograms.
Gestodene 75 micrograms
Excipient with known effect: Lactose
Each tablet also contains 50 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablets.
White to off white round, biconvex, approximately 5mm diameter, film
coated tablets debossed with
“GE1” on one side and plain on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Oral contraception
The decision to prescribe Aidulan 20/75 should take into consideration
the individual woman's current
risk factors, particularly those for venous thromboembolism (VTE), and
how the risk of VTE with
Aidulan 20/75 compares with other CHCs (see sections 4.3 and 4.4).
4.2 Posology and method of administration
_How to use Aidulan 20/75 _
Tablets must be taken every day at about the same time, in accordance
with the instructions written on the
package. One tablet is to be taken daily for 21 consecutive days. Each
subsequent pack is started after
keeping a tablet-free interval. Withdrawal bleed occurs usually 2-3
days after the last tablet and should
not finish before the next pack is started.
_How to start Aidulan 20/75 _
_No preceding hormonal contraceptive use in the last month _
Taking of the tablets should begin the first day of the woman's
natural cycle (i.e. the first day of the
woman's menstrual bleeding). One may begin taking the Pills on 2nd to
5th day, but in these cases it is
recommended that a barrier method also be used (e.g. condom or
spermicide) for the first 7 days, while
Pills are taken during the first cycle.
_Changing from a combined contraceptive (combined oral contraceptive
(COC), vaginal ring or _
_transdermal patch) to Aidulan 20/75 _
The woman should start taking Aidul