1. Name of the Medicinal Product
2. Qualitative and Quantitative Composition
Each tablet contains 0.150mg desogestrel and 0.020mg ethinylestradiol.
Excipient: lactose < 80 mg
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Tablets for oral use
Tablets are round, biconvex and 6 mm in diameter. They are coded on one side
TR above 4 and on
the reverse side Organon*.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.2.1 How to take Mercilon
Tablets must be taken in the order directed on the package every day at
about the same time with some liquid as needed. One tablet is to be taken
daily for 21 consecutive days. Each subsequent pack is started after a 7-day
tablet-free interval, during which time a withdrawal bleed usually occurs.
This usually starts on day 2-3 after the last tablet and may not have
finished before the next pack is started.
4.2.2 How to start taking Mercilon
No preceding hormonal contraceptive use [in the past month]
Tablet-taking has to start on day 1 of the woman's natural cycle (i.e. the
first day of her menstrual
bleeding). Starting on days 2-5 is allowed, but during the first cycle a
barrier method is recommended
in addition for the first 7 days of tablet-taking.
Changing from a combined hormonal contraceptive (combined oral
contraceptive (COC), vaginal ring, or transdermal patch)
The woman should start with Mercilon preferably on the day after the last
active tablet (the last tablet containing the active substances) of her
previous COC, but at the latest on the day following the usual tablet-free
or placebo tablet interval of her previous COC. In case a vaginal ring or
transdermal patch has been used, the woman should start using Mercilon
preferably on the day of removal, but at the latest when the next
application would have been due.
If the woman has been using her previous method consistently and correctly
and if it is reasonably certain that she is not pregnant she may also switch
from her previous combined hormonal contraceptive on any day of the cycle.
The hormone-free interval of the previous method should never be extended
beyond its recommended length.
Changing from a progestogen-only-method (minipill, injection, implant) or
from a progestogen-releasing intrauterine system (IUS]
The woman may switch any day from the minipill (from an implant or the IUS
on the day of its removal, from an injectable when the next injection would
be due), but should in all of these cases be advised to additionally use a
barrier method for the first 7 days of tablet-taking.
Following first-trimester abortion
The woman may start immediately. When doing so, she need not take additional
Following delivery or second-trimester abortion
For breastfeeding women see Section 4.6
Women should be advised to start at day 21 to 28 after delivery or
second-trimester abortion. When starting later. the woman should be advised
to additionally use a barrier method for the first 7 days of tablet-taking.
However. if intercourse has already occurred, pregnancy should be excluded
before the actual start of COC use or the woman has to wait for her first
The increased risk of VTE during the postpartum period should be considered
when restarting Mercilon (see section 4.4).
4.2.3 Management of missed tablets
If the user is less than 12 hours late in taking any tablet, contraceptive
protection is not reduced. The woman should take the tablet as soon as she
remembers and should take further tablets at the usual time.
If she is more than 12 hours late in taking any tablet, contraceptive
protection may be reduced. The management of missed tablets can be guided by
the following two basic rules:
1. tablet-taking must never be discontinued for longer than 7 days.
2. 7 days of uninterrupted tablet-taking are required to attain adequate
suppression of the hypothalamic-pituitary-ovarian-axis.
Accordingly the following advice can be given in daily practice:
• Week 1
The user should take the last missed tablet as soon as she remembers, even
if this means taking two tablets at the same time. She then continues to
take tablets at her usual time. In addition, a barrier method such as a
condom should be used for the next 7 days. If intercourse took place in the
preceding 7 days, the possibility of a pregnancy should be considered. The
more tablets are missed and the closer they are to the regular tablet-free
interval, the higher the risk of a pregnancy.
• Week 2
The user should take the last missed tablet as soon as she remembers. even
if this means taking two tablets at the same time. She then continues to
take tablets at her usual time. Provided that the woman has taken her
tablets correctly in the 7 days preceding the first missed tablet, there is
no need to use extra contraceptive precautions. However, if this is not the
case, or if she missed more than 1 tablet, the woman should be advised to
use extra precautions for 7 days.
• Week 3
The risk of reduced reliability is imminent because of the forthcoming
tablet-free interval. However, by adjusting the tablet-intake schedule,
reduced contraceptive protection can still be prevented. By adhering to
either of the following two options, there is therefore no need to use extra
contraceptive precautions, provided that in the 7 days preceding the first
missed tablet the woman has taken all tablets correctly. If this is not the
case, the woman should be advised to follow the first of these two options
and to use extra precautions for the next 7 days as well.
1. The user should take the last missed tablet as soon as she remembers,
even if this means taking two tablets at the same time. She then continues
to take tablets at her usual time. The next pack must be started as soon as
the current pack is finished, i.e.. no gap should be left between packs. The
user is unlikely to have a withdrawal bleed until the end of the second
pack, but she may experience spotting or breakthrough bleeding on
2. The woman may also be advised to discontinue tablet-taking from the
current pack. She should then have a tablet-free interval of up to 7 days,
including the days she missed tablets, and subsequently continue with the
If a woman misses tablets and subsequently has no withdrawal bleed in the
first normal tablet-free interval, the possibility of a pregnancy should be
4.2.4 Advice in case of gastro-intestinal disturbances
In case of severe gastro-intestinal disturbance, absorption may not be
complete and additional contraceptive measures should be taken.
If vomiting occurs within 3-4 hours after tablet-taking, the advice
concerning missed tablets, as given in Section 4.2.3, is applicable. If the
woman does not want to change her normal tablet-taking schedule, she has to
take the extra tablet(s) needed from another pack.
4.2.5 How to shift periods or how to delay a period
To delay a period the woman should continue with another pack of Mercilon
without a tablet-free interval. The extension can be carried on for as long
as wished until the end of the second pack. During the extension the woman
may experience breakthrough bleeding or spotting. Regular intake of Mercilon
is then resumed after the usual 7-day tablet-free interval.
To shift her period to another day of the week than the woman is used to
with her current scheme, she can be advised to shorten her forthcoming
tablet-free interval by as many days as she likes. The shorter the interval,
the higher the risk that she does not have a withdrawal bleed and will
experience breakthrough bleeding and spotting during the second pack (just
as when delaying a period).
Combined hormonal contraceptives (CHCs) should not be used in the presence
of any of the conditions listed below. Should any of the conditions appear
for the first time during CHC use, the product should be stopped
Presence or history of venous thrombosis (deep venous thrombosis, pulmonary
• Presence or history of arterial thrombosis (myocardial infarction, cerebrovascular accident) or prodromal conditions e.g. (e.g. transient
ischaemic attack, angina pectoris).
• Known predisposition for venous or arterial thrombosis, such as Activated
Protein C (APC) resistance, antithrombin-III deficiency, protein C
deficiency, protein S deficiency, hyperhomocysteinaemia, and
• History of migraine with focal neurological symptoms (see section 4.4.1).
• Diabetes mellitus with vascular involvement.
• The presence of a severe or multiple risk factor(s) for venous or arterial
thrombosis may also constitute a contraindication (see section 4.4.1).
• Major surgery with prolonged immobilization (see section 4.4).
• Pancreatitis or a history thereof if associated with severe
• Presence or history of severe hepatic disease as long as liver function
values have not returned to normal; cholestatic jaundice; a history of
jaundice of pregnancy or jaundice due to the use of steroids; Rotor syndrome
and Dubin-Johnson syndrome
• Presence or history of liver tumours (benign or malignant).
• Known or suspected sex steroid-influenced malignancies (e.g., of the
genital organs or the breasts).
• Undiagnosed vaginal bleeding.
• Known or suspected pregnancy.
• Hypersensitivity to any of the active substances of Mercilon or to any of
• Severe hypertension.
• Endometrial hyperplasia.
• Hyperlipoproteinaemia, especially in the presence of other risk factors
predisposing to cardiovascular disorders.
• A history during pregnancy or previous use of steroids of severe pruritus
or herpes gestationis.