Femilon (Desogestrel and Ethinyl Estradiol tablets)

Femilon (Desogestrel and Ethinyl Estradiol Tablets) is a highly effective oral contraceptive therapy of 21 white round tablets each containing 0.15 mg Desogestrel and 0.03 mg Ethinyl Estradiol.

1. Femilon Tablets
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Femilon (Desogestrel and Ethinyl Estradiol
Tablets) is an oral contraceptive therapy of 21
white round tablets each containing 0.15 mg
Desogestrel and 0.03 mg Ethinyl Estradiol.

2. Femilon Tablets
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Femilon Tablets are manufactured by
Mylan Laboratories Ltd., India and
Marketed by Organon (India) Private
Limited
(Website: www.merck.co.in/en/ )

3. Desogestrel and Ethinyl Estradiol Tablets –
Brand Names
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Desogestrel and Ethinyl Estradiol
tablets are available as Femilon,
Novelon, Elogen, Intimacy Plus 2,
Destrogen, Apri, Azurette, Caziant,
Cesia, Cyclessa, Desogen,
Emoquette, Kariva, Mircette, Ortho-
Cept, Reclipsen, Solia, Velivet, Viorele
and Locipil.

4. Active Ingredients
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The active ingredient contained in Femilon
tablets are Desogestrel and Ethinyl Estradiol .
Each Femilon Tablet contains 0.030 mg of
Ethinyl Estradiol and 0.150 mg of
Desogestrel.

5. Chemical Structure
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The structure of Desogestrel is given below:

6. Chemical Structure
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The structure of Ethinyl Estradiol is given
below:

7. Uses of Femilon Tablets
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Desogestrel and Ethinyl Estradiol Tablets
(Femilon) are highly effective method for the
prevention of pregnancy with a 0.1% failure
rate.
This medicine contains female hormones
that prevent ovulation (the release of an egg
from an ovary). This medication also causes
changes in the cervical mucus and uterine
lining, making it harder for sperm to reach
the uterus and harder for a fertilized egg to
attach to the uterus.

8. Storage Instructions

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Femilon (Desogestrel and Ethinyl
Estradiol tablets) have to be stored at
controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) with
excursions permitted between 15° to
30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

9. Femilon Dosage

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➢In order to prevent pregnancy, it is
recommended to take Femilon tablets every
day for 21 days. Femilon comes in strips of 21
pills. Take your tablet at the same time every
day.
➢You will take your first pill on the first day of
your period or on the first Sunday after your
period begins. You may need to use back-up
birth control when you first start using this
medicine.
The dosage of Femilon tablets (Desogestrel And
Ethinyl Estradiol Pills) is given below:

10. Femilon Dosage

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➢Take one tablet each day, until you have finished
all the 21 pills. After you have taken all 21 tablets
present in the strip, you have seven days when you
take no tablets. Swallow each pill whole, with water
if necessary. Do not chew the pill.
The dosage of Femilon tablets (Desogestrel and
Ethinyl Estradiol Pills) is given below:

11. Femilon Tablets - Contraindications
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Femilon is contraindicated in patients with a
hypersensitivity to Desogestrel, Ethinyl Estradiol or any
other component of this medication.
This medicine should not be used in women who currently
have the following conditions:
Thrombophlebitis or thromboembolic disorders.
A past history of deep vein thrombophlebitis or
thromboembolic disorders.
Cerebral vascular or coronary artery disease (current or
history).
Valvular heart disease with thrombogenic complications.
Severe hypertension.
Diabetes with vascular involvement.
Headaches with focal neurological symptoms.
Major surgery with prolonged immobilization.

12. © Clearsky Pharmacy
Femilon tablets (Desogestrel and Ethinyl Estradiol Pills) is
contraindicated in patients with the following conditions:
Known or suspected carcinoma of the breast (or personal
history of breast cancer).
Carcinoma of the endometrium or other known or suspected
estrogen-dependent neoplasia.
Undiagnosed abnormal genital bleeding.
Cholestatic jaundice of pregnancy or jaundice with prior
hormonal contraceptive use.
Hepatic tumors (benign or malignant) or active liver disease.
Known or suspected pregnancy.
Heavy smoking and over age 35.
Receiving Hepatitis C drug combinations containing
Ombitasvir/Paritaprevir/Ritonavir, with or without Dasabuvir,
due to the potential for ALT elevations.
Femilon Tablets - Contraindications

13. Warnings

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An increased risk of thromboembolic and thrombotic
disease associated with the use of oral contraceptives
like Femilon is well established.
An increased risk of myocardial infarction has been
attributed to oral contraceptive use. This risk is mainly in
smokers or women with other underlying risk factors for
coronary artery disease such as hypertension,
hypercholesterolemia, morbid obesity, and diabetes.
Oral contraceptives including Desogestrel and Ethinyl
Estradiol Tablets (Femilon pills) have been shown to
increase both the relative and attributable risks of
cerebrovascular events (thrombotic and hemorrhagic
strokes), although, in general, the risk is greatest among
older (greater than 35 years), hypertensive women who
also smoke.

14. Warnings

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A positive association has been noticed between the
amount of estrogen and progestogen present in oral
contraceptives and the risk of vascular disease.
In a study in the United States, the risk of developing
myocardial infarction after discontinuing oral
contraceptives persists for at least 9 years for women
40 to 49 years old who had used oral contraceptives
for five or more years, but this increased risk was not
demonstrated in other age groups.
A study concluded that with the exception of oral
contraceptive users 35 and older who smoke and 40
and older who do not smoke, mortality associated with
all methods of birth control is low and below that
associated with childbirth.

15. Warnings

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The risk of having breast cancer diagnosed may
be slightly increased among current and recent
users of combination oral contraceptives.
However, this excess risk appears to decrease
over time after discontinuation of combination
oral contraceptives and by 10 years after
cessation the increased risk disappears.
Benign hepatic adenomas are associated with
oral contraceptive use, although the incidence of
benign tumors is rare in the United States.
There have been clinical case reports of retinal
thrombosis associated with the use of oral
contraceptives.

16. Warnings

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Oral contraceptives must be stopped if there
is unexplained partial or complete loss of
vision; onset of proptosis or diplopia;
papilledema; or retinal vascular lesions.
Extensive epidemiological studies have
revealed no increased risk of birth defects in
women who have used oral contraceptives
prior to pregnancy.

17. Femilon Side Effects
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➢Femilon tablets (Desogestrel and Ethinyl Estradiol Pills)
side effects can include nausea, vomiting, headache,
bloating, breast tenderness, swelling of the ankles/feet (fluid
retention), or weight change may occur. Vaginal bleeding
between periods (spotting) or missed/irregular periods may
occur, especially during the first few months of use. In case
any of these effects persist or worsen, tell your doctor or
pharmacist immediately.
➢This medication could increase your blood pressure. Check
your blood pressure regularly and tell your doctor if the results
are high.
➢Tell your doctor immediately in case you have any serious
side effects, including: lumps in the breast, mental/mood
changes (such as new/worsening depression), severe
stomach/abdominal pain, unusual changes in vaginal
bleeding (such as continuous spotting, sudden heavy
bleeding, missed periods), dark urine, yellowing eyes/skin.

18. Femilon Side Effects
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➢Femilon Tablets may rarely cause serious problems from
blood clots (such as deep vein thrombosis, heart attack,
pulmonary embolism, stroke).
➢Get medical help immediately if any of these side effects
occur: chest/jaw/left arm pain, confusion, sudden
dizziness/fainting, pain/swelling/warmth in the groin/calf,
slurred speech, sudden shortness of breath/rapid breathing,
unusual headaches (including headaches with vision
changes/lack of coordination, worsening of migraines,
sudden/very severe headaches), unusual sweating,
weakness on one side of the body, vision problems/changes
(such as double vision, partial/complete blindness).
➢A very serious allergic reaction to this medicine is rare.
However, get medical help immediately in case you notice
any symptoms of a serious allergic reaction, including: rash,
itching/swelling (especially of the face/tongue/throat), severe
dizziness, trouble breathing.

19. Femilon Tablets Overdose
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Serious adverse effects have not been
reported following acute ingestion of large
doses of oral contraceptives like Femilon
tablets by young children.
Overdosage may cause nausea, and
withdrawal bleeding may occur in females.

20. Femilon Tablets During Pregnancy
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Desogestrel and Ethinyl Estradiol Tablets
(Femilon) have been classified by the US FDA
as Pregnancy Category X.
Animal studies of Estrogen at high doses have
revealed evidence of urogenital malformations.
There are no controlled data for either medicine
in human pregnancy.
Epidemiological data have failed to reveal an
increased risk of birth defects when this drug
was taken before pregnancy, and teratogenicity
when patients inadvertently used this medicine
in early pregnancy.

21. Femilon Tablets
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© Clearsky Pharmacy
Femilon (Desogestrel and Ethinyl Estradiol tablets) by
Mylan Laboratories Limited, India and Marketed by
Organon (India) Private Limited.