Novelon Contraceptive Tablets (Generic Desogestrel and Ethinyl Estradiol Tablets)

Novelon Contraceptive Tablets (Generic Desogestrel and Ethinyl Estradiol Tablets)
© The Swiss Pharmacy

Novelon (Generic Desogestrel and Ethinyl Estradiol Tablets) is a
combined oral contraceptive preparation used to prevent pregnancy
for continuous administration. It is a birth control pill that contains
two types of hormones, desogestrel and ethinyl estradiol, and when
taken properly, prevents pregnancy. It works by stopping a woman's
egg from fully developing each month. The egg can no longer accept
a sperm and fertilization (pregnancy) is prevented.
Besides contraception, Novelon is also used to treat androgen-
related skin disorders such as mild to moderate acne.

Other beneficial effects include lower risk of anaemia as a
result of lighter and shorter periods.
In addition, some serious disorders have been reported to
occur less frequently in users of Combined Pills.
These are: benign breast disease, ovarian cysts, pelvic
infections (pelvic inflammatory disease), ectopic pregnancy
(pregnancy in which the embryo implants outside of the
womb) and cancer of the endometrium (lining of the womb)
and ovaries.

Novelon Tablets are manufactured by N. V
.
Organon, The Netherlands and marketed
by Organon India Private Limited
(Website: https://www.organon.com/ )

Chemical Structure - Desogestrel

Chemical Structure - Ethinyl Estradiol

The active pharmaceutical ingredients contained in
Novelon Tablets are Desogestrel and Ethinyl
Estradiol. Each pack of Novelon tablets
contains 21 active tablets containing 0.030 mg of
Ethinyl Estradiol and 0.150 mg of Desogestrel.
URL: https://www.theswisspharmacy.com/product_info.php?info=p9803_Novelon-Contraceptive-Pills.html

Uses of Novelon Tablets:
Novelon (Generic Desogestrel and Ethinyl Estradiol Tablets) is a
combined oral hormonal contraceptive, used to prevent pregnancy. It
contains 2 hormones: a progestin and an estrogen. Besides preventing
pregnancy, birth control pills may make your periods more regular,
decrease blood loss and painful periods, decrease your risk of ovarian
cysts, and also treat acne. Using this medication does not protect you or
your partner against sexually transmitted diseases (such as HIV,
gonorrhea, chlamydia).
Oral contraceptives are a very effective method of birth control. When
taken correctly (without missing tablets) the chance of becoming
pregnant is very low.

Novelon consists of 21 large white tablets, each containing 2 active
ingredients: 30 micrograms of ethinyloestradiol (an oestrogen) and 150
micrograms of desogestrel (a progestogen).
Because of the small amounts of different female hormones in the active
tablets, Novelon is considered a low-dose combined oral contraceptive.
Novelon prevents pregnancy in several ways:
It inhibits the egg release by stopping it maturing;
Changing the cervical mucus consistency making it difficult for sperm to
reach the egg;and
Changing the lining of the uterus making it less suitable for implantation.

The following non-contraceptive health benefits have been associated with the
Combined Pill:
Your periods may be lighter and shorter. As a result, the risk of anaemia may be
lower. Your period pains may become less severe or may completely disappear.
In addition, some serious disorders have been reported to occur less frequently
in users of Combined Pills containing 50 micrograms of ethinyloestradiol (‘high-
dose Combined Pills’). These are: benign breast disease, ovarian cysts, pelvic
infections (pelvic inflammatory disease), ectopic pregnancy (pregnancy in which
the embryo implants outside of the womb) and cancer of the endometrium
(lining of the womb) and ovaries.
This may also be the case for low-dose Combined Pills but so far this has only
been confirmed for endometrial and ovarian cancer.
Novelon is also used to treat mild to moderate acne.

Recommended Adult Dosage
One white Novelon tablet (Generic Desogestrel and Ethinyl
Estradiol tablets) is to be taken for 21 consecutive days (three
weeks). Tablets are then discontinued for one week. The patient
must not be off the pill for more than seven consecutive days.
A new pack will be started on the eighth day.
The patient will have a period during the seven days off the pill
(bleeding may be lighter and shorter than their usual period.)

To achieve maximum contraceptive effectiveness, Novelon must be taken
exactly as directed and at intervals not exceeding 24 hours.
Day 1 Start: The dosage of Novelon for the initial cycle of therapy is one
“active” tablet administered daily from the 1st day through the 21st day
of the menstrual cycle, counting the first day of menstrual flow as “Day
1”. Tablets are taken without interruption as follows: One “active” tablet
daily for 21 days, followed by 7 tablet free days. After which new course
is started and a “active” tablet is taken the next day.

Sunday Start: When taking Novelon , the first “active” tablet should be
taken on the first Sunday after menstruation begins. If the period begins
on Sunday, the first “active” tablet is taken on that day. If switching
directly from another oral contraceptive, the first “active” tablet should
be taken on the first Sunday after the last ACTIVE tablet of the previous
product. Tablets are taken without interruption as follows: One “active”
tablet daily for 21 days, followed by 7 tablet free days.
When initiating a Sunday start regimen, another method of contraception
should be used until after the first 7 consecutive days of administration.

Contraindications
➔
Hypersensitivity to the active ingredients Desogestrel, Ethinyl Estradiol or
to any of the inactive ingredients present in Novelon tablets.
➔
Presence or a history of venous or arterial thrombotic / thromboembolic
events
➔
Presence or history of prodromi of a thrombosis
➔
History of migraine with focal neurological symptoms
➔
Diabetes mellitus with vascular involvement.
➔
Presence of a severe or multiple risk factor(s) for venous or arterial
thrombosis
➔
Pancreatitis or a history thereof if associated with severe
hypertriglyceridaemia.

Contraindications
➔
Presence or history of severe hepatic disease as long as liver function
values have not returned to normal.
➔
Presence or history of liver tumors (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.

Storage Instructions
Novelon Contraceptive Tablets (Generic 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.

Warnings
Cigarette smoking increases the risk of serious cardiovascular events from combination oral
contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with
the number of cigarettes smoked.
Thromboembolic Disorder and Other Vascular Problems:
An increased risk of thromboembolic and thrombotic disease associated with the use of oral
contraceptives is well established.
An increased risk of myocardial infarction has been attributed to oral contraceptive use. This risk is
primarily in smokers or women with other underlying risk factors for coronary artery disease such as
hypertension, hypercholesterolemia, morbid obesity, and diabetes.
Estimates of Mortality from Contraceptive Use: The 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.
Malignant Neoplasms:
Breast Cancer: Novelon (Desogestrel and Ethinyl Estradiol combination tablets) is contraindicated in
females who currently have or have had breast cancer because breast cancer may be hormonally
sensitive.

Warnings
Cervical Cancer: Some studies suggest that oral contraceptive use has been associated with an increase
in the risk of cervical intraepithelial neoplasia in some populations of women.
Hepatic Neoplasia: Benign hepatic adenomas are associated with oral contraceptive use, although the
incidence of benign tumors is rare in the United States.
Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment: During clinical trials with the
Hepatitis C combination drug regimen that contains Ombitasvir/ Paritaprevir/ Ritonavir, with or
without Dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including
some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl
Estradiol-containing medications such as COCs.
Ocular Lesions: There have been clinical case reports of retinal thrombosis associated with the use of
oral contraceptives. Oral contraceptives should be discontinued if there is unexplained partial or
complete loss of vision; onset of proptosis or diplopia; papilledema; or retinal vascular lesions.
Appropriate diagnostic and therapeutic measures should be undertaken immediately.
Oral Contraceptive Use Before or During Early Pregnancy: Extensive epidemiological studies have
revealed no increased risk of birth defects in women who have used oral contraceptives prior to
pregnancy.

Warnings
Gallbladder Disease: Earlier studies have reported an increased lifetime relative risk of
gallbladder surgery in users of oral contraceptives and estrogens.60,61 More recent studies,
however, have shown that the relative risk of developing gallbladder disease among oral
contraceptive users may be minimal.
Carbohydrate and Lipid Metabolic Effects: Oral contraceptives have been shown to cause a
decrease in glucose tolerance in a significant percentage of users.17 This effect has been
shown to be directly related to estrogen dose.
Elevated Blood Pressure:Women with significant hypertension should not be started on
hormonal contraception.98 An increase in blood pressure has been reported in women
taking oral contraceptives68 and this increase is more likely in older oral contraceptive
users69 and with extended duration of use.

Warnings
Headache: The onset or exacerbation of migraine or development of headache
with a new pattern which is recurrent, persistent or severe requires
discontinuation of oral contraceptives and evaluation of the cause.
Bleeding Irregularities:Breakthrough bleeding and spotting are sometimes
encountered in patients on oral contraceptives, especially during the first three
months of use. Nonhormonal causes should be considered and adequate
diagnostic measures taken to rule out malignancy or pregnancy in the event of
breakthrough bleeding, as in the case of any abnormal vaginal bleeding.
Ectopic Pregnancy: Ectopic as well as intrauterine pregnancy may occur in
contraceptive failures.

Possible Side Effects
The common possible side effects (occurring in more than one per 100
users) reported in patients treated with Novelon tablets are : Depressed
mood, mood changes Headache,
Nausea, abdominal pain, Breast pain, breast tenderness, Increase in body
weight.
The uncommon side effects (occurring in more than one per 1000 users
but not more than one per 100 users): Fluid retention, Decreased sexual
drive, Migraine, Vomiting, diarrhoea Rash, hives, Breast enlargement.

Possible Side Effects
Stop taking Novelon and tell your doctor immediately, or go to accident
and emergency at your nearest hospital, if you notice signs of any of the
following:
Thrombosis, An unusual cough, Severe pain in the chest which may reach
the left arm, Breathlessness, Any unusual, severe, or prolonged headache
or migraine attack, Partial or complete loss of vision, or double vision,
Slurring or speech disability, Sudden changes to your hearing, sense of
smell, or taste; Dizziness or fainting; Weakness or numbness in any part
of your body; Severe pain in your abdomen; Severe pain or swelling in
either of your legs; Liver disease including liver cancer (jaundice or a
yellowing of the eyes or skin).

Overdosage
Symptoms of overdose may include nausea, vomiting or vaginal
bleeding. Available information from cases of accidental ingestion of
oral contraceptives by children indicates no serious effects.
Contact your doctor, your hospital or your local Poison Control
Centre in case of accidental overdose.

Overdosage
In case of overdose or accidental ingestion by children, the physician
should observe the patient closely, although generally no treatment
is required. Gastric lavage may be utilized if considered
necessary.
Overdosage may cause nausea and vomiting and withdrawal
bleeding may occur in females. There are no antidotes and
treatment should be symptomatic.

Novelon Tablets during Pregnancy
Desogestrel and Ethinyl Estradiol Tablets (Novelon Tablets) has been
classified by the US FDA as Pregnancy Category X.
Novelon (Generic Desogestrel and Ethinyl Estradiol Tablets) is not
indicated during pregnancy. If pregnancy occurs during treatment with
Novelon , further intake should be stopped.
However, most epidemiological studies have revealed neither an increased
risk of birth defects in children born to women who used COCs prior to
pregnancy, nor a teratogenic effect when COCs were taken inadvertently
during early pregnancy.

Novelon Contraceptive Tablets are manufactured
by N. V. Organon, The Netherlands and
marketed by Organon India Private Limited.

Novelon Contraceptive Tablets (Generic Desogestrel and Ethinyl Estradiol Tablets)

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