Elogen Tablet 21'S

INTRODUCTION ABOUT ELOGEN TABLET

ELOGEN TABLET is a fixed-dose combination of Desogestrel and ethinyl estradiol
which belongs to the group of medicines called Hormonal contrace
ELOGEN TABLET is a contrace
works by managing unwanted or unplanned pregnancies.

Contrace
there are also other o
pregnancy. It can be achieved by a device, a medication, a procedure, or a
behaviour. Contrace
to be active participants in family planning.

Before prescribing ELOGEN TABLET, your doctor will ask you about your past and
present medical history and family history. Your doctor will check your blood
pressure and blood glucose levels and perform a physical examination to rule out
conditions like blood clots in the body and breast and liver cancer. A pap smear
test will be conducted for sexually active women. Your doctor will advise you to
visit for regular check-ups while on management with ELOGEN TABLET.

ELOGEN TABLET is not recommended for use in women who have blood clots in their
bodies or in patients who are at high risk of getting a blood clot: those with
diabetes that affects blood vessels, cancer, migraine headaches, being immobile
for an extended period, scheduled surgery, if you are over 35 years old, if you
smoke, if you have heart disease, and patients with liver diseases.ELOGEN TABLET
should be used with caution in patients with inflammatory bowel disease,
anaemia, varicose veins, blood disorders, obesity, hereditary angioedema, and
diabetes.

ELOGEN TABLET is not recommended for use by pregnant or breastfeeding women. If
you are found to be pregnant, stop taking the medicine and consult your doctor
immediately. ELOGEN TABLET is not intended for use by post-menopausal women.
There is no data on the use of ELOGEN TABLET in children and adolescents under
the age of 18. It is not recommended for use in male children.

Avoid concomitant use of Hepatitis drugs such as ombitasvir, paritaprevir,
ritonavir and dasabuvir along with ELOGEN TABLET. The most common side effects
of ELOGEN TABLET are unusual spotting or bleeding, nausea, breast
tendernessand headache.

USES OF ELOGEN TABLET

• Prevents pregnancy

HOW ELOGEN TABLET WORKS

ELOGEN TABLET is an oral contrace
or unplanned pregnancies. Desogestrel and Estradiol are both synthetic forms of
the female sex hormones progesterone and oestrogen that work together to manage
egg release from the ovaries (ovulation) by suppressing the hormone responsible
for ovulation and promoting changes in the uterine thickening and mucus
membrane. These changes make it difficult for the sperm to enter the uterus and
implant the fertilised egg. ELOGEN TABLET works by suppressing hormones and
managing unwanted or unplanned pregnancies.

DIRECTIONS FOR USE

Take ELOGEN TABLET strictly as advised by your physician. Do not miss any doses
between the courses because the management may not be effective if any doses are
missed. Swallow the medicine with a glass of water. Do not crush or chew the
medicine. In case you have missed a dose, take it as soon as you remember it.
Missing doses cause bleeding or spotting. Your doctor will determine the correct
dose and duration for you depending upon your age, body weight, and disease
condition.

SIDE EFFECTS OF ELOGEN TABLET

COMMON

• headache
• weight gain
• breast pain, tenderness
• depression, mood changes
• nausea, stomach pain

UNCOMMON

• oedema
• decreased libido
• vomiting, diarrhoea
• rash, hives
• breast enlargement

RARE

• vaginal secretions, irregular vaginal bleeding
• breasts discharge
• difficulty in wearing contact lenses
• skin diseases, bruising
• weight loss
• increased libido
• blood clots

Stop taking ELOGEN TABLET and contact your doctor immediately if you experience
any of the following side effects:

• deep vein thrombosis symptoms include persistent leg pain felt only when standing or walking, warmness in the leg, colour changes in the affected leg like pale, red or blue
• pulmonary embolism. symptoms include sudden breathlessness or rapid breathing, sudden cough with blood, chest pain on breathing, dizziness, irregular heartbeat, severe stomach pain
• retinal vein thrombosis (blood clot in eyes). symptoms include painless blurring of vision leading to sudden loss of vision
• chest pain, discomfort, heaviness, squeezing sensation or sensation of fullness in the chest, arms or below the breast, fullness, indigestion, choking feeling, pain in the upper body radiating towards back, jaw, throat, arm, stomach, sweating, nausea, vomiting, dizziness, extreme tiredness, anxiety, shortness of breath and irregular heartbeats. symptoms of heart attack
• stroke. symptoms weakness or numbness in an arm or leg, trouble speaking, sudden confusion and trouble sleeping in one or both eyes, trouble walking, loss of balance, severe headache, and fainting with or without seizures.
• blood clots blocking other blood vessels symptoms include swelling and blue colour of legs or arms swelling and slight blue discolouration of legs or arms
• severe allergic reactions include swelling of the face, lips, mouth, tongue, or throat
• breast cancer symptoms include dimpling of the skin, changes in the nipple and lump formation
• signs of cancer of the cervix such as vaginal discharge with odour or blood, unusual bleeding, pelvic pain, painful sex
• severe liver problems. symptoms include severe stomach pain, yellow skin, or eyes (jaundice), inflammation of the liver (hepatitis)
• liver tumours symptoms include severe pain or lump in the stomach region

HOW TO MANAGE SIDE EFFECTS

Headache

Rest in a quiet place. Avoid using mobile phones and other electronic devices
for a while. Drink enough water; dehydration can cause headaches. Consult your
doctor if symptoms worsen.

!### Nausea And Vomiting

Drink clear or ice-cold drinks. Eat light, bland foods. Avoid fried, greasy, or
sweet foods. Eat slowly and eat smaller, more frequent meals, drink gradually
larger amounts of clear liquids, avoid solid food until the vomiting episode has
passed, and take rest. Consult your doctor if symptoms worsen.

!### Stomach Pain

Try to rest and relax. eating a healthy diet, drinking lots of water, exercising
regularly, eating smaller meals, eating and drinking slowly, or trying to have
smaller and more frequent meals. Keep a heating pad on your stomach. If the
symptom does not improve, contact your doctor.

WARNING & PRECAUTIONS

!### PREGNANCY

ELOGEN TABLET is not recommended for use in pregnant and women suspected to be
pregnant. ELOGEN TABLET is not recommended if you had jaundice during
pregnancy. ELOGEN TABLET should be used with caution in women who are in the
postpartum period. Consult your doctor before taking it.

!### BREASTFEEDING

ELOGEN TABLET is not recommended for use in breastfeeding women. Consult your
doctor before taking it.

!### DRIVING AND USING MACHINES

Use with CautionDo not drive or handle heavy machines if you experience side effects like
dizziness, drowsiness, tiredness, or if you have blurred vision while taking
GBNKEYWORD].

!### ALCOHOL

ContraindicatedConsum

!### KIDNEY

Consult your doctorELOGEN TABLET is not recommended for use in patients with blood clots in the
kidney and kidney disease associated with diabetes (diabetic nephropathy).
ELOGEN TABLET should be used with caution in patients with another kidney
disease. Consult your doctor before taking it.

!### LIVER

Consult your doctorELOGEN TABLET is not recommended for use in patients with severe liver diseases,
yellowish skin, and eyes(jaundice), cholestatic jaundice (jaundice caused by
reduced bile secretion), pancreatitis (inflammation of the pancreas), Hepatitis
C and liver tumours.ELOGEN TABLET should be used with caution in patients with
gall bladder, liver or pancreatic diseases. Consult your doctor before
taking it.

!### ALLERGY

ContraindicatedDo not take ELOGEN TABLET if you are allergic toDesogestrel or Ethinyl
Estradiol.

LUNGS

ContraindicatedELOGEN TABLET is not recommended for use in patients with blood clots in the
lungs (pulmonary embolism). Consult your doctor before taking it.

!### HEART DISEASE

Consult your doctorELOGEN TABLET is not recommended for use in patients with heart diseases like
heart attack, stroke, angina, mini-stroke, high blood pressure and high or low
cholesterol levels. ELOGEN TABLET can be used with caution in patients with
irregular heartbeat or heart valve disease. Consult your doctor before taking
it.

OTHERS

ELOGEN TABLET is not recommended for use if you:

• have or had blood clots in legs (deep vein thrombosis) and eyes (retinal thrombosis)
• have high risks of having blood clots such to obesity, family history, planned surgeries, age (above 35 years), new mothers who delivered four weeks ago
• have diabetes with complications (diabetic retinopathy, neuropathy)
• have a disorder affecting your blood clotting which causes immediate blood clots (protein C deficiency, protein S deficiency, antithrombin-III deficiency, antiphospholipid antibodies in the blood
• have been bed-ridden or immobile for a long time
• have or ever had migraine headaches
• have or ever had breast cancer or other cancers
• have unexplained bleeding from the vagina
• have scheduled for a major surgery
• have or ever had vision loss due to blood vessel disease of the eye
• have an inflammation in the veins under the skin (superficial thrombophlebitis)

Before taking ELOGEN TABLET inform your doctor if you:

• have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
• have systemic lupus erythematosus (disease affecting your immune system)
• have haemolytic uraemic syndrome (blood clotting disorder causing kidney failure)
• have sickle cell anaemia (an inherited red blood cell disease)
• have varicose veins (enlarged or twisted veins)
• have brown patches on your face or body (chloasma)
• have a family history of breast cancer
• have or ever had depression
• use contact lenses
• have epilepsy
• you smoke. Your doctor may advise you to stop smoking. If you’re older than 35 and you are unable to quit smoking, your doctor may advise you to use another medicine
• are obese
• have a lab test
• have diabetes
• have fibroid tumours of the uterus
• have porphyria (an inherited disease affecting red blood cells)
• have hereditary angioedema (swelling in hands, feet, face, or airway passage)

Use in paediatrics:

There is no information regarding the use of ELOGEN TABLET in children and
adolescence under the age of 18 years. ELOGEN TABLET it is not intended for use
in male children. Consult your doctor before taking it.

Use in geriatrics:

ELOGEN TABLETis not intended for use in post-menopause women. Consult your
doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking ELOGEN TABLET, inform your doctor if you are taking any of the
following medicine:

• medicines used to manage epilepsy (Ex. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, lamotrigine)
• medicines used to manage tuberculosis (Ex. rifampicin)
• medicines used to manage HIV infection (Ex. ritonavir, nevirapine, efavirenz)
• medicines used to manage fungal infections (Ex. Griseofulvin)
• medicines used to manage increased blood pressure in the lungs (Ex. bosentan),
• medicines used to manage increased blood pressure (Ex enalapril, verapamil, telmisartan)
• herbal remedy St. John’s wort used to manage mental illness
• medicines used to manage graft rejection in organ transplants (Ex. cyclosporin)
• theophylline (used to manage breathing problems)
• tiz
• medicines used to manage hepatitis C infections Ex. ombitasvir, paritaprevir, ritonavir and dasabuvir
• medicines used to relieve pain Ex. ibuprofen, aceclofenac, meperidine, phenylbutazone
• medicines used to manage diabetes Ex. insulin, metformin
• medicines used to manage inflammation and allergic infections EX. prednisone
• medicines used to produce relaxation and sleep Ex. benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate
• medicines used to manage depression Ex. clomipramine
• medicines used as supplements Ex. Vit. B 12, folic acid
• medicines used to manage acidity Ex. Aluminium hydrochloride, magnesium hydrochloride
• medicines used to manage infections Ex. nitrofurantoin
• medicines used to lower cholesterol levels Ex. clofibrate
• medicines used as blood – thinners Ex. heparin, warfarin
• medicines used to manage migraine headaches Ex. sumatriptan

B. Drug-Food interactions

Avoid consuming grapefruit along with ELOGEN TABLET it may interfere with ELOGEN
TABLET

Overdosage:

If you or anyone else accidentally took more of ELOGEN TABLET, consult your
doctor immediately or visit the nearby hospital. Symptoms of overdose are
nausea, vomiting, or vaginal bleeding. Vaginal bleeding may occur in girl
children even before their first menstruation who have taken it accidentally.

SYNOPSIS

Drug	:	Ethinyl Estradiol, Desogestrel
Pharmacological Category	:	Oral contrace
Therapeutic Indication	:	contrace
Dosage Forms	:	Tablet

MORE INFORMATION

• Keep ELOGEN TABLET out of reach from children
• Store at room temperature

FAQs ABOUT ELOGEN TABLET

Q: Does ELOGEN TABLET cause any serious side effects?

A: The serious side effects of ELOGEN TABLET aredeep vein thrombosis, loss of
eyesight, stroke, jaundice, pulmonary embolism, allergic reactions, breast
cancer, cervical cancer, and inflammation of the liver.

Q: What precautions need to be followed while taking ELOGEN TABLET?

A: ELOGEN TABLET increases the risk of blood clots, so people with pre-existing
blood clot disorders and people at high risk of blood clots should avoid using
ELOGEN TABLET. Your doctor may advise you to do blood tests and will collect
data about your family’s medical history. ELOGEN TABLET is not recommended for
use in women with kidney disease, heart disease, liver disease, or scheduled
surgeries. ELOGEN TABLET should be used with caution in patients with
inflammatory bowel disease, anaemia, and depression. Do not discontinue use
without consulting your doctor. Take the medicine without missing any doses.
Avoid concomitant use of hepatitis C medicines such as ombitasvir, paritaprevir,
ritonavir, and dasabuvir, along with ELOGEN TABLET.

Q: Is it safe to take ELOGEN TABLET immediately after delivery?

A: No, it is not safe to take ELOGEN TABLET immediately after delivery. It is
advisable to take it only after 4 weeks post-delivery. Consult your doctor
before taking it.

Q: Can ELOGEN TABLET be used by children?

A: In post-pubertal female children under the age of 18, ELOGEN TABLET should be
used with caution. It is not intended to be used in male or female children who
have not reached puberty. Consult your doctor before taking it.

Q: Can ELOGEN TABLET be used by post-menopausal women?

A: In older women, ELOGEN TABLET should be used with caution. Consult your
doctor before taking it.

Q: Is ELOGEN TABLET Carcinogenic?

A: ELOGEN TABLET does not cause breast cancer. If you have breast cancer or have
had it in the past, do not use ELOGEN TABLET because some breast cancers are
sensitive to hormones. Women who use ELOGEN TABLET may have a slightly higher
chance of getting cervical cancer.

Q: How and when should I take ELOGEN TABLET?

A: Take ELOGEN TABLET strictly as advised by your physician. Do not miss any
doses between the courses because the management may not be effective if any
doses are missed. Swallow the medicine with a glass of water. ELOGEN TABLET can
be taken with or without food. Do not crush or chew the medicine. In case you
have missed a dose, take it as soon as you remember it. Missing doses cause
bleeding or spotting. Your doctor will decide the correct dose and duration for
you depending on your age, body weight, and disease condition. If you have any
doubts regarding the doses, consult your doctor.

Q: Can ELOGEN TABLET cause abortion?

A: No, it does not cause abortion; it just works by suppressing ovulation and
fertilization. ELOGEN TABLET is not recommended for use during pregnancy.
Consult your doctor before taking it.

Q: Can the use of ELOGEN TABLET cause depression?

A: Yes, the use of ELOGEN TABLET can cause depression. Exercise will increase
the production of hormones, which improve our mood. Drinking alcohol or misusing
substances may make you feel better for a short time, but after a long time,
these substances can make depression symptoms even worse and even cause severe
other health problems. So please avoid using alcohol and drugs to overcome
depression. Self-care is particularly important to overcome depression. This
includes getting good sleep, eating a healthy diet, avoiding negativity, and
participating in other activities. If you still feel depressed or low, contact
your doctor.

Q: What should I do if I forgot to take ELOGEN TABLET?

A: If you miss a dose, take it as soon as you remember. If you have missed a
dose, use proper safety measures like condoms to avoid pregnancy. Do not take
double doses to compensate for the missed ones. Spotting or sudden bleeding can
occur in the case of missed doses.

Q: Will the use of ELOGEN TABLET produce complete protection from pregnancy?

A: Yes, ELOGEN TABLET will produce complete protection from pregnancy when all
the doses are taken correctly every day. If you miss any dose, it will not be
effective, and you will have a high chance of getting pregnant.

Q: Is it necessary to use a condom while using ELOGEN TABLET?

A: No, it is not required to use condemn while using ELOGEN TABLET. But if you
miss any dose of ELOGEN TABLET and you do not want to be pregnant, then you
should use condoms to manage an unwanted pregnancy.

REFERENCES

1. KD Tripathi Hormones and Related drugs, Essentials of Pharmacology seventh
   edition Page no: 322, 316.

2. Stone S. Clinical review of a monophasic oral contrace
   desogestrel and ethinyl estradiol. 1993 NCBI: National Library of Medicine,
   PubMed [Accessed on 24th May 2022]

3. Merck Canada Inc. [Revised on December 2018] [Accessed on 24th May 2022]

4. Janssen Inc Health Canada. [Revised on June 2013] [Accessed on 24th May 2022]

5. Organon Pharma (UK) Limited. Electronic Medicines Compendium (EMC). [Revised
   on February 2022] [Accessed on 24th May 2022]

6. Teva Women’s Health, Inc Food and Drug Administration. [Accessed on 24th May
   2022]