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EMILY(Levonorgestrel releasing Intrauterine System)

BRIEF PRESCRIBING INFORMATION

This information does not include all details needed to use Emily safely and effectively. See full prescribing information for Emily. Emily (Levonorgestrel releasing Intrauterine System) Approval date (India): 2011

INDICATIONS

Emily is a sterile, Levonorgestrel releasing Intrauterine System indicated for:

DOSAGE AND ADMINISTRATION

DOSAGE FORMS AND STRENGTHS

One sterile Intrauterine System consisting of M-shaped polyethylene frame with a steroid reservoir containing 52 mg Levonorgestrel held within an inserter tube.

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions reported in clinical trials with a similar device (> 10%users) are uterine/vaginal bleeding alterations (51.9%), amenorrhea (23.9%), intermenstrual bleeding and spotting (23.4%), abdominal/pelvic pain (12.8%) and ovarian cysts (12%).

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Frequently asked questions about EMILY

1. What is Emily (Levonorgestrel-releasing Intrauterine System)? How does Emily prevent pregnancy?

EMILY is an intrauterine delivery system (IUS) consisting of a small white M-shaped frame made from soft, flexible plastic. The vertical arm is surrounded by a narrow cylindrical shaped reservoir that contains Levonorgestrel which slowly releases into your uterus. It prevents pregnancy and decrease the abnormally heavy menstrual blood loss.
EMILY works by slowly releasing Levonorgestrel into the uterus at a rate of approximately 20 micrograms per day. This amount of Levonorgestrel:
  • Reduces the normal monthly thickening of the lining of the uterus.
  • Thickens the cervical mucus which prevents passage of sperm through the cervical canal (opening to the uterus).

2. Is Emily effective in treating Heavy Menstrual bleeding?

Yes, Emily is effective in treating heavy menstrual bleeding (DUB) in globally.

3. Why should I prefer Emily?

  • Long term Contraception and effective treatment for DUB.
  • Less systemic side effects like oral contraceptives.
  • Easy insertion with less pain.
  • Available at affordable cost.

4. Is it a difficult process to insert Emily?

No, The insertion procedure usually takes a few minutes after your doctor has completed the pelvic examination. You will be protected from pregnancy as soon as insertion of the system is complete; however, it is best to wait 24 to 48 hours before having sexual intercourse. A reduction in menstrual blood loss should be apparent from the first menstrual cycle.

5. Will my periods change with Emily?

EMILY will affect your menstrual cycle. You might experience frequent spotting (a small amount of blood loss) or light bleeding in addition to your periods for the first 3 to 6 months. In some cases, you may have heavy or prolonged bleeding during this time. Overall, gradually, your menstrual period may disappear when using EMILY. Due to the hormone’s effect on the lining of the uterus it’s become thicken. Therefore there is little or no bleeding, as happens during a usual menstrual period. But, when the system is removed, periods should return to normal. Menstruation disappearance does not necessarily mean you have reached menopause or are pregnant. If, however, you are having regular menstrual periods and then do not have one for 6 weeks or longer, it is possible that you may be pregnant. You should consult with your doctor.

6. Which are the conditions were Emily should not be used?

EMILY is not suitable for every woman. Your doctor can advise you if you have any conditions that would pose a risk to you. You should not use EMILY if you:
  • have any allergies to the hormone levonorgestrel, or to any of the other ingredients of EMILY,
  • are pregnant, or if you suspect that you may be pregnant,
  • Currently have pelvic inflammatory disease (PID) or have a recurrent PID
  • had an infection of the uterus (womb)/cervix after delivering a baby or having abortion during the past 3 months
  • have a condition of the uterus that distorts the uterine cavity, such as large fibroids
  • have cell abnormalities in the cervix (your doctor can tell you if you have this)
  • have a known or suspected progestogen-dependent tumour, including breast cancer
  • have liver disease or liver tumor
  • have bacterial endocarditis (an infection of the heart valves or lining of the heart)
  • have immunodeficiency (a doctor will have told you if you have this)
  • have cancer affecting the blood, or if you have leukemia
  • have or have had trophoblastic disease (a doctor will have told you if you have this)
  • have cancer of the uterus or the cervix (uterine or cervical malignancy.

7. Are there any potential serious complications and any side effects with Emily?

Pelvic inflammatory disease (PID). Some IUD users get a serious pelvic infection called pelvic inflammatory disease. PID is usually sexually transmitted. You have a higher chance of getting PID if you or your partner has sex with other partners. PID can cause serious problems such as infertility, ectopic pregnancy or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID may require surgery. A hysterectomy (removal of the uterus) is sometimes needed. In rare cases, infections that start as PID can even cause death. Tell your healthcare provider right away if you have any of these signs of PID: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal (stomach area) pain, painful sex, chills, or fever.

Embedment : Emily may become attached to the uterine wall. This is called embedment. If embedment happens, Emily may no longer prevent pregnancy and you may need surgery to have it removed.

Perforation
 : Emily may go through the uterus. This is called perforation. If your uterus is perforated, Emily may no longer prevent pregnancy. It may move outside the uterus and can cause internal Scarring, infection, or damage to other organs, and you may need surgery to have Emily removed.

Common Side Effects

  • Abdominal pain, Back pain, Breast pain,
  • Painful periods,
  • Altered mood, Headache,
  • Depression and Nervousness,
  • Genital discharge,
  • Vaginal hemorrhage,
  • Withdrawal bleeding,
  • Menorrhagia,
  • Vaginal infection,
  • Ovarian cyst
  • Decreased sex drive,
  • Weight increase,
  • Nausea,
  • Acne,
  • Skin disorder

8. How often should I see my doctor once Emily is placed?

You should have the system checked by your doctor approximately 4 to 12 weeks after it is fitted, again at 12 months and then once a year until it is removed. EMILY can stay in place for 3 years.

9. What should I do, if I wish to become pregnant?

If you wish to become pregnant, ask your doctor to remove EMILY. Your usual level of fertility should return soon after the system is removed.

10. Will my partner be able to feel Emily during intercourse?

During sexual intercourse, you or your partner should not be able to feel EMILY. If you can feel EMILY, or any pain or discomfort that you suspect may be caused by it, then you should not have sexual intercourse until you consult your doctor to verify it is still in the correct position.

11. Will Emily protect from HIV or STDs (sexually transmitted diseases)?

No. Emily (Levonorgestrel-releasing Intrauterine System) does not protect against HIV or STDs. So, if while using Emily you should think you or your partner is at a risk of getting an STD, use a condom and call your healthcare provider.

About HLL R&D

HLL strives for excellence in innovation.

Through the interchange of creative, imaginative people, a global Research and Development (R&D) centre that encourages collaboration and cooperation among highly reputed research centers in the country; and a strong commitment to ongoing investment, we have put R&D at the centre of everything we do.

From Blood Transfusion Bags to Hydrocephalus Shunts, once-a-week Non Steroidal Oral Contraceptive Pills and several variants of condoms, every product from HLL is a result of innovation.

The last four decades have seen HLL network with various scientific and academic institutions of excellence for developing novel healthcare products. HLL has a state-of-the-art R&D centre at Thiruvananthapuram in Kerala, India.

R & D Centre, Thiruvananthapuram, Kerala

HLL's R&D centre has several projects in hand, carried out in-house or on collaborative mode, with premier academic and research institutions in the country and abroad. These projects cover a wide area of research ranging from development of novel techniques for drug delivery to blood filters, novel contraceptives and cancer-care devices. Some of the institutions HLL has networked with are-Indian Institute of Technology (IIT), Kanpur; Central Drug Research Institute (CDRI), Lucknow; Sree Chitra Thirunal Institute of Medical Sciences & Technology (SCTIMST), Thiruvananthapuram; Regional Cancer Centre (RCC), Thiruvananthapuram, and Population Council, USA.

HLL has set up a Technology Business Incubation centre (TBlC) at Rajiv Gandhi centre for Biotechnology (RGCB), Thiruvananthapuram. The goal of the TBlC is to develop novel, fast and easy-to-use diagnostic methodologies for various infectious diseases. As part of this collaboration, HLL has developed a duplex kit for viral infections. This project would be extended to development of newer and less expensive diagnostic kits.

Based on its technological competency, the R&D centre is implementing sponsored projects from organisations including Department of Science and Technology (DST), Defense Research Development Organisation (DRDO), Department of Biotechnology (DBT), Council of Scientific Industrial Research (CSlR) and international agencies like Bill& Melinda Gates Foundation.

Know more about HLL

News & Press Release

HLL's R&D division introduced 'Emily', a new Intra Uterine hormonal System (IUS) for effective management of Dysfunctional Uterine Bleeding (DUB) in Bengaluru on October18, 2012

DUB affects 22 to 30% of women and accounts for 12% of gynaecological referrals. Within five years of referral, 20% of women undergo hysterectomy, making it is the most common major gynaecological operation. ‘Emily' works as a contraceptive option and also effectively treats heavy and painful menstrual bleeding. The device is removable and releases the hormone in a controlled way for a period of five years to offer therapeutic action for contraception and against heavy menstrual bleeding. The action of this device is reversible after removal, allowing the user to become pregnant again.

The last four decades have seen HLL network with various scientific and academic institutions of excellence for developing novel healthcare products. HLL has a state-of-the-art R&D centre at Thiruvananthapuram in Kerala, India.

"Emily substantiates HLL's motto of 'Quality Healthcare at affordable cost'," said HLL C&MD Dr. M. Ayyappan.

Contact Information

Corporate R & D Centre
HLL Lifecare Limited
Akkulam
Trivandrum
Kerala -695017


Phone : 04712774781
Email: emily@lifecarehll.com