LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS I.P
OVRAL L
(ORAL CONTRACEPTIVE TABLETS)
Patient Information Leaflet
1. What is Ovral'L?
Ovral'L is an oral contraceptive pill. This pill is an effective and reversible contraceptive tor woman wanting to delay her first pregnancy or space the next child. Each Ovral'L package contains 21 tablets, each containing hormones (30 meg of Ethinylestradiol and 150 meg of Levonorgestrel) which prevent pregnancy
2. How does Ovral'L work?
Ovral'L works by suppressing the release of the ovum (egg cell) from the ovaries.
3. When should I start Ovral'L?
If you are using the oral contraceptive pill for the first time, wait until your next menstrual period begins. Then counting the first day of bleeding as Day-1 take your first tablet on this day.
Take your pill at the same time each day. preferably at the evening meal or at bedtime, tf you have been taking another oral contraceptive, start Ovral'L on the day after the last active (hormonal) tablet of your previous pill.
4. How do I continue taking Ovral'L?
When you finish your first pack, do not take Ovral'L for the next 7 days (Your period usually begins about 3-4 days after the last tablet)
Start the next pack on Day 8 after the last active (hormonal) tablet, even if you are still bleeding. A new pack is always started on the same day of the week as the day vou started taking Ovral'L. For the first time e.g. if you begin your first pack on Monday, your next pack will also start on Monday, 4 weeks later. Your schedule then is 1 tablet daily tor 21 days, followed by 7 days without a tablet.
5. What do I do if a pill is missed?
Ovral'L is designed to protect you from pregnancy but it will do this only as long as you follow the schedule carefully. However, should you forget to take 1 or more pills or if you start a package late, your body may not have enough of the hormones needed to prevent pregnancy. In such cases, use a supplementary birth control method (other than oral contraceptives tablets) until you have taken a tablet for 7 days or until you finish the package if less than 7 tablets remain, e.g. suppose you forget Wednesday's pill and remember on Thursday, take the missed pill when you remember on Thursday and the pill for Thursday at the regular time. In this case you take 2 pills on Thursday. Continue your schedule until the package is finished. Remember to use a supplementary contraceptive method for 7 days after the last tablet if missed.
Suppose you forget 2 tablets in a row. take the 2 missed pills when you remember and pill for that day at the regular time. In this case you take 3 pills on the day you remember. Continue your schedule until the package is finished. Remember to use a supplementary contraceptive method tor the length of the time described above for 7 days after the last tablet if missed.
If you forget 3 tablets in row, do not take them when you remember and do not finish the package. Do not take any tablets tor the next four days. This makes one week without tablets. Then begin a new package 8 days after the last tablet you took, even if you are still bleeding. During the 7 days without tablet and until you have taken a tablet for 7 days from the new Ovral'L package, use a supplementary birth control method.
6. What do I do If I miss a period?
A missed period rarely means a pregnancy provided you have followed the schedule. Failure to menstruate occurs occasionally with all oral contraceptives. Even if you have taken your tablets regularly should you miss a period, consult your doctor before starting your next Ovrall package. If you have omitted any pill or started a package late, or do not menstruate during the 7 days, see the doctor. Take no more Ovral'L until he says you can resume. Use an alternative method o! contraception (not oral contraceptive tablet) until pregnancy is ruled out.
7. When should I not take this pill?
Some women should not take the pill. You should not take the pill if you have any of the following conditions:
• History of heart attack or stroke
History of Wood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
• History of blood clots in the deep veins of your legs
• Known or suspected breast cancer or cancer of the lining of the uterus, cervix, or vagina or certain hormonally-sensitive cancers ' Liver tumor (benign or cancerous)
• Chest pain (angina pectoris)
- Unexplained vaginai bleeding (until a diagnosis is reached oy your health-care professional)
- Yellowing of the whites of the eyes or of the skin, jaundice) during pregnancy or during previous use of the pill
- Known or suspected pregnancy
Heart valve or heart rhythm disorders that may be associated with formation of blood clots
- Diabetes affecting your circulation
- Headaches with neurological symptoms
• Uncontrolled high blood pressure
- Active liver disease with abnormal liver function tests
• Allergy or hypersensitivity to any of the components of Ovral'L
- A need for surgery with prolonged bedrest
Tell your health-care professional if you have any of these
conditions. Your health-care professional can recommend
another method of birth control.
Other considerations before starting oral contraceptives:
Tell your health-care professional if you or any family member has ever had:
- Breast nodules, fibrocystic disease of the breast, an abnormal breast X-ray or mammogram
- Diabetes
- Elevated cholesterol or triglycerides
- High blood pressure
- A tendency to form blood clots
- Migraine or other headaches or epilepsy
- Depression
- Gallbladder, liver, heart, or kidney disease
- History of scanty or irregular menstrual periods Women with any of these conditions should be checked often by their health-care professional if they choose to use oral contraceptives. Also, be sure to inform your doctor or health-care professional if you smoke or are on any medications.
8. What are the side effects of this pill?
• Irregular vaginal bleeding: Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral-contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your healthcare professional.
• Contact lenses: If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health-care professional.
• Fluid retention: Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your health-care professional.
• Melasma: A spotty darkening of the skin is possible, particularly of the face.
• Other side etfects: Other side effects may include nausea, breast tenderness, change in appetite, headache, nervousness, depression, dizziness, toss of scalp hair, rash, vaginal infections, inflammation of the pancreas, and allergic reactions.
9. Where to get Ovral'L?
Ovral'L is sold in chemist shops and by social marketing promoters. If you get this pill from market outlets, please consult a doctor before using the pill. Health Benefits from Oral Contraceptives
In addition to preventing pregnancy, use of oral contraceptives may provide certain benefits. They are:
- Menstrual cycles may become more regular.
- Blood flow during menstruation may be lighter, and less iron may be lost. Therefore, anemia due to iron deficiency is less likely to occur.
- Pain or other symptoms during menstruation may be encountered less frequently.
- Ovarian cysts may occur less frequently.
- Ectopic (tubal) pregnancy may occur less frequently.
- Noncancerous cysts or lumps in the breast may occur less frequently.
- Acute pelvic inflammatory disease may occur less frequently.
- Oral-contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus.
Effectiveness of Oral Contraceptives
Oral contraceptives or "birth-control pills* or "the pill" are used to prevent pregnancy. When they are taken correctly without missing any pills, the chance of becoming pregnant is approximately 1 % per year. Average failure rates are approximately 5% per year when women who miss pills are included. The chance of becoming pregnant increases with each missed pill during the menstrual cycle. This product (like all oral contraceptives) Is intended to prevent pregnancy. Oral contraceptives do not protect against transmission of HIV (AIDS) and other sexually transmitted diseases (STDs) such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.
Presentation: Each Blister contains 21 tablets
Each uncoated tablet contains:
Levonorgestrel I.P. 0.15 mg
Ethinyloestradiol I.P. 0.03mg
Store in a cool place
Keep out of the reach of children
Wyeth
Manufactured in India by
Wyeth Limited
Plot No. L-137, Phase lll-A, Vema Industrial Estate, Verna, Goa 403 722
*Registered Trade Mark