Ovral L is an estrogen and progestin combination contraceptive pill used to prevent pregnancy.
Ovral L may also be used to regulate the menstrual cycle, treat symptoms of menopause, or treat other conditions as determined by your doctor.
Each combined oral contraceptive (COC) tablet contains
Levonorgestrel I.P. 150 µg
Ethinyl estradiol I.P. 30 µg
ETHINYL ESTRADIOL/LEVONORGESTREL products are effective as oral contraceptives (birth control pills or `the pill).
These products combine natural or synthetic estrogens and progestins, similar to the natural sex hormones (estrogen and progesterone) produced in a woman`s body. Ethinyl estradiol is an estrogen and levonorgestrel is a progestin. These products can prevent ovulation and pregnancy.
In general, a combination of estrogen and progestin works better than a single-ingredient product.
No preceding hormonal contraceptive use (in the past month)
Ovral L tablet should be taken on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bleeding).
Starting from days 2-7 is allowed but for the first 7 days of Ovral L tablet-taking during the first cycle a non-hormonal backup method of birth control (such as condoms and spermicide) is recommended.
Ovral L tablets must be taken orally in the order directed on the package every day at about the same time.
One tablet is to be taken daily for 21 consecutive days.Each subsequent pack is started on the day after the tablet-free interval. A withdrawal bleed usually starts on days 2-3 after the last tablet and may not have finished before the next pack is started.
Severe side effects are relatively rare in women who are healthy and do not smoke while they are taking oral contraceptives.
The following symptoms or side effects may be related to blood clots and require immediate medical or emergency help:
Hypersensitivity to any of the components of Ovral L tablets.
Cerebrovascular or coronary artery disease
Deep vein thrombosis (current or history)
Diabetes with vascular involvement
Headache with focal neurological symptoms, such as aura
Hepatic adenomas or carcinomas or active liver disease as long as liver function has not returned to normal.
Hereditary or acquired thrombophilias
Known or suspected carcinoma of the breast or other known or suspected estrogens dependant neoplasia
Known or suspected pregnancy
Thromboembolism (current or history)
Thrombogenic rhythm disorders
Thrombogenic valvulopathies
Uncontrolled hypertension
Undiagnosed vaginal bleeding
Contact your health care provider as soon as you can.
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products.
•antibiotics or medicines for infections, especially rifampin
•aprepitant
•barbiturate medicines for producing sleep or treating seizures (convulsions)
•bosentan
•carbamazepine
•caffeine
•clofibrate
•cyclosporine
•dantrolene
•doxercalciferol
•grapefruit juice
•hydrocortisone
•medicines for anxiety or sleeping problems, such as diazepam or temazepam
•medicines for mental depression
•medicines for diabetes, including troglitazone and pioglitazone
•mineral oil
•modafinil
•mycophenolate
•nefazodone
•oxcarbazepine
•phenytoin
•prednisolone
•ritonavir or other medicines for the treatment of the HIV virus or AIDS
•selegiline
•soy isoflavones supplements
•St. John's wort
•tamoxifen or raloxifene
•theophylline
•topiramate
•warfarin
Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works.
Check before stopping or starting any of your medicines.
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea, vomiting, and vaginal bleeding.
The use of COCs may cause certain physiologic changes which may be reflected in the results of certain laboratory tests, including
biochemical parameters of:
adrenal function (increased plasma cortisol, increased cortisol binding globulin, decreased dehydroepiandrosterone sulfate (DHEAS)
liver function (including a decrease in bilirubin and alkaline phosphatase)
renal function (increased plasma creatinine and creatinine clearance).
thyroid function (increased total T3 and T4 due to increased TBG, decreased free T3 resin uptake)
plasma levels of (carrier) proteins, such as corticosteroid-binding globulin and lipid/lipoprotein fractions
parameters of carbohydrate metabolism
parameters of coagulation and fibrinolysis
decreased serum folate levels
If you miss one dose of Ovral L, take it as soon as you remember and then take the next pill at the regular time as usual.
You may take 2 tablets in one day. If you miss two doses (days) in a row, take 2 tablets the day you remember and 2 tablets the next day, then, continue with your regular schedule.
Whenever 1 or 2 doses are missed, you should use a second method of contraception for the next 7 days in addition to taking the pills. If you miss three doses of Ovral L in a row, you should notify your physician or other health care professional for instructions.
If you vomit the dose within an hour of taking it, you MUST contact your health care professional for instructions.
Keep out of the reach of children.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.
A complete personal and family medical history and physical examination, including blood pressure, should be taken prior to the initiation of COC use.
Such medical examinations should be repeated periodically during the use of COCs.
Please consult your physician for all precautions to observe before starting on a course with Ovral L Tablets.