OPTIONELLE- levonorgestrel tablet, 1.5 mg tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)

Available from:

Strides Pharma Inc

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Emergency contraceptive for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control) - if you are already pregnant (because it will not work) - for regular birth control taking efavirenz (HIV medication) or rifampin (tuberculosis treatment) or medication for seizures (epilepsy). These medications may reduce the effectiveness of levonorgestrel.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OPTIONELLE - LEVONORGESTREL TABLET, 1.5 MG TABLET
STRIDES PHARMA INC
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OPTIONELLE
(LEVONORGESTREL TABLET 1.5 MG)
EMERGENCY CONTRACEPTIVE
_ACTIVE INGREDIENT_
Levonorgestrel 1.5 mg
_PURPOSE_
Emergency contraceptive
_USE_
for women to reduce chance of pregnancy after unprotected sex (if a
contraceptive
failed or if you did not use birth control)
_WARNINGS_
ALLERGY ALERT: Do not use if you have ever had an allergic reaction to
levonorgestrel
SEXUALLY TRANSMITTED DISEASES (STDS) ALERT: This product does NOT
protect against
HIV/AIDS or other STDs
DO NOT USE
if you are already pregnant (because it will not work)
for regular birth control
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking efavirenz (HIV medication) or rifampin (tuberculosis treatment)
or medication for
seizures (epilepsy). These medications may reduce the effectiveness of
levonorgestrel.
WHEN USING THIS PRODUCT you may have
menstrual changes
nausea
lower stomach (abdominal) pain
tiredness
headache
dizziness
breast pain
vomiting
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control
center right away at 1-
800-222-1222.
_DIRECTIONS_
TAKE AS SOON AS POSSIBLE WITHIN 72 HOURS (3 DAYS) AFTER UNPROTECTED
SEX.
THE SOONER YOU TAKE IT THE BETTER IT WILL WORK.
IF YOU VOMIT WITHIN 2 HOURS AFTER TAKING THE MEDICATION, CALL A
HEALTHCARE
PROFESSIONAL TO FIND OUT IF YOU SHOULD REPEAT THE DOSE
_OTHER INFORMATION_
READ THE INSTRUCTIONS, WARNINGS AND ENCLOSED PRODUCT LEAFLET BEFORE
USE
this product works mainly by preventing ovulation (egg release). It
may also prevent
fertilization of a released egg (joining of sperm and egg) or
attachment of a fertilized
egg to the uterus (implantation).
DO NOT USE IF CARTON IS OPEN OR BLISTER SEAL IS BROKEN OR MISSING
store at 20° to 25°C (68° to 77°F)
_INACTIVE INGREDIENTS_
colloidal silicon dioxide, FD&C Yellow No. 6 aluminum lake, lactose
monohydrate,
magnesium stearate, and pregelatinized starch
_QUESTIONS OR COMMENTS?_
CALL 1-877-244-9825.
MANUFACTURED FOR:
STRIDES PHARMA