Kurvelo (Page 9 of 9)

WHEN TO START THE FIRST PACK OF PILLS

The 28-day pill pack accommodates a SUNDAY START only. Pick a time of day which will be easy to remember.

SUNDAY START:

These instructions are for the 28-day pill pack.

  1. Take the first “active” light orange pill of the first pack on the Sunday after your period starts , even if you are still bleeding. If your period begins on Sunday, start the pack that same day.
  2. Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). Condoms, spermicide, or the sponge are good back-up methods of birth control.

WHAT TO DO DURING THE MONTH

1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY.

Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea).

Do not skip pills even if you do not have sex very often.

2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS:

28 pills: Start the next pack on the day after your last “reminder” pill. Do not wait any days between packs.

WHAT TO DO IF YOU MISS PILLS

The pill may not be as effective if you miss light orange “active” pills, and particularly if you miss the first few or the last few light orange “active” pills in a pack.

If you MISS 1 light orange “active” pill:

  1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day.
  2. You do not need to use a back-up birth control method if you have sex.

If you MISS 2 light orange “active” pills in a row in WEEK 1 OR WEEK 2 of your pack:

  1. Take 2 pills on the day you remember and 2 pills the next day.
  2. Then take 1 pill a day until you finish the pack.
  3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, spermicide, or sponge) as a back-up for those 7 days.

If you MISS 2 light orange “active” pills in a row in THE 3rd WEEK:

The Sunday Starter instructions are for the 28-day pill pack.

1.Sunday Starter:

Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.

2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.

3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, spermicide, or sponge) as a back-up for those 7 days.

If you MISS 3 OR MORE light orange “active” pills in a row (during the first 3 weeks):

The Sunday Starter instructions are for the 28-day pill pack.

1. Sunday Starter:

Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day.

2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant.

3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, spermicide, or sponge) as a back-up for those 7 days.

A REMINDER FOR THOSE ON 28-DAY PACKS

If you forget any of the 7 pink “reminder” pills in Week 4:

THROW AWAY the pills you missed.

Keep taking 1 pill each day until the pack is empty.

You do not need a back-up method if you start your next pack on time.

FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED

Use a BACK-UP METHOD anytime you have sex.

KEEP TAKING ONE PILL EACH DAY until you can reach your doctor or clinic.

PREGNANCY DUE TO PILL FAILURE

The incidence of pill failure resulting in pregnancy is approximately less than 1% if taken every day as directed, but average failure rates are 5%. If you do become pregnant, the risk to the fetus is minimal, but you should stop taking your pills and discuss the pregnancy with your doctor.

PREGNANCY AFTER STOPPING THE PILL

There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy.

There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill.

OVERDOSAGE

Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your healthcare provider or pharmacist.

OTHER INFORMATION

Your healthcare provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the healthcare provider believes that it is appropriate to postpone it. You should be reexamined at least once a year. Be sure to inform your healthcare provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your healthcare provider, because this is a time to determine if there are early signs of side effects of oral contraceptive use.

Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills.

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.

If you want more information about birth control pills, ask your doctor or pharmacist. They have a more technical leaflet called the Professional Labeling which you may wish to read.

Kurvelo™ is a trademark of Lupin Pharmaceuticals, Inc.

The other brands listed are trademarks or registered trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

Distributed by:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

Manufactured by:

Lupin Limited

Pithampur (M.P.) — 454 775

INDIA

October 10, 2013 ID#: 234571

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KurveloTM [levonorgestrel and ethinyl estradiol tablets USP]0.15 mg and 0.03 mg

NDC 68180-844-11

Wallet Label: 28 Tablets

figure-5
(click image for full-size original)

KurveloTM [levonorgestrel and ethinyl estradiol tablets USP]0.15 mg and 0.03 mg

Rx Only

NDC 68180-884-13

Carton: 3Wallet of 28 Tablets Each

figure-6
(click image for full-size original)
KURVELO levonorgestrel and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57297-844
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57297-844-13 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK (57297-844-11)
1 NDC:57297-844-11 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (57297-844-13)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 7
Part 1 of 2
KURVELO levonorgestrel and ethinyl estradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.03 mg
LEVONORGESTREL (LEVONORGESTREL) LEVONORGESTREL 0.15 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C YELLOW NO. 6
CELLULOSE, MICROCRYSTALLINE
POVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color ORANGE (light) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code LU;U31
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091408 10/26/2012
Part 2 of 2
INERT inert tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
D&C RED NO. 30
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
Product Characteristics
Color PINK (pink colored) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code LU;U32
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091408 10/26/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091408 10/26/2012
Labeler — LUPIN LIMITED (675923163)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650582310 MANUFACTURE (57297-844), PACK (57297-844)

Revised: 12/2018 LUPIN LIMITED

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