PIMTREA (Page 11 of 11)

WHAT TO DO IF YOU MISS PILLS

If you MISS 1 “active” [dark blue] pill:

1. Take it as soon as you remember. Take the next pill at your regular time. This means you 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 “active” [dark blue] 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, foam, or sponge) as a back-up method for those 7 days.

If you MISS 2 “active” [dark blue] pills in a row in WEEK 3:

1. If you are a Day 1 Starter:

THROW OUT the rest of the pill pack and start a new pack that same day.

If you are a 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 health care provider 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, foam, or sponge) as a back-up method for those 7 days.

If you MISS 3 OR MORE “active” [dark blue] pills in a row (during the first 3 weeks):

1. If you are a Day 1 Starter:

THROW OUT the rest of the pill pack and start a new pack that same day.

If you are a 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 health care provider 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, foam, or sponge) as a back-up method for those 7 days.

A REMINDER FOR THOSE ON 28-DAY PACKS:

If you forget any of the 2 [white] or 5 [green] 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.

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 “ACTIVE” [DARK BLUE] PILL EACH DAY until you can reach your doctor or health care provider.

PREGNANCY DUE TO PILL FAILURE

The incidence of pill failure resulting in pregnancy is approximately one percent (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are about 5%. If failure does occur, the risk to the fetus is minimal.

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 doctor, health care provider or pharmacist.

OTHER INFORMATION

Your doctor or health care 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 your doctor or the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year. Be sure to inform your doctor or health care 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 doctor or health care 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 combination 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.

• ectopic (tubal) pregnancy may occur less frequently.

• non-cancerous 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, health care provider, or pharmacist. They have a more technical leaflet called the Prescribing Information which you may wish to read.

Manufactured by: Novast Laboratories Ltd.

Nantong, China 226009

Rev. 09/17

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PimtreaTM

(Desogestrel and Ethinyl Estradiol Tablet, USP and Ethinyl Estradiol Tablets, USP)

Each dark blue tablet (21) contains 0.15 mg desogestrel and 0.02 mg ethinyl estradiol.

Each white tablet (2) contains inert ingredients. Each green tablet (5) contains 0.01 mg

ethinyl estradiol.

image-10
(click image for full-size original)
PIMTREA desogestrel/ethinyl estradiol and ethinyl estradiol kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-404
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-404-01 1 BLISTER PACK in 1 PACKET contains a BLISTER PACK
1 1 KIT in 1 BLISTER PACK This package is contained within the PACKET (16714-404-01)
2 NDC:16714-404-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (16714-404-02)
3 NDC:16714-404-03 3 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (16714-404-03)
4 NDC:16714-404-04 6 BLISTER PACK in 1 CARTON contains a BLISTER PACK
4 1 KIT in 1 BLISTER PACK This package is contained within the CARTON (16714-404-04)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 21
Part 2 2
Part 3 5
Part 1 of 3
PIMTREA desogestrel and ethinyl eatradiol tablet
Product Information
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESOGESTREL (DESOGESTREL) DESOGESTREL 0.15 mg
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.02 mg
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
HYPROMELLOSES
FD&C RED NO. 40
FD&C YELLOW NO. 6
FD&C BLUE NO. 1
LACTOSE MONOHYDRATE
POVIDONE
STEARIC ACID
STARCH, PREGELATINIZED CORN
Product Characteristics
Color BLUE (dark blue) Score no score
Shape ROUND Size 5mm
Flavor Imprint Code M3
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091247 08/01/2013
Part 2 of 3
INERT placebo tablet
Product Information
Route of Administration ORAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
TITANIUM DIOXIDE
POLYDEXTROSE
HYPROMELLOSES
TRIACETIN
POLYETHYLENE GLYCOL 8000
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code P;N
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091247 08/01/2013
Part 3 of 3
PIMTREA 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 0.01 mg
Inactive Ingredients
Ingredient Name Strength
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL 3000
LECITHIN, SOYBEAN
FD&C BLUE NO. 1
FERRIC OXIDE YELLOW
FD&C RED NO. 40
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
STARCH, PREGELATINIZED CORN
FD&C YELLOW NO. 5
FERROSOFERRIC OXIDE
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 5mm
Flavor Imprint Code M4
Contains
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091247 08/01/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091247 08/01/2013
Labeler — Northstar Rx LLC (830546433)
Registrant — Novast Laboratories, Ltd. (527695995)
Establishment
Name Address ID/FEI Operations
Novast Laboratories, Ltd. 527695995 analysis (16714-404), label (16714-404), manufacture (16714-404), pack (16714-404)

Revised: 09/2017 Northstar Rx LLC

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