LEENA- norethindrone and ethinyl estradiol kit

Leena by

Drug Labeling and Warnings

Leena by is a Prescription medication manufactured, distributed, or labeled by Mayne Pharma Inc., Patheon Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WHAT TO DO IF YOU MISS PILLS

If you MISS 1 light blue or light yellow-green "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 blue or light yellow-green "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, foam, or sponge) as a back-up for those 7 days.

If you MISS 2 light blue or light yellow-green "active" pills in a row in THE 3rd WEEK:

  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 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, foam, or sponge) as a back-up for those 7 days.

If you MISS 3 OR MORE light blue or light yellow-green "active" 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 of pills 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 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, foam, or sponge) as a back-up for those 7 days.

A REMINDER:

If you forget any of the 7 orange "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.

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" PILL EACH DAY until you can reach your doctor or clinic.

6. Missed periods, spotting or light bleeding

At times, you may not have a period after you have completed a pack of pills. If you miss 1 period but you have taken the pills exactly as you were supposed to, continue as usual into the next cycle. If you have not taken the pills correctly, and have missed a period, you may be pregnant and you should stop taking the pill until your doctor or clinic determines whether or not you are pregnant. Until you can talk to your doctor or clinic, use an appropriate back-up birth control method. If you miss 2 consecutive periods, you should stop taking the pill until it is determined that you are not pregnant.

Even if spotting or light bleeding should occur, continue taking the pill according to the schedule. Should spotting or light bleeding persist, you should notify your doctor or clinic.

7. Stopping the pill before surgery or prolonged bed rest

If you are scheduled for surgery or you need to stay in bed for a long period of time you should tell your doctor that you are on the pill. You should stop taking the pill four weeks before your operation to avoid an increased risk of blood clots. Talk to your doctor about when you may start taking the pill again.

8. Starting the pill after pregnancy

After you have a baby it is advisable to wait 4–6 weeks before starting to take the pill. Talk to your doctor about when you may start taking the pill after pregnancy.

9. Pregnancy due to pill failure

When the pill is taken correctly, the expected pregnancy rate is approximately 1% (ie, 1 pregnancy per 100 women per year). If pregnancy occurs while taking the pill, there is little risk to the fetus. The typical failure rate of large numbers of pill users is less than 3% when women who have missed pills are included. If you become pregnant, you should discuss your pregnancy with your doctor.

10. Pregnancy after stopping the pill

There may be some delay in becoming pregnant after you stop taking the pill, especially if you had irregular periods before you started using the pill. Your doctor may recommend that you delay becoming pregnant until you have had one or more regular periods.

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

11. Overdosage

There are no reports of serious illness or side effects in young children who have swallowed a large number of pills. In adults, overdosage may cause nausea and/or bleeding in females. In case of overdosage, contact your doctor, clinic or pharmacist.

12. Other information

Your doctor or clinic will take a medical and family history and will examine you before prescribing the pill. The physical examination may be delayed to another time if you request it and 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 clinic 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 clinic because this is a time to determine if there are early signs of side effects from using the pill.

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

If you want more information about birth control pills, ask your doctor or clinic. They have a more technical leaflet called PHYSICIAN LABELING which you might want to read.

NON-CONTRACEPTIVE HEALTH BENEFITS

In addition to preventing pregnancy, use of oral contraceptives may provide certain non-contraceptive health benefits:

Store at 20-25ºC (68-77ºF). [See USP controlled room temperature.]

Keep this and all medication out of the reach of children.

  • BRIEF SUMMARY

    PATIENT PACKAGE INSERT

    This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

    Oral contraceptives, also known as "birth control pills" or "the pill", are taken to prevent pregnancy and, when taken correctly, have a failure rate of about 1% per year when used without missing any pills. The typical failure rate of large numbers of pill users is less than 3% per year when women who miss pills are included. For most women, oral contraceptives are also free of serious or unpleasant side effects. However, forgetting to take oral contraceptives considerably increases the chances of pregnancy.

    For the majority of women, oral contraceptives can be taken safely, but there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. The risks associated with taking oral contraceptives increase significantly if you:

    • Smoke
    • Have high blood pressure, diabetes or high cholesterol
    • Have or have had clotting disorders, heart attack, stroke, angina pectoris, cancer of the breast or sex organs, jaundice or malignant or benign liver tumors

    You should not take the pill if you suspect you are pregnant or have unexplained vaginal bleeding.

    Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

    Most side effects of the pill are not serious. The most common such effects are nausea, vomiting, bleeding between menstrual periods, weight gain, breast tenderness, and difficulty wearing contact lenses. These side effects, especially nausea and vomiting, may subside within the first 3 months of use.

    The serious side effects of the pill occur very infrequently, especially if you are in good health and are young. However, you should know that the following medical conditions have been associated with or made worse by the pill:

    1. Blood clots in the legs (thrombophlebitis) or lungs (pulmonary embolism), stoppage or rupture of a blood vessel in the brain (stroke), blockage of blood vessels in the heart (heart attack or angina pectoris), eye or other organs of the body. As mentioned above, smoking increases the risk of heart attacks and strokes and subsequent serious medical consequences.
    2. Liver tumors, which may rupture and cause severe bleeding. A possible but not definite association has been found with the pill and liver cancer. However, liver cancers are extremely rare. The chance of developing liver cancer from using the pill is thus even rarer.
    3. High blood pressure, although blood pressure usually returns to normal when the pill is stopped.

    The symptoms associated with these serious side effects are discussed in the detailed leaflet given to you with your supply of pills. Notify your doctor or health care provider if you notice any unusual physical disturbances while taking the pill. In addition, drugs such as rifampin, as well as some anti-convulsants and some antibiotics, may decrease oral contraceptive effectiveness.

    Studies to date of women taking the pill have not shown an increase in the incidence of cancer of the breast or cervix. There is, however, insufficient evidence to rule out the possibility that the pill may cause such cancers. Some studies have reported an increase in the risk of developing breast cancer, particularly at a younger age. This increased risk appears to be related to duration of use.

    Taking the pill provides some important non-contraceptive health benefits. These include less painful menstruation, less menstrual blood loss and anemia, fewer pelvic infections and fewer cancers of the ovary and the lining of the uterus.

    Be sure to discuss any medical condition you may have with your health care provider. Your 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 the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year while taking oral contraceptives. The detailed patient information leaflet gives you further information which you should read and discuss with your health care provider.

    HOW TO TAKE THE PILL

    See full text of HOW TO TAKE THE PILL which is printed in full in the DETAILED PATIENT LABELING.

    Call your doctor for medical advice about side effects. You may report side effects to Mayne Pharma at 1-844-825-8500 or to FDA at 1-800-FDA-1088.

    Distributed By:
    Mayne Pharma
    Greenville, NC 27834

    Manufactured By: Patheon, Inc.
    Mississauga, Ontario L5N 7K9
    CANADA

    Content Updated: August 2018

    2000010899

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    NDC 51862-471-06

    Leena®

    Norethindrone and Ethinyl Estradiol
    Tablets USP

    28-DAY REGIMEN

    Each light blue tablet (12) contains norethindrone 0.5 mg and ethinyl estradiol
    0.035 mg; each light yellow-green tablet (9) contains norethindrone 1 mg and
    ethinyl estradiol 0.035 mg; each orange tablet (7) contains inert ingredients.

    Rx Only

    6 Blister Cards, 28 Tablets Each

    mayne pharma

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    LEENA 
    norethindrone and ethinyl estradiol kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 51862-471
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 51862-471-066 in 1 CARTON08/03/2016
    1NDC: 51862-471-011 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1 12 
    Part 2
    Part 3
    Part 1 of 3
    LEENA 
    norethindrone and ethinyl estradiol tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Norethindrone (UNII: T18F433X4S) (Norethindrone - UNII:T18F433X4S) Norethindrone0.5 mg
    Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U) Ethinyl Estradiol0.035 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorBLUE (light blue) Scoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code Watson;243
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA01897708/03/2016
    Part 2 of 3
    LEENA 
    norethindrone and ethinyl estradiol tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Norethindrone (UNII: T18F433X4S) (Norethindrone - UNII:T18F433X4S) Norethindrone1 mg
    Ethinyl Estradiol (UNII: 423D2T571U) (Ethinyl Estradiol - UNII:423D2T571U) Ethinyl Estradiol0.035 mg
    Inactive Ingredients
    Ingredient NameStrength
    D&C Green No. 5 (UNII: 8J6RDU8L9X)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Magnesium Stearate (UNII: 70097M6I30)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorYELLOW (light yellow-green) Scoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code Watson;244
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA01897708/03/2016
    Part 3 of 3
    INERT 
    inert tablet
    Product Information
    Route of AdministrationORAL
    Inactive Ingredients
    Ingredient NameStrength
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Lactose Monohydrate (UNII: EWQ57Q8I5X)  
    Anhydrous Lactose (UNII: 3SY5LH9PMK)  
    Magnesium Stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize5mm
    FlavorImprint Code Watson;P1
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA01897708/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDA authorized genericNDA01897708/03/2016
    Labeler - Mayne Pharma Inc. (867220261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Inc.240769596MANUFACTURE(51862-471) , PACK(51862-471) , ANALYSIS(51862-471) , LABEL(51862-471)

  • Trademark Results [Leena]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LEENA
    LEENA
    76505310 2998666 Live/Registered
    MAYNE PHARMA LLC
    2003-04-09
    LEENA
    LEENA
    74120625 not registered Dead/Abandoned
    Wings Manufacturing Corporation
    1990-12-04

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