Tarina Fe 1/20 EQ (Page 7 of 8)

GENERAL PRECAUTIONS

1. Missed Periods and Use of Oral Contraceptives Before or During Early Pregnancy


There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your healthcare provider before doing so. If you have not taken the pills daily as instructed and missed a menstrual period, or if you missed two consecutive menstrual periods, you may be pregnant. Check with your healthcare provider immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of contraception. There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these studies have not been confirmed. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor. You should check with your doctor about risks to your unborn child of any medication taken during pregnancy.


2. While Breastfeeding


If you are breastfeeding, consult your doctor before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, oral contraceptives may decrease the amount and quality of your milk. If possible, do not use oral contraceptives while breastfeeding. You should use another method of contraception since breastfeeding provides only partial protection from becoming pregnant, and this partial protection decreases significantly as you breastfeed for longer periods of time. You should consider starting oral contraceptives only after you have weaned your child completely.


3. Laboratory Tests


If you are scheduled for any laboratory tests, tell your doctor you are taking birth control pills. Certain blood tests may be affected by birth control pills.


4. Drug Interactions


Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin; drugs used for epilepsy such as barbiturates (for example, phenobarbital), carbamazepine, and phenytoin (Dilantin® is one brand of this drug); troglitazone; phenylbutazone; and possibly certain antibiotics. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective.
Birth control pills interact with certain drugs. These drugs include acetaminophen, clofibric acid, cyclosporine, morphine, prednisolone, salicylic acid, temazepam, and theophylline. You should tell your doctor if you are taking any of these medications.


5. This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as Chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis.


INSTRUCTIONS TO PATIENT


Blister Pack


The Tarina Fe 1/20 EQ blister pack has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in four rows of seven tablets each, with the days of the week appearing above the first row of tablets.


Each light yellow to yellow tablet contains 1 mg norethindrone acetate and 20 mcg ethinyl estradiol.


Each brown tablet contains 75 mg ferrous fumarate and is intended to help you remember to take the tablets correctly. These brown tablets are not intended to have any health benefit.

DIRECTIONS


To remove a tablet, press down on it with your thumb or finger. The tablet will drop through the back of the blister pack. Do not press with your thumbnail, fingernail, or any other sharp object.


HOW TO TAKE THE PILL

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IMPORTANT POINTS TO REMEMBER

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BEFORE YOU START TAKING YOUR PILLS:

1. BE SURE TO READ THESE DIRECTIONS:
Before you start taking your pills.
Anytime you are not sure what to do.
2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant.
3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1 TO 3 PACKS OF PILLS. If you do have spotting or light bleeding or feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn’t go away, check with your doctor or clinic.
4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach.
5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason, or IF YOU TAKE SOME MEDICINES, including some antibiotics, your birth control pills may not work as well. Use a back-up birth control method (such as condoms or foam) until you check with your doctor or clinic.
6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control.
7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or clinic.
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BEFORE YOU START TAKING YOUR PILLS

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1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day.
2. LOOK AT YOUR PILL PACK TO SEE IF IT HAS 28 PILLS:
The 28-Day pill pack has 21 “active” light yellow to yellow pills (with hormones) to take for 3 weeks, followed by 1 week of reminder brown pills (without hormones).
3. ALSO FIND:

1) where on the pack to start taking pills,
2) in what order to take the pills (follow the arrows), and
3) the week numbers as shown in the following picture:
Tarina Fe 1/20 EQ — contains 21 LIGHT YELLOW TO YELLOW PILLS for WEEKS 1, 2 and 3. WEEK 4 will contain 7 BROWN PILLS ONLY.

figure-3
(click image for full-size original)

4. BE SURE YOU HAVE READY AT ALL TIMES:
ANOTHER KIND OF BIRTH CONTROL (such as condoms or foam) to use as a back-up in case you miss pills.
AN EXTRA, FULL PILL PACK.
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WHEN TO START THE FIRST PACK OF PILLS

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You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember.

DAY-1 START

1. Pick the day label sticker that starts with the first day of your period. (This is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins.)
2. Place this day label sticker on the blister pack over the area that has the days of the week (starting with Sunday) printed on the blister pack.
3. Take the first “active” light yellow to yellow pill of the first pack during the first 24 hours of your period.
4. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period.

SUNDAY START

1. Take the first “active” light yellow to yellow 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 or foam are good back-up methods of birth control.
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WHAT TO DO DURING THE MONTH

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

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WHAT TO DO IF YOU MISS PILLS

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If you MISS 1 light yellow to yellow “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 yellow to yellow “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 COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a light yellow to yellow “active” pill every day for 7 days.
If you MISS 2 light yellow to yellow “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 COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a light yellow to yellow “active” pill every day for 7 days.
If you MISS 3 OR MORE light yellow to yellow “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 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 COULD GET PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms or foam) as a back-up method of birth control until you have taken a light yellow to yellow “active” pill every day for 7 days.

A REMINDER IF YOU FORGET ANY OF THE 7 BROWN “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 LIGHT YELLOW TO YELLOW “ACTIVE” 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 1% (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are about 3%. 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 healthcare provider or pharmacist.


OTHER INFORMATION


Your healthcare provider will take a medical and family history and examine you before prescribing oral contraceptives. The physical examination may be delayed to another time if you request it and your healthcare 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 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
  • 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 “Physician Insert,” which you may wish to read.


Remembering to take tablets according to schedule is stressed because of its importance in providing you the greatest degree of protection.


MISSED MENSTRUAL PERIODS FOR DOSAGE REGIMEN


At times there may be no menstrual period after a cycle of pills. Therefore, if you miss one menstrual period but 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 miss a menstrual period, you may be pregnant and should stop taking oral contraceptives until your doctor or healthcare provider determines whether or not you are pregnant. Until you can get to your doctor or healthcare provider, use another form of contraception. If two consecutive menstrual periods are missed, you should stop taking pills until it is determined whether or not you are pregnant. Although there does not appear to be any increase in birth defects in newborn babies if you become pregnant while using oral contraceptives, you should discuss the situation with your doctor or healthcare provider.


Periodic Examination


Your doctor or healthcare provider will take a complete medical and family history before prescribing oral contraceptives. At that time and about once a year thereafter, he or she will generally examine your blood pressure, breasts, abdomen, and pelvic organs (including a Papanicolaou smear, i.e., test for cancer).


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


Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].


To report SUSPECTED ADVERSE REACTIONS, contact the Afaxys Health and Safety Team at 1-855-888-2467 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


The brands listed are trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

Manufactured For:

Afaxys Pharma, LLC

Charleston, SC, 29403, USA.

Manufactured by:

Aurobindo Pharma Limited

Unit-VII (SEZ)

Mahaboob Nagar (Dt)-509302, India

Issued: 05/2018

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