Aurovela 1.5/30: Uses, Side Effects and Dosage

INSTRUCTIONS TO PATIENT

Blister Pack

The Aurovela 1.5/30 blister pack has been designed to make oral contraceptive dosing as easy and as convenient as possible. The tablets are arranged in three rows of seven tablets each with the days of the week appearing above the first row of tablets.

Each white to off-white tablet contains 1.5 mg norethindrone acetate and 30 mcg ethinyl estradiol.

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. 1. BE SURE TO READ THESE DIRECTIONS:

Before you start taking your pills.

Anytime you are not sure what to do.

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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. 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. 2. LOOK AT YOUR PILL PACK TO SEE IF IT HAS 21 PILLS:

The 21-Day pill pack has 21 “active” white to off-white pills (with hormones) to take for 3 weeks, followed by 1 week without pills.

1. 3. ALSO FIND:
2. 1) where on the pack to start taking pills,
3. 2) in what order to take the pills (follow the arrows), and
4. 3) the week numbers as shown in the following pictures:

Aurovela 1.5/30 will contain: ALL WHITE TO OFF-WHITE

1. 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. 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. 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. 3. Take the first “active” white to off-white pill of the first pack during the first 24 hours of your period.
4. 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. 1. Take the first “active” white to off-white 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. 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:

Wait 7 days to start the next pack. You will probably have your period during that week.

Be sure that no more than 7 days pass between 21-day packs.

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WHAT TO DO IF YOU MISS PILLS

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If you MISS 1 white to off-white “active” pill:

1. 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. 2. You do not need to use a back-up birth control method if you have sex.

If you MISS 2 white to off-white “active” pills in a row in WEEK 1 OR WEEK 2 of your pack:

1. 1. Take 2 pills on the day you remember and 2 pills the next day.
2. 2. Then take 1 pill a day until you finish the pack.
3. 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 white to off-white “active” pill every day for 7 days.

If you MISS 2 white to off-white “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.

1. 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.
2. 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 white to off-white “active” pill every day for 7 days.

If you MISS 3 OR MORE white to off-white “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.

1. 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.
2. 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 white to off-white “active” pill every day for 7 days.

Based on his or her assessment of your medical needs, your doctor or healthcare provider has prescribed this drug for you. Do not give this drug to anyone else.

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].