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Afirmelle: Uses, Side Effects and Dosage

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Facts
Status:
Prescription (Rx) Boxed warning
Strength:
0.1 mg, 0.02 mg
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Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Afirmelle

HOW TO TAKE AFIRMELLE

IMPORTANT POINTS TO REMEMBER

BEFORE YOU START TAKING AFIRMELLE:

  1. 1. BE SURE TO READ THESE DIRECTIONS:

Before you start taking Afirmelle.

And

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. See “WHAT TO DO IF YOU MISS PILLS” below.

  1. 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 feel sick to your stomach, do not stop taking Afirmelle. The problem will usually go away. If it doesn’t go away, check with your health-care provider.

  1. 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.

  1. 5. IF YOU HAVE VOMITING (within 4 hours after you take your pill), you should follow the instructions for WHAT TO DO IF YOU MISS PILLS. IF YOU HAVE DIARRHEA or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well.

Use a back-up nonhormonal method (such as condoms or spermicide) until you check with your health-care provider.

  1. 6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your health-care provider about how to make pill-taking easier or about using another method of birth control.
  2. 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your health-care provider.

BEFORE YOU START TAKING AFIRMELLE

  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.

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

  1. 3. FIND:
  2. 1. where on the pack to start taking pills, and
  3. 2. in what order to take the pills (follow the arrow).
  1. 4. BE SURE YOU HAVE READY AT ALL TIMES:

ANOTHER KIND OF BIRTH CONTROL (such as condoms or spermicide) to use as a back-up in case you miss pills.

AN EXTRA, FULL PILL PACK.

WHEN TO START THE FIRST PACK OF PILLS

You have a choice of which day to start taking your first pack of pills.

Decide with your health-care provider 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 strip that starts with the first day of your period. Place this day label strip over the area that has the days of the week (starting with Sunday) pre-printed on the tablet blister pack.

Note: if the first day of your period is a Sunday, you can skip step#1.

  1. 2. Take the first “active” white pill of the first pack during the first 24 hours of your period.
  2. 3. You will not need to use a back-up nonhormonal 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 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 a nonhormonal method of birth control (such as condoms or spermicide) as a backup method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days).

WHAT TO DO DURING THE MONTH

  1. 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.

  1. 2. When you finish a pack:

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

IF YOU SWITCH FROM ANOTHER BRAND OF COMBINATION PILLS

If your previous brand had 21 pills: Wait 7 days to start taking Afirmelle. You will probably have your period during that week. Be sure that no more than 7 days pass between the 21-day pack and taking the first white Afirmelle pill (“active” with hormone).

If your previous brand had 28 pills: Start taking the first white Afirmelle pill (“active” with hormone) on the day after your last reminder pill. Do not wait any days between packs.

WHAT TO DO IF YOU MISS PILLS

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

If you MISS 1 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 COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 2 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 BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 2 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 health-care provider because you might be pregnant.

  1. 3. You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills. You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you MISS 3 OR MORE 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 health-care provider because you might be pregnant.

  1. 3. You COULD BECOME PREGNANT if you have sex in the 7 days after you restart your pills.

You MUST use a nonhormonal birth-control method (such as condoms or spermicide) as a back-up for those 7 days.

If you forget any of the 7 green “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 nonhormonal birth-control 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 NONHORMONAL BIRTH-CONTROL METHOD anytime you have sex.

KEEP TAKING ONE PILL EACH DAY until you can reach your health-care provider.

BIRTH CONTROL AFTER STOPPING THE PILL

If you do not wish to become pregnant after stopping the pill, speak to your health-care provider about another method of birth control.

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 206886 · View the label on DailyMed

Revision date stated in the text: December 2021

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Drug information for Afirmelle

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Boxed warning Yes – this drug has a boxed warning (also called a black box warning), the strongest warning of the FDA.
Drug class Estrogen, Progestin, Progestin-containing Intrauterine System
Active ingredients Levonorgestrel 0.1 mg, Ethinyl estradiol 0.02 mg
Dosage form Kit
Marketing status listed in the FDA NDC Directory
Company (applicant) AUROBINDO PHARMA
FDA approval ANDA 206886Abbreviated New Drug Application (ANDA) – generic drug Approved November 14, 2016
Therapeutic equivalence (TE) code AB1Codes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Generics Altavera, Ashlyna, Aubra EQ, Aviane, Ayuna, Balcoltra, Chateal EQ, Daysee, Enpresse, Falmina, Iclevia, Introvale with the same TE code
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.1 mg, 0.02 mg – 1 in 1 blister pack / 1 in 1 pouch / 3 in 1 carton NDC 65862-849-28
0.1 mg, 0.02 mg – 1 in 1 blister pack / 1 in 1 pouch / 6 in 1 carton NDC 65862-849-92

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.