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

RISKS OF TAKING POPs

Cigarette smoking greatly increases the possibility of suffering heart attacks and strokes. Women who use oral contraceptives are strongly advised not to smoke.

WARNING:

If you have sudden or severe pain in your lower abdomen or stomach area, you may have an ectopic pregnancy or an ovarian cyst. If this happens, you should contact your healthcare professional immediately.

Ectopic Pregnancy

An ectopic pregnancy is a pregnancy outside the womb. Because POPs protect against pregnancy, the chance of having a pregnancy outside the womb is very low. If you do get pregnant while taking POPs, you have a slightly higher chance that the pregnancy will be ectopic than do users of some other birth control methods.

Ovarian Cysts

These cysts are small sacs of fluid in the ovary. They are more common among POP users than among users of most other birth control methods. They usually disappear without treatment and rarely cause problems.

Cancer of the Reproductive Organs and Breasts

Some studies in women who use combined oral contraceptives that contain both estrogen and a progestin have reported an increase in the risk of developing breast cancer, particularly at a younger age and apparently related to duration of use. There is insufficient data to determine whether the use of POPs similarly increases this risk.

A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. This increase in the frequency of breast cancer diagnosis, within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use.

Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives and there is insufficient data to determine whether the use of POPs increases the risk of developing cancer of the cervix.

Liver Tumors

In rare cases, combined oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer among women who use combined oral contraceptives. However, liver cancers are rare. There is insufficient data to determine whether POPs increase the risk of liver tumors.

Diabetic Women

Diabetic women taking POPs do not generally require changes in the amount of insulin they are taking. However, your healthcare professional may monitor you more closely under these conditions.

SEXUALLY TRANSMITTED DISEASES (STDs)

WARNING: POPs do not protect against getting or giving someone HIV (AIDS) or any other STD, such as chlamydia, gonorrhea, genital warts or herpes.

SIDE EFFECTS

Irregular Bleeding:

The most common side effect of POPs is a change in menstrual bleeding. Your periods may be either early or late, and you may have some spotting between periods. Taking pills late or missing pills can result in some spotting or bleeding.

Other Side Effects:

Less common side effects include headaches, tender breasts, nausea and dizziness. Weight gain, acne and extra hair on your face and body have been reported, but are rare.

If you are concerned about any of these side effects, check with your healthcare professional.

USING POPs WITH OTHER MEDICINES

Before taking a POP, inform your healthcare professional of any other medication, including over-the-counter medicine, that you may be taking.

These medicines can make POPs less effective:

Medicines for seizures such as:

Phenytoin (Dilantin^®)
Carbamazepine (Tegretol)
Phenobarbital

Medicine for TB:

Rifampin (Rifampicin)

Before you begin taking any new medicines be sure your healthcare professional knows you are taking a progestin-only birth control pill.

HOW TO TAKE POPs

IMPORTANT POINTS TO REMEMBER

POPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.
Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready.
You may have some menstrual spotting between periods. Do not stop taking your pills if this happens.
If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours.
If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don't wish to become pregnant, be certain to use another birth control method.
If you are not sure about how to take POPs, ask your healthcare professional.

STARTING POPs

It's best to take your first POP on the first day of your menstrual period.
If you decide to take your first POP on another day, use a backup method (such as a condom and/or a spermicide) every time you have sex during the next 48 hours.
If you have had a miscarriage or an abortion, you can start POPs the next day.

IF YOU ARE LATE OR MISS TAKING YOUR POPs

If you are more than 3 hours late or you miss one or more POPs: 1)TAKE a missed pill as soon as you remember that you missed it,2)THEN go back to taking POPs at your regular time,3)BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.

IF YOU ARE BREASTFEEDING

If you are fully breastfeeding (not giving your baby any food or formula), you may start your pills 6 weeks after delivery.
If you are partially breastfeeding (giving your baby some food or formula), you should start taking pills by 3 weeks after delivery.

IF YOU ARE SWITCHING PILLS

If you are switching from the combined pills to POPs, take the first POP the day after you finish the last active combined pill. Do not take any of the 7 inactive pills from the combined pill pack. You should know that many women have irregular periods after switching to POPs, but this is normal and to be expected.
If you are switching from POPs to the combined pills, take the first active combined pill on the first day of your period, even if your POPs pack is not finished.
If you switch to another brand of POPs, start the new brand anytime.
If you are breastfeeding, you can switch to another method of birth control at any time, except do not switch to the combined pills until you stop breastfeeding or at least until 6 months after delivery.

PREGNANCY WHILE ON THE PILL

If you think you are pregnant, contact your healthcare professional. Even though research has shown that POPs do not cause harm to the unborn baby, it is always best not to take any drugs or medicines that you don't need when you are pregnant.

You should get a pregnancy test:

If your period is late and you took one or more pills late or missed taking them and had sex without a backup method.
Anytime it has been more than 45 days since the beginning of your last period.

WILL POPs AFFECT YOUR ABILITY TO GET PREGNANT LATER?

If you want to become pregnant, simply stop taking POPs. POPs will not delay your ability to get pregnant.

BREASTFEEDING

If you are breastfeeding, POPs will not affect the quality or amount of your breastmilk or the health of your nursing baby. However, isolated cases of decreased milk production have been reported.

OVERDOSE

No serious problems have been reported when many pills were taken by accident, even by a small child, so there is usually no reason to treat an overdose.

HOW TO STORE YOUR POPs

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).

Rx only

Keep out of reach of children.

ORTHO-McNEIL

PHARMACEUTICAL, INC.

Raritan, New Jersey 08869

©OMP 1998

PRINTED IN U.S.A.

ISSUED June, 2008

635-50-894

If you are late or you miss taking your POPs:

If you are more than 3 hours late or you miss one or more POPs: 1)TAKE a missed pill as soon as you remember that you missed it,2)THEN go back to taking POPs at your regular time,3)BUT be sure to use a backup method (such as a condom and/or a spermicide) every time you have sex for the next 48 hours.
If you are not sure what to do about the pills you have missed, keep taking POPs and use a backup method until you can talk to your healthcare professional.

Important points to remember:

POPs must be taken at the same time every day, so choose a time and then take the pill at that same time every day. Every time you take a pill late, and especially if you miss a pill, you are more likely to get pregnant.
Start the next pack the day after the last pack is finished. There is no break between packs. Always have your next pack of pills ready.
You may have some menstrual spotting between periods. Do not stop taking your pills if this happens.
If you vomit soon after taking a pill, use a backup method (such as a condom and/or a spermicide) for 48 hours.
If you want to stop taking POPs, you can do so at any time, but, if you remain sexually active and don't wish to become pregnant, be certain to use another birth control method.
If you are not sure about how to take POPs, ask your healthcare professional.

INSTRUCTIONS FOR USE

VERIDATE^®Tablet Dispenser-28's

1. Place the refill in the VERIDATE so that the V notch in the refill is at the top of the dispenser (see drawing). Press the refill down so that it fits firmly under all nibs.

2. The first time you use these pills, take your first pill on the first day of your menstrual period.
3. Choose a pill that corresponds with the day of the week on which you are taking the first pill.
4. Continue taking one pill daily, clockwise, until no pills remain in the outer circle. It is important that you take your pills at the same time every day.
5. The next day, take a pill from the inner circle that corresponds with the day of the week it happens to be. Take a pill each day until all seven are taken.
6. After you have taken all 28 pills, insert a new refill in the veridate and begin taking your pills again the next day. Be sure the calendar day on the package corresponds with the actual day.

ORTHO-MCNEIL PHARMACEUTICAL, INC.