Consumer Information for: JENCYCLA
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
- prevention of pregnancy
What it does
JENCYCLA Tablets are progestin-only pills (POP) which contain
a low dosage of norethindrone without the addition of an estrogen
agent. It has been shown to be effective in preventing pregnancy
when taken as prescribed by your doctor. Pregnancy is always
more risky than taking birth control pills, except in smokers older
than age 35.
Progestin-only birth control pills work in different ways including:
- They prevent ovulation (release of the egg from the ovary) in about half of the cycles.
- They change the mucus produced by the cervix. This slows the movement of the sperm through the mucus and through the uterus (womb).
- They also affect other hormones, the fallopian tubes and the lining of the uterus.
Effectiveness of birth control pills:
The progestin-only pill is slightly less effective than combination
birth control pills. The typical failure rate is estimated to be closer
to 5 percent, due to late or missed pills.
Combination birth control pills are more than 99 percent effective
in preventing pregnancy when:
- the pill is TAKEN AS DIRECTED, and
- the amount of estrogen is 20 micrograms or more.
A 99 percent effectiveness rate means that if 100 women used birth
control pills for one year, one woman in the group would get
pregnant.
The chance of becoming pregnant increases with incorrect use.
Other ways to prevent pregnancy:
Other methods of birth control are available to you. They are usually less effective than birth control pills. When used properly, however, other methods of birth control are effective enough for many women.The following table gives reported pregnancy rates for various forms of birth control, including no birth control. The reported rates represent the number of women out of 100 who would become pregnant in one year.
Reported pregnancies per 100 women per year:
| Combination pill | less than 1 to 2 |
| Intrauterine device (IUD) | less than 1 to 6 |
| Progestin-only pillH | 1 to 5 |
| Condom with spermicidal foam or gel | 1 to 6 |
| Condom | 2 to 12 |
| Diaphragm with spermicidal foam or gel | 3 to 18 |
| Spermicide | 3 to 21 |
| Sponge with spermicide | 3 to 28 |
| Cervical cap with spermicide | 5 to 18 |
| Periodic abstinence (rhythm), all types | 2 to 20 |
| No birth control | 60 to 85 |
HAbout 1 in 200 progestin-only pill users will get pregnant in the
first year if they all take progestin-only pills perfectly (that is, on
time, every day). About 1 in 20 “typical” progestin-only pill users
(including women who are late taking pills or miss pills) gets
pregnant in the first year of use.
Pregnancy rates vary widely because people differ in how
carefully and regularly they use each method. (This does not
apply to IUDs since they are implanted in the uterus.). Regular
users may achieve pregnancy rates in the lower ranges. Others
may expect pregnancy rates more in the middle ranges.
The effective use of birth control methods other than birth control
pills and IUDs requires more effort than taking a single pill every
day. It is an effort that many couples undertake successfully.
When it should not be used
The progestin-only pill is not suitable for every woman. In a small
number of women, serious side effects may occur. Your doctor
can advise you if you have any conditions that would pose a risk
to you. The use of the birth control pill should always be
supervised by your doctor.
You should not use JENCYCLA if you have or have had any of
the following conditions:
- unusual vaginal bleeding that has not yet been diagnosed;
- smoker and over age 35;
- known or suspected cancer of the breast;
- liver tumours either benign or cancerous;
- acute liver disease;
- if you are taking certain drugs for epilepsy (seizures) or for tuberculosis (see INTERACTIONS WITH THIS MEDICATION);
- you are pregnant or if pregnancy is suspected; and/or
- allergic reaction to norethindrone or to any of the other ingredients in JENCYCLA (see What the nonmedicinal ingredients are).
What the medicinal ingredient is
Norethindrone
What the non-medicinal ingredients are
D&C Yellow No.10 Aluminium Lake, FD&C Blue No.1 Aluminium Lake, lactose anhydrous, magnesium stearate, povidone K30 and sodium starch glycolate.
What dosage form it comes in
JENCYCLA (norethindrone) Tablets are available in a 28-day
regimen.
28-day Package contains: 28 GREEN tablets each containing 0.35
mg norethindrone.
Warnings and precautions
Serious Warnings and Precautions
Cigarette smoking increases the risk of serious adverse
effects on the heart and blood vessels. This risk increases
with age and becomes significant in hormonal contraceptive
users older than 35 years of age. Women should not smoke.
Birth control pills DO NOT PROTECT against sexually
transmitted infections (STIs), including HIV/AIDS.
For protection against STIs, it is advisable to use latex or
polyurethane condoms IN COMBINATION WITH the birth
control pills.
There are also conditions that your doctor will want to watch
closely or that might cause your doctor to recommend a method of
contraception other than birth control pills.
BEFORE you use JENCYCVLA talk to your doctor or
pharmacist if the following apply to you:
- breast disease (e.g., breast lumps) or a family history of breast cancer
- diabetes
- cigarette smoking
- migraine headaches
- depression
- fibroid tumours of the uterus
- pregnant or breast-feeding
- plan for forthcoming surgery.
You should also inform your doctor about a family history of
blood clots, heart attacks or strokes.
If you see a different doctor, inform him or her that you are using
JENCYCLA.
Tell your doctor if you are scheduled for any laboratory tests since
certain blood tests may be affected by hormonal contraceptives.
Also tell your doctor if you are scheduled for MAJOR surgery.
You should consult your doctor about stopping the use of
JENCYCLA four weeks before surgery and not using JENCYCLA
for a time period after surgery or during bed rest.
JENCYCLA should be used only under the supervision of a
doctor, with regular follow-up to identify side effects associated
with its use. Your visits may include a blood pressure check, a
breast exam, an abdominal exam and a pelvic exam, including a
Pap smear. Visit your doctor three months or sooner after the
initial examination. Afterward, visit your doctor at least once a
year.
If you don’t have your period for 6 months or more after
stopping JENCYCLA, contact your doctor.
Use JENCYCLA only on the advice of your doctor and carefully
follow all directions given to you. You must use the birth control
pill exactly as prescribed. Otherwise, you may become pregnant.
If you and your doctor decide that, for you, the benefits of
JENCYCLA outweigh the risks, you should be aware of the
following risks:
THE RISKS OF USING JENCYCLA
1. Ectopic Pregnancy
An ectopic pregnancy is a pregnancy outside the womb. Because
progestin-only pills protect against pregnancy, the chance of
having a pregnancy outside the womb is very low. If you do get
pregnant while taking progestin-only pills, you have a slightly
higher chance that the pregnancy will be ectopic than do users of
some other birth control methods.
2. Ovarian Cysts
These cysts are small sacs of fluid in the ovary. They are more
common among progestin-only pill users than among users of
most other birth control methods. They usually disappear without
treatment and rarely cause problems.
3. Breast Cancer
Some studies in women who use combined oral contraceptives
that contain both estrogen and 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 data to
determine that the use of progestin-only pills may also increase
this risk.
In progestin-only pill (POP) users, the older the age at stopping,
the more breast cancers are diagnosed.
The most significant risk factors for breast cancer are increasing
age and a strong history of breast cancer in the family (mother or
sister). Other established risk factors include obesity, never
having children, and having your first full-term pregnancy at a
late age.
Some women who use birth control pills may be at increased risk
of developing breast cancer before menopause which occurs
around age 50. These women may be long-term users of birth
control pills (more than eight years) or women who start using
birth control pills at an early age. In a few women, the use of birth
control pills may accelerate the growth of an existing but
undiagnosed breast cancer. Early diagnosis, however, can reduce
the effect of breast cancer on a woman's life expectancy. The
potential risks related to birth control pills seem to be small;
however, a yearly breast examination by a doctor is recommended
for all women.
ASK YOUR DOCTOR FOR ADVICE AND INSTRUCTIONS ON REGULAR SELF-EXAMINATION OF YOUR BREASTS.
4. Cervical CancerSome 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 progestin-only pills increases the risk of developing cancer of the cervix.
5. Liver Tumours
In rare cases, combined oral contraceptives can cause benign liver tumours. These benign liver tumours can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with combined oral contraceptives and liver cancers in studies in which a few women who developed these very rare cancers were found to have used combined oral contraceptives for long periods of time. There is insufficient data to determine whether progestin-only pills increase the risk of liver tumours.
6. Diabetic Women
Diabetic women taking progestin-only pills generally require changes in the amount of insulin they are taking. However, your physician may monitor you more closely under these conditions.
7. Use During Pregnancy
Birth control pills should never be taken if you think you are pregnant. They will not prevent the pregnancy from continuing. There is no evidence, however, that the progestin-only pill can damage a developing child. You should check with your doctor about risks to your unborn child from any medication taken during pregnancy.
8. Use After Pregnancy, Miscarriage or An Abortion
Your doctor will advise you of the appropriate time to start the use of JENCYCLA after childbirth, miscarriage, or therapeutic abortion.
9. Pregnancy After Stopping JENCYCLA
You will have a menstrual period when you stop taking JENCYCLA. You should delay pregnancy until another menstrual period occurs within four to six weeks. Contact your doctor for recommendations on alternative methods of contraception during this time.
10. Use While Breast-feeding
In most women, progestin-only contraceptives, such as JENCYCLA, do not affect the quantity and quality of breast milk or length of lactation. However, isolated postmarketing cases of decreased milk production have been reported. Studies with various orally administered progestin-only contraceptives have shown that small amounts of progestins pass into the breast milk of nursing mothers resulting in detectable steroid levels in infant plasma.
No adverse effects have been found on the health, growth or development of the infant.
Interactions with this medication
Certain drugs may interact with birth control pills to make them
less effective in preventing pregnancy or cause an increase in
breakthrough bleeding. You may also need to use a nonhormonal
method of contraception during any cycle in which you take drugs
that can make oral contraceptives less effective.
Drugs that may interact with JENCYCLA include:
- drugs used for the treatment of epilepsy (e.g., primidone, phenytoin, carbamazepine, rufinamide);
- drugs used for the treatment of tuberculosis (e.g., rifampin, rifabutin);
- drugs used for HIV/AIDS (e.g., nelfinavir, ritonavirboosted protease inhibitors, darunavir, (fos)amprenavir, lopinavir, nevirapine);
- (fos)aprepitant (drug used for nausea);
- bosentan (drug used for pulmonary hypertension);
- antifungals (griseofulvin);
- the herbal remedy St. John’s wort (primarily used for the treatment of depressive moods); and
- sedatives and hypnotics (e.g., benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate).
The pill may also interfere with the working of other drugs.
Please inform your doctor and pharmacist if you are taking or
have recently taken any other drugs or herbal products, even those
without a prescription. Also tell any other doctor or dentist who
prescribes another drug (or the dispensing pharmacist) that you
use JENCYCLA. They can tell you if you need to use an
additional method of contraception and if so, for how long.
This is not a complete list of possible drug interactions with
JENCYCLA . Talk to your doctor for more information about
drug interactions.
Proper use of this medication
HOW TO TAKE JENCYCLA (PROGESTIN-ONLY PILLS):
1. READ THESE DIRECTIONS
- before you start taking your pills, and
- any time you are not sure what to do.
2. LOOK AT YOUR PILL PACK
28-PILL PACK: 28 active pills (with a hormone) taken
daily for 28 days.
ALSO CHECK: the pill pack for instructions on 1) where to start
and 2) direction to take pills.
28-Day Package
3. You may wish to use a second method of birth control
(e.g., latex or polyurethane condoms and spermicidal
foam or gel) for the first seven days of the first cycle of
pill use. This will provide a backup in case pills are
forgotten while you are getting used to taking them.
4. When receiving any medical treatment, be sure to tell
your doctor that you are using birth control pills.
5. MANY WOMEN HAVE SPOTTING OR LIGHT
BLEEDING, OR MAY FEEL SICK TO THEIR
STOMACH DURING THE FIRST THREE
MONTHS ON THE PILL. If you do feel sick, do not
stop taking the pill. The problem will usually go away. If
it does not go away, check with your doctor or clinic. The
most common side effect of progestin-only pills is a
change in menstrual bleeding. Your period may be either
late or early and you may have some spotting.
6. MISSING PILLS ALSO CAN CAUSE SOME
SPOTTING OR LIGHT BLEEDING, even if you
make up the missed pills. You also could feel a little sick
to your stomach on the days you take two pills to make up
for missed pills.
7. IF YOU MISS PILLS AT ANY TIME, YOU COULD
GET PREGNANT. THE GREATEST RISKS FOR
PREGNANCY ARE:
- when you start a pack late, or
- if you are more than 3 hours late or you miss one or more progestin-only pills.
8. ALWAYS BE SURE YOU HAVE READY:
- ANOTHER KIND OF BIRTH CONTROL (such as latex or polyurethane condoms and spermicidal foam or gel) to use as a backup in case you miss pills, and
- AN EXTRA, FULL PACK OF PILLS.
9. IF YOU EXPERIENCE VOMITING OR
DIARRHEA, OR IF YOU TAKE CERTAIN
MEDICINES, your pills may not work as well. Use a
backup method, such as latex or polyurethane condoms
and spermicidal foam or gel, until you can check with
your doctor or clinic.
10. IF YOU FORGET MORE THAN ONE PILL TWO
MONTHS IN A ROW, talk to your doctor or clinic
about how to make pill-taking easier or about using
another method of birth control.
11. THERE IS NO NEED TO STOP TAKING BIRTH
CONTROL PILLS FOR A REST PERIOD.
12. IF YOUR QUESTIONS ARE NOT ANSWERED
HERE, CALL YOUR DOCTOR OR CLINIC.
WHEN TO START THE FIRST PACK OF PILLS
BE SURE TO READ THESE INSTRUCTIONS:
- before you start taking your pills, and
- any time you are not sure what to do.
STARTING PROGESTIN-ONLY PILLS
1. THE FIRST DAY OF YOUR MENSTRUAL
PERIOD (BLEEDING) IS DAY 1 OF YOUR
CYCLE. With JENCYCLA Tablets, it is best to start
your first package of progestin-only pills on the first day
of your menstrual period (Day 1)H. Then you simply
continue taking one tablet every single day until your
package is empty. Without missing a day, start taking
JENCYCLA Tablets from your new package.
2. If you have had a miscarriage or an abortion, you can
start progestin-only pills the next day.
3. Take one pill at the same time every day for 28 days.
Begin a new pack the next day, NOT MISSING ANY
DAYS ON THE PILLS. Your period should occur
during the last seven days of using that pill pack.
JENCYCLA Tablets are taken every day, even when you
are having some menstrual bleeding.
INSTRUCTIONS FOR USING YOUR PACKAGE. FOLLOW
THESE INSTRUCTIONS CAREFULLY:
1. For Day 1 start: Label the package by selecting the day label
that starts with Day 1 of your menstrual period (the first day of
menstruation is Day 1). For example, if your first day of
menstruation is Tuesday, attach the day label that begins with TUE
in the space provided.
OR
For Sunday start: No day label is required. The Package is
printed for a Sunday start. (The first Sunday after your period
begins, or, if your period starts on Sunday, start that same day.)
2. Place the day label on the dispenser over the printed days of the
week. Having the Package labelled with the days of the week will
help remind you to take your pill every day.
3. To begin taking your pills, start with the pill inside the red circle
(where you see the word START). This pill should correspond to
the day of the week that you are taking your first pill. To remove
the pill, push through the back of the Package.
4. On the following day, take the next pill in the same row, always
proceeding from left to right (→). Each row will always begin on
the same day of the week.
IF YOU ARE BREAST-FEEDING
IF YOU ARE BREAST-FEEDING
- If you are fully breast-feeding (not giving your baby any food or formula), you may start taking your pills 6 weeks after delivery.
- If you are partially breast-feeding (giving your baby some food or formula), you should start taking your pills 3 weeks after delivery.
IF YOU ARE SWITCHING PILLS
- If you are switching from the combined pills to progestinonly pills, and you were on a 21-Day regimen, take the first progestin-only pill the day after you finish the last active combined pill. If you have been on a 28- Day regimen, 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 progestin-only pills, but this is normal and to be expected.
- If you are switching from progestin-only pills to the combined pills, take the first active combined pill on the first day of your period, even if your progestin-only pill pack is not finished.
- If you are breast-feeding, 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.
WHAT TO DO DURING THE MONTH
1. TAKE A PILL AT THE SAME TIME EVERY
DAY UNTIL THE PACK IS EMPTY. Progestin-only pills must
be taken at the same time every day since its action is time
dependent. Every time you take a pill late, and especially if you
miss a pill, you are more likely to get pregnant.
- Try to associate taking your pill with some regular activity such as eating a meal or going to bed.
- Do not skip pills even if you have 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 OF 28 PILLS
- Start the next pack ON THE NEXT DAY. Take one pill every day. Do not wait any days between packs.
Overdose
Symptoms of overdose may include nausea, vomiting or vaginal bleeding. Available information from cases of accidental ingestion of oral contraceptives by children indicates no serious effects.
WHAT TO DO IF YOU MISS PILLS
IF YOU ARE MORE THAN 3 HOURS LATE OR MISS TAKING YOUR PROGESTIN-ONLY PILLS
- Take a missed pill as soon as you remember you missed it.
- Then go back to taking progestin-only pills at your regular time.
- 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 progestin-only pills and use a backup method until
you can talk to your doctor or clinic.
Always be sure you have on hand:
- a backup method of birth control (such as latex or polyurethane condoms and spermicidal foam or gel) in case you miss pills, and
- an extra, full pack of pills.
IF YOU FORGET MORE THAN ONE PILL TWO MONTHS IN A ROW, TALK TO YOUR DOCTOR OR CLINIC about ways to make pill-taking easier or about using another method of birth control.
Side effects and what to do about them
Some users of birth control pills have side effects. The most
common side effect of progestin-only pills is a change in
menstrual bleeding. Your periods may be either early or late. You
may have some spotting between periods or you may not have a
period. Taking pills late or missing pills can result in some
spotting or bleeding.
Less common side effects of progestin-only pills include
headaches, tender breasts, nausea, vomiting, tiredness, weight
gain, dizziness, acne, extra hair on your face or body, loss of hair,
rash, abdominal pain, yellowing of the skin or eyes (jaundice), and
tubal pregnancy.
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
|---|---|---|---|
| Common | |||
| Abnormal vaginal bleeding | ✔ | ||
| Uncommon | |||
| Sudden or severe pain in lower abdomen | ✔ | ||
| Allergic reaction | ✔ | ||
How to store
Store in original packaging, between 15°C - 30°C. Keep out of the reach of children.
Reporting side effects
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugshealth-products/medeffect-canada/adverse-reactionreporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for
health professionals can be found by contacting the manufacturer,
Lupin Pharma Canada Limited at 1-844-587-4623.
This leaflet was prepared by Lupin Pharma Canada Limited.
Manufactured by :
Lupin Pharma Canada Limited,
1001 De Maisonneuve Est, Suite 304
Montréal, Québec
H2L 4P9
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