General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some
common questions about BREVINOR 21 and BREVINOR 28
Day tablets.
It does not contain all the
available information.
It does not take the
place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your
doctor has weighed the risks of you taking
BREVINOR against the benefits it is expected to
have for you.
Use BREVINOR as directed by
your doctor and follow advice given in this
leaflet.
If you have any concerns about
taking this medicine, ask your doctor or
pharmacist.
Keep this leaflet with the
medicine. You may need to read it again.
What BREVINOR is used for
BREVINOR is a
birth control pill commonly known as a "Combined
Oral Contraceptive" that contains both an
oestrogen (ethinyloestradiol) and progestogen
(norethisterone) hormone.
Oral
contraceptives belonging to this group produce
their birth control (or contraceptive) effect by
preventing ovulation ( the release of an egg from
the ovary) during each menstrual cycle. Combined
Oral Contraceptives also cause changes to the
mucus of the cervix and the lining of the womb
which contribute to the contraceptive action.
If taken according to directions the combined
oral contraceptives are very effective in
preventing pregnancy. The failure rate of this
type of contraceptive is such that for every 1,000
women using the pill for one year, two will become
pregnant.
BREVINOR (like all oral
contraceptives) is intended to prevent pregnancy.
It does not protect against HIV infection (AIDS)
and other sexually transmitted diseases.
BREVINOR 21 and 28 Day are only available on a
prescription from your doctor.
This
medicine is prescribed for you and should not be
given to others.
Before you start to take
BREVINOR
When you must not take it
BREVINOR tablets are not suitable for some
women.
If you have or have had any of these
problems, do not take BREVINOR until you have
talked to your doctor.
Do not take it if:
you have had a stroke or heart attack.
you
have or have had inflammation, infection or
clotting in any blood vessel(s), including a clot
in the lung.
you have or have had liver
disease (including tumours of any type), a history
of jaundice or cholestatic jaundice of pregnancy,
or severe generalised itch in the body during
pregnancy; Dubin-Johnson Syndrome or Rotor
Syndrome.
you have abnormal vaginal bleeding,
the cause of which is unknown.
you are
pregnant or suspect that you may be pregnant.
you have cancer or suspected cancer of the
breast or sex organs (e.g. cervix, vagina,
ovaries, endometrium, womb) and known or suspected
oestrogen-dependent tumours.
you have a family
history of breast nodules, fibrocystic disease or
have had an abnormal mammograph.
you have
sickle cell anaemia.
you have lipid metabolism
disorders such as congenital hyperlipidaemia.
you have diabetes with blood vessel damage.
you have a history of herpes of pregnancy.
you have otosclerosis (an ear disorder) which
worsened in past pregnancies.
you have an
allergy to ethinyloestradiol, norethisterone or
any of the ingredients listed at the end of this
leaflet.
Symptoms of an allergic reaction
may include:
asthma, wheezing or shortness of
breath
swelling of the face, lips or tongue
which may cause difficulty in swallowing or
breathing
hives, itching or skin rash
fainting
Tell your doctor about any
existing medical condition as this may be affected
by taking the birth control pill.
Do not
take BREVINOR if the packaging is torn or shows
signs of tampering.
Before you start to
take it
You must tell your doctor if:
you are a heavy smoker (15 or more cigarettes
per day), especially if you are aged over 35
years.
Oral contraceptives increase your
risk of having a stroke or heart attack. Smoking
while taking oral contraceptives further increases
this risk.
you have gallbladder disease.
you have kidney or heart disease.
you have
high blood pressure.
you have high
cholesterol.
you have diabetes.
you have
epilepsy.
you have asthma.
you have
migraine.
you have or have had depression.
you are breast feeding.
Small amounts
of oral contraceptives have been found in breast
milk.
you wear contact lenses.
you are
lactose intolerant. This medicine contains
lactose.
Taking other medicines
Tell
your doctor or pharmacist if you are taking any
other medicines, including any that you buy
without a prescription from your pharmacy,
supermarket or health food shop.
Some
medicines may interfere with the effectiveness of
BREVINOR. These include medicines such as:
Rifampicin for the treatment of tuberculosis.
Antibiotics such as ampicillin, oxacillin,
tetracyclines, sulfamethoxazole and trimethoprim.
Anti-fungal agents such as griseofulvin
Barbiturates
Medicines for epilepsy such
as carbamazepine and phenytoin.
Phenylbutazone, a medicine used to relieve
symptoms of inflammation, including arthritis.
St John's wort, an ingredient found in
medicines you can purchase without a prescription
from a pharmacy, supermarket or health food shop.
While you are taking these medicines, and
for seven days after stopping them, you should use
a non-hormonal method of contraception (such as
condoms or a diaphragm, but not the rhythm or
temperature methods). If the seven days extend
into the inactive orange tablet section (28 day
pack) or the 7 tablet-free days (21 day pack),
then you should start a new pack on the next day
after having taken the last blue active tablet
from the current pack.
This is particularly
important if you need to take antibiotics or
medicines for epilepsy.
How to take
BREVINOR
How to take it
Swallow one
BREVINOR tablet with a glass of water at the same
time each day, preferably at bedtime.
BREVINOR 21 Day
Starting a hormonal
contraceptive for the first time
To begin
BREVINOR 21 Day, take your first tablet on the
first day of your next period, that is, the day
your bleeding starts.
Take your first tablet
from the top row of the strip. Take the tablet
which corresponds to the appropriate day of the
week. For example, if your first day of bleeding
is on TUESDAY, take a blue tablet marked "TUE".
Continue to take one tablet every day,
following the arrows around the strip so that you
are taking the correct tablet for the day of the
week.
Once all 21 blue tablets have been
taken, leave 7 tablet-free days before starting
your new strip.
You can expect your period
during the tablet-free week. Your protection
continues during the week you are without tablets.
On the day after your last (seventh) tablet-
free day, begin the next strip with a blue tablet
from the top row that matches the day of the week.
Do this even if you are still bleeding.
You
should start your tablets the same day of the week
every four weeks.
Repeat this sequence of
tablet taking for as long as birth control is
required.
This product is effective from
the first day if taken as directed above.
Although spotting and break-through bleeding
may occur in some women, these tend to disappear
in the majority of patients after the first three
to four cycles.
Changing from a different
oral contraceptive
If you are switching to
BREVINOR 21 Day from another 21 or 28 Day oral
contraceptive, follow the instructions below
carefully.
If switching from a 21 day oral
contraceptive:
Stop taking your current oral
contraceptive after you have taken the last active
tablet.
Leave 7 tablet-free days.
Start
the new BREVINOR 21 Day pack on the eighth day by
taking a blue active tablet from the top row which
corresponds to the day of the week.
Continue
to take one tablet every day, following the arrows
around the strip so that you are taking the
correct tablet for the day of the week.
Once
all 21 blue tablets have been taken, leave 7
tablet-free days before starting your new strip.
You must use an additional non-hormonal
method of contraception (such as condoms or a
diaphragm, but not the rhythm or temperature
methods), until a blue tablet has been taken daily
for 7 days without a break.
If switching
from a 28 day oral contraceptive:
Stop taking
your current oral contraceptive after you have
taken the last inactive tablet in the strip.
Start the new BREVINOR 21 Day pack on the next
day by taking a blue active tablet from the top
row which corresponds to the day of the week.
Continue to take one tablet every day,
following the arrows around the strip so that you
are taking the correct tablet for the day of the
week.
Once all 21 blue tablets have been
taken, leave 7 tablet-free days before starting
your new strip.
You must use an additional
non-hormonal method of contraception (such as
condoms or a diaphragm, but not the rhythm or
temperature methods) until a blue tablet has been
taken daily for 7 days without a break.
If
you suffer from a stomach upset which results in
vomiting or diarrhoea, the effectiveness of
BREVINOR may be reduced.
During any period
of vomiting or diarrhoea, continue taking BREVINOR
tablets. Also use a non-hormonal method of
contraception (such as condoms or a diaphragm, but
not the rhythm or temperature methods), and
continue for seven days following the episode of
vomiting or diarrhoea. If these seven days extend
into the 7 tablet-free days, you should start a
new pack on the next day after having taken the
last blue tablet from the current pack.
You
may not have a period until you finish the second
pack.
BREVINOR 28 Day
Starting a
hormonal contraceptive for the first time
To
begin BREVINOR 28 Day, take your first tablet on
the first day of your next period, that is, the
day your bleeding starts.
Take your first
tablet from the top row of the green section of
the strip (ie the section which contains all the
blue tablets). Take the tablet which corresponds
to the appropriate day of the week. For example,
if your first day of bleeding is on TUESDAY, take
the blue tablet marked "TUE" from the top row of
the green section of the strip.
Continue to
take one tablet every day, following the arrows
around the strip, until you finish all 21 blue
tablets in the green section of the strip.
Then take one orange tablet daily for the next
7 days, following the arrows so that you are
taking the correct tablet for the day of the week.
Taking these orange tablets helps you to remember
to take a tablet every day.
You can expect
your period during the week that you are taking
these orange inactive tablets. Your protection
continues during this week.
On the day after
your last orange tablet, begin the next strip with
a blue tablet from the top row of the green
section that matches the day of the week. Do this
even if you are still bleeding.
You should
start your tablets the same day of the week every
4 weeks.
Repeat this sequence of tablet taking
for as long as birth control is required.
This product is effective from the first day
if taken as directed above.
Although
spotting and break-through bleeding may occur in
some women, these tend to disappear in the
majority of patients after the first three to four
cycles.
Make sure you always have a new
strip of tablets available, so that you can
continue to take the tablets without interruption.
Changing from a different oral
contraceptive
If you are switching to
BREVINOR 28 Day from another 21 or 28 Day oral
contraceptive, follow the instructions below
carefully.
If switching from a 21 day oral
contraceptive:
Stop taking your current oral
contraceptive after you have taken the last active
tablet.
Leave 7 tablet-free days.
Start
the new BREVINOR 28 Day pack on the eighth day by
taking a blue active tablet from the top row of
the green section which corresponds to the day of
the week.
Continue to take one tablet every
day, following the arrows around the strip until
you finish all 21 blue tablets in the green
section of the strip.
Then take one orange
tablet daily for the next 7 days, before starting
your new strip.
You must use an additional,
non-hormonal method of contraception (such as
condoms or a diaphragm, but not the rhythm or
temperature methods) until a blue tablet has been
taken daily for 7 days without a break.
If
switching from a 28 day oral contraceptive:
Stop taking your current oral contraceptive
after you have taken the last inactive tablet in
the strip.
Start the new BREVINOR 28 Day pack
on the next day by taking a blue active tablet
from the top row which corresponds to the day of
the week.
Continue to take one tablet every
day, following the arrows around the strip until
you finish all 21 blue tablets in the green
section of the strip.
Then take one orange
tablet daily for the next 7 days, before starting
your new strip.
You must use an additional,
non-hormonal method of contraception (such as
condoms or a diaphragm, but not the rhythm or
temperature methods) until a blue tablet has been
taken daily for 7 days without a break.
If
you suffer from a stomach upset which results in
vomiting or diarrhoea, the effectiveness of
BREVINOR may be reduced.
During any period
of vomiting or diarrhoea, continue taking BREVINOR
tablets. Also use a non-hormonal method of
contraception (such as condoms or a diaphragm, but
not the rhythm or temperature methods), and
continue for seven days following the episode of
vomiting or diarrhoea. If these seven days extend
into the inactive orange tablet section you should
start a new pack on the next day after having
taken the last active blue tablet from the green
section of the current pack (i.e. skip the orange
inactive tablets).
You may not have a
period until you finish the second pack.
When to take it
Take your tablet at
approximately the same time each day, preferably
at bedtime. Taking your tablet at the same time
each day will also help you remember when to take
the tablets.
If you forget to take a
tablet
If you forget to take BREVINOR it
may not work as well in protecting you from
becoming pregnant.
Do not try to make up
for missed doses by taking more than one tablet at
a time.
If you miss a blue active tablet:
If you are less than 12 hours late in
taking your tablet, you should take that tablet at
once and then take the next one at your usual
time.
If you are more than 12 hours late in
taking your tablet, do not take it. Take the next
day's tablet at the usual time and use an
additional, non-hormonal method of contraception
for the next seven days (such as condoms or a
diaphragm, but not the rhythm or temperature
methods).
If the seven days extend into the
inactive orange tablet section (if using a 28 day
pack) or the 7 tablet-free days (if using a 21 day
pack),then start a new pack on the day after
taking the last blue active tablet from the
current pack. Take your first tablet from the top
row of the new strip, then repeat the sequence of
tablet taking for as long as birth control is
required. This will mean that you will not have a
period until you finish the second pack.
If
you miss an orange inactive tablet (if using a 28
day pack), take it as soon as you remember and
continue on as before. Additional birth control
method is not necessary in this case.
If
your doctor told you to take BREVINOR differently,
or you are unclear about the above directions,
discuss this with him or her.
If you have
trouble remembering to take BREVINOR, ask your
pharmacist for some hints.
If you miss a
period
If you have missed a period you may
be pregnant.
Contact your doctor to check
if you are pregnant.
If you take too much
(overdose)
Immediately telephone your
doctor or pharmacist or the Poisons Information
Centre (telephone 13 11 26) for advice, or go to
Accident and Emergency at your nearest hospital if
you think you or anyone else may have taken too
much BREVINOR. Do this even if there are no signs
of discomfort or poisoning.
Serious ill
effects have not been reported in young children
who have taken large doses of birth control pills.
Overdosage may cause nausea. This may be
followed by vaginal bleeding in some women.
While you are taking BREVINOR
Things
you must do
Tell all doctors, dentists and
pharmacists who are treating you that you are
taking BREVINOR.
Tell the hospital doctor
that you are taking BREVINOR birth control pills
if you need to have an operation, or go to
hospital in an emergency.
If you are about
to be started on any new medicine, tell your
doctor or dentist and your pharmacist that you are
taking BREVINOR.
If you become pregnant
while taking BREVINOR, see your doctor
immediately.
Visit your doctor regularly
for check-ups, including a Pap smear. A pap smear
can detect any abnormal cells from the cervix,
which may develop into cancer. Cervical cancer has
been reported to occur more frequently in women
who use oral contraceptives.
Your doctor
will advise you of the type and frequency of any
tests required.
Perform regular breast
self-examination Examining your breasts for lumps
or any changes in size or shape can help you find
a breast cancer early. Breast cancer has been
found more frequently in women who use oral
contraceptives. It is not known whether this
increase is caused by the use of oral
contraceptives, or if it is due to the fact that
users were examined more often, and therefore the
breast cancer was detected earlier.
If you
are unsure, ask your doctor about breast self-
examination.
If you are worried about
contracting a sexually transmitted disease (STD)
use a barrier contraceptive method. BREVINOR does
not protect against the transmission of STDs such
as
HIV-AIDS, chlamydia, genital herpes and
warts, gonorrhoea, hepatitis B or human papilloma
virus. To protect against STDs ask your partner to
wear a condom when having sexual intercourse with
you.
Tell your doctor if you feel
depressed, think you are retaining water,
experience headaches, experience persistent or
recurrent irregular bleeding or your eyes are
uncomfortable whilst wearing contact lenses. Your
doctor will make an assessment of your condition
and advise whether or not you should continue to
take BREVINOR.
Things you must not do
Do not smoke while you are taking oral
contraceptives. Cigarette smoking increases the
risk of blood clotting and damage to the heart and
blood vessels from birth control pills. The risk
increases with age and with heavy smoking (15 or
more cigarettes per day) and is quite marked in
women over 35 years of age.
Do not stop
taking your tablets if a full monthly period or
slight spotting starts before all tablets have
been taken. Slight spotting during tablet taking
is normally of no significance.
See your
doctor if such bleeding persists, or if heavier
bleeding occurs.
Do not take BREVINOR past
the expiry date shown on the label. If you take
the tablets after the expiry date has passed, they
may not work as well.
Things to be careful
of
Slight breast tenderness or a feeling of
sickness may occur in the first few months of use.
This usually improves or stops with continued use.
If vaginal irritation or discharge occurs,
it may be an indication of yeast infection for
which treatment is available from your doctor.
Talk to your doctor if you are breast feeding.
BREVINOR may affect the amount and quality of
breast milk as the components of BREVINOR are
found in breast milk.
Side effects
Tell your doctor or pharmacist as soon as
possible if you do not feel well while you are
taking BREVINOR. All medicines can have side
effects. Sometimes they are serious, most of the
time they are not. You may need medical treatment
if you get some of the side effects.
Ask
your doctor or pharmacist to answer any questions
you may have.
Tell your doctor if you
notice any of the following and they worry you:
break-through bleeding
spotting
gastric or stomach discomforts including
nausea,vomiting and diarrhoea
change in
menstrual flow
change in weight
retention
of fluids
dark discolouration of the skin
blotchy discolouration on the face or limbs
(which may persist after the tablets have been
stopped)
absence of periods
breast changes
(tenderness, enlargement and secretion)
headache, dizziness
mental depression
fatigue or tiredness
hair growth or loss
of scalp hair
acne, rashes, itching
leg
cramps
back ache
change in sexual drive
vaginal thrush, vaginal irritation, bladder
irritation or urinary tract infection
pre-
menstrual-like symptoms
change in cervical
secretions
suppression of milk production
change in appetite
The most serious
known side effect with Combined Oral Contraceptive
use is abnormal blood clotting, which may have
serious consequences. Deaths have occurred in some
women as a result of blood clots carried by the
blood stream causing obstruction of blood vessels
in the lungs or in the brain. The risk of
developing blood clotting disorders and other
blood vessel diseases in oral contraceptive users
increases with age from 30 years onwards.
Cigarette smoking also increases the risk. These
problems may persist after a woman has stopped
taking the birth control pill.
The use of a
Combined Oral Contraceptive can increase the risk
of a woman having a heart attack. Other risk
factors for a heart attack include cigarette
smoking; high blood pressure; high cholesterol;
obesity; diabetes; a history of pre-eclamptic
toxaemia in pregnancy and age over 40 years.
Tell your doctor immediately, or go to
accident and emergency at your nearest hospital if
you notice any of the following:
unexplained or
persistent pains in the head, chest, stomach or
legs
gradual or sudden, partial or complete
loss of vision
double vision, or symptoms of
severe vision impairment
eye protrusion,
swelling of the eye or eye lesions
migraine
headaches for the first time
more frequent or
severe migraines if you already suffer from them
breast lumps
jaundice or a yellowing of
the skin or eyes, often with fever, fatigue, loss
of appetite, dark coloured urine, nausea and
vomiting. Taking oral contraceptives may be
associated with liver disease including liver
cancer
rise in blood pressure
swelling of
the face, lips, tongue or other parts of the body,
shortness of breath, wheezing or trouble
breathing
Rarer side effects associated
with the use of combined oral contraceptives are
not listed here. You may wish to discuss these, or
any of the side effects listed above, with your
doctor if you are concerned.
Side effects
not previously reported with BREVINOR may also
occur.
If you notice anything unusual while
you are taking BREVINOR, see your doctor.
Do not be alarmed by this list of possible
side effects. You may not experience any of them.
After stopping BREVINOR
Delays in
becoming pregnant may occur after BREVINOR therapy
is stopped. This is more likely to occur in women
whose periods were irregular before using birth
control pills.
See your doctor if you
continue to experience difficulties in falling
pregnant.
After taking BREVINOR
Storage
Keep your tablets in a safe
place away from the sight and reach of children. A
locked cupboard at least one-and-a-half metres
above the ground is a good place to store
medicines.
Keep your BREVINOR tablets in a
dry place, at a temperature below 25°C.
Do
not keep your tablets in the refrigerator.
Do not store BREVINOR or any other medicine in
the bathroom or near a sink. Do not leave it in
the car on hot days or on window sills. Heat and
dampness can destroy some medicines.
Disposal
If your doctor tells you to
stop taking BREVINOR or if the tablets have passed
their expiry date, ask your pharmacist what to do
with any that are left over.
Product
description
What it looks like
BREVINOR 21 Day
BREVINOR 21 Day is
available in calendar packs consisting of four
strips of tablets (4 months' supply) each with 21
blue active tablets marked "SEARLE" on one side
and "BX" on the other.
BREVINOR 28 Day
BREVINOR 28 Day is available in calendar packs
consisting of four strips of tablets (4 months'
supply) each with 21 blue active tablets marked
"SEARLE" on one side and "BX" on the other, and 7
orange inactive tablets. Ingredients
BREVINOR 21 Day
Each blue tablet
contains:
norethisterone 500 micrograms (mcg)
ethinyloestradiol 35 micrograms (mcg)
magnesium stearate
povidone
maize
starch
lactose
indigo carmine CI 73015.
BREVINOR 28 Day
Each blue tablet
contains:
norethisterone 500 micrograms (mcg)
ethinyloestradiol 35 micrograms (mcg)
magnesium stearate
povidone
maize
starch
lactose
indigo carmine CI 73015.
The orange inactive tablets contain:
magnesium stearate
cellulose
microcrystalline
lactose
sunset yellow FCF
(CI No. 15985).
BREVINOR does not contain
sucrose, gluten or tartrazine.
Identification
BREVINOR can be
identified by the Australian Register Number on
the carton labels.
BREVINOR 21 Day Tablets
-
AUST R 62131
BREVINOR 28 Day Tablets
-
AUST R 62132
Supplier
Pfizer
Australia Pty Ltd
ABN 50 008 422 348
38-42
Wharf Road
West Ryde NSW 2114
Australia
Toll Free number: 1800 675 229
This
leaflet was prepared in December 1997, revised in
September 2005.
© Pfizer Australia Pty Ltd
(2005)
® Registered trademark