General Information
Consumer Medicine Information
What is in
this leaflet
This leaflet answers some
common questions about NORIMIN-1 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 NORIMIN-1 against
the benefits it is expected to have for you.
Use NORIMIN-1 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 NORIMIN-1 is used for
NORIMIN-1 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.
NORIMIN-1 (like all oral
contraceptives) is intended to prevent pregnancy.
It does not protect against HIV infection (AIDS)
and other sexually transmitted diseases.
NORIMIN-1 28 Day is 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
NORIMIN-1
When you must not take it
NORIMIN-1 tablets are not suitable for some
women.
If you have or have had any of these
problems, do not take NORIMIN-1 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 NORIMIN-1 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
NORIMIN-1. 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, then you
should start a new pack on the next day after
having taken the last white active tablet from the
current pack.
This is particularly
important if you need to take antibiotics or
medicines for epilepsy.
How to take
NORIMIN-1
How to take it
Swallow one
NORIMIN-1 tablet with a glass of water at the same
time each day, preferably at bedtime.
Starting a hormonal contraceptive for the
first time
To begin NORIMIN-1 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 silver
section of the strip (ie the section which
contains all the white 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 white tablet marked "TUE"
from the top row of the silver section of the
strip.
Continue to take one tablet every day,
following the arrows around the strip, until you
finish all 21 white tablets in the silver 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 white tablet from the top row of the
silver 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
NORIMIN-1 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 NORIMIN-1 28 Day pack on the eighth day by
taking a white active tablet from the top row of
the silver 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 white tablets in the silver
section of the strip.
Then take one orange
tablet daily for the next seven 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 white
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
NORIMIN-1 28 Day pack on the next day by taking a
white 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 white
tablets in the silver 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
white 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 NORIMIN-1 may be reduced.
During any period of vomiting or diarrhoea,
continue taking NORIMIN-1 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 white
tablet from the silver 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
NORIMIN-1 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 white 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, do not take the
orange tablets. Start a new pack on the day after
taking the last active tablet from the silver
section of the current pack. Take your first
tablet from the top row of the silver section of
the 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, 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 NORIMIN-1 differently, or you are unclear
about the above directions, discuss this with him
or her.
If you have trouble remembering to
take NORIMIN-1, 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 NORIMIN-1. 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 NORIMIN-1
Things
you must do
Tell all doctors, dentists and
pharmacists who are treating you that you are
taking NORIMIN-1.
Tell the hospital doctor
that you are taking NORIMIN-1 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 NORIMIN-1.
If you become pregnant
while taking NORIMIN-1, 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. NORIMIN-1 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
NORIMIN-1.
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 NORIMIN-1 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.
NORIMIN-1 may affect the amount and quality of
breast milk as the components of NORIMIN-1 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 NORIMIN-1. 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
appetite
change in menstrual flow
absence
of periods
change in weight
retention of
fluids
dark discolouration of the skin
blotchy discolouration on the face or arms or
legs (which may persist after the tablets have
been stopped)
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
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 NORIMIN-1 may also occur.
If
you notice anything unusual while you are taking
NORIMIN-1, see your doctor.
Do not be
alarmed by this list of possible side effects. You
may not experience any of them.
After
stopping NORIMIN-1
Delays in becoming
pregnant may occur after NORIMIN-1 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 NORIMIN-1
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 NORIMIN-1 tablets in a
dry place, at a temperature below
25°C.
Do not keep your
tablets in the refrigerator.
Do not store
NORIMIN-1 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 NORIMIN-1 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
NORIMIN-1 28 Day is available in
calendar packs consisting of four strips of
tablets (4 months' supply) each with 21 white
active tablets marked "SEARLE" on one side and
"BX" on the other, and 7 orange inactive tablets.
Ingredients
Each white tablet
contains:
norethisterone 1 milligram (mg)
ethinyloestradiol 35 micrograms (mcg)
magnesium stearate
povidone
maize
starch
lactose.
The orange inactive
tablets contain:
magnesium stearate
cellulose microcrystalline
lactose
sunset yellow FCF (CI No. 15985).
NORIMIN-1 does not contain sucrose, gluten or
tartrazine.
Identification
NORIMIN-1
can be identified by the Australian Register
Number on the carton labels.
NORIMIN-1 28
Day Tablets -
AUST R 62136
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