contains drospirenone 3 mg and ethinylestradiol 20 micrograms
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about BROOKE.
It does not contain all the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking
BROOKE against the benefits expected for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this leaflet with your medicine.
You may need to read it again.
What BROOKE is used for
BROOKE is a combined oral contraceptive, commonly known as a ‘birth control pill’
or ‘the Pill’.
BROOKE is used to prevent pregnancy.
It is also used to treat moderate acne in women seeking oral contraception and to
treat symptoms of premenstrual dysphoric disorder (PMDD).
You may also experience the following benefits:
improvement in symptoms like bloating, swelling or weight gain related to fluid retention
more regular, shorter and lighter periods
a decrease in anaemia (iron deficiency)
a decrease in period pain
improvement in symptoms like bloating, swelling or weight gain related to fluid retention.
Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy,
fibrocystic breast changes and cancer of the uterus (womb) and ovaries may be less
common in women taking the Pill.
When taken correctly, it prevents you from becoming pregnant in several ways including:
inhibiting the egg release by stopping it maturing
changing the cervical mucus consistency, making it more difficult for the sperm to
reach the egg.
BROOKE has 24 active (hormone) tablets and 4 inactive tablets, rather than the traditional
21 active tablets and 7 inactive tablets. This means that with BROOKE, you take the
active (hormone) tablets for three more days. This helps your hormone levels to stay
even.
When the Pill is taken by women under close observation in clinical trials, it is
more than 99% effective in preventing pregnancy. However, in real life the Pill is
around 92% effective. This is because pills might be missed, or taken with medicines
that may interfere with their effectiveness.
Like all oral contraceptives, BROOKE is intended to prevent pregnancy. It does not
protect against HIV infection (AIDS) and other sexually transmitted diseases.
Ask your doctor if you have any questions about why this medicine has been prescribed
for you.
Your doctor may have prescribed it for another reason.
Before you take BROOKE
When you must not take it
Do not take BROOKE if you have an allergy to:
drospirenone and/or ethinyloestradiol, the active ingredients in BROOKE
any of the ingredients listed at the end of this leaflet
Some of the symptoms of an allergic reaction may include
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
Do not take this medicine if you have or have had a blood clot in:
the blood vessels of the legs (deep vein thrombosis)
the lungs (pulmonary embolism)
the heart (heart attack)
the brain (stroke)
other parts of the body.
Do not take BROOKE if you are concerned about an increased risk of blood clots.
Blood clots are rare. Very occasionally blood clots may cause serious permanent disabilities,
or may even be fatal.
You are more at risk of having a blood clot when you take the Pill. But the risk of
having a blood clot when taking the Pill is less than the risk during pregnancy.
Do not take this medicine if you are concerned about an increased risk of blood clots
because of age or smoking.
The risk of having a heart attack or stroke increases as you get older. It also increases
if you smoke. You should stop smoking when taking the Pill, especially if you are
older than 35 years of age.
Do not take BROOKE if you have, or have had:
angina (chest pain)
mini stroke (also known as TIA or transient ischaemic attack)
severe kidney insufficiency or an acute failure of your kidney
migraine, accompanied by visual symptoms, speech disability, or weakness or numbness
in any part of your body
diabetes mellitus with blood vessel damage
pancreatitis (an inflammation of the pancreas) associated with high levels of fatty
substances in your blood
severe liver disease and your liver function has not returned to normal
cancer that may grow under the influence of sex hormones (e.g. of the breast or the
genital organs)
benign or malignant liver tumour
unexplained vaginal bleeding.
If any of these conditions appear for the first time while using the Pill, stop taking
it at once and tell your doctor. In the meantime use non-hormonal (barrier) methods
of contraception (such as condoms or a diaphragm).
Do not take this medicine if you are pregnant or think you might be pregnant.
Do not give this medicine to a child.
Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.
Tell your doctor if you smoke.
Tell your doctor if you or anyone in your immediate family has had blood clots in
the legs (thrombosis), a heart attack, a stroke, breast cancer or high cholesterol.
Tell your doctor if you have or have had any of the following medical conditions:
diabetes
high blood pressure
heart valve disorders or certain heart rhythm disorders
inflammation of your veins (superficial phlebitis)
varicose veins
migraine
epilepsy
an increased potassium blood level (e.g. due to problems with your kidney/s) and also
use diuretics or other drugs that may increase the potassium in your blood.
Ask your doctor to check if you:
are overweight
have high cholesterol or triglycerides
have liver disease
have kidney disease
have gall bladder disease
have Crohn’s disease or ulcerative colitis (chronic inflammatory bowel disease)
have systemic lupus erythematosus (SLE – a disease affecting the skin all over the
body)
have haemolytic uraemic syndrome (HUS– a disorder of blood coagulation causing failure
of the kidneys)
have sickle cell disease
have a condition that occurred for the first time, or worsened during pregnancy or
previous use of sex hormones (e.g. hearing loss, a metabolic disease called porphyria,
a skin disease called herpes gestationis, a neurological disease called Sydenham’s
chorea)
have chloasma (yellowish-brown pigmentation patches on the skin, particularly of the
face) – if so, avoid exposure to the sun or ultraviolet radiation
have hereditary angioedema – you should see your doctor immediately if you experience
symptoms of angioedema, such as swollen face, tongue and/or pharynx and/or difficulty
swallowing, or hives together with difficulty in breathing.
If any of the above conditions appear for the first time, recur or worsen while taking
BROOKE, you should contact your doctor.
Tell your doctor if you are breastfeeding.
BROOKE is generally not recommended if you are breastfeeding.
BROOKE contains lactose.
If you have intolerance to some sugars, tell your doctor before you start taking BROOKE.
If you have not told your doctor about any of the above, tell him/her before you start
taking BROOKE.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and BROOKE may interfere with each other. These include:
medicines used to treat tuberculosis such as rifampicin, rifabutin
medicines used to treat epilepsy such as phenytoin, primidone, barbiturates (e.g.
phenobarbitone), carbamazepine, oxcarbazepine, topiramate, felbamate, lamotrigine
medicines used to treat HIV, such as ritonavir or nevirapine
antibiotics (penicillin, ampicillin, erythromycin, tetracycline)
medicines used to treat fungal infections, such as griseofulvin
cyclosporin, an immunosuppressant medicine
herbal medicines containing St John’s Wort.
These medicines may be affected by BROOKE or may affect how well it works. You may
need different amounts of your medicines, or you may need to take different medicines.
You might have an increase in potassium in the blood if you are taking BROOKE with
medicines that may increase potassium levels in the blood. These include:
medicines used to treat high blood pressure, such as ACE inhibitors, angiotensin-II-receptor
antagonists and diuretics
certain anti-inflammatory medicines, such as indomethacin
aldosterone antagonists, such as spironolactone and eplerenone.
In a study of women taking drospirenone together with an ACE inhibitor, no significant
differences were observed in the potassium levels when compared to the placebo.
You may need to use additional barrier methods of contraception (such as condoms or
a diaphragm) while you are taking any of these medicines and for some time after stopping
them.
Your doctor will be able to advise you about how long you will need to use additional
contraceptive methods.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while taking this medicine.
How to take BROOKE
Follow all directions given to you by your doctor and pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.
How much to take
Take one tablet daily at about the same time every day. You must take BROOKE every
day regardless of how often you have sexual intercourse.
How to take it
Swallow the tablet whole with water.
It does not matter if you take it before or after food.
Each blister pack is marked with the day of the week.
Take your first light pink (active) tablet from the green area on the blister pack
corresponding to the day of the week.
Follow the direction of the arrows on the blister pack until all the tablets have
been taken.
Always start a new blister pack on the same day of the week as your previous pack.
Taking BROOKE for the first time
If you are starting BROOKE after a natural cycle, and you have not used a hormonal
contraceptive in the past month, start on the first day of your period, i.e. on the
first day of your menstrual bleeding.
You may also start on days 2-5 of your period, but in that case make sure you also
use additional barrier contraceptive precautions (e.g. condom) for the first 7 days
of tablet-taking.
Your doctor will advise you when to start if you
are taking BROOKE after having a baby
have had a miscarriage or an abortion.
Switching from another contraceptive
Changing from a combined oral contraceptive:
Start taking BROOKE on the day after taking the last active tablet in your previous
Pill pack. Bleeding may not occur until the end of the first pack of BROOKE.
You can also switch to BROOKE after taking one or more inactive tablets in your previous
Pill pack, but no later than the day after taking the last inactive tablet.
If you are not sure which the active/inactive tablets are in your previous Pill pack,
ask your doctor or pharmacist.
Your previous Pill pack may have different colour tablets to those of BROOKE.
Changing from a progestogen-only pill (‘minipill’):
If you are switching from a progestogen-only Pill (minipill), stop taking the minipill
on any day and start taking BROOKE at the same time the next day.
You must also use additional barrier contraceptive precautions (e.g. condoms or a
diaphragm) for the first 7 days of tablet-taking when having intercourse.
Changing from a progestogen-only injection, implant or intrauterine system (IUS):
Start taking BROOKE when your next injection is due, or on the day that your implant
or IUS is removed.
You must also use additional barrier contraceptive precautions (e.g. condoms or a
diaphragm) for the first 7 days of tablet-taking when having intercourse.
Changing from a vaginal ring:
Start BROOKE on the day of removal of the vaginal ring but at the latest when the
next application would have been due.
Stopping BROOKE
You can stop taking BROOKE at any time. If you are considering becoming pregnant,
it is recommended that you begin taking a vitamin supplement containing folic acid.
It is best that you start taking folic acid tablets before you stop taking BROOKE
and not stop until your doctor advises this. Seek advice from your doctor or pharmacist
about suitable supplements. It is both safe and recommended that you take folic acid
during pregnancy.
If you forget to take it
If you are late taking a tablet but still take it within 24 hours, contraception is
maintained. If you are more than 24 hours late, this is called a missed pill. Follow
these detailed instructions:
For BROOKE to be most effective, light pink active tablets need to be taken uninterrupted
for 7 days.
If you have been taking the light pink active tablets for 7 uninterrupted days and
miss a light pink active tablet, take the missed tablet as soon as you remember, then
go back to taking your medicine as you would normally, even if this means taking two
tablets in one day.
You will not need to use additional barrier contraceptive precautions.
The chance of pregnancy after missing a light pink active tablet depends on when you
missed the tablet.
There is a higher risk of becoming pregnant if you miss a tablet at the beginning
or end of a pack.
If after taking your missed tablet you have less than 7 days of light pink active
tablets left in a row, you should finish the active tablets in your pack but skip
the white inactive tablets and start a new pack.
This is the best way to maintain contraceptive protection. However, you may not have
a period until the end of the light pink active tablets of the second pack. You may
have spotting or breakthrough bleeding on tablet-taking days.
If you have been taking the light pink active tablets for less than 7 days and miss
a light pink active tablet, take the missed tablet as soon as you remember, then go
back to taking your medicine as you would normally, even if this means taking two
tablets in one day. In addition, you must also use additional barrier contraceptive
precautions (e.g. condoms or a diaphragm) for the next 7 days.
If you have had sexual intercourse during that time, there is a possibility of pregnancy
and you may need emergency contraception.
If you forget to take more than one light pink active tablet, seek advice from your
doctor or pharmacist about what to do.
If you have had sexual intercourse in the week before missing your tablets, there
is a possibility of becoming pregnant.
If you forget to take a white inactive tablet, take it as soon as you remember and
take the next tablet at the usual time. You are still protected against pregnancy
because the white tablets do not contain any active ingredients.
Summary of advice if you missed a tablet more than 24 hours ago:
Before missing your tablet, did you take light pink active tablets for the previous
7 days?
NO Did you have sex in the 7 days before missing the tablet?
NO Take the tablet missed AND use extra barrier precaution for 7 days
YES See your doctor or pharmacist for advice
YES Does your pack still have 7 active light pink tablets in a row to follow?
NO Take the tablet you missed AND complete taking the light pink active tablets.
Skip the white inactive tablets
YES Take the tablet you missed AND complete the pack as normal
Ask your doctor or pharmacist to answer any questions you may have.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you
think that you or anyone else may have taken too much BROOKE. Do this even if there
are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking BROOKE
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking BROOKE.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
Stop taking BROOKE and see your doctor immediately if you notice possible signs of
thrombosis. These include:
an unusual cough
severe pain or heaviness in the chest
breathlessness
any unusual, severe, or prolonged headache or migraine attack
partial or complete loss of vision, or double vision
slurring or speech disability
sudden changes to your hearing, sense of smell, or taste
dizziness or fainting
weakness or numbness in any part of your body
severe pain in your abdomen
severe pain, swelling or discolouration in either of your legs.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
The risk of having deep venous thrombosis is temporarily increased as a result of
an operation or immobilisation (for example, when you have your leg or legs in plaster
or splints). In women who take the Pill, the risk may be higher.
Your doctor may tell you to stop taking the Pill several weeks before surgery, or
at the time of immobilisation, and when you can start taking the Pill again. If you
notice possible signs of a thrombosis, stop taking the Pill and consult your doctor
immediately.
Consult your doctor if you develop high blood pressure while taking BROOKE – you may
be told to stop taking it.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
It may interfere with the results of some tests.
Have regular check-ups with your doctor.
When you are taking the Pill, your doctor will tell you to return for regular check-ups,
including getting a pap smear test. Your doctor will advise how often you need a pap
smear test. A pap smear test can detect abnormal cells lining the cervix. Sometimes
abnormal cells can progress to cancer.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you vomit within 3-4 hours or have severe diarrhoea after taking a light pink active
tablet, the active ingredients may not have been completely absorbed. This is like
missing a tablet. Follow the advice for missed tablets.
If you have unexpected bleeding and it continues, becomes heavy, or occurs again,
tell your doctor.
When taking these tablets for the first few months, you can have irregular vaginal
bleeding (spotting or breakthrough bleeding) between your periods. You may need to
use sanitary protection, but continue to take your tablets as normal. Irregular vaginal
bleeding usually stops once your body has adjusted to the Pill, usually after about
3 months.
If you have missed a period, but you have taken all your tablets, it is very unlikely
that you are pregnant, as long as:
you have taken the light pink active tablets at the right time
you have not been taking medicine(s) that may interfere with BROOKE
you have not vomited or had severe diarrhoea during this cycle.
If this is so, continue to take BROOKE as usual. If you have any concerns consult
your doctor or pharmacist.
If you miss your period twice in a row, you may be pregnant even if you have taken
the Pill correctly. Stop taking BROOKE and seek advice from your doctor. You must
use a non-hormonal method of contraception (such as condoms or a diaphragm) until
your doctor rules out pregnancy.
BROOKE will not protect you from HIV-AIDS or any other Sexually Transmitted Diseases
(STDs), such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis B,
human papilloma virus and syphilis.
To protect yourself from STDs, you will need to use additional barrier contraceptives
(e.g. condoms).
Things you must not do
Do not take BROOKE to treat any other conditions unless your doctor tells you to.
Do not give your medicine to anyone else.
Do not stop taking your medicine or change the dosage without checking with your doctor.
You may become pregnant if you are not using any other contraceptive and you stop
taking BROOKE, or do not take a tablet every day.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking BROOKE.
This medicine helps most people, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time
they are not. You may need medical attention if you get some of the side effects.
Do not be alarmed by the following list of side effects.
You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
nausea
stomach pain
changes in weight
headache, including migraines
mood changes, including depression
breast tenderness or pain.
The above list includes the more common side effects of your medicine. They are usually
mild and lessen with time.
If any of the following happen, tell your doctor immediately or go to Accident and
Emergency at your nearest hospital:
pain in the chest, arm or below the breastbone
discomfort radiating to the back
breathlessness and/or difficulty breathing
swelling, pain or tenderness of one leg
sudden weakness, numbness or bad ‘pins and needles’ of the face, arm or leg, especially
on one side of the body
sudden trouble walking, dizziness, loss of balance or coordination
severe, sudden stomach pains
a fainting attack, or you collapse
unusual headaches or migraines that are worse than usual
sudden problems with your speech, understanding or eyesight.
The side effects listed above are possible signs of a thrombosis.
jaundice (yellowing skin or yellowing eyes)
you cough up blood
breast lumps
unexplained vaginal bleeding.
The list includes very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are very rare.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people.
Thrombosis and the Pill
Thrombosis is the formation of a blood clot that may block a blood vessel.
Thrombosis sometimes occurs in the deep veins of the legs (deep venous thrombosis
– DVT). If a blood clot breaks away from the veins where it has formed, it may reach
and block the arteries of the lungs, causing pulmonary embolism (PE).
Blood clots can also occur in the blood vessels of the heart (causing a heart attack)
or the brain (causing a stroke).
Blood clots are a rare occurrence and can develop whether or not you are taking the
Pill. They can also happen during pregnancy. The risk of having blood clots is higher
in Pill users than in non-users, but not as high as during pregnancy.
The excess risk of a blood clot is highest during the first year of taking the Pill
for the first time or when re-starting after having a break from the Pill for 4 weeks
or more.
Therefore, one should keep the possibility of an increased risk of blood clots in
mind, particularly where there is a history of thrombosis.
If you notice possible signs of a blood clot, stop taking BROOKE and consult your
doctor immediately.
Cancer and the Pill
Breast cancer has been diagnosed slightly more often in women who take the Pill than
in women of the same age who do not take the Pill.
This slight increase in the numbers of breast cancer diagnoses gradually disappears
during the course of the 10 years after women stop taking the Pill.
It is not known whether the difference is caused by the Pill. It may be that these
women were examined more often, so that the breast cancer was noticed earlier.
It is important that you check your breasts regularly and contact your doctor if you
feel any lump.
In rare cases benign liver tumours and, even more rarely, malignant liver tumours
have been reported in users of the Pill. These tumours may lead to internal bleeding.
Contact your doctor immediately if you have severe pain in your abdomen.
Cervical cancer has been reported to occur more often in women who have been taking
the Pill for a long time. This finding may not be caused by the Pill, but may be related
to sexual behaviour and other factors.
After taking BROOKE
Storage
Keep your tablets in the pack until it is time to take them.
If you take the tablets out of the pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Do not store BROOKE or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place
to store medicines.
Disposal
If your doctor tells you to stop taking this medicine or the expiry date has passed,
ask your pharmacist what to do with any medicine that is left over.
Product description
What it looks like
BROOKE active tablets are round, light pink, uncoated biconvex tablet with ‘420’ debossed
on one side and other side plain.
BROOKE inactive tablets are round, white to off-white, uncoated biconvex tablet with
‘303’ debossed on one side and other side plain.
BROOKE is available in a carton of 1 or 3 blister packs. Each blister pack contains
24 light pink active tablets and 4 white inactive tablets.
Ingredients
Each BROOKE light pink active tablet contains:
Active ingredients:
3 mg of drospirenone
20 micrograms of ethinylestradiol as the active ingredients.
Inactive ingredients:
lactose
maize starch
crospovidone
povidone
magnesium stearate
iron oxide red
Each BROOKE inactive tablet contains:
lactose
polacrilin potassium
magnesium stearate
Supplier
BROOKE is supplied in Australia by:
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
Australian registration numbers:
BROOKE: AUST R 219081
This leaflet was prepared in
December 2022.
BROOKE_cmiDec22/00
