Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using BRENDA-35 ED?
BRENDA-35 ED contains the active ingredient cyproterone acetate and ethinylestradiol.
BRENDA-35 ED is used for treatment of signs of androgenization in women and as a contraceptive
to prevent pregnancy in women who are taking it for the treatment of signs of androgenization.
For more information, see Section
1. Why am I using BRENDA-35 ED? in the full CMI.
2. What should I know before I use BRENDA-35 ED?
Do not use if you have ever had an allergic reaction to BRENDA-35 ED or any of the
ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use BRENDA-35 ED? in the full CMI.
3. What if I am taking other medicines?
4. How do I use BRENDA-35 ED?
Take one tablet daily at about the same time everyday. Take your first tablet from
the red 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.
Follow the instructions provided and use BRENDA-35 ED until your doctor tells you
to stop.
5. What should I know while using BRENDA-35 ED?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit and if you are going to have surgery,
tell the surgeon or anesthetist beforehand that you are using BRENDA-35 ED.
If you are about to have any blood tests, tell your doctor that you are taking this
medicine.
Consult your doctor immediately if you become pregnant or develop high blood pressure
or unexpected bleeding/vomit or have severe diarrhea or if you plan to air travel
for greater than 4 hours.
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Things you should not do
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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 BRENDA-35 ED, or do not take a tablet every day.
Do not use BRENDA-35 ED to treat any other conditions unless your doctor tells you
to.
Do not give BRENDA-35 ED to anyone else, even if they have the same condition as you.
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Looking after your medicine
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Keep your tablets in a cool dry place where the temperature stays below 25°C.
Keep your tablets where young children cannot reach it.
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6. Are there any side effects?
If you notice possible signs/concerned about increased risk of blood clots, stop taking
BRENDA-35 ED and consult your doctor immediately. Breast Cancer/Cervical Cancer has
been diagnosed more often in women who take pill than who do not take. Increased Risk
of Meningioma is reported in women who take high doses (25 mg and above) of cyproterone
acetate.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
cyproterone acetate and ethinylestradiol
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BRENDA-35 ED. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using BRENDA-35 ED.
Where to find information in this leaflet:
1. Why am I using BRENDA-35 ED?
BRENDA-35 ED contains the active ingredients cyproterone acetate and ethinylestradiol. BRENDA-35 ED contains a progestogen and an oestrogen hormone, and therefore works
similarly to the combined oral contraceptive birth control pill, also known as 'the
Pill'. It should not be used in combination with another hormonal contraceptive.
BRENDA-35 ED is used for the treatment of signs of physical male characteristics caused
by the male sex hormone, androgen, produced by the male sex hormone, androgen, produced
in women in small amounts (androgenisation), such as:
severe acne when other treatments have not been successful
for excessive growth of facial or body hair (known as hirsutism) of a mild to moderate
degree, where no underlying cause has been found.
BRENDA-35 ED can also be used as a contraceptive to prevent pregnancy in women who
are taking it for the treatment of signs of physical male characteristics as described
above.
While taking BRENDA-35 ED you may also experience the following benefits:
more regular and lighter periods - potentially resulting in a decreased risk in anaemia
(iron deficiency)
a decrease in period pain
reduction of greasiness in skin and hair.
Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy
(where the foetus is carried outside of your womb), lumpy breasts and cancer of the
uterus (womb) and ovaries may be less common in women taking BRENDA-35 ED.
Ask your doctor if you have any questions about why BRENDA-35 ED has been prescribed
for you.
Your doctor may have prescribed BRENDA-35 ED for another reason.
2. What should I know before I use BRENDA-35 ED?
Warnings
Do not use BRENDA-35 ED if:
you are allergic to cyproterone, ethinylestradiol (the active ingredients in BRENDA-35
ED), or 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
Always check the ingredients to make sure you can use this medicine.
you are taking antiviral medicines which contain glecaprevir, pibrentasvir, sofosbuvir,
velpatasvir, voxilaprevir, ombitasvir, paritaprevir, or dasabuvir, and combinations
of these. These antiviral medicines are used to treat chronic (long-term) hepatitis
C (an infectious disease that affects the liver, caused by the hepatitis C virus).
you have or have had a blood clot in:
the blood vessels of the legs (deep vein thrombosis- DVT)
the lungs (pulmonary embolism-PE)
the heart (heart attack)
the brain (stroke)
other parts of the body
you are concerned about or have an increased risk of blood clots.
Blood clots are rare. Very occasionally blood clots may cause serious permanent disabilities
and may even be fatal.
All combined oral contraceptive pills, including BRENDA-35 ED, increase the risk of
having a blood clot. However, the risk of having a blood clot when taking the Pill
is less than the risk of having a blood clot during pregnancy.
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.
you have or have had:
blood clots in your legs
any blood clotting disorders such as Protein C deficiency, Protein S deficiency, Leiden
Factor V mutation, Antithrombin III deficiency or other inherited blood clotting conditions.
A confirmed blood test showing:
increased levels of homocysteine
antiphospholipid antibodies (APLAs) e.g. anticardiolipin-antibodies and lupus anticoagulant.
These may increase your risk for blood clots or pregnancy losses (miscarriage).
major surgery after which you have not been able to move around for a period of time
angina (chest pain)
mini-stroke (also known as TIA or transient ischaemic attack)
migraine, where you have also had problems with seeing, speaking or had weakness or
numbness in any part of your body
high risk of blood clots due to conditions such as diabetes with blood vessel damage,
severe high blood pressure or severe high or low level of fats in your blood.
pancreatitis, an inflammation of the pancreas associated with high triglyceride (blood
fats) levels in the blood
severe liver disease and your liver function has not returned to normal
a benign or malignant liver tumour
cancer that may grow under the influence of sex hormones (e.g. cancer of the breast
or genital organs)
meningioma or history of meningioma (a generally benign tumour of the tissue layer
between the brain and the skull)
unexplained vaginal bleeding.
If any of these conditions appear for the first time while using the BRENDA-35 ED,
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).
you are using another hormonal contraceptive.
Do not take this medicine if you are pregnant or think you might be pregnant.
Do not breast-feed if you are taking this medicine.
BRENDA-35 ED is not for use in men.
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.
Check with your doctor if:
you are allergic to any other medicines or any foods, preservatives or dyes.
you smoke
you, or anyone in your immediate family has had blood clots in the legs (DVT), or
lungs (PE), a heart attack, a stroke, breast cancer or high cholesterol.
you have, or have had, any other medical conditions, especially the following:
diabetes
high blood pressure
heart valve disorders or certain heart rhythm disorders
migraine
cancer
polycystic ovary syndrome, a hormonal condition which can cause menstrual irregularity
and excess hair growth
hyperhomocysteinaemia, a condition characterised by high levels of the amino acid
homocysteine in the blood
severe high or low levels of fats in the blood.
you take any medicines for any other condition
Ask your doctor to check if you:
are overweight
have any hereditary or acquired conditions that may make it more likely for you to
get blood clots
have high cholesterol or triglycerides
have liver disease
have jaundice (yellowing of the skin) and/or pruritus (itching of the skin) related
to cholestasis (condition in which the flow of bile from the liver stops or slows)
have gall bladder disease
have Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease)
have systemic lupus erythematosus (SLE - an autoimmune disease affecting different
parts of 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 angio-oedema – you should see your doctor immediately if you experience
symptoms of angio-oedema, 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, or recur or worsen while
taking BRENDA-35 ED, you should contact your doctor.
BRENDA-35 ED contains lactose.
If you have been told by your doctor that you have intolerance to some sugars, contact
your doctor before you start taking BRENDA-35 ED.
If you have not told your doctor about any of the above, tell him/her before you start
taking BRENDA-35 ED.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take BRENDA-35 ED if you are pregnant or think you might be pregnant.
Check with your doctor if you are pregnant or intend to become pregnant.
Do not breast-feed if you are taking this medicine.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
If you do not wish to fall pregnant, you should use additional barrier contraceptive
precautions (e.g. condoms or a diaphragm) when you stop taking BRENDA-35 ED.
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 BRENDA-35 ED and not stop until your doctor advises
this. Ask your doctor or pharmacist about suitable supplements. It is both safe and
recommended that you take folic acid during pregnancy.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interact with BRENDA-35 ED. These include:
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Medicines used to treat:
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Examples of drugs:
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Tuberculosis
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Rifampicin, Rifabutin
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Epilepsy
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Phenytoin, Primidone, Barbiturates (e.g. Phenobarbitone), Carbamazepine, Oxcarbazepine,
Topiramate, Felbamate, Lamotrigine
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HIV
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Ritonavir or Nevirapine
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Hepatitis C Virus (HCV)
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Boceprevir, Telaprevir, Glecaprevir, Pibrentasvir, Ombitasvir, Paritaprevir, Dasabuvir
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Bacterial infections (antibiotics)
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Clarithromycin, Erythromycin
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Fungal infections
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Ketoconazole and Griseofulvin
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Immunosuppressant
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Ciclosporin
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High blood pressure, chest pain and/or irregular heartbeats
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Diltiazem, Verapamil
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Anti-inflammatory medicine to treat pain
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Etoricoxib
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Medicines used to relax the body
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Tizanidine, Melatonin or Midazolam
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Medicine that helps with breathing
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Theophyllin
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Other supplements that may interact with BRENDA-35 ED include:
herbal medicines containing St John's Wort
grapefruit juice.
These medicines may be affected by BRENDA-35 ED, or may affect how well it works.
Your doctor may need to alter the dose of your medicine or prescribe a different medicine.
Some medicines:
can have an influence on the blood levels of BRENDA-35 ED
can make it less effective in preventing pregnancy or
can cause unexpected bleeding.
You may need to use additional barrier methods of contraception (such as a condom
or diaphragm) while you are taking any of these medicines with BRENDA-35 ED for some
time after stopping them.
Your doctor or pharmacist 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 BRENDA-35 ED.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BRENDA-35 ED.
4. How do I use BRENDA-35 ED?
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 pack, ask your doctor or pharmacist.
How much to take
Take one tablet once a day, at about the same time each day. You must take BRENDA-35
ED every day regardless of how often you have sex. This will also help you remember
when to take it.
Follow the instructions provided and use BRENDA-35 ED until your doctor tells you
to stop.
Swallow the tablet whole with a full glass of water. It does not matter if you take
it before or after food.
The BRENDA -35 ED pack contains 28 tablets. On the blister pack each tablet is marked
with the day of the week on which it is to be taken.
Take your first tablet from the red section marked with the appropriate day of the
week.
Follow the direction of the arrows on the pack until all 28 tablets have been taken.
A period should begin 2-3 days after starting to take the white inactive tablets (last
row) and may not have finished before the next pack is started.
Always start a new blister pack on the same day of the week as your previous pack.
Taking BRENDA-35 ED for the first time
If you are starting BRENDA-35 ED 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 must also use additional barrier contraceptive precautions (e.g. condoms or a
cap or diaphragm plus spermicide) for the first 14 days of tablet-taking when having
intercourse.
Your doctor will advise you when to start if you:
are taking BRENDA-35 ED after having a baby
have had a miscarriage or an abortion.
Changing from another contraceptive
1.
Switching from another combined oral contraceptive
Start BRENDA-35 ED on the day after the last active tablet from the previous Pill
pack. Bleeding may not occur until the end of the first pack of BRENDA-35 ED.
Ask your doctor or pharmacist if you are not sure which the active/inactive tablets
were in your previous Pill pack.
Your previous Pill pack may have different colour tablets to those of BRENDA-35 ED.
2.
Changing from a vaginal ring:
Start taking BRENDA-35 ED on the day of removal of the last vaginal ring.
3.
Changing from a progestogen-only pill 'minipill'
Stop taking the minipill on any day and start taking BRENDA-35 ED at the same time
the day after you took your last minipill.
You must also use additional barrier contraceptive precautions (e.g. condoms or a
cap or diaphragm plus spermicide) for the first 14 days of tablet-taking when having
intercourse.
4.
Changing from a progestogen only injection, implant, intrauterine system (IUS)
Start taking BRENDA-35 ED 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
cap or diaphragm plus spermicide) for the first 14 days of tablet taking when having
intercourse.
How long to take BRENDA-35 ED
Keep taking BRENDA-35 ED for as long as your doctor tells you to.
You may need to take BRENDA-35 ED for about 6 months before you notice an improvement
in your condition. The length of treatment depends on the severity of the condition
and how well it responds to treatment.
You may be advised by your doctor to stop BRENDA-35 ED 3 to 4 months after your symptoms
have completely resolved.
You should have regular check-ups with your doctor to determine how long to keep taking
BRENDA-35 ED.
Stopping BRENDA-35 ED
You can stop taking BRENDA-35 ED at any time.
It is possible that original condition may recur once BRENDA-35 ED is stopped.
Do not start taking BRENDA-35 ED again without seeing your doctor first.
If you do not wish to fall pregnant, you should use additional barrier contraceptive
precautions (e.g. condoms or a diaphragm) when you stop taking BRENDA-35 ED.
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 BRENDA-35 ED and not stop until your doctor advises
this. Ask your doctor or pharmacist about suitable supplements. It is both safe and
recommended that you take folic acid during pregnancy.
If you forget to use BRENDA-35 ED
BRENDA-35 ED should be used regularly at the same time each day. If you miss your
dose at the usual time and take the missing tablet within 12 hours of missing it,
you should still be protected against pregnancy.
If you are more than 12 hours late follow these detailed instructions:
For BRENDA-35 ED to be most effective, beige active tablets need to be taken uninterrupted
for 7 days.
If you have been taking the beige active tablets for 7 uninterrupted days and miss
a beige active tablet, take the missed tablet as soon as you remember, then go back
to taking your medicine as you would normally, even if it means taking 2 tablets in
one day at the same time.
You will not need to use additional barrier contraceptive precautions.
The chance of pregnancy after missing a beige active tablet depends on when you missed
the tablet.
There is a higher risk of becoming pregnant if you miss a beige tablet at the beginning
or end of a pack.
If after taking your missed tablet you have less than 7 days of beige 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 with the beige active tablets corresponding
to the correct day of the week.
This is the best way to maintain contraceptive protection. However, you may not have
a period until the end of the beige active tablets of the second pack.
You may have spotting or breakthrough bleeding on tablet-taking days.
If you have been taking the beige active tablets for less than 7 days and miss a beige
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 at the same time. 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 in the preceding 7 days, there is a possibility
of pregnancy and you may need emergency contraception. You should discuss this with
your doctor or pharmacist.
If you forget to take more than one beige 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. You should discuss this with your doctor or
pharmacist.
If you forget to take a white inactive tablet, you do not need to take them later
because they do not contain any active ingredients.
However, it is important that you discard the missed white tablet(s) to make sure
that the number of days between taking active tablets is not increased as this would
increase the risk of pregnancy. Continue with the next tablet at the usual time.
Please see the diagram at the end of this leaflet entitled "Summary of advice if you
missed an active tablet more than 12 hours ago". Ask your doctor or pharmacist to
answer any questions you may have.
If you use too much BRENDA-35 ED
If you think that you have used too much BRENDA-35 ED, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
You may need medical attention.
If you take several beige active tablets at once, you may feel sick or vomit or may
bleed from the vagina. Even girls who have not yet started to menstruate but have
accidentally taken this medicine may experience such bleeding.
5. What should I know while using BRENDA-35 ED?
Things you should do
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
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 BRENDA-35 ED, your doctor will tell you to return for regular
check-ups, including getting a Cervical Screening Test. Your doctor will advise how
often you need a Cervical Screening Test. A Cervical Screening Test can detect abnormal
cells lining the cervix. Sometimes abnormal cells can progress to cancer.
If you are about to start on any new medicine, remind your doctor and pharmacist that
you are taking BRENDA-35 ED.
Stop taking BRENDA-35 ED, call your doctor immediately or go to the Emergency Department
at your nearest hospital if you notice the following signs:
one-sided swelling of the leg and/or foot or along a vein in the leg
pain or tenderness in the leg which may be felt only when standing or walking
increased warmth in the affected leg; red or discoloured skin on the leg
sudden onset of unexplained shortness of breath or rapid breathing
sudden coughing or coughing up of blood
sharp chest pain or sudden severe pain in the chest which may increase with deep breathing
severe light headedness or dizziness
rapid or irregular heartbeat
sudden pain, swelling and slight blue discoloration of an extremity
sudden numbness or weakness of the face, arm or leg, especially on one side of the
body
sudden trouble walking, dizziness, loss of balance or coordination
sudden confusion, slurred speech or aphasia; sudden partial or complete loss of vision,
double vision, painless blurring of vision which can progress to loss of vision
sudden, severe or prolonged headache with no known cause
loss of consciousness or fainting with or without seizure.
pain, discomfort, pressure, heaviness, sensation of squeezing or fullness in the chest
arm, or below the breastbone
discomfort radiating to the back, jaw, throat, arm, stomach
feeling of being full, having indigestion or choking
sweating, nausea, vomiting
extreme weakness and anxiety
If you are going to have surgery, tell the surgeon or anesthetist beforehand that
you are taking BRENDA-35 ED.
The risk of having blood clots is temporarily increased as a result of major surgery,
any surgery to the legs or pelvis, neurosurgery or major trauma. In women who take
BRENDA-35 ED, the risk may be higher.
In women at risk of prolonged immobilisation (including major surgery, any surgery
to the legs or pelvis, neurosurgery, or major trauma), your doctor may tell you to
stop taking (in the case of elective surgery at least four weeks in advance) and not
resume until two weeks after complete remobilisation. Another method of contraception
should be used to avoid unintentional pregnancy. Your doctor may prescribe other treatment
(e.g. treatment for blood clots) if BRENDA-35 ED has not been discontinued in advance.
Other risk factors for blood clotting include temporary immobilisation including air
travel of greater than 4 hours, particularly in women with other risk factors.
Consult your doctor if you plan to air travel for greater than 4 hours.
Consult your doctor if you develop high blood pressure while taking BRENDA-35 ED –
you may be told to stop taking it.
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 beige 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 products, but continue to take your tablets as normal. Irregular vaginal
bleeding usually stops once your body has adjusted to the BRENDA-35 ED, 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 beige active tablets at the right time,
you have not vomited or had severe diarrhoea during this cycle,
you have not been taking other medicine(s) that interfere with BRENDA-35 ED
If this is so, continue to take BRENDA-35 ED 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
BRENDA-35 ED correctly. Stop taking BRENDA-35 ED 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.
BRENDA-35 ED will not protect you from HIV-AIDS or any other Sexually Transmitted
Infections (STIs), such as chlamydia, genital herpes, genital warts, gonorrhoea, hepatitis
B, human papilloma virus and syphilis.
To protect yourself from STIs, you will need to use additional barrier contraceptives
(e.g. condoms).
Remind any doctor, dentist or pharmacist you visit that you are using BRENDA-35 ED.
Things you should not do
Do not use BRENDA-35 ED to treat any other conditions unless your doctor tells you
to.
Do not give BRENDA-35 ED to anyone else, even if they have the same condition as you.
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 BRENDA-35 ED, or do not take a tablet every day.
Looking after your medicine
Keep your tablets in the blister pack until it is time to take them.
If you take the tablets out of the pack they will not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25°C.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Heat and dampness can destroy some medicines.
Keep BRENDA-35 ED 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.
Getting rid of any unwanted medicine
If your doctor tells you to stop taking BRENDA-35 ED, or your tablets have passed
their expiry date, ask your pharmacist what to do with any that are left over.
Return any unused medicine to your pharmacist.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking BRENDA-35 ED.
This medicine helps most women, but it may have unwanted side effects in some women.
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.
Do not be alarmed by the following lists of possible side effects. You may not experience
any of them.
Ask your doctor or pharmacist to answer any questions you may have.
The following list includes the more common side effects of BRENDA-35 ED. These are
usually mild and lessen with time.
Less serious side effects
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Less serious side effects
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What to do
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nausea
stomach pain or discomfort
changes in weight
headache, including migraines
mood changes, including depression
breast tenderness or pain
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
The following list includes very serious but rare side effects. You may need urgent
medical attention or hospitalisation.
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Serious side effects
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What to do
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pain in the chest, arm, or below the breastbone
pain or discomfort that goes to your back
breathlessness and/or difficulty breathing
swelling, pain or tenderness of one leg or along a vein in the 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 speaking, seeing or understanding what people are saying to you.
The side effects listed above are possible signs of a blood clot (thrombosis).
jaundice (yellowing of the skin or eyes)
you cough up blood
breast lumps
unexplained vaginal bleeding.
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Blood clots and BRENDA-35 ED
Blood clots may block blood vessels in your body. This type of blood clot is also
called thrombosis.
Blood clots sometimes occur in the deep veins of the legs. If a blood clot breaks
away from the veins where it has formed, it may reach and block the blood vessels
of the lungs, causing pulmonary embolism.
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 BRENDA-35
ED.
They can also happen during pregnancy. The risk of having blood clots is higher in
BRENDA-35 ED users than in non-users, but not as high as during pregnancy.
The risk of a blood clot is highest during the first year of taking BRENDA-35 ED for
the first time, or after having a break from BRENDA-35 ED for 4 weeks or more.
If you notice possible signs of a blood clot, stop taking BRENDA-35 ED and consult
your doctor immediately.
To prevent pregnancy, you must also use additional barrier contraceptive precautions
(e.g. condoms or a diaphragm).
If you are concerned about an increased risk of blood clots while on BRENDA-35 ED,
speak to your doctor.
Cancer and BRENDA-35 ED
BRENDA-35 ED contains a progestogen and an oestrogen hormone, and therefore works
similarly to the combined oral contraceptive birth control pill, 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 lumps.
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.
For high doses (25 mg and above) of cyproterone acetate, an increased risk of a benign
brain tumour (meningioma) has been reported. If you are diagnosed with meningioma,
your doctor will stop all cyproterone containing products, including BRENDA-35 ED
as a precautionary measure (see section ‘Do not take BRENDA-35 ED’).
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What BRENDA-35 ED contains
|
Active ingredient
(main ingredient)
|
cyproterone acetate 2 mg
ethinylestradiol 35 microgram
|
|
Other ingredients
(inactive ingredients)
|
Each beige active tablet contains:
lactose monohydrate
maize starch
povidone
magnesium stearate
sucrose
macrogol 6000
calcium carbonate
purified talc
glycerol
titanium dioxide (E171)
iron oxide yellow CI77492 (E172)
glycol montanate
purified water
Each white inactive tablet contains:
lactose monohydrate
maize starch
povidone
magnesium stearate
sucrose
macrogol 6000
calcium carbonate
glycol montanate
titanium dioxide
purified talc
|
Do not take this medicine if you are allergic to any of these ingredients.
What BRENDA-35 ED looks like
BRENDA-35 ED is available as a calendar pack and contains 2 different tablets:
21 small beige round active tablets
7 white round non-active tablets.
On the pack each tablet is marked with a day of the week on which it is to be taken.
BRENDA-35 ED is AUST R 55128.
Who distributes BRENDA-35 ED
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in Jun 2023.
BRENDA-35 ED® is a Viatris company trade mark
BRENDA-35 ED_cmi\Jun23/00
8. Summary of advice if you missed an active tablet more than 12 hours ago
Before missing your tablet, did you take beige 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. If there are fewer
than 7 beige active tablets left in the pack, finish the beige active tablets and
go straight to the beige active tablets of the next pack. This means you skip the
white inactive tablets.
YES
See your doctor or pharmacist for advice.
YES:
Does your pack still have 7 active beige tablets in a row to follow?
NO
Take the tablet you missed AND complete taking the beige active tablets. Skip the
white inactive tablets. Start your next pack with beige active tablets.
YES
Take the tablet you missed AND complete the pack as normal.