onsumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Brenda-35 ED.
It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or health clinic.
All medicines have benefits and risks. Your doctor has weighed the risks of you taking Brenda-35 ED 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 Brenda-35 ED is used for
Brenda-35 ED is a hormonal preparation used to treat the following androgen-dependent conditions in women:
severe acne when other treatments have failed
mild to moderate increased growth of facial or body hair (hirsutism).
Androgens are male sex hormones, produced by women in small amounts. If a woman's body produces too much of these hormones or is overly sensitive, then androgen-dependent conditions occur. Brenda-35 ED works by blocking the action of these hormones.
Brenda-35 ED is also an effective oral contraceptive, commonly known as the "Pill" or "birth control pill".
As a contraceptive, Brenda-35 ED prevents pregnancy by:
thickening the cervical mucus to act as a barrier to sperm
making the lining of the uterus less suitable for implantation of the fertilised egg.
Oral contraceptives such as
Brenda-35 ED may have the following theoretical benefits:
a decrease in the amount of blood you lose each cycle during your period
a decrease in anaemia
a decrease in period pain
a reduced risk of pelvic inflammatory disease
a reduced risk of developing ovarian cysts
an improvement in acne
a reduced risk of tubal (ectopic) pregnancy
a reduced risk of benign breast disease (breast lumpiness)
a reduced risk of getting cancer of the uterus (womb) lining and ovaries.
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.
Brenda-35 ED is not for use in men.
Brenda-35 ED does not protect against HIV infections (AIDS) or other sexually transmitted diseases (STDs). A barrier form of contraception such as a condom or diaphragm is needed.
Brenda-35 ED is available only with a doctor's prescription.
Before you take Brenda-35 ED
When you must not take it
Do not take Brenda-35 ED if you are allergic to:
any other medicines containing cyproterone or ethinyloestradiol
any other oral contraceptive
any other medicine known as a progestagen or oestrogen, including injections and implants
any of the ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.
Do not take Brenda-35 ED if you have or have had:
any condition affecting blood circulation, in particular those conditions relating to thrombosis, (formation of blood clots in the legs, lungs or other parts of the body)
a heart attack, stroke or angina (chest pain)
a migraine accompanied by visual symptoms, speech disability or weakness or numbness in any part of the body
diabetes mellitus with blood vessel complications
inflammation of the pancreas associated with high triglyceride (blood fats) levels in the blood
jaundice (yellowing of the skin) or severe liver disease
benign or malignant liver tumours
cancer of the breast or genital organs
unexplained vaginal bleeding.
Do not take Brenda-35 ED if you are pregnant or think you might be pregnant. Brenda-35 ED may affect your developing baby if you take it during pregnancy.
Do not take Brenda-35 ED if you are breastfeeding. Brenda-35 ED passes into breast milk and may affect your baby.
Do not take Brenda-35 ED after the expiry date printed on the pack has passed. If you take this medicine after the expiry date, it may not work as well.
Do not take Brenda-35 ED if the packaging shows signs of tampering or the tablets do not look quite right.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
A complete medical check-up must be done by your doctor before starting Brenda-35 ED. This includes determining if you are pregnant or not, a Pap smear, a blood test, and a check of blood pressure, breasts, abdomen and pelvic organs. Your doctor will also note your family medical history.
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
Tell your doctor if you smoke.
The use of oral contraceptives like Brenda-35 ED by cigarette smokers may increase the risk of cardiovascular disease, especially if you are over the age of 35. Your doctor or pharmacist can advise you about stopping smoking.
Tell your doctor if you have, or have had, any medical conditions, especially the following:
blood circulation problems, including a positive family history of blood clots, heart attack or stroke
high blood pressure
a heart valve or rhythm disorder
systemic lupus erythematosus, a disease affecting the skin all over the body
hereditary angioedema, a genetic disease causing local swelling at various parts of your body, due to an allergic reaction
polycystic ovary syndrome
chronic inflammatory bowel disease, e.g. Crohn's disease, ulcerative colitis
sickle cell anaemia
haemolytic uraemic syndrome, a blood clotting disorder causing kidney failure
breast cancer including a family history of breast cancer
liver or gall bladder problems
high blood triglyceride or cholesterol levels, including a family history
chloasma, dark patches on the skin, especially the face. (If so, avoid too much exposure to the sun or UV radiation.)
Your doctor may want to take special care if you have any of these conditions. If you have not told your doctor about any of the above, tell him/her before you start taking Brenda-35 ED.
The Pill and Thrombosis
A thrombosis is the formation of a blood clot, which may block a blood vessel.
A thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs (pulmonary embolism). Deep vein thrombosis is a rare occurrence. It can develop whether or not you are taking the Pill. It can also happen if you
become pregnant. The risk is higher in Pill users than in non-users but not as high as the risk during pregnancy. The risk for venous thromboembolism is highest during the first year a woman ever uses a combined oral contraceptive. Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye. Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal. Biochemical factors (hereditary or acquired) that may indicate a possible predisposition for blood clot formation include having Activated Protein C (APC) resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C deficiency, protein S deficiency and antiphospholipid antibodies. The risk of having a heart attack or stroke increases as you get older. It also increases the more you smoke. When using Brenda-35ED you should stop smoking, especially if you are older than about 35 years of age. If you develop high blood pressure while using Brenda-35ED, you may be told to stop using it. Tell your doctor if you:
plan to have surgery or be in hospital.
have had recent surgery
have been confined to bed or immobilized for a prolonged period of time.
These situations may also increase the risk of developing a blood clot. Your doctor may tell you to stop taking Brenda-35 ED 4 weeks before surgery or at the time of immobilisation. Your doctor will also tell you when you can start taking Brenda-35 ED again after you are back on your feet.
If you notice possible signs of thrombosis, stop taking Brenda-35 ED and consult your doctor immediately (See 'Side effects').
The Pill and Cancer
Breast cancer has been diagnosed slightly more often in women who use the Pill than in women of the same age who do not use the Pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the Pill. It is not known whether the difference is caused by the Pill. It may be that the women were examined more often, so that that the breast cancer was noticed earlier.
Cervical cancer has been reported to occur more often in women using 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.
Contact your doctor immediately if you have severe pain in your abdomen. 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.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines reduce the contraceptive effectiveness of Brenda-35 ED. These include:
certain medicines used in the treatment of epilepsy, such as barbiturates, primidone, phenytoin, topiramate, lamotrigine, oxcarbazepine and carbamazepine
cyclosporin, a medicine used in patients with transplants
antibiotics such as ampicillins, tetracyclines
rifampicin, a medicine used in the treatment of tuberculosis
griseofulvin, an antifungal
St John's wort, a herbal remedy.
If you are using any of the above medicines on a short-term basis, use an additional barrier method of contraception (such as a condom or diaphragm) while you are taking it and for 7 days after finishing the other medicine.
If you take rifampicin, use additional contraception for four weeks after finishing the course of rifampicin. Your doctor may also advise you to skip the 7 inactive tablets (the white tablets).
If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist. Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking Brenda-35 ED.
How to take 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 each day, with some water.
When to take it
Brenda-35 ED can be taken with or without food.
Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How to use it
The Brenda-35 ED pack contains 28 tablets. On the pack each tablet is marked with the day of the week on which it is to be taken. The ED in the name refers to the "every day" presentation where 7 white lactose tablets (placebos or sugar tablets) are also included in the pack so that a tablet is taken each day of the month instead of having a break.
Take your first tablet from the red section marked with the appropriate day of the week, e.g., if starting on Sunday - select SUN.
Follow the direction of the arrows on the pack until all 28 tablets have been taken.
Usually a menstrual period will start within 2 to 4 days after taking the last active tablet (i.e. while you are taking tablets from the last row of your pack).
Do not leave a gap between packs, i.e. start taking your next pack on the day after you have finished the current one, even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days, each month.
Additional contraceptive methods
When additional contraceptive methods are required, either do not have sexual intercourse or use a barrier method such as a condom or diaphragm plus spermicide.
Rhythm methods are not advised as the Pill disrupts the cyclical changes associated with the natural menstrual cycle, e.g. changes in temperature and cervical mucus.
When to start it
After a natural cycle
Take the first tablet on the first day of your period from the red section of the pack. Additional contraceptive methods must be used for the next 14 days.
Switching from another combined oral contraceptive
Start Brenda-35 ED on the day after the last active tablet from the previous pill pack has been taken.
If your present pill pack contains placebo (sugar) tablets, you should throw away the placebo tablets and start Brenda-35 ED on the day after taking the last active tablet from your present pack (if you are not sure which this is, ask your doctor or pharmacist). This means no tablet free break. If you follow these instructions, it is not necessary to use an additional contraceptive method. A withdrawal bleed may not occur until the end of the first pack of Brenda 35 ED. This is not harmful.
Switching from progestagen-only contraceptives, e.g. minipill, implant, injectable or a progestogen-releasing intrauterine device (IUD)
Brenda-35 ED may be started on any day when switching from the minipill, or on the day when your implant or IUD is removed or next injection is due. Additional contraceptive methods must be used for the next 14 days. After having a baby
Your doctor will advise you when it is best to start Brenda-35 ED. If you are breastfeeding, you should discuss this with your doctor first.
Additional contraceptive methods must be used for the next 14 days.
After a miscarriage or abortion
Your doctor will advise you. Additional contraceptive methods must be used for the first 14 days.
How long to take it for
Keep taking Brenda-35 ED for as long as your doctor tells you to.
You will probably need to take Brenda-35 ED for about 6 months before you notice an improvement in your condition. To effectively treat your acne and excess hair you will probably need to take it for much longer. It is possible that acne and excess hair may return when treatment is stopped.
Repeat courses of Brenda-35 ED may be taken, however, it is recommended that you have a "pill-free" period.
If you forget to take it
If you forget to take Brenda-35 ED, it may not work as well in protecting you from becoming pregnant.
Additional contraceptive methods
When additional contraceptive methods are required, either do not have sexual intercourse or use a barrier method such as a condom or diaphragm plus spermicide.
If you are less than 12 hours late in taking a tablet, take the missed dose as soon as you remember, and then go back to taking your tablets as you would normally. Additional contraceptive measures are not necessary and contraceptive protection is not reduced.
If you are more than 12 hours late in taking an active (beige) tablet, take the missed tablet as soon as you remember, even if this means taking two tablets at the same time, then continue to take the next tablet at the normal time. Additional contraceptive methods must be used for the next 7 days as there is an increased risk of becoming pregnant. If the 7 days include taking any of the non-active (white) tablets, discard the non-active tablets and continue with the small beige active tablets of the next pack. You are unlikely to have a period until you reach the red section of the second pack. This is not harmful.
See your doctor if you forget to take more than one active tablet in a pack or if you have missed one or more active tablets within the first week of the pack. There is an increased risk of becoming pregnant. An alternative method of contraception should be used until you are sure that you are not pregnant.
If you have forgotten to take a non-active (white) tablet, discard the missed tablet and continue taking the tablets as you would normally. No additional contraceptive precautions are needed.
If you are not sure what to do or have any questions, ask your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much Brenda-35 ED. Do this even if there are no signs of discomfort or poisoning.
You may experience nausea, vomiting and vaginal bleeding.
While you are taking Brenda-35 ED
Things you must do
Before starting any new medicine, tell your doctor or pharmacist that you are taking Brenda-35 ED.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking Brenda-35 ED.
Stop taking Brenda-35 ED and tell your doctor immediately if you fall pregnant or think you are pregnant while taking Brenda-35 ED. Pregnancy must be ruled out before you continue treatment. In the meantime, use an alternative method of contraception.
Tell your doctor if you plan to have surgery or be immobilized for a long period of time (eg. leg in plaster). Your doctor may advise you stop taking Brenda-35 ED during this period.
Avoid excessive sun exposure and use a SPF 30+ sunscreen if you have a tendency to develop chloasma (dark pigments on the face or skin).
If you need to have any blood or urine tests, tell your doctor that you are taking Brenda-35 ED. Brenda-35 ED may affect the results of some tests.
Visit your doctor regularly so they can check on your progress. In general, you should have a check-up once every year, including a Pap smear, breast examination and blood pressure check.
Vomiting and Diarrhoea Advice
If you vomit within 3 to 4 hours of taking an active beige tablet, follow the advice under "If you forget to take Brenda-35 ED". This is like missing a tablet.
If you have severe diarrhoea, please contact your doctor. Vomiting or diarrhoea while taking white placebo tablets do not reduce contraceptive reliability.
Like other contraceptive pills, irregular vaginal bleeding (spotting or break through bleeding) may occur for the first few months.
Continue to take your tablets as you would normally. Irregular bleeding should stop once your body adjusts to the pill (usually after about 3 cycles). If bleeding continues or becomes heavy, see your doctor.
If you have taken all your tablets as directed, and you have not vomited while taking an active pill, or taken other medicines that interfere with Brenda-35 ED, then you are very unlikely to be pregnant. Continue to take Brenda-35 ED as usual.
If you miss your period twice in a row stop taking Brenda-35 ED and tell your doctor immediately. Pregnancy must be excluded before you start the next pack of Brenda-35 ED. In the meantime, use another form of contraception such as a condom or diaphragm.
Things you must 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.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Brenda-35 ED. Like all other medicines, Brenda-35 ED may have unwanted side effects in some people. 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 this list of possible side effects. You may not experience any of them.
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:
changes in vaginal secretion
breast tenderness, pain or secretion
contact lens intolerance
change in sex drive
change in body weight.
See your doctor as soon as possible if you notice any of the following:
a lump in your breast
unusual, heavy vaginal bleeding
sudden increase in facial or body hair
dark patches of the skin, in particular the face
yellowing of the skin or eyes
The above list includes serious side effects that may require medical attention. Serious side effects are rare.
See your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any signs of a blood clot, heart attack or stroke:
sudden severe chest pain that may radiate down your left arm
severe pain and/or swelling in either leg
sudden onset of coughing
unusual or severe prolonged headache
sudden partial or complete loss of eyesight, double vision
dizziness or fainting
weakness or numbness suddenly affecting any part of the body
problems with speech or movement
severe stomach pain.
The symptoms above occur very rarely and can happen whether or not you are taking the pill. They are, however, serious and require urgent medical attention or hospitalisation.
If any of the following allergic reactions occur, see your doctor immediately, or go to Accident and Emergency at the nearest hospital:
swelling of the face, lips, tongue or throat causing difficulty breathing
severe itch or rash on the body.
Tell your doctor if you notice anything that is making you feel unwell. This is not a complete list of all possible side effects. Other side effects not listed above may also occur in some people. Some of these side effects (for example, high blood pressure) can only be found when your doctor does tests from time to time to check your progress.
After taking Brenda-35 ED
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.
Keep your tablets in the 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.
Do not store Brenda-35 ED or any other medicine in the bathroom or near a sink.
Do not leave Brenda-35 ED in the car or on window sills. Heat and dampness can destroy some medicines.
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.
What it 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.
The beige active tablets contain two active ingredients: cyproterone acetate 2 mg and ethinyloestradiol 35 mcg.
The white non-active tablets contain lactose. These are also known as placebos or "sugar tablets".
The tablets also contain the following ingredients:
starch - maize
talc - purified
titanium dioxide (E171)
iron oxide yellow CI77492 (E172)
water - purified.
The tablets do not contain gluten, tartrazine or any other azo dyes.
Brenda-35 ED is supplied by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Chase Building 2
Wentworth Park Road
Glebe NSW 2037
Phone: (02) 9298 3999
Phone: 1800 028 365
Australian registration number:
Brenda-35 ED - AUST R 55128
This leaflet was prepared on
4 April 2007.