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 BIJUVA 1/100?
BIJUVA 1/100 contains the active ingredient estradiol (as hemihydrate) and progesterone.
BIJUVA 1/100 is used during continuous combined hormone replacement therapy (HRT)
for estrogen deficiency symptoms in postmenopausal women who still have a uterus with
at least 12 months (1 year) since their last natural period.
2. What should I know before I use BIJUVA 1/100?
Do not use if you have ever had an allergic reaction to BIJUVA 1/100 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. BIJUVA 1/100 is only
for use in postmenopausal women who still have a uterus.
3. What if I am taking other medicines?
Some medicines may interfere with BIJUVA 1/100 and affect how it works.
4. How do I use BIJUVA 1/100?
BIJUVA 1/100 should be taken at the same time every day in the evening, to ensure
it works effectively. Follow all instructions given to you by your doctor.
5. What should I know while using BIJUVA 1/100?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using BIJUVA 1/100.
Monitor your health and contact your doctor if you notice any changes.
Keep all of your doctor’s appointments and go for regular check-ups.
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Things you should not do
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Do not stop using this medicine suddenly without telling your doctor.
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Driving or using machines
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BIJUVA 1/100 is not expected to affect your ability to drive or operate machinery.
If you experience any side effects which impact your ability to drive or operate machinery
when taking this medicine, act appropriately and contact your doctor.
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Drinking alcohol
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Alcohol is not expected to interact with BIJUVA 1/100. If you drink alcohol, talk
to your doctor about the possible effects of taking alcohol with this medicine.
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Looking after your medicine
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Store BIJUVA 1/100 in a cool dry place, out of direct light, where the temperature
is below 25°C.
Keep BIJUVA 1/100 in the original packaging, in a safe place, away from children.
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6. Are there any side effects?
The most common side effects are breast tenderness, headache, vaginal bleeding, vaginal
discharge, and pelvic pain. Serious side effects include heart attack, stroke, blood
clots, breast cancer, ovarian cancer, cancer of the womb, gall bladder disease and
dementia.
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WARNING:
The Women’s Health Initiative (WHI) trial examined the health benefits and risks of
combined estrogen plus progestogen therapy (n=16,608) and estrogen-alone therapy (n=10,739) in postmenopausal women aged 50 to 79 years.
The estrogen plus progestogen arm of the WHI trial indicated an increased risk of myocardial infarction (MI), stroke, invasive breast cancer, pulmonary embolism and
deep vein thrombosis in postmenopausal women receiving treatment with combined conjugated equine estrogens
(CEE, 0.625 mg/day) and medroxyprogesterone acetate (MPA, 2.5 mg/day) for 5.2 years
compared to those receiving placebo.
The estrogen-alone arm of the WHI trial indicated an increased risk of stroke and deep vein thrombosis in hysterectomised women treated with CEE-alone (0.625 mg/day) for 6.8 years compared
to those receiving placebo.
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other
combinations and dosage forms of estrogens and progestogens were not studied in the
WHI clinical trials and, in the absence of comparable data, these risks should be
assumed to be similar.
Therefore, the following should be given serious consideration at the time of prescribing:
Estrogens with or without progestogens should not be prescribed for primary or secondary prevention of cardiovascular diseases.
Estrogens with or without progestogens should be prescribed at the lowest effective dose for the approved indication.
Estrogens with or without progestogens should be prescribed for the shortest period possible for the approved indication.
For the prevention of osteoporosis, estrogen treatment should be considered in light
of other available therapies.
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Active ingredient(s):
estradiol (as hemihydrate) and progesterone
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using BIJUVA 1/100. 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 BIJUVA 1/100.
Where to find information in this leaflet:
1. Why am I using BIJUVA 1/100?
BIJUVA 1/100 contains the active ingredients estradiol (as hemihydrate) and progesterone. BIJUVA 1/100 is a Hormone Replacement Therapy (HRT).
BIJUVA 1/100 is used during continuous combined hormone replacement therapy (HRT)
for estrogen deficiency symptoms in postmenopausal women who still have a uterus with
at least 12 months (1 year) since their last natural period.
BIJUVA 1/100 contains two types of female hormones, an estrogen and a progestogen.
During menopause, the amount of estrogen produced by a woman’s body drops. This can
cause symptoms such as hot face, neck and chest (“hot flushes”). BIJUVA 1/100 alleviates
these symptoms after menopause.
2. What should I know before I use BIJUVA 1/100?
Warnings
Do not use BIJUVA 1/100 if:
you are allergic to estradiol or progesterone, or any of the ingredients listed in
Section
7. Always check the ingredients to make sure you can use this medicine.
you have or have ever had breast cancer, or if you are suspected of having it
you have cancer which is sensitive to estrogens, such as cancer of the womb lining
(endometrium), or if you are suspected of having it
you have any unexplained vaginal bleeding
you have excessive thickening of the womb lining (endometrial hyperplasia) that is
not being treated
you have or have ever had a blood clot in a vein (thrombosis), such as in the legs
(deep venous thrombosis) or the lungs (pulmonary embolism)
you have a blood clotting disorder (such as protein C, protein S, or antithrombin
deficiency)
you have or recently have had a disease caused by blood clots in the arteries, such
as a heart attack, stroke, or angina
you have or have ever had a liver disease and your liver function tests have not returned
to normal
you have a rare blood problem called “porphyria” which is passed down in families
(inherited)
If any of the above conditions appear for the first time while taking BIJUVA 1/100,
stop taking it at once and consult your doctor immediately.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
If you have had any of the following conditions, tell your doctor before starting
BIJUVA 1/100 as these may return or become worse during treatment with this medicine:
fibroids inside your womb
growth of womb lining outside your womb (endometriosis) or a history of excessive
growth of the womb lining (endometrial hyperplasia)
increased risk of developing blood clots (see “Blood clots in a vein (thrombosis)”)
increased risk of getting an estrogen-sensitive cancer (such as having a mother, sister
or grandmother who has had breast cancer)
high blood pressure
a liver disorder, such as a benign liver tumour
diabetes
gallstones
migraine or severe headaches
a disease of the immune system that affects many organs of the body (systemic lupus
erythematosus, SLE)
epilepsy
asthma
a disease affecting the eardrum and hearing (otosclerosis)
a very high level of fat in your blood (triglycerides)
fluid retention due to cardiac or kidney problems
hereditary or acquired angioedema.
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
BIJUVA 1/100 is for use in postmenopausal women only. If you become pregnant, stop
taking BIJUVA 1/100 and contact your doctor.
HRT and cancer
Excessive thickening of the lining of the womb (endometrial hyperplasia) and cancer
of the lining of the womb (endometrial cancer)
Taking estrogen-only HRT will increase the risk of excessive thickening of the lining
of the womb (endometrial hyperplasia) and cancer of the womb lining (endometrial cancer).
The progestogen in BIJUVA 1/100 protects you from this extra risk.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first 3-6
months of taking BIJUVA 1/100. However, if the irregular bleeding:
carries on for more than the first 6 months
starts after you have been taking BIJUVA 1/100 for more than 6 months
carries on after you have stopped taking BIJUVA 1/100
See your doctor as soon as possible.
Breast cancer
Evidence shows that taking combined estrogen-progestogen or estrogen-only hormone-replacement-therapy
(HRT) increases the risk of breast cancer. The extra risk depends on how long you
use HRT. The additional risk becomes clear within 3 years of use. After stopping HRT,
the extra risk will decrease with time, but the risk may persist for 10 years or more
if you have used HRT for more than 5 years.
Compare
Women aged 50 to 54 who are not taking HRT, on average, 13 to 17 in 1000 will be diagnosed
with breast cancer over a 5-year period.
For women aged 50 who start taking estrogen-only HRT for 5 years, there will be 16-17
cases in 1000 users (i.e., an extra 0 to 3 cases).
For women aged 50 who start taking estrogen-progestogen HRT for 5 years, there will
be 13 to 21 cases in 1000 users (i.e., an extra 4 to 8 cases).
Women aged 50 to 59 who are not taking HRT, on average, 27 in 1000 will be diagnosed
with breast cancer over a 10-year period.
For women aged 50 who start taking estrogen-only HRT for 10 years, there will be 34
cases in 1000 users (i.e., an extra 7 cases)
For women aged 50 who start taking estrogen-progestogen HRT for 10 years, there will
be 48 cases in 1000 users (i.e., an extra 21 cases).
Regularly check your breasts. See your doctor if you notice any changes such as:
dimpling of the skin
changes in the nipple
any lumps you can see or feel
Additionally, you are advised to join mammography screening programs when offered
to you. For mammogram screening, it is important that you inform the nurse/healthcare
professional who is actually taking the x-ray that you use HRT, as this medication
may increase the density of your breasts which may affect the outcome of the mammogram.
Where the density of the breast is increased, mammography may not detect all lumps.
Ovarian cancer
Ovarian cancer is much rarer than breast cancer. The use of estrogen-only or combined
estrogen-progestogen HRT has been associated with a slightly increased risk of ovarian
cancer. The risk of ovarian cancer varies with age. For example, in women aged 50
to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian
cancer over a 5-year period. For women who have been taking HRT for 5 years, there
will be about 3 cases per 2000 users (i.e., about 1 extra case).
Effect of HRT on heart and circulation Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT users
than in non-users, especially during the first year of taking it. Blood clots can
be serious, and if one travels to the lungs, it can cause chest pain, breathlessness,
fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if any
of the following applies to you. Inform your doctor if any of these situations applies
to you:
you are unable to walk for a long time because of major surgery, injury, or illness
you are seriously overweight (BMI >30 kg/m2)
you have any blood clotting problem that needs long-term treatment with a medicine
used to prevent blood clots
if any of your close relatives has ever had a blood clot in the leg, lung, or any
other organ
you have systemic lupus erythematosus (SLE)
you have cancer
Compare
Looking at women in their 50s who are not taking HRT, on average, over a 5-year period,
4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking estrogen-progestogen HRT for over 5 years,
there will be 9 to 12 cases in 1000 users (i.e., an extra 5 cases).
Stroke
The risk of having a stroke is about 1.5 times higher in HRT users than in non-users.
The number of extra cases of stroke due to use of HRT will increase with age.
Compare
Looking at women in their 50s who are not taking HRT, on average, 8 in 1000 would
be expected to have a stroke over a 5-year period.
For women in their 50s who are taking HRT, there will be 11 cases in 1000 users, over
5 years (i.e., an extra 3 cases).
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 interfere with BIJUVA 1/100 and affect how it works. This may lead
to irregular bleeding. This applies to the following medicines:
medicines for epilepsy (such as phenobarbital, phenytoin, and carbamazepine)
medicines for tuberculosis (such as rifampicin, rifabutin)
medicines for HIV infection (such as nevirapine, efavirenz, ritonavir and nelfinavir)
herbal remedies containing St John’s Wort (Hypericum perforatum)
bromocriptine used for problems with the pituitary gland or Parkinsons disease
ketoconazole, griseofulvin (used for fungal infections)
ciclosporin (used to suppress the immune system)
lamotrigine (used to control seizures)
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect BIJUVA 1/100.
4. How do I use BIJUVA 1/100?
How much to take
Take one capsule every day in the evening.
Follow the instructions provided and use BIJUVA 1/100 until your doctor tells you
to stop.
Your doctor will aim to prescribe the lowest dose to treat your symptom for as short
as necessary. Speak to your doctor if you think this dose is too strong or not strong
enough.
When to take BIJUVA 1/100
BIJUVA 1/100 should be taken every day in the evening.
How to take BIJUVA 1/100
Capsules should be taken with food and swallowed with water.
If you forget to use BIJUVA 1/100
BIJUVA 1/100 should be used regularly at the same time each day. If you miss your
dose at the usual time, take it as soon as you remember.
If more than 12 hours have lapsed, skip the missed dose.
Do not take a double dose to make up for the dose you missed.
If you use too much BIJUVA 1/100
If you think that you have used too much BIJUVA 1/100, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), 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.
5. What should I know while using BIJUVA 1/100?
Things you should do
Keep all of your doctor’s appointments and become familiar with potential risks associated
when taking combined hormone replacement therapy.
Call your doctor straight away if you:
have yellowing of your skin or the whites of your eyes (jaundice). These may be signs
of a liver disease
have swelling in your face, tongue and/or throat and/or difficulty swallowing or hives,
together with difficulty breathing as this is suggestive of an angioedema
have a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
have migraine-like headaches which happen for the first time
become pregnant
notice signs of a blood clot, such as:
painful swelling and redness of the legs;
sudden chest pain;
difficulty in breathing;
For more information, see Blood clots in a vein (thrombosis)
have a very high level of fat in your blood (triglycerides)
have fluid retention due to cardiac or kidney problems
Remind any doctor or dentist you visit that you are using BIJUVA 1/100.
Things you should not do
Do not take BIJUVA 1/100 to treat any other complaints unless your doctor tells you
to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Do not stop taking your medicine without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how BIJUVA
1/100 affects you.
BIJUVA 1/100 is not expected to affect your ability to drive or operate machinery.
If you experience any side effects which impact your ability to drive or operate machinery
when taking this medicine, act appropriately and contact your doctor.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol is not expected to interact with BIJUVA 1/100. If you drink alcohol, talk
to your doctor about the possible effects of taking alcohol with this medicine.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Keep your capsules in the original pack until it is time to take them. If you take
your capsules out of the pack, they may not keep well.
Store BIJUVA 1/100 in a cool dry place below 25°C, 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 windowsills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
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.
Less serious side effects
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Less serious side effects
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What to do
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irregular vaginal bleeding or spotting (if bleeding is heavy, check with your doctor
as soon as possible)
tender, painful, or swollen breasts or painful nipples
vaginal itching, burning sensation, inflammation, or fluid discharge (white or yellowish
discharge)
infection of the ear
swelling of the lower legs, ankles, fingers, or abdomen due to fluid retention
muscle spasms or pain, pain in extremities or joints
nausea (feeling sick), abdominal cramps, vomiting, heartburn, wind, diarrhoea, constipation
loss of smell or taste
weakness or dizziness
headaches
hair loss or excessive growth of hair (hirsutism)
back pain, pain in the pelvic region
hot flushes
change in sex drive
depression, nervousness, changes in mood, difficulty sleeping or abnormal dreams
disturbance in attention, memory loss
loss of coordination
visual impairment, blurred vision
numbness or tingling in an arm or leg
benign breast or uterine tumour (cysts in uterus),
vertigo
excessive eating
weight gain or weight loss
acne, itchy or dry skin, skin discolouration
dry mouth
rash or appearance of red lines on the skin
pain in extremity (e.g. back pain, arms, legs, wrists, ankles)
high blood pressure
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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
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.
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 BIJUVA 1/100 contains
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Active ingredient
(main ingredient)
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Estradiol (as hemihydrate) and progesterone
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Other ingredients
(inactive ingredients)
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Capsule content contains:
Mono di-glycerides
Lauroyl Macrogolglycerides
Capsule shell contains:
Gelatin
Hydrolyzed gelatin
Glycerol
Opatint® Red DG-15001(PI-141454)
Opatint® Concentrated Colour Dispersion G-18006 (PI-140158)
Printing ink:
Opacode® WB water based Monogramming Ink
NSP-78-18022 White (PI 3883)
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Do not take this medicine if you are allergic to any of these ingredients.
What BIJUVA 1/100 looks like
BIJUVA 1/100 1 mg/100 mg capsules
BIJUVA 1/100 is presented in PVC/PE/PCTFE Aluminium backed blister strips containing
14 soft gel capsules.
The blister strip is packed in a carton to protect BIJUVA 1/100 from light. The carton
contains 2 or 6 BIJUVA 1/100 strips, together with the Consumer Medicines Information
leaflet.
BIJUVA 1/100 soft gel capsules are opaque, light pink on one side and dark pink on
the other, imprinted with “1C1” in white ink. Capsules are approximately 5.2- 6 mm
in size.
Australian Registration Numbers
BIJUVA 1/100 1 mg/100 mg – 28 capsules per pack
BIJUVA 1/100 1 mg/100 mg – 84 capsules per pack
AUST R 367690
Who distributes BIJUVA 1/100
Theramex Australia Pty Ltd
Level 22, 60 Margaret Street,
Sydney NSW 2000
1800 THERAMEX or 1800 843 726
This leaflet was updated in January 2024