BIJUVA 1/100 estradiol (as hemihydrate) 1 mg progesterone 100 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol hemihydrate, Quantity: 1 mg; progesterone, Quantity: 100 mg

Available from:

Theramex Australia Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: mono- and di- glycerides; Gelatin; glycerol; purified water; lauroyl macrogolglycerides; hydrolysed gelatin; allura red AC; titanium dioxide; propylene glycol; ethyl acetate; ethanol; isopropyl alcohol; strong ammonia solution; polyvinyl acetate phthalate; macrogol 400

Administration route:

Oral

Units in package:

84, 28

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BIJUVA 1/100 is indicated for use during continuous combined hormone replacement therapy (HRT) for estrogen deficiency symptoms in postmenopausal women with an intact uterus and with at least 12 months since last menses.

Product summary:

Visual Identification: Softgel capsules are oval, opaque, light pink on one side and dark pink on the other side, printed in white ink '1C1'; Container Type: Blister Pack; Container Material: PVC/PE/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-05-03

Patient Information leaflet

BIJUVA
® 1/100
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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.
For more information, see Section 1. Why am I using BIJUVA 1/100? in
the full CMI.
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.
For more information, see Section 2. What should I know before I use
BIJUVA 1/100? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with BIJUVA 1/100 and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
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.
More instructions can be found in Section 4. How do I use BIJUVA
1/100? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BIJUVA 1/100?
THINGS YOU SHOULD DO
•
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.
THINGS YOU SHOULD NOT
DO
•
Do not stop using this medicine suddenly without telling your doctor.

Summary of Product characteristics

BIJUVA
®
1/100 (estradiol (as hemihydrate) and progesterone)
Theramex Australia Pty Ltd
Version 1.0
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of
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AUSTRALIAN PI – BIJUVA
® 1/100 (ESTRADIOL (AS HEMIHYDRATE) AND
PROGESTERONE) SOFT CAPSULES
1
NAME OF THE MEDICINE
Estradiol (as hemihydrate) and progesterone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 1 mg of estradiol (as hemihydrate) and 100
mg of progesterone.
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Soft capsule
BIJUVA 1/100
soft capsules are oval and opaque, light pink on one side and dark
pink on the
other side with the marking “1C1” printed in white ink.
Capsules are oval and approximately 5.2 – 6 mm in size.
WARNING
Estrogens and progestogens should not be used for the prevention of
cardiovascular disease or dementia.
The Women’s Health Initiative (WHI) study reported increased risks
of myocardial infarction, stroke, invasive
breast cancer, pulmonary emboli, and deep vein thrombosis in
postmenopausal women (50 to 79 years of age)
during 5 years of treatment with conjugated estrogens (0.625 mg)
combined with medroxyprogesterone acetate
(2.5 mg) relative to placebo (see Section 5.1 Pharmacodynamic
properties– Clinical trials and Section 4.4 Special
warnings and precautions for use).
The WHI study reported increased risks of stroke and deep vein
thrombosis in postmenopausal women (50 to
79 years of age) during 6.8 years of treatment with conjugated
estrogens (0.625 mg) relative to placebo (see Section
5.1 Pharmacodynamic properties- Clinical trials and Section 4.4
Special warnings and precautions for use).
The Women’s Health Initiative Memory Study (WHIMS), a sub-study of
WHI, reported increased risk of
developing probable dementia in postmenopausal women 65 years of age
or older during 4 to 5.2 years of treatment
with conjugated estrogens, with or without medroxyprogesterone
acetate, relative to placebo. It is unknown
whether this finding applies to younger postmenopausal women (see
Section 5.1 Pharmacodyn