FEMOSTON 2/10 estradiol 2mg and estradiol 2mg with Dydrogesterone 10mg tablet blister pack (CP)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dydrogesterone, Quantity: 10 mg; estradiol, Quantity: 2 mg

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: magnesium stearate; hypromellose; colloidal anhydrous silica; lactose monohydrate; maize starch; titanium dioxide; purified talc; iron oxide yellow; macrogol 400

Administration route:

Oral

Units in package:

84 tablets (42 of each tablet), 28 tablets (14 of each tablet)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Hormone Replacement therapy (HRT) in oestrogen deficiency associated with natural or artificial menopause in women with an intact uterus. Prevention of postmenopausal bone mineral density loss in women. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration should be used with the goal being short term use (See DOSAGE AND ADMINISTRATION and CLINICAL TRIALS). When prescribed solely for the prevention of postmenopausal bone mineral density loss in women, therapy should only be prescribed for women who are at high risk of future fracture and who are intolerant of, or contraindicated for non-oestrogen products approved for prevention of osteoporosis. Life style modifications and the risk benefit profile of FEMOSTON should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing( See PRECAUTIONS and DOSAGE AND ADMINISTRATION).

Product summary:

Visual Identification: Round, biconvex, yellow, film-coated tablet, bearing the inscription 379 on one side.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2000-09-08

Patient Information leaflet

FEMOSTON
® 2/10
F
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o
s
t
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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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHEN I MUST NOT USE FEMOSTON?
Do not use FEMOSTON or other estrogens, with or without a progestogen
to prevent heart attacks, stroke or dementia.
2.
WHY AM I USING FEMOSTON?
FEMOSTON contains the active ingredients estradiol and dydrogesterone.
It is used to relieve the discomfort many women feel
during and after the menopause. It also helps to prevent thinning of
the bones, which can cause fractures. FEMOSTON is used by
women who still have a uterus (womb). For more information, see
Section 2. Why am I using FEMOSTON? in the full CMI.
3.
WHAT SHOULD I KNOW BEFORE I USE FEMOSTON?
Do not use if you have ever had an allergic reaction to any medicine
containing estradiol or dydrogesterone 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 3. What should I know before I
use FEMOSTON? in the full CMI.
4.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FEMOSTON and affect how it works. A
list of these medicines is in Section 4. What if I am
taking other medicines? in the full CMI.
5.
HOW DO I USE FEMOSTON?
•
Follow all directions given to you by your doctor carefully. The usual
dose is one tablet daily. More instructions can be found in
Section 5. How do I use FEMOSTON? in the full CMI.
6.
WHAT SHOULD I KNOW WHILE USING FEMOSTON?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
FEMOSTON.
•
If you become pregnant while you are taking this medicine, tell your
doctor or pharmacist immediately.
•
See your doctor at least once a year fo

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FEMOSTON
® 2/10
_estradiol (as hemihydrate) and dydrogesterone tablets _
1
NAME OF THE MEDICINE
Estradiol (as hemihydrate) and dydrogesterone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FEMOSTON 2/10 tablets are immediate-release film-coated tablets for
oral use, with each tablet containing 2
mg estradiol (as hemihydrate) and 10 mg dydrogesterone or 2 mg
estradiol (as hemihydrate).
Excipients with known effect: sugars (as lactose monohydrate)
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Each blister strip contains:
•
14 round, biconvex, brick-red, film-coated tablets, each containing 2
mg estradiol (as hemihydrate)
bearing the inscriptions "379" on one side, and
•
14 round, biconvex, yellow, film-coated tablets, each containing 2 mg
estradiol (as hemihydrate)
combined with 10 mg dydrogesterone bearing the inscriptions "379" on
one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone replacement therapy (HRT) in estrogen deficiency associated
with natural or artificial menopause
in women with an intact uterus. Prevention of postmenopausal bone
mineral density loss in women. For
initiation and continuation of treatment of postmenopausal symptoms,
the lowest effective dose for the shortest
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 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 (0.62