FEMOSTON-CONTI tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol, Quantity: 1 mg (Equivalent: estradiol hemihydrate, Qty 1.03 mg); dydrogesterone, Quantity: 5 mg

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

56 tablets, 7 tablets, 84 tablets, 28 tablets

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 uteri. Prevention of postmenopausal bone mineral density loss in women. For initiation and continuation of treatment of postmenopausal symptoms, the lowest possible effective dose for the shortest duration should be used with the goal being short term use.

Product summary:

Visual Identification: Round, biconvex, salmon, 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:

2001-05-30

Patient Information leaflet

FEMOSTON
®
-CONTI
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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-CONTI?
Do not use FEMOSTON-CONTI or other estrogens, with or without a
progestogen to prevent heart attacks, stroke or dementia.
2.
WHY AM I USING FEMOSTON-CONTI?
FEMOSTON-CONTI 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. It is used by women
who still have a uterus (womb). For more information, see Section 2.
Why am I using FEMOSTON-CONTI? in the full CMI.
3.
WHAT SHOULD I KNOW BEFORE I USE FEMOSTON-CONTI?
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-CONTI? in the full CMI.
4.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with FEMOSTON-CONTI 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-CONTI?
•
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-CONTI? in the full CMI.
6.
WHAT SHOULD I KNOW WHILE USING FEMOSTON-CONTI?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
FEMOSTON-CONTI.
•
If you become pregnant while you are taking this medicine, tell yo

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
FEMOSTON
®
-CONTI
_estradiol (as hemihydrate) and dydrogesterone tablets _
1
NAME OF THE MEDICINE
Estradiol (as hemihydrate) and dydrogesterone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FEMOSTON-CONTI tablets are immediate-release, film-coated tablets for
oral use containing 1 mg
estradiol (as hemihydrate) and 5 mg dydrogesterone.
Excipients with known effect: sugars (as lactose monohydrate).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Round, biconvex, salmon-coloured, film-coated tablets each containing
1 mg estradiol (as hemihydrate) and
5 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 duration should be used with the goal being short term use.
(see Section 4.2 DOSE AND METHOD
OF ADMINISTRATION and Section 5.1 PHARMACODYNAMIC PROPERTIES –
Clinical Trials).
When prescribed solely for the prevention of postmenopausal bone
mineral density loss, therapy should only
be prescribed for women who are at high risk of osteoporosis and
future fracture and who are intolerant of, or
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 increa