VAGIFEM LOW estradiol 10 ug (as hemihydrate) modified release pessary blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol hemihydrate, Quantity: 10.3 microgram (Equivalent: estradiol, Qty 10 microgram)

Available from:

Novo Nordisk Pharmaceuticals Pty Ltd

INN (International Name):

estradiol hemihydrate

Pharmaceutical form:

Pessary, modified release

Composition:

Excipient Ingredients: macrogol 6000; magnesium stearate; lactose monohydrate; hypromellose; maize starch

Administration route:

Vaginal

Units in package:

18 modified release pesaries, 24 modified release pessaries, 8 modified release pessaries, 6 modified release pessaries

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Vagifem Low is indicated for the treatment of atrophic vaginitis due to oestrogen deficiency. Vagifem Low is not intended for children or males.

Product summary:

Visual Identification: White film-coated round biconvex pessary, 6mm diameter, marked NOVO 278 on one side and blank on the obverse.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2010-10-19

Patient Information leaflet

Vagifem
®
Low
Page 1 of 5
Vagifem Low cmi-v14
VAGIFEM
®
LOW
_Estradiol _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
WHAT VAGIFEM® LOW IS USED FOR 1
BEFORE YOU USE VAGIFEM
® LOW .... 1
HOW TO USE VAGIFEM
® LOW .......... 3
WHILE YOU ARE USING VAGIFEM
® LOW ....................................................... 3
SIDE EFFECTS .................................... 3
STORAGE .......................................... 4
PRODUCT DESCRIPTION .................... 4
DIRECTIONS FOR USE ........................ 5
This leaflet answers some common
questions about Vagifem
®
Low. It does
not contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you using Vagifem
®
Low against the
benefits they expect it will have for you.
ASK YOUR DOCTOR OR PHARMACIST IF YOU
HAVE ANY CONCERNS ABOUT USING THIS
MEDICINE.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
Vagifem
®
Low is available only by
prescription at pharmacies.
WHAT VAGIFEM
® LOW IS
USED FOR
Vagifem
®
Low is a local hormone
replacement therapy (HRT). Vagifem
®
Low is a modified release pessary
containing the female sex hormone,
estradiol. The estradiol in Vagifem
®
Low is identical to the estradiol
produced in the ovaries of women, and is
classified as a natural estrogen.
Vagifem
®
Low is prescribed to treat a
condition called atrophic vaginitis. The
symptoms include dryness and irritation
in the vagina, and pain during sexual
intercourse. Atrophic vaginitis is caused
by a loss of the female sex hormone,
estrogen, which occurs around the
menopause.
Vagifem
®
Low when placed in the
vagina allows estradiol to be released.
This may relieve discomfort in the
vagina.
Your doctor may have prescribed
Vagifem
®
Low for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY VAGIFEM
® LOW
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE
VAGIFEM
® LOW
_WHEN YOU MUST NOT USE IT _
DO NOT USE VAGIFEM
® LOW I

Summary of Product characteristics

Vagifem Low pi-v10
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
VAGIFEM
® LOW
ESTRADIOL 10 ΜG (AS HEMIHYDRATE) MODIFIED RELEASE PESSARY BLISTER
PACK
1.
NAME OF THE MEDICINE
Estradiol hemihydrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vagifem Low is an estrogen preparation for intravaginal application
based on the active
human estrogen estradiol. The Vagifem Low modified release pessary
formulation is based
on a hydrophilic cellulose-derived matrix which on contact with
moisture hydrates and
provides a controlled release of estradiol.
Each modified release pessary contains 10 µg estradiol (as
hemihydrate).
Excipient with known effect: lactose monohydrate. For the full list of
excipients, see ‘Section
6.1 List of Excipients.’
3.
PHARMACEUTICAL FORM
Modified release pessary.
Each pessary is white, film-coated, biconvex, 6 mm in diameter, and
marked with ‘Novo 278’
on one side and blank on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vagifem Low is indicated for the treatment of atrophic vaginitis due
to estrogen deficiency in
postmenopausal women.
Vagifem Low is not intended for children or males.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage
Vagifem Low may be used in women with or without an intact uterus.
Initial dose: 1 modified release pessary daily for 2 weeks.
Maintenance dose: 1 modified release pessary twice a week.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest
effective dose for the shortest duration (see ‘Section 4.4 Special
Warnings and Precautions
for Use’) should be used. Patient review should occur 3-6 months
after treatment initiation.
Reassessment of risks and benefits should occur no less frequently
than annually.
Method of Administration
Vagifem Low is administered deep intravaginally using the applicator.
Vagifem Low pi-v10
Page 2 of 14
If a dose is forgotten, it should be taken as soon as the patient
remembers. A double dose
should be avoided.
4.3
CONTRAINDICATIONS
•
Known, suspected or past history of carcinoma of the b