SANDRENA estradiol 0.1% gel 1g sachets

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estradiol, Quantity: 1 mg/g

Available from:

Orion Pharma (AUS) Pty Limited

Pharmaceutical form:

Gel

Composition:

Excipient Ingredients: purified water; propylene glycol; carbomer 934P; ethanol; trolamine

Administration route:

Transdermal

Units in package:

91 sachets, 7 sachets sample pack, 28 sachets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short-term treatment of climacteric symptoms after natural or surgical menopause. Whenever possible the lowest effective dose should be used. Review the need for continuation of treatment after 6 months, taking into account the risk-benefit ratio for the individual user at that moment (including cardiovascular disease and breast cancer, see section 5.1 Pharmacodynamic properties - Clinical Trials and section 4.4 Special warnings and precautions for use). SANDRENA should only be continued for as long as the benefit outweighs the risks

Product summary:

Visual Identification: Smooth opalescent gel; Container Type: Sachet; Container Material: Al laminated with PVC/paper; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2003-04-08

Patient Information leaflet

SANDRENA GEL - Consumer Medicine Information
1
SANDRENA GEL
_estradiol _
CONSUMER MEDICINE INFORMATION (CMI)
_BEFORE ADMINISTRATION OF THIS MEDICINE PLEASE READ THIS LEAFLET
CAREFULLY. IF YOU HAVE ANY QUESTIONS OR WORRIES, ASK YOUR _
_DOCTOR OR PHARMACIST _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sandrena. It does not
contain all the available information.
It does not take the place to talking to
your doctor or pharmacist.
KEEP THIS INFORMATION WITH THE
PACK.
You may wish to read it again.
GENERAL ADVICE
1. This medicine has been
prescribed only for your current
medical problem. It should not be
used for other medical conditions.
2. Never give your medicine to
anyone else and do not use
medicines meant for other people.
3. Tell every doctor treating you
what medicines you are taking.
Always carry a medical
information card stating which
medicines you are using. This can
be very important if for example
you are involved in an accident.
4. Return unused medicines to your
pharmacy for disposal.
5. Make sure that other people who
live with you or who look after
you read this information.
A doctor's prescription is required to
obtain this medicine.
WHAT SANDRENA IS USED
FOR
During and after menopause the
production of sex hormones
produced by the body decreases.
Women may then suffer from
complaints such as hot flushes, night
sweats, vaginal irritation, depression,
and loss of sexual desire. Sandrena
can be used for the short-term relief
of menopausal complaints.
It can also relieve these symptoms in
women who have had their ovaries
removed. Relief of symptoms usually
starts within a few weeks, but
optimal results are obtained after
three months of treatment. Sandrena
is not intended for contraceptive use.
If you have not had a hysterectomy,
your doctor will probably combine
the Sandrena treatment with another
hormone product, a progestogen.
BEFORE YOU USE IT
Sandrena may not be suitable for you
if you suffer from certain medical
conditions.
_BEFORE YOU TAKE IT _
TELL YOUR DOCTOR IF YO

Summary of Product characteristics

PI – Sandrena (estradiol) gel
1 of 15
AUSTRALIAN PRODUCT INFORMATION –
SANDRENA (ESTRADIOL) GEL
1
NAME OF THE MEDICINE
estradiol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SANDRENA gel contains estradiol 1 mg/g.
Each sachet contains either 0.5 mg or 1.0 mg of estradiol.
For the full list of excipients, see _section 6.1 List of excipients_.
3
PHARMACEUTICAL FORM
Gel
The product is a smooth opalescent gel.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Short-term treatment of climacteric symptoms after natural or surgical
menopause. Wherever
possible the lowest effective dose should be used.
Review the need for continuation of treatment after 6 months, taking
into account the risk-
benefit ratio for the individual user at that moment (including
cardiovascular disease and
breast cancer, see _section 5.1 Pharmacodynamic properties –
Clinical Trials_ and _section 4.4 _
_Special warnings and precautions for Use_). SANDRENA should only be
continued for as long
as the benefit outweighs the risks.
4.2 DOSE AND METHOD OF ADMINISTRATION
SANDRENA is used either cyclically or continuously, in individually
adjusted doses of 0.5 g to
1.5 g per day, corresponding to 0.5 to 1.5 mg estradiol per day. Most
patients usually start
with a 1.0 mg estradiol dose daily. This can be adjusted after 2 to 3
cycles.
In patients with intact uteri it is recommended to combine SANDRENA
treatment with cyclic
progestin, for example 10 mg medroxyprogesterone acetate, 2.5 mg
norethisterone, 1-2 mg
norethisterone acetate or 10 mg dydrogesterone for 10 -14 days
monthly.
One to two dose units (0.5 g or 1.0 g) of SANDRENA (0.5 to 1.5 mg
estradiol) are applied
once daily on the skin of the lower trunk or the thigh. The
application surface area should be
one to two times the size of the hand. SANDRENA should not be applied
on the breasts, on
the face or on irritated or broken skin. Accidental contact of the gel
with the eyes should be
avoided. Hands should be washed thoroughly after application.
In clinical trials the use of SANDRENA has induced