Ovestin 1mg tablet blister pack

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

estriol, Quantity: 1 mg

から入手可能:

Aspen Pharmacare Australia Pty Ltd

医薬品形態:

Tablet, uncoated

構図:

Excipient Ingredients: amylopectin; potato starch; lactose monohydrate; magnesium stearate

投与経路:

Oral

パッケージ内のユニット:

30 tablets

クラス:

Medicine Registered

処方タイプ:

(S4) Prescription Only Medicine

適応症:

Short-term treatment of menopausal syndrome. Review the need for continuation of treatment after 6 months treatment, taking into account the risk-benefit ratio for the individual user at that moment (including cardiovascular disease and breast cancer, refer to clinical trials and precautions). Ovestin tablets should only be continued for as long as the benefit outweighs the risks.

製品概要:

Visual Identification: white flat round tablet with bevelled edges and a single breakline. Coded DG above 7 on one side, below the score line.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius

認証ステータス:

Registered

承認日:

1991-09-20

情報リーフレット

OVESTIN
®
TABLETS
1
OVESTIN
®
TABLETS
_estriol 1 mg_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ovestin tablets.
It does not contain all the available
information and 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 taking Ovestin
Tablets against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST
KEEP THIS LEAFLET.
You may need to read it again.
WHAT OVESTIN TABLETS
ARE USED FOR
Ovestin tablets is a Hormone
Replacement Therapy (HRT). It
contains the female hormone oestriol
(an oestrogen). Ovestin is used in
postmenopausal women with at least
12 months since their last natural
period. Ovestin is used for relief of
symptoms occurring after
menopause. During menopause, the
amount of oestrogens produced by a
woman's body gradually drops. If the
ovaries are removed surgically
(ovariectomy) before menopause, the
decrease in oestrogen production
occurs very abruptly. In many cases
the decrease in oestrogen production
leads to well-known menopausal
complaints such as hot flushes and
night sweating. The shortage of
oestrogens may cause the vaginal
wall to become thin and dry. As a
result sexual intercourse become
painful and vaginal itching and
infections may occur. Oestrogen
deficiency may also lead to
symptoms like urinary incontinence
and recurrent cystitis. Ovestin
alleviates these symptoms after
menopause. It may take several days
or even weeks before you notice an
improvement. You will only be
prescribed Ovestin if your symptoms
seriously hinder your daily life. In
addition to the above uses, Ovestin
Tablets may also be prescribed to
treat certain forms of infertility,
improve wound healing in
postmenopausal women undergoing
vaginal surgery or help assess
cervical smears taken from
postmenopausal women.
A doctor's prescription is required to
obtain this medicine.
This medicine is

製品の特徴

1
AUSTRALIAN PRODUCT INFORMATION
OVESTIN (ESTRIOL) TABLETS
1
NAME OF THE MEDICINE
Ovestin
®
Tablets 1 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Tablets, each containing 1 mg oestriol.
Ovestin Tablets 1 mg are white, round, flat, scored tablets, with
bevelled edges. All
tablets are coded "DG" above "7" below the score line on one side. The
score line is
only to facilitate breaking for ease of swallowing and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
•
Short-term treatment of menopausal syndrome.
Review the need for continuation of treatment after 6 months
treatment, taking into
account the risk- benefit ratio for the individual user at that moment
(including
cardiovascular disease and breast cancer, refer to SECTION 4.4 SPECIAL
WARNING AND
PRECAUTIONS FOR USE). Ovestin tablets should only be continued for as
long as the
benefit outweighs the risks.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Ovestin is an oestrogen-only product that may be given to women with
or without a uterus.
•
Ovestin tablets should be taken orally and swallowed with some water
or other
drink, preferably at the same time every day.
•
When initiating therapy, depending on the severity of the symptoms, a
daily
dosage of up to 4 mg (4 tablets) will usually be required. This dosage
should be
given in the first 5 to 7 days and can then be reduced to the
maintenance level
(1 to 2 mg daily, i.e. 1 to 2 tablets) in the course of the following
1 to 3 weeks
depending on the degree of patient response. The lowest dose which
will control
the symptoms should be used.
•
Oestriol tablets should be prescribed for the shortest duration
consistent with
treatment goals. Review the need for continuation of treatment at
least every
6 months, taking into account the risk-benefit ratio for the
individual user at
2
that moment (refer to SECTION 4.4 SPECIAL WARNING AND PRECAUTIONS FOR
USE and SECTION 4.1 THERAPEUTIC INDICATIONS).