OVESTIN OVULA 0.5mg pessary strip pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

estriol, Quantity: 0.5 mg

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Pessary, moulded

Composition:

Excipient Ingredients: Hard fat; cetomacrogol 1000; glyceryl ricinoleate

Administration route:

Vaginal

Units in package:

15 pessaries, 5 PESSARIES

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Vulvo-vaginal complaints due to oestrogen deficiency associated with the climacteric and the postmenopause or after ovariectomy - Atrophic vaginitis; - Pruritus vulvae; - Dyspareunia due to vulvo-vaginal atrophy; - As auxillary therapy in the treatment of vaginal infections - As pre-operative therapy for vulvo-vaginal surgery and during subsequent convalescence; - Ulcers in cases of prolapse of the uterus or vagina; - To avoid misinterpretation of a cytological smear.

Product summary:

Visual Identification: White to light cream coloured torpedo shaped pessaries of uniform texture.; Container Type: Strip Pack; Container Material: PVC; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-11-23

Patient Information leaflet

OVESTIN OVULA
1
OVESTIN OVULA
®
_estriol 0.5 mg per pessary _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ovestin Ovula.
It does not contain all of 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 using Ovestin Ovula
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT OVESTIN OVULA IS
USED FOR
Ovestin Ovula 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. The shortage of
oestrogens during menopause may
cause the vaginal wall to become thin
and dry. As a result, sexual
intercourse may 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 o

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
OVESTIN OVULA (ESTRIOL) PESSARY
1
NAME OF THE MEDICINE
Ovestin Ovula
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pessaries, each containing 0.5 mg estriol.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Vulvo-vaginal complaints due to oestrogen deficiency associated with
the climacteric
and the postmenopause or after ovariectomy:
•
Atrophic vaginitis
•
Pruritus vulvae
•
Dyspareunia due to vulvo-vaginal atrophy
•
As auxiliary therapy in the treatment of vaginal infections
•
As pre-operative therapy for vulvo-vaginal surgery and during
subsequent
convalescence
•
Ulcers in cases of prolapse of the uterus or vagina
•
To avoid misinterpretation of a cytological smear
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 Ovula is intended for intravaginal administration, before
retiring at night.
Each pessary contains 0.5 mg estriol.
•
For initiation and continuation of treatment of postmenopausal
symptoms, the
lowest effective dose for the shortest duration of time should be used
(see
SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
•
Usual dosage for vulvo-vaginal complaints associated with the
menopause: one
pessary per day for 2-3 weeks initially.
•
As maintenance dosage, one pessary once or twice a week is
recommended.
2
Medication should be discontinued every 2 to 3 months for a period of
4
weeks to assess the necessity for further treatment.
•
Pre-surgery therapy (one pessary per day) should begin 2 weeks before
the
operation
(see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
•
In the case of a suspect cytological smear a daily application of 0.5
mg estriol
for 7 days is recommended before re-evaluating the cytology.
•
A missed dose should be administered as soon as remembered, unless the
missed
dose is noticed at the day of the next dose. In the latter case th