Ovestin 1mg cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estriol

Available from:

Aspen Pharma Trading Ltd

ATC code:

G03CA04

INN (International Name):

Estriol

Dosage:

1mg/1gram

Pharmaceutical form:

Vaginal cream

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07020100; GTIN: 5013257000483

Patient Information leaflet

Read all of this leaflet carefully before you
start using this medicine.
•
Keep this leaflet. You may need to
read it again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Ovestin is and what it is used for
2. Before you use Ovestin
3. How to use Ovestin
4. Possible side effects
5. How to store Ovestin
6. Further information
1. What Ovestin is and
what it is used for
The name of your medicine is Ovestin 1 mg
cream. Ovestin contains a medicine called estriol.
Ovestin belongs to a group of medicines called
Hormone Replacement Therapy (HRT).
It is used to relieve menopausal symptoms in the
vagina such as dryness or irritation. In medical
terms this is known as ‘vaginal atrophy’. It is
caused by a drop in the levels of oestrogen
in your body. This happens naturally after the
menopause.
Ovestin works by replacing the oestrogen which
is normally produced in the ovaries of women.
It is inserted into your vagina, so the hormone
is released where it is needed. This may relieve
discomfort in the vagina.
When women get older the ovaries gradually
produce less oestrogen.
• This happens at the menopause (usually around
the age of 50).
• If the ovaries are removed before the
menopause, oestrogen production stops
very suddenly.
Shortage of oestrogens may cause the vaginal
wall to become thin and dry. So sexual
intercourse may become painful and you may
get vaginal infections. These problems can be
relieved by using medicines like Ovestin which
contain oestrogen. It may take several days or
weeks before you notice an improvement.
Ovestin is used:
•
Before or after vaginal surgery to help
wound healing.
2.
What you need to
know before you
use Ovestin
Medical history and regular check-ups
Th

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ovestin 1 mg cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1mg estriol in 1g cream
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Vaginal cream
Homogeneous, smooth, white to nearly white mass of creamy consistency.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
TREATMENT OF VAGINAL OESTROGEN DEFICIENCY SYMPTOMS:
•
Treatment of symptoms of vaginal atrophy due to oestrogen deficiency
in postmenopausal women.
•
As pre-surgery therapy for vaginal operations and during subsequent
convalescence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Ovestin cream is an estrogen-only product for intravaginal use._ _
_ _
_Adults and Elderly _
•
Treatment of atrophic vaginitis
1 application per day for the first weeks (maximally 4 weeks),
followed by a
gradual reduction, based on relief of symptoms, until a maintenance
dosage
(e.g. 1 application twice a week) is reached.
•
Pre-surgery therapy
One applicator-dose per day should begin 2 weeks before the operation.
•
Post-surgery therapy
Following surgery a period of at least 2 weeks should be allowed
before
resuming therapy using one applicator-dose twice a week.
A missed dose should be administered as soon as remembered, unless it
is more than
12 hours overdue. In the latter case the missed dose should be skipped
and the next
dose should be administered at the normal time. Two doses should never
be
administered on the same day.
_Route of Administration _
Ovestin cream is administered intravaginally by means of a calibrated
applicator.
One applicator-dose (applicator filled to the red mark) is 0.5g
Ovestin cream
containing 0.5 mg estriol.
The following ‘Instructions for Use’ should be given to the
patient and are included in
the Patient Information Leaflet:
How to Apply the Cream
Use the applicator to apply the cream in the vagina. A good time to do
this is before
going to bed.
The applicator has a ring marked on the body. Fill the applicator up
to the ring mark
with Ovesti