OVESTIN

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

ESTRIOL

Tilgjengelig fra:

PADAGIS ISRAEL AGENCIES LTD, ISRAEL

ATC-kode:

G03CA04

Legemiddelform:

CREAM

Sammensetning:

ESTRIOL 0.1 %

Administreringsrute:

VAGINAL

Resept typen:

Required

Produsert av:

ASPEN PHARMA TRADING LTD, IRELAND

Terapeutisk område:

ESTRIOL

Indikasjoner:

For the treatment of vulvo-vaginal complaints related to estrogen deficiency.

Autorisasjon dato:

2016-10-27

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE WITH
THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
OVESTIN
®
CREAM
Estriol 0.1% w/w
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each gram of cream contains 1 mg Estriol.
One dose (when the amount of cream in the applicator reaches the ring
mark) contains 0.5 g OVESTIN CREAM corresponding
to 0.5 mg Estriol.
For a list of inactive ingredients, see section 6 “FURTHER
INFORMATION”. Also see section 2 “IMPORTANT INFORMATION REGARDING
SOME OF THE INGREDIENTS OF THE MEDICINE”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet contains concise information about
the medicine. If you have further questions, ask the doctor or
pharmacist.
• This medicine has been prescribed for your treatment. Do not pass
it on to others. It may harm them even if it seems to
you that their medical condition is similar.
• If any of the side effects worsen, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended for the treatment of vaginal disorders due to
estrogen deficiency.
THERAPEUTIC GROUP: OVESTIN CREAM contains an active ingredient called
estriol. It belongs to a group of medicines called
HORMONE REPLACEMENT THERAPY (HRT).
Estriol (the active ingredient in OVESTIN CREAM) is one of the natural
estrogens.
• Estrogens are female sex hormones.
• Estrogens are produced in the ovaries.
• Estrogens cause sexual development in women and control the
menstrual cycle during the child-bearing years.
When women get older, the ovaries gradually produce less estrogen.
• This process happens at menopause (usually around the age of 50).
• If the ovaries are removed before the menopause, estrogen
production stops suddenly.
Shortage of estrogens may cause the vaginal wall to become thin and
dry, so that sexual intercourse may become painful
and you may get vaginal infections. These problems c

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OVESTIN CREAM
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Estriol 0.1% w/w (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
For the treatment of vulvo-vaginal complaints related to estrogen
deficiency.
4.2
Posology and method of administration
Ovestin cream is an estrogen-only product for intravaginal use.
One applicator-dose (applicator filled to the red mark) is 0.5g
Ovestin cream
containing 0.5 mg estriol.
_Adults and Elderly _
•
Treatment of atrophic vaginitis
For initiation and continuation of treatment of postmenopausal
symptoms,
the lowest effective dose for the shortest duration (see also section
4.4)
should be used.
The usual dose for atrophic vaginitis associated with the menopause is
one applicator-dose per day for 2 to 3 weeks.
As maintenance dosage, one applicator-dose twice a week is
recommended.
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 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.
In women not taking HRT or women who switch from another continuous
combined HRT product, treatment with Ovestin cream may be started on
any
day. Women who switch from cyclic HRT regimen should start Ovestin
cream
treatment one week after completion of the cycle.
_Route of Administration _
Ovestin cream is administered intravaginally by means of a calibrated
applicator.
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