Estriol 0.01% vaginal cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Estriol

Available from:

Atnahs Pharma UK Ltd

ATC code:

G03CA04

INN (International Name):

Estriol

Dosage:

100microgram/1gram

Pharmaceutical form:

Vaginal cream

Administration route:

Vaginal

Class:

No Controlled Drug Status

Prescription type:

Invalid to prescribe in NHS primary care

Product summary:

BNF: 07020100; GTIN: 5060129500039

Patient Information leaflet

This leaflet was last revised in January 2020

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
ESTRIOL 0.01% w/w Cream
GYNEST 0.01% w/w Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Estriol 0.01% w/w
Excipients: Arachis oil and Benzoic acid
For a full list of excipients, see Section 6.1
3
PHARMACEUTICAL FORM
Vaginal Cream.
Description of the product:
Estriol Cream is a whitish cream.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Hormone replacement therapy for treatment of atrophic vaginitis and
kraurosis in post-
menopausal women.
2.
Treatment of pruritus vulvae and dyspareunia associated with atrophic
vaginal
epithelium.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Gynest Cream is an estrogen-only product for intravaginal use.
No progestogen needs to be added (but please refer to section 4.4).
Guidance on how to start therapy and maintenance
Gynest Cream can be started any time after the manifestation of
atrophic vaginitis or
associated symptoms (eg dyspareunia, pruritus).
The recommended initial daily dose is one applicator full per day.
A maintenance dose of one applicator full twice a week may be used
after restoration
of the vaginal mucosa has been achieved.
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. Attempts
to discontinue medication should be made at three to six month
intervals following
physical examination.
Missed Dose: When a dose is inadvertently forgotten, resume dosing
when the
omission is realized.
Administration:
Gynest Cream is to be applied into the vagina, using an applicator.
The applicator
holds 5ml of cream containing 0.5mg estriol. The filled applicator
should be inserted
high into the vagina and emptied, preferably in the evening.
Remove the cap from a new tube and use the top of the cap to pierce
the metal seal on
the tube.
One end of the applicator is fitted with a plunger. Ensure the plunger
is fully inserted
into the applicator. Screw the other end of the applicator onto the
tube. Sque