ESTRIOL 0.03 Milligram Pessary

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ESTRIOL

Available from:

Besins Healthcare (UK) Ltd

ATC code:

G03CA04

INN (International Name):

ESTRIOL

Dosage:

0.03 Milligram

Pharmaceutical form:

Pessary

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Natural and semisynthetic estrogens, plain

Authorization status:

Authorised

Authorization date:

2018-03-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESTRIOL 0.03 MG PESSARY
Estriol
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 any 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Estriol is and what it is used for
2.
What you need to know before you use Estriol
3.
How to use Estriol
4.
Possible side effects
5.
How to store Estriol
6.
Contents of the pack and other information
1.
WHAT ESTRIOL IS AND WHAT IT IS USED FOR
Estriol contains a female sex hormone (oestrogen) for the vaginal use
which is suitable for the treatment of
local complaints.
Estriol is used for

local treatment of disorders caused by estrogen deficiency in the
vaginal region in women after their last
regular menstrual period (menopause).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ESTRIOL
DO NOT USE ESTRIOL
if any of the following applies to you. If you are not sure about any
of the points below, TALK TO YOUR DOCTOR
before using Estriol.
Do not use Estriol

if you have or have had BREAST CANCER, or if you are suspected to
having it

if you have CANCER WHICH IS SENSITIVE TO OESTROGENS, such as cancer of
the womb lining
(Endometrium), or if you are suspected of having it

if you have EXCESSIVE THICKENING OF THE WOMB LINING (endometrial
hyperplasia) that is not being
treated

if you have any UNEXPLAINED VAGINAL BLEEDING

if you have or have ever had a BLOOD CLOT IN A VEIN (thrombosis), such
as in the legs (deep venous
thrombosis) or the lungs (pulmonary embolism)

if you have a BLOOD CLOTTING DISORDER (such as protein C, protein S,
or antithrombin deficiency)


Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Estriol 0.03 mg pessary
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pessary contains 0.03 mg estriol.
Excipient with known effect: butylhydroxytoluene
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pessary
White, homogenous pessaries.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Local treatment of vaginal symptoms of estrogen deficiency in
postmenopausal women.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
During the first 3 weeks of treatment one pessary is administered
daily. Thereafter a maintenance dose of 1 pessary
twice a week is recommended.
Method of administration and duration of treatment
The pessary should be introduced deeply into the vagina, preferably in
the evening before going to bed.
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose for the shortest
duration should be used (see also section 4.4).
Missed dose
during daily use within the first 3 weeks of treatment:
If a missed dose is not realized before the next day, it should not be
replaced. In that case the usual dosing schedule
should be resumed.
during twice-weekly use:
If the administration of the medicinal product has been forgotten at a
scheduled date during the twice-weekly
maintenance treatment, the missed dose should be administered as soon
as possible.
4.3 CONTRAINDICATIONS
Known, past or suspected breast cancer,
known or suspected estrogen-dependent malignant tumours (e. g.
endometrial cancer),
untreated endometrial hyperplasia,
undiagnosed genital bleeding,
previous idiopathic or current venous thromboembolism (deep venous
thrombosis, pulmonary embolism)
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__