Estriol DR. KADE 0,03 mg ovules

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ESTRIOL 0,03 mg/stuk

Beschikbaar vanaf:

Dr. Kade Pharmazeutische fabrik GMBH Rigistrasse 2 12277 BERLIN (DUITSLAND)

ATC-code:

G03CA04

INN (Algemene Internationale Benaming):

ESTRIOL 0,03 mg/stuk

farmaceutische vorm:

Ovule

Samenstelling:

BUTYLHYDROXYTOLUEEN (E 321) ; GLYCERYLMONORICINOLAAT (E 471) ; HARD VET ; MACROGOLCETOSTEARYLETHER,

Toedieningsweg:

Vaginaal gebruik

Therapeutisch gebied:

Estriol

Product samenvatting:

Hulpstoffen: BUTYLHYDROXYTOLUEEN (E 321); GLYCERYLMONORICINOLAAT (E 471); HARD VET; MACROGOLCETOSTEARYLETHER;

Autorisatie datum:

2018-05-23

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ESTRIOL DR. KADE 0,03 MG OVULES
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 is and what it is used for
2.
What you need to know before you use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
belongs to a group of medicines called vaginal 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.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when deciding
whether to start using it, or whether
to carry on using it.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is limited.
If you have a premature menopause the risks of using HRT may be
different. Please talk to your doctor.
Before you start (or restart) HRT, your doctor will ask about your own
and your family’s

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Estriol DR. KADE 0,03 mg ovules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 pessary contains 0.03 mg estriol.
Excipient with known effect:
Each pessary contains a maximum of 0.008 mg 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.
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).
For estrogen products for vaginal application of which the systemic
exposure to the estrogen is very
low, it is not recommended to add a progestagen (but see section 4.4).
Method of administration
The pessary should be introduced deeply into the vagina, preferably in
the evening before going to
bed.
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);
−
Undiagnosed genital bleeding;
−
Untreated endometrial hyperplasia;
−
Previous or current venous thromboembolism (deep venous thrombosis,
pulmonary embolism);
−
Known thrombophilic disorders (e.g. protein C, protein S, or
antithrombin deficiency, see
section 4.4);
−
Act