IMVAGGIS 0.03 mg pessary

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Estriol

Available from:

Laboratoires Besins International

ATC code:

G03CA; G03CA04

INN (International Name):

Estriol

Dosage:

0.03 milligram(s)

Pharmaceutical form:

Pessary

Prescription type:

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

Therapeutic area:

Natural and semisynthetic estrogens, plain; estriol

Authorization status:

Marketed

Authorization date:

2018-03-16

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
IMVAGGIS 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 IMVAGGIS is and what it is used for
2.
What you need to know before you use IMVAGGIS
3.
How to use IMVAGGIS
4.
Possible side effects
5.
How to store IMVAGGIS
6.
Contents of the pack and other information
1.
WHAT IMVAGGIS IS AND WHAT IT IS USED FOR
IMVAGGIS
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.
IMVAGGIS
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 IMVAGGIS
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 medical history.
Your doctor may decide to perform a physical e

Summary of Product characteristics

Health Products Regulatory Authority
04 April 2022
CRN00CSTP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
IMVAGGIS 0.03 mg pessary
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
a