Progynova TS 50 micrograms/24 hours Transdermal Patch

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

ESTRADIOL

זמין מ:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

קוד ATC:

G03CA03

INN (שם בינלאומי):

ESTRADIOL 50 µg/24 h

טופס פרצבטיות:

TRANSDERMAL PATCH

הרכב:

ESTRADIOL 50 µg/24 h

סוג מרשם:

POM

איזור תרפויטי:

SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM

מצב אישור:

Withdrawn

תאריך אישור:

2005-09-02

עלון מידע

PACKAGING TECHNOLOGY BERLIN SGQWX
page 1
Bayer AG
client: JS86
material-no.: 86406306
PZ: 2599F-4A
code-no.: 334
name: LF-INS-PROGYNOVA TS 50 PAT GB
country: GB/-/BPH
colors: BLACK
version: 12.07.2018/03
Restricted Document
dimension: 594 X 160 MM
READ ALL OF THIS BOOKLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
R Keep this booklet. You may need to read it again.
R If you have any further questions, ask your doctor or
pharmacist.
R 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.
R 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 BOOKLET
1.
WHAT PROGYNOVA TS 50 IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
PROGYNOVA TS 50
MEDICAL HISTORY AND REGULAR CHECK-UPS
DO NOT USE PROGYNOVA TS 50
WARNINGS AND PRECAUTIONS
HRT AND CANCER
EFFECTS OF HRT ON HEART AND CIRCULATION
OTHER CONDITIONS
OTHER MEDICINES AND PROGYNOVA TS 50
LABORATORY TESTS
PREGNANCY, BREAST-FEEDING AND FERTILITY
DRIVING OR USING MACHINES
3.
HOW TO USE PROGYNOVA TS 50
APPLYING THE PATCH
IF YOU HAVE BEEN TAKING OTHER HRT PREPARATIONS
IF YOU APPLY MORE PROGYNOVA TS 50 THAN YOU SHOULD
IF A PATCH FALLS OFF OR IF YOU FORGET TO APPLY
PROGYNOVA TS 50
IF YOU STOP USING PROGYNOVA TS 50
IF YOU NEED TO HAVE SURGERY
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE PROGYNOVA TS 50
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT PROGYNOVA TS 50 IS AND
WHAT IT IS USED FOR
Progynova TS 50 is a Hormone Replacement Therapy (HRT). It
contains the female hormone oestrogen. Progynova TS 50 is
used in postmenopausal women with at least 12 months
(1 year) since their last natural period.
PROGYNOVA TS 50 IS USED FOR:
RELIEF OF SYMPTOMS OCCURING AFTER MENOPAUSE
During the menopause, the amount of oestrogen produced by
a woman’s body drops. This can cause symptoms such as hot
face, neck and ch

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF MEDICINAL PRODUCT
Progynova® TS 50 micrograms/24 hours Transdermal Patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 12.5 cm
2
patch contains 3.8 mg estradiol (formed from 3.9 mg estradiol
hemihydrate),
releasing a nominal 50 micrograms of estradiol per 24 hours.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal patch.
Oval transdermal patch with a translucent homogenous matrix on a
transparent carrier film.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS

Hormone replacement therapy for oestrogen deficiency symptoms in
postmenopausal
women more than 1 year postmenopause.

Prevention of osteoporosis in postmenopausal women at high risk of
future fractures who are
intolerant of, or contraindicated for, other medicinal products
approved for the prevention of
osteoporosis. (See also Section 4.4)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Progynova TS 50 is an oestrogen-only patch applied to the skin once
weekly.
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.
Treatment to control menopausal
symptoms should be initiated with the lowest Progynova TS patch dose.
If considered necessary, a
higher dosed patch should be used. Once treatment is established the
lowest effective dose patch
necessary for relief of symptoms should be used.
For prevention of postmenopausal osteoporosis Progynova TS 50 is
recommended. Women
receiving Progynova TS 100 for postmenopausal symptoms can continue at
this dose.
In women with an intact uterus, a progestogen should be added to
Progynova TS 50 for at least 12-
14 days each month. Unless there is a previous diagnosis of
endometriosis, it is not recommended
to add a progestogen in hysterectomised women.
_For continuous use:_
_ _
The patches should be applied once weekly on a continuous basis, each
used patch being
removed after 7 days and a fresh patch a