Progynova TS 50micrograms/24hours transdermal patches

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Estradiol

Disponível em:

Bayer Plc

Código ATC:

G03CA03

DCI (Denominação Comum Internacional):

Estradiol

Dosagem:

50microgram/24hour

Forma farmacêutica:

Transdermal patch

Via de administração:

Transdermal

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06040101; GTIN: 5016703003663

Folheto informativo - Bula

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Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
PACKAGE BOOKLET: INFORMATION FOR THE USER
PROGYNOVA TS 50 MICROGRAMS/24 HOURS TRANSDERMAL PATCH
Estradiol
READ ALL OF THIS BOOKLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this booklet. You may need to read it again.

If you have any further questions, 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 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
......................................................................................................................................

Características técnicas

OBJECT 1
PROGYNOVA TS 50 MICROGRAMS/24 HOURS
TRANSDERMAL PATCH
Summary of Product Characteristics Updated 28-Sep-2017 | Bayer plc
1. Name of the 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 conti