Sandrena 500microgram gel sachets

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Estradiol hemihydrate

Disponível em:

Orion Pharma (UK) Ltd

Código ATC:

G03CA03

DCI (Denominação Comum Internacional):

Estradiol hemihydrate

Dosagem:

500microgram

Forma farmacêutica:

Transdermal gel

Via de administração:

Transdermal

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 06040101; GTIN: 5013257001312

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
SANDRENA_ _0.5 MG GEL
SANDRENA_ _1 MG GEL
ESTRADIOL
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, 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 Sandrena is and what it is used for
2.
What you need to know before you use Sandrena
3.
How to use Sandrena
4.
Possible side effects
5.
How to store Sandrena
6.
Contents of the pack and other information
1. WHAT SANDRENA IS AND WHAT IT IS USED FOR
Sandrena is a Hormone Replacement Therapy (HRT). It contains the
female hormone oestrogen.
Sandrena is used for:
RELIEF OF SYMPTOMS OCCURRING AFTER MENOPAUSE
During the menopause, the amount of the oestrogen produced by a
woman’s body drops. This
can cause symptoms such as hot face, neck and chest (“hot
flushes”). Sandrena alleviates these
symptoms after menopause. You will only be prescribed Sandrena if your
symptoms seriously
hinder your daily life.
You must talk to your doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SANDRENA
MEDICAL HISTORY AND REGULAR CHECK-UPS
The use of HRT carries risks which need to be considered when deciding
whether to start taking
it, or whether to carry on taking 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 examinat

Características técnicas

OBJECT 1
SANDRENA 0.5 MG GEL
Summary of Product Characteristics Updated 27-May-2016 | Orion Pharma
(UK) Limited
1. Name of the medicinal product
Sandrena 0.5 mg gel
2. Qualitative and quantitative composition
Estradiol hemihydrate corresponding to 0.5 mg estradiol per
single-dose container.
Excipient with known effect: propylene glycol
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gel, single-dose container. Smooth, opalescent gel.
4. Clinical particulars
4.1 Therapeutic indications
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women.
The experience of treating women more than 65 years old is limited.
4.2 Posology and method of administration
Posology
Sandrena is a gel for transdermal use. Sandrena can be used for
continuous or cyclical treatment.
The usual starting dose is 1.0 mg estradiol (1.0 g gel) daily but the
selection of the initial dose can be
based on the severity of the patient's symptoms. Depending on the
clinical response, the dosage can be
readjusted after 2-3 cycles individually from 0.5 g to 1.5 g per day,
corresponding to 0.5 to 1.5 mg
estradiol per day. 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.
In patients with an intact uterus, it is recommended to combine
Sandrena with an adequate dose of
progestagen, for adequate duration for at least 12-14 consecutive days
per month/28 day cycle or to
oppose oestrogen-stimulated hyperplasia of the endometrium. Unless
there is a previous diagnosis of
endometriosis, it is not recommended to add a progestagen in
hysterectomised women.
In women who are not using hormone replacement therapy (HRT), or women
transferring from
continuous combined HRT product, treatment with Sandrena may be
started on any convenient day. In
women transferring from a continuous sequential HRT regimen, treatment
should begin the day following
completion of the prior regimen.
If the patient has forgot