Evorel 100 patches

Země: Velká Británie

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivní složka:

Estradiol

Dostupné s:

Theramex HQ UK Ltd

ATC kód:

G03CA03

INN (Mezinárodní Name):

Estradiol

Dávkování:

100microgram/24hour

Léková forma:

Transdermal patch

Podání:

Transdermal

Třída:

No Controlled Drug Status

Druh předpisu:

Valid as a prescribable product

Přehled produktů:

BNF: 06040101; GTIN: 5012946314085

Informace pro uživatele

- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVOREL
®
Estradiol
Evorel is a registered trademark
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 5.
WHAT IS IN THIS LEAFLET
1.
What Evorel is and what it is used for
2.
What you need to know before you use Evorel
3.
Safety of HRT
4.
How to use Evorel
5.
Possible side effects
6.
How to store Evorel
7.
Contents of the pack and other information
1. WHAT EVOREL IS AND WHAT IT IS USED FOR
The name of your medicine is Evorel. It belongs to a group of
medicines called
hormone replacement therapy (HRT).
Evorel contains an oestrogen (estradiol) which is a female hormone. It
comes in
4 different sizes: Evorel 25, Evorel 50, Evorel 75 and Evorel 100.
Evorel comes in a ‘memory pack’. This can be used to help you
remember when
to change your patches. Each pack contains eight patches. Evorel 50
also
comes in packs of two and twenty-four patches.
The hormone is spread evenly in each patch. It passes slowly into your
body
through the skin.
EVOREL IS USED FOR
•
The symptoms of the menopause (see ‘What is the menopause?’)
EVOREL 50, 75 AND 100 CAN ALSO BE USED TO
•
Prevent osteoporosis (fragile bones) in women who have had the
menopause and are most likely to have bone problems. Evorel 50, 75 and
100 are only used if other medicines for osteoporosis have been tried
first
and they have not worked.
- 2 -
WHAT IS THE MENOPAUSE?
Women produce oestrogen hormones from their ovaries throughout their
adult
life. These hormones are important in sexual development and control
of the
menstrua

Charakteristika produktu

OBJECT 1
EVOREL 100 PATCHES
Summary of Product Characteristics Updated 16-Dec-2020 | Theramex UK
Limited
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Evorel 25 Patch, Evorel 50 Patch, Evorel 75 Patch and Evorel 100
Patch.
2. Qualitative and quantitative composition
• Evorel 25:
• Evorel 50:
• Evorel 75:
• Evorel 100:
1.6 mg estradiol/patch
3.2 mg estradiol/patch
4.8 mg estradiol/patch
6.4 mg estradiol/patch
3. Pharmaceutical form
Evorel is a square shaped, transparent, self-adhesive transdermal
delivery system (patch) of 0.2 mm
thickness for application to the skin surface. It consists of a
monolayered adhesive matrix throughout
which 17β estradiol is uniformly distributed. The adhesive matrix is
protected on the outside surface
(from clothes etc) by a polyethylene teraphthalate backing foil, while
the adhesive surface of the patch is
covered by a polyester sheet (the release liner) which is removed
before placing the patch on the body
surface. This release liner has an