EVOREL CONTI

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

ESTRADIOL AS HEMIHYDRATE; NORETHISTERONE ACETATE

Commercializzato da:

TRUEMED LTD.

Codice ATC:

G03CA53

Forma farmaceutica:

PATCHES

Composizione:

ESTRADIOL AS HEMIHYDRATE 3.2 MG; NORETHISTERONE ACETATE 11.2 MG

Via di somministrazione:

TRANSDERMAL

Tipo di ricetta:

Required

Prodotto da:

THERAMEX IRELAND LIMITED, IRELAND

Gruppo terapeutico:

ESTRADIOL, COMBINATIONS

Area terapeutica:

ESTRADIOL, COMBINATIONS

Indicazioni terapeutiche:

Hormone replacement therapy for the relief of menopausal symptoms.

Data dell'autorizzazione:

2021-01-31

Foglio illustrativo

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
Evorel
®
Conti
Transdermal Patch
Active ingredients and their quantity per dosage unit:
Each patch contains:
estradiol (as hemihydrate) 3.2 mg
norethisterone acetate 11.2 mg
Each patch of Evorel Conti releases 50 mcg estradiol and
170 mcg norethisterone acetate/24 hours.
Inactive ingredients and allergens in the preparation – see
section 6 “Further Information”.
Read this leaflet carefully in its entirety before using the
medicine. This leaflet contains concise information about the
medicine. If you have further questions, refer to the doctor
or pharmacist.
This medicine has been prescribed for you. Do not pass it
on to others. It may harm them even if it seems to you that
their medical condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Hormone replacement therapy (HRT) for the relief of
menopausal symptoms.
Therapeutic group: a combination of estrogen and
progestogen.
Menopause happens when the level of hormones produced
by the ovaries goes down. This is a gradual process. During
this period, the estrogen levels can go up and down. This
can cause:
• Hot flushes, night sweats or mood swings
• Vaginal problems such as dryness or itching
• Uncomfortable or painful sexual intercourse.
You may experience these symptoms if you have had your
ovaries taken out in an operation.
How Evorel Conti works – both hormones in the patch are
continuously released.
Evorel Conti patches replace the estrogen that is normally
released by the ovaries. However, in women who have a
womb, taking an estrogen hormone regularly may cause
thickening of the lining of the womb.
• This means it is necessary to add a progestogen hormone
to the estrogen
• This supplement helps shed the thickened lining of the
womb and prevent problems from happening
Most women do not have a regular monthly period with
Evorel Conti. However, bleeding or spotting does usually
occur

Scheda tecnica

1
1. NAME OF THE MEDICINAL PRODUCT EVOREL ®
CONTI
2. QUALITATIVE AND QUANTITATIVE
COMPOSITION
Each transdermal patch contains:
3.2 mg of estradiol hemihydrate equivalent to 3.1 mg estradiol.
11.2 mg of norethisterone acetate equivalent to 9.82 mg
norethisterone.
Each patch releases a nominal 50 μg estradiol and 170 μg
norethisterone acetate over
24 hours.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Transdermal Patch
Evorel Conti is a matrix type transdermal patch.
The Evorel Conti transdermal patch or Transdermal Delivery System
(TDS), , is a flat
two-layer laminate which is 0.1 mm in thickness. The first layer is a
flexible,
translucent, and nearly colourless backing film. The second layer is a
monolayer
adhesive film (matrix) composed of acrylic adhesive and guar gum and
contains the
hormones. This system is protected by a polyester foil release liner,
which is affixed
to the adhesive matrix and is removed prior to application of the
patch to the skin.
The polyester foil used is coated with silicone on both sides. The
release liner has a S-
shaped opening to facilitate its removal prior to use. Each TDS is
enclosed in a
protective, hermetically-sealed sachet.
Evorel Conti has a surface area of 16 sq cm and contains 3.2 mg of
estradiol
corresponding to a nominal release of 50 micrograms of estradiol per
24 hours and
11.2 mg of norethisterone acetate corresponding to a nominal release
of 170
micrograms of norethisterone acetate per 24 hours. Each TDS is marked
in the centre
of the lower margin on the outside of the backing film: CEN1
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Hormone replacement therapy (HRT) for the relief of menopausal
symptoms.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Adults_
Evorel Conti is a continuous combined HRT preparation.
_ _
Evorel Conti TDSs
_ _
should be applied individually without interruption. TDSs should
be applied twice weekly, every three to four days, to the trunk below
the waist.
Insufficient data are available to guide dose adjustmen