EVIANA

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

ESTRADIOL AS HEMIHYDRATE; NORETHISTERONE ACETATE

Dostopno od:

NOVO NORDISK LTD., ISRAEL

Koda artikla:

G03CA53

Farmacevtska oblika:

FILM COATED TABLETS

Sestava:

ESTRADIOL AS HEMIHYDRATE 0.5 MG; NORETHISTERONE ACETATE 0.1 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

NOVO NORDISK A/S, DENMARK

Terapevtska skupina:

ESTRADIOL, COMBINATIONS

Terapevtsko območje:

ESTRADIOL, COMBINATIONS

Terapevtske indikacije:

Eviana is indicated for women who have a uterus for the: Treatment of moderate to severe vasomotor symptoms associated with menopause. Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered .The experience treating women older than 65 years is limited .

Datum dovoljenje:

2023-11-30

Navodilo za uporabo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
EVIANA
FILM-COATED TABLETS
ACTIVE INGREDIENTS: ESTRADIOL AS HEMIHYDRATE 0.5 MG
NORETHISTERONE ACETATE 0.1 MG
Inactive ingredients and allergens in this medicine: See section 2
under ‘Important
information about some of this medicine’s ingredients’, and
section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat you. Do not pass it on to
others. It may harm
them, even if it seems to you that their condition is similar to
yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Eviana is used in women who have a uterus:
•
For treatment of moderate to severe vasomotor symptoms that occur when
a
woman’s menstrual cycle stops (menopause).
•
For prevention of osteoporosis (bone thinning) in postmenopausal women
who
are at high risk of fractures in cases where using an estrogen-free
treatment for
osteoporosis is not suitable.
There is limited experience treating women over 65 years old.
THERAPEUTIC GROUP: combined estrogen and progestagen medicines.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (ALLERGIC) to the active ingredients or to any of
the other ingredients in this
medicine (see section 6 ‘Additional information’).
•
You have, have had or suspect having BREAST CANCER.
•
You have, have had or suspect having CANCER OF THE WOMB LINING (cancer
of the
endometrium), or some other estrogen-dependent cancer.
•
You have any UNEXPLAINED VAGINAL BLEEDING.
•
You have EXCESSIVE THICKENING OF THE WOMB LINING (endometrial
hyperplasia) that is not
being treated.
•
You have or have ever had a BLOOD CLOT IN A VEIN (thrombosis), such as
in the legs (deep
venous thrombosis) or the lungs (pulmonary embolism).
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Lastnosti izdelka

EVIANA IL SPC NOV2023-Notification
1
1.
NAME OF THE MEDICINAL PRODUCT
Eviana
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
estradiol 0.5 mg (as estradiol hemihydrate) and norethisterone acetate
0.1 mg.
Excipient with known effect: Each film-coated tablet contains lactose
monohydrate 37.5 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex tablets with a diameter of 6 mm. The tablets
are engraved with NOVO 291 on
one side and the APIS bull on the other side.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Eviana is indicated for women who have a uterus for the:
Treatment of moderate to severe vasomotor symptoms associated with
menopause.
Prevention of postmenopausal osteoporosis.
When prescribing solely for the prevention of postmenopausal
osteoporosis therapy should only be
considered for women at significant risk of osteoporosis and
non-estrogen medications should be
carefully considered .
The experience treating women older than 65 years is limited.
4.2
Posology and method of administration
Eviana is a continuous combined HRT product intended for use in women
with an intact uterus. One
tablet should be taken orally once a day without interruption,
preferably at the same time every 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.
A switch to a higher dose combination product, e.g. Activelle 1 mg/0.5
mg tablets, should be
considered if the response after 3 months is insufficient for symptom
relief.
In women with amenorrhoea and not taking HRT or women in transition
from another continuous
combined HRT product, treatment with Eviana may be started on any
convenient day. In women in
transition from a sequential HRT regimen, treatment should start right
after their withdrawal bleeding
has ended.
EVIANA IL SPC NOV2023-Notification
2
If the patient has forgotten to take a tablet, the tablet shou