Eviana, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ESTRADIOL 0,5-WATER SAMENSTELLING overeenkomend met ; ; ESTRADIOL ; NORETHISTERONACETAAT

Beschikbaar vanaf:

Novo Nordisk B.V. Flemingweg 18 2408 AV ALPHEN A/D RIJN

ATC-code:

G03FA01

INN (Algemene Internationale Benaming):

ESTRADIOL 0,5-WATER COMPOSITION corresponding to ; ; ESTRADIOL ; norethisterone acetate

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

GLYCEROLTRIACETAAT (E 1518) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROMELLOSE (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; TALK (E 553 B),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Norethisterone And Estrogen

Product samenvatting:

Hulpstoffen: GLYCEROLTRIACETAAT (E 1518); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROMELLOSE (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; TALK (E 553 B);

Autorisatie datum:

2008-12-04

Bijsluiter

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
EVIANA 0,5 MG/0,1 MG FILMOMHULDE TABLETTEN
Estradiol/norethisterone acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Eviana is and what it is used for
2.
What you need to know before you take Eviana
3.
How to take Eviana
4.
Possible side effects
5.
How to store Eviana
6.
Contents of the pack and other information
1.
WHAT EVIANA IS AND WHAT IT IS USED FOR
Eviana is a continuous combined
_ _
Hormone Replacement Therapy (HRT). It contains two types of
female hormones, an oestrogen and a progestagen. Eviana is used in
postmenopausal women with at
least 1 year since their last natural period.
Eviana 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’).
Eviana alleviates these symptoms
after menopause. You will only be prescribed Eviana if your symptoms
seriously hinder your daily
life.
Eviana is prescribed for women who have not had their womb removed,
and whose periods stopped
more than a year ago.
The experience of treating women older than 65 years is limited
_. _
2_. _
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVIANA
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

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Eviana 0,5 mg/0,1 mg filmomhulde tabletten
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
Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in
postmenopausal women
with more than 1 year since last menses.
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.
If the patient has forgotten to take a tablet, the tablet should be
taken as soon as possible within the
next 12 hours. If more than 12 hours have passed, the tablet should be
discarded. Forgetting a dose
may increase the likelihood of breakthrough bleeding and spotting.
4.3
CONTRAINDICATIONS
–
Known, past or suspected br