Duavive

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

oestrogens conjugated, bazedoxifene

Διαθέσιμο από:

Pfizer Europe MA EEIG

Φαρμακολογική κατηγορία (ATC):

G03CC07

INN (Διεθνής Όνομα):

oestrogens conjugated, bazedoxifene

Θεραπευτική ομάδα:

conjugated estrogens and bazedoxifene

Θεραπευτική περιοχή:

Postmenopause

Θεραπευτικές ενδείξεις:

Duavive is indicated for:Treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.The experience treating women older than 65 years is limited.

Περίληψη προϊόντος:

Revision: 15

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2014-12-16

Φύλλο οδηγιών χρήσης

31
B. PACKAGE LEAFLET
32
Package leaflet: Information for the patient
DUAVIVE 0.45 mg/20 mg modified-release tablets
conjugated oestrogens/bazedoxifene
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 DUAVIVE is and what it is used for
2.
What you need to know before you take DUAVIVE
3.
How to take DUAVIVE
4.
Possible side effects
5.
How to store DUAVIVE
6.
Contents of the pack and other information
1.
What DUAVIVE is and what it is used for
DUAVIVE is a medicine that contains two active substances called
conjugated oestrogens and
bazedoxifene. Conjugated oestrogens is a medicine that belongs to a
group of medicines called
hormone replacement therapy (HRT). Bazedoxifene belongs to a group of
non-hormonal medicines
called selective oestrogen receptor modulators (SERMs).
DUAVIVE is used in postmenopausal women who still have their uterus
(womb) and have not had a
natural period in the last 12 months.
DUAVIVE 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").
DUAVIVE alleviates these
symptoms after menopause. You will only be prescribed this medicine if
your symptoms seriously
hinder your daily life and your doctor determines that other types of
HRT are not appropriate for you.
2.
What you need to know before you take DUAVIVE
Medical history and regular check-ups
The use of DUAVIVE carries risks, which need to be considered when
decidi

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
DUAVIVE 0.45 mg/20 mg modified-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 0.45 mg of conjugated oestrogens
and bazedoxifene acetate
equivalent to 20 mg bazedoxifene.
Excipients with known effect
Each modified-release tablet contains 96.9 mg sucrose (includes 0.7 mg
sucrose as sucrose
monopalmitate), 62.9 mg lactose (as monohydrate), 0.2 mg maltitol
liquid, 0.0176 mg glucose, and
0.0088 mg sorbitol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Modified-release tablet.
Pink, oval-shaped, modified-release tablet of 12 mm printed on one
side with “0.45/20”.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
DUAVIVE is indicated for the treatment of oestrogen deficiency
symptoms in postmenopausal women
with a uterus (with at least 12 months since the last menses) for whom
treatment with
progestin-containing therapy is not appropriate.
The experience treating women older than 65 years is limited.
4.2
Posology and method of administration
Posology
For initiation and continuation of treatment of postmenopausal
symptoms, the lowest effective dose
for the shortest duration should be used (see section 4.4).
The recommended dose is 0.45 mg conjugated oestrogens (CE) and 20 mg
bazedoxifene (BZA) taken
as a single oral tablet, once daily.
If a tablet is forgotten, it should be taken as soon as the patient
remembers. Therapy should then be
continued as before. If more than one tablet has been forgotten, only
the most recent tablet should be
taken, the patient should not take double the usual dose to make up
for missed tablets.
Special populations
Elderly
CE/BZA has not been studied in women over 75 years of age. Based on
available data no dosage
adjustment is necessary based on age (see section 5.2). The experience
treating women older than
65 years is limited.
3
Renal impairment
The pharmacokinetics of CE/BZA have not been evaluated in patients
with renal impairm