Conbriza

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

bazedoxifene

Available from:

Pfizer Europe MA EEIG

ATC code:

G03XC02

INN (International Name):

bazedoxifene

Therapeutic group:

Sex hormones and modulators of the genital system,

Therapeutic area:

Osteoporosis, Postmenopausal

Therapeutic indications:

Conbriza is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established.When determining the choice of Conbriza or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Product summary:

Revision: 15

Authorization status:

Authorised

Authorization date:

2009-04-17

Patient Information leaflet

24
B. PACKAGE LEAFLET
25
Package Leaflet: Information for the patient
CONBRIZA 20 mg film-coated tablets
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 CONBRIZA is and what it is used for
2.
What you need to know before you take CONBRIZA
3.
How to take CONBRIZA
4.
Possible side effects
5.
How to store CONBRIZA
6.
Contents of the pack and other information
1.
What CONBRIZA is and what it is used for
CONBRIZA contains the active substance bazedoxifene, and is a medicine
that belongs to a group of
non-hormonal medicines called Selective Oestrogen Receptor Modulators
(SERMs). It is used for the
treatment of osteoporosis in women after they have reached menopause,
when they are at an increased
risk of fractures. It works by slowing or stopping the thinning of
bone in these women. This medicine
should not be used for the treatment of osteoporosis in men.
2.
What you need to know before you take CONBRIZA
Do not take CONBRIZA

if you are allergic to bazedoxifene or any of the other ingredients of
this medicine (listed in
section 6).

if you have or have had a blood clot (for example, in the blood
vessels in your legs, lungs, or
eyes).

if you are pregnant or could still become pregnant. This medicine may
cause harm to your
unborn child if taken during pregnancy.

if you have any unexplained vaginal bleeding. This must be
investigated by your doctor.

if you have active uterine cancer.
Warnings and precautions
Talk to your doctor or pharmacist before taking CONBRIZA

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
CONBRIZA 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains bazedoxifene acetate equivalent to 20
mg bazedoxifene.
Excipient with known effect
Each film-coated tablet contains 142.8 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, capsule-shaped, film-coated tablet debossed on one
side with “WY20”. The tablet
is approximately 1.5 cm in length.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
CONBRIZA is indicated for the treatment of postmenopausal osteoporosis
in women at increased risk
of fracture. A significant reduction in the incidence of vertebral
fractures has been demonstrated;
efficacy on hip fractures has not been established.
When determining the choice of CONBRIZA or other therapies, including
oestrogens, for an
individual postmenopausal woman, consideration should be given to
menopausal symptoms, effects
on uterine and breast tissues, and cardiovascular risks and benefits
(see section 5.1).
4.2
Posology and method of administration
Posology
The recommended dose of CONBRIZA is one tablet once daily, at any time
of day, with or without
food (see section 5.2).
Doses higher than 20 mg are not recommended because there is no
demonstrable increased efficacy
and higher doses may be associated with additional risk (see section
5.1).
Supplemental calcium and/or vitamin D should be added to the diet if
daily intake is inadequate.
Special populations
Renal impairment
Bazedoxifene has not been sufficiently evaluated in patients with
severe renal impairment; caution
should be used in this population (see sections 4.4 and 5.2).
No dose adjustment is required for mild or moderate renally impaired
patients.
3
Hepatic impairment
Safety and efficacy of bazedoxifene have not been evaluated in
patients with hepatic impairment; use
in this population is not recommended (see sections 4.4 and 5.