Raloxifene Teva

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

raloxifene hydrochloride

Available from:

Teva B.V.

ATC code:

G03XC01

INN (International Name):

raloxifene

Therapeutic group:

Sex hormones and modulators of the genital system,

Therapeutic area:

Osteoporosis, Postmenopausal

Therapeutic indications:

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.When determining the choice of raloxifene 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: 10

Authorization status:

Authorised

Authorization date:

2010-04-29

Patient Information leaflet

20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET: INFORMATION FOR THE USER
RALOXIFENE TEVA 60 MG FILM-COATED TABLETS
raloxifene hydrochloride
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 Raloxifene Teva is and what it is used for
2.
What you need to know before you take Raloxifene Teva
3.
How to take Raloxifene Teva
4.
Possible side effects
5.
How to store Raloxifene Teva
6.
Contents of the pack and other information
1.
WHAT RALOXIFENE TEVA IS AND WHAT IT IS USED FOR
Raloxifene Teva is used to treat and prevent osteoporosis in
postmenopausal women. Raloxifene Teva
reduces the risk of vertebral fractures in women with postmenopausal
osteoporosis. A reduction in the
risk of hip fractures has not been shown.
How Raloxifene Teva works
Raloxifene Teva belongs to a group of non-hormonal medicines called
selective oestrogen receptor
modulators (SERMs). When a woman reaches the menopause, the level of
the female sex hormone
oestrogen goes down. Raloxifene Teva mimics some of the helpful
effects of oestrogen after the
menopause.
Osteoporosis is a disease that causes your bones to become thin and
fragile - this disease is especially
common in women after the menopause. Although it may have no symptoms
at first, osteoporosis
makes you more likely to break bones, especially in your spine, hips
and wrists and may cause back
pain, loss of height and a curved back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RALOXIFENE TEVA
DO NOT TAKE RALOXIFENE TEVA
-
If you are allergic to raloxifene or any of the other ingredien

Summary of Product characteristics

1
_ _
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Raloxifene Teva 60 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg raloxifene hydrochloride,
equivalent to 56 mg raloxifene free
base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, film coated, oval shaped tablets, embossed with
the number “60” on one side and
“N” on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Raloxifene is indicated for the treatment and prevention of
osteoporosis in postmenopausal women. A
significant reduction in the incidence of vertebral, but not hip
fractures has been demonstrated.
When determining the choice of raloxifene 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 is one tablet daily.Due to the nature of this
disease process, raloxifene is
intended for long term use.
Generally calcium and vitamin D supplements are advised in women with
a low dietary intake.
_Elderly: _
No dose adjustment is necessary for the elderly.
_Patients with renal impairment: _
Raloxifene should not be used in patients with severe renal impairment
(see section 4.3). In patients
with moderate and mild renal impairment, raloxifene should be used
with caution.
_Patients with hepatic impairment_
:
Raloxifene should not be used in patients with hepatic impairment (see
section 4.3 and 4.4).
_Paediatric population: _
Raloxifene should not be used in children of any age. There is no
relevant use of Raloxifene in the
paediatric population.
Method of administration
Oral administration.
The tablet can be taken at any time of the day without regard to
meals.
3
4.3
CONTRAINDICATIONS
Hypersensitivity to the active subst