RALOXIFENE TEVA

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

RALOXIFENE HYDROCHLORIDE

Disponível em:

TEVA ISRAEL LTD

Código ATC:

G03XC01

Forma farmacêutica:

TABLETS

Composição:

RALOXIFENE HYDROCHLORIDE 60 MG

Via de administração:

PER OS

Tipo de prescrição:

Required

Fabricado por:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Grupo terapêutico:

RALOXIFENE

Área terapêutica:

RALOXIFENE

Indicações terapêuticas:

- Treatment of osteoporosis in post menopausal women.- Prevention of osteoporosis in post menopausal women.- Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. - Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer.

Data de autorização:

2016-02-29

Folheto informativo - Bula

PATIENT LEAFLET IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) – 1986
The medicine is dispensed with a doctor's
prescription only
RALOXIFENE TEVA 60 MG
Film-coated tablets
THE ACTIVE INGREDIENT AND ITS QUANTITY:
Each tablet contains:
Raloxifene Hydrochloride 60 mg
For a list of inactive ingredients in the preparation,
see section 6 - “Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING
THE MEDICINE. This leaflet contains concise
information about the medicine. If you have
additional questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for treatment
of your illness. Do not pass it on to others. It may
harm them, even if their medical condition seems
similar to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Raloxifene Teva is used for treatment and
prevention of osteoporosis in postmenopausal
women.
Raloxifene Teva is used for prevention of
osteoporosis in postmenopausal women when
estrogen therapy is not indicated.
Prevention of breast cancer - Raloxifene Teva
reduces the risk for invasive breast cancer in
postmenopausal women with osteoporosis and in
postmenopausal women at high risk for invasive
breast cancer.
THERAPEUTIC CLASS:
Raloxifene Teva belongs to a group of nonhormonal
medicines called Selective Estrogen Receptor
Modulators (SERMs). When a woman reaches
menopause, the level of the sex hormone estrogen
goes down. Raloxifene Teva mimics some of the
helpful effects of estrogen after menopause.
Osteoporosis is a disease that causes bone thinning
and increases bones’ tendency to break - this
disease is especially common in postmenopausal
women, although it may not cause any symptoms
at first. Osteoporosis increases the risk of bone
fractures, especially the bones of the spine, hips
and wrists, and may cause back pain, loss of
height and a curved back.
2.
BEFORE USING THE MEDICINE:
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active
ingredient or to any of the other ingredients
this medicine contains (see sectio