Raloxon Film-coated Tablets 60 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Raloxifene hydrochloride (eqv. to raloxifene free base 56 mg)

Available from:

NOVEM PHARMA PRIVATE LIMITED

ATC code:

G03XC01

Dosage:

60.0 mg

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Raloxifene hydrochloride (eqv. to raloxifene free base 56 mg) 60.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Pharmathen S.A.

Authorization status:

ACTIVE

Authorization date:

2011-09-16

Summary of Product characteristics

RALOXON
®
60 MG FILM-COATED TABLETS
RALOXIFENE HYDROCHLORIDE
1. NAME OF THE MEDICINAL PRODUCT
RALOXON 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 excipients, see Section 6.1.
3. PHARMACEUTICAL FORM
White elliptical film-coated tablets.
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.
For those postmenopausal women taking raloxifene for osteoporosis
treatment,
Raloxifene has been to shown to reduce the risk of invasive breast
cancer.
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
The recommended posology is one tablet daily by oral administration,
which may be
taken at any time of the day without regard to meals. No dose
adjustment is
necessary for the elderly. 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.
4.3. CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Must not be used in women with child bearing potential.
Active or past history of venous thromboembolic events (VTE),
including deep vein
thrombosis, pulmonary embolism and retinal vein thrombosis.
Hepatic impairment including cholestasis.
Severe renal impairment.
Unexplained uterine bleeding.
Raloxifene should not be used in patients with signs or symptoms of
endometrial
cancer as safety in this patient group has not been adequately
studied.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Raloxi