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Raloxifene hydrochloride 60 mg, film-coated tablets

$95.00$5,783.00

Raloxifene hydrochloride 60 mg, film-coated tablets

$95.00$5,783.00

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral.

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Description

Each tablet contains 60 mg raloxifene hydrochloride, equivalent to 56 mg raloxifene free base.

Excipient with known effect:

Each tablet contains 123.02 mg lactose monohydrate.

For the full list of excipients, see section 6.1.

.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 by oral administration, which may be taken at any time of the day without regard to meals. 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.

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.

Hepatic impairment:

Raloxifene should not be used in patients with hepatic impairment

Additional information

Dosage

30 tabs, 50 tabs, 90 tabs, 100 tabs, 300 tabs, 500 tabs, 1000 tabs, 2000 tabs

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