Raloxifene 60mg tablets

Страна: Великобритания

Език: английски

Източник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активна съставка:

Raloxifene hydrochloride

Предлага се от:

Sandoz Ltd

АТС код:

G03XC01

INN (Международно Name):

Raloxifene hydrochloride

дозиране:

60mg

Лекарствена форма:

Tablet

Начин на приложение:

Oral

Клас:

No Controlled Drug Status

Вид предписание :

Valid as a prescribable product

Каталог на резюме:

BNF: 06040101; GTIN: 5050650119015

Данни за продукта

OBJECT 1
RALOXIFENE 60 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 28-Jan-2016 | Sandoz
Limited
1. Name of the medicinal product
Raloxifene 60 mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film coated tablet contains 60 mg raloxifene hydrochloride,
equivalent to 56mg raloxifene free base.
Excipient(s) with known effect:
Each tablet contains lactose monohydrate (1.5 mg).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet.
Elliptically shaped, white 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.
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 (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.
4.3 Contraindications
• Hypersensitivity to the active substance or to any of the
excipient