Ostiral 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Raloxifene hydrochloride

Available from:

Lupin Healthcare (UK) Ltd

ATC code:

G03XC01

INN (International Name):

Raloxifene hydrochloride

Dosage:

60mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101; GTIN: 8901107024109

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
OSTIRAL 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 Ostiral is and what it is used for
2.
What you need to know before you take Ostiral
3.
How to take Ostiral
4.
Possible side effects
5.
How to store Ostiral
6.
Contents of the pack and other information
1.
WHAT OSTIRAL IS AND WHAT IT IS USED FOR
Ostiral contains the active substance raloxifene hydrochloride.
Ostiral is used to treat and prevent osteoporosis in postmenopausal
women. Ostiral reduces the risk of
vertebral fractures in women with postmenopausal osteoporosis. A
reduction in the risk of hip
fractures has not been shown.
How Ostiral works
Ostiral 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. Ostiral 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 OSTIRAL
DO NOT TAKE OSTIRAL:
•
If you are being treated or have been treated for blood clots in the
legs (deep vein thrombosis),
i

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ostiral 60 mg film-coated tablets
Raloxifene hydrochloride 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.
Excipients with known effect:
Each tablet contains lactose monohydrate (1.5 mg).
Each tablet contains less than 1 mmol (23 mg) sodium.
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
Ostiral 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 Ostiral 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, Ostiral 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:_
Ostiral should not be used in patients with severe renal impairment
(see section 4.3). In
patients with moderate and mild renal impairment, Ostiral should be
used with caution.
_Hepatic impairment:_
Ostiral should not be used in patients with hepatic impairment (see
section 4.3 and 4.4).
_Paediatric population: _
Ostiral should not be used in children of any age. There is no
relevant use of Ostiral in the
paediatric
population.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipi