Evista 60mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Raloxifene hydrochloride

Available from:

Daiichi Sankyo UK Ltd

ATC code:

G03XC01

INN (International Name):

Raloxifene hydrochloride

Dosage:

60mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06040101; GTIN: 5015494600280 5015494600846

Patient Information leaflet

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

Summary of Product characteristics

OBJECT 1
EVISTA 60MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 05-Feb-2018 | Daiichi
Sankyo UK Limited
1. Name of the medicinal product
Evista 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.
Excipient with known effect:
Each tablet contains lactose (149.40 mg).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film coated tablet.
Elliptically shaped, white tablets imprinted with the code '4165'.
4. Clinical particulars
4.1 Therapeutic indications
Evista 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 Evista 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, Evista 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: _
Evista should not be used in patients with severe renal impairment
(see section 4.3). In patients with
moderate and mild renal impairment, Evista should be used with
caution.
_Hepatic impairment: _
Evista should not be used in patients with hepatic impairment (see
section 4.3 and 4.4).
_Paediatric population:_
Evista should not be used in children of any age. There is no relevant
use of Evista in the paediatric
population.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
liste