Raloxifene Hydrochloride Fair-Med 60mg Film-coated tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

raloxifene hydrochloride

Available from:

Fair-Med Healthcare GmbH

ATC code:

G03XC01.

INN (International Name):

raloxifene hydrochloride

Dosage:

60mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

Blister boxes contain 14, 28, or 84 tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Pharmadox Healthcare Ltd

Therapeutic group:

Selective Oestrogen Receptor Modulator

Therapeutic indications:

It 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.

Authorization status:

Authorised

Authorization date:

2015-05-21

Patient Information leaflet

1 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

RALOXIFENE HYDROCHLORIDE FAIR-MED 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, pharmacist or nurse. 
• 
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, pharmacist or nurse. This includes any possible 
side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET 
1. 
What Raloxifene Hydrochloride Fair-Med is and what it is used for 
2. 
What you
need to know before you take Raloxifene Hydrochloride Fair-Med 
3. 
How to take Raloxifene Hydrochloride Fair-Med 
4. 
Possible side effects 
5. 
How to store Raloxifene Hydrochloride Fair-Med 
6. 
Contents of the pack and other information 

1. 
WHAT RALOXIFENE HYDROCHLORIDE FAIR-MED IS AND WHAT IT IS USED FOR 

Raloxifene
Hydrochloride Fair-Med contains the active substance raloxifene hydrochloride. 

Raloxifene Hydrochloride Fair-Med is used to treat and
prevent osteoporosis in postmenopausal 
women. Raloxifene Hydrochloride Fair-Med reduces the risk of vertebral fractures in women with 
postmenopausal osteoporosis.
A reduction in the risk of hip fractures has not been
shown. 

_How Raloxifene Hydrochloride Fair-Med works _
Raloxifene Hydrochloride Fair-Med 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. 

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Raloxifene Hydrochloride Fair-Med 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 the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Film coated tablet. 
White to off-white, oval biconvex film-coated tablets with 'C' on
one side and '12' on 
other side. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Raloxifene Hydrochloride Fair-Med 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 Hydrochloride Fair-Med 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 Hydrochloride Fair-Med 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 Hydrochloride Fair-Med should not be used in patients
with severe renal 
impairment (see section 4.3). In patients with moderate and mild
renal impairment, 
Raloxifene Hydrochloride Fair-Med should be used with caution. 

_Hepatic impairment:_ 
Raloxifene Hydrochloride Fair-Med should not be used in p