ACTONEL ONCE A WEEK

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

RISEDRONATE SODIUM

Beschikbaar vanaf:

Primecrown 2010 Ltd

ATC-code:

M05BA07

INN (Algemene Internationale Benaming):

RISEDRONATE SODIUM

Dosering:

35 Milligram

farmaceutische vorm:

Film Coated Tablet

Prescription-type:

Product subject to prescription which may be renewed (B)

Therapeutisch gebied:

risedronic acid

Autorisatie-status:

Authorised

Autorisatie datum:

2010-04-09

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL® ONCE A WEEK 35MG FILM-COATED TABLETS
risedronate sodium
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 Actonel Once a Week is and what it is used for
2. What you need to know before you take Actonel Once a Week
3. How to take Actonel Once a Week
4. Possible side effects
5. How to store Actonel Once a Week
6. Contents of the pack and other information
1. WHAT ACTONEL ONCE A WEEK IS AND WHAT IT IS USED FOR
WHAT ACTONEL ONCE A WEEK IS
Actonel Once a Week belongs to a group of non-hormonal medicines
called
bisphosphonates which are used to treat bone diseases. It works
directly on
your bones to make them stronger and therefore less likely to break.
Bone is a living tissue. Old bone is constantly removed from your
skeleton
and replaced with new bone.
Postmenopausal osteoporosis is a condition occurring in women after
the
menopause where the bones become weaker, more fragile and more likely
to
break after a fall or strain.
Osteoporosis can also occur in men due to a number of causes including
ageing and/or a low level of the male hormone, testosterone.
The spine, hip and wrist are the most likely bones to break, although
this can
happen to any bone in your body. Osteoporosis – related fractures
can also
cause back pain, height loss and a curved back. Many patients with
osteoporosis have no symptoms and you may not even have known that you
had it.
WHAT ACTONEL ONCE A WEEK IS USED FOR
Treatment of osteoporosis in postmenopausal women, eve

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actonel Once A Week 35mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35mg risedronate sodium (equivalent
to 32.5mg risedronic acid)
Excipients with known effect: Each film-coated tablet contains lactose
monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated Tablet
_Product imported from the UK:_
Oval, light-orange, film-coated tablet with RSN on one side and 35mg
on the other
4 CLINICAL PARTICULARS
As per PA1635/001/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1635/001/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Tablet Core:
Lactose monohydrate
Cellulose microcrystalline
Crospovidone
Magnesium stearate
Film Coating:
Iron oxide yellow (E172)
Iron oxide red (E172)
Hypromellose
Macrogol
Hyprolose
Silicon dioxide
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_0_
_3_
_/_
_0_
_2_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_2_
_1_
_8_
_8_
_1_
_8_
_1_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer carton of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage conditions
6.5 NATURE AND CONTENTS OF CONTAINER
Clear PVC/aluminium foil blister in an over-labelled cardboard