ACTONEL ONCE A WEEK 35 Milligram Film Coated Tablet

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

RISEDRONATE SODIUM

Commercializzato da:

Clear Pharmacy

Codice ATC:

M05BA07

INN (Nome Internazionale):

RISEDRONATE SODIUM

Dosaggio:

35 Milligram

Forma farmaceutica:

Film Coated Tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Bisphosphonates

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2010-04-09

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACTONEL® ONCE A WEEK 35 MG 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, even i

Scheda tecnica

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 35 mg risedronate sodium (equivalent
to 32.5 mg risedronic acid).
Excipients: Each film-coated tablet contains lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy_:
Oval, light orange film-coated tablet with RSN on one side and 35 mg
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 A
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
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer package of the product on the market
in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special storage
conditions.
6.5 NATURE AND CONTENTS OF CONTAINER
Clear foil blisters in an over labelled cardboard carton
Blisters in pack