Risedronate Sodium Accord Once a Week 35 mg film-coated tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Risedronate sodium

Pieejams no:

PCO Manufacturing Ltd.

ATĶ kods:

M05BA07

SNN (starptautisko nepatentēto nosaukumu):

Risedronate sodium

Deva:

35 milligram(s)

Zāļu forma:

Film-coated tablet

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

risedronic acid

Autorizācija statuss:

Authorised

Autorizācija datums:

2005-11-04

Lietošanas instrukcija

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISEDRONATE SODIUM ACCORD 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.

The full name of this medicine is Risedronate Sodium Accord Once
a Week 35 mg film-coated tablets but within this leaflet it will be
referred to as Risedronate Sodium Accord Once a Week.
WHAT IS IN THIS LEAFLET
1.
What Risedronate Sodium Accord Once a Week is and what it is
used for
2.
What you need to know before you take Risedronate Sodium
Accord Once a Week
3.
How to take Risedronate Sodium Accord Once a Week
4.
Possible side effects
5.
How to store Risedronate Sodium Accord Once a Week
6.
Contents of the pack and other information
1.
WHAT RISEDRONATE SODIUM ACCORD ONCE A WEEK IS AND WHAT IT IS
USED FOR
WHAT RISEDRONATE SODIUM ACCORD ONCE A
WEEK IS
Risedronate Sodium Accord 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 likel

Produkta apraksts

Health Products Regulatory Authority
21 September 2022
CRN00D5ML
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Sodium Accord Once a Week 35 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 35 mg risedronate sodium, (equivalent
to 32.5 mg risedronic acid).
Excipient with known effect:
Lactose monohydrate
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Italy, Spain, Greece, France and Romania:_
Oval, light-orange tablet with 'RSN' engraved one side and '35 mg' on
the other.
4 CLINICAL PARTICULARS
As per PA2315/140/003
5 PHARMACOLOGICAL PROPERTIES
As per PA2315/140/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Italy, Spain, Greece and France:_
_Tablet core:_
Lactose monohydrate
Microcrystalline cellulose
Crospovidone
Magnesium stearate
_Film coating:_
Dri-Klear (hypromellose, macrogol 400, hyprolose macrogol 400,
macrogol 8000 and colloidal hydrated silica)
Chroma-Tone White DDB-7536W (titanium dioxide (E171), hypromellose)
Ferric oxide yellow (E172)
_ _
_Product imported from Romania:_
_Tablet core:_
Lactose monohydrate
Microcrystalline cellulose
Crospovidone
Magnesium stearate
_Film coating:_
Macrogol
Hypromellose
Hydroxypropyl cellulose
Polyethylene glycol
Health Products Regulatory Authority
21 September 2022
CRN00D5ML
Page 2 of 2
Colloidal anhydrous silica
Titanium dioxide (E171)
Ferric oxide yellow (E172)
Ferric oxide red (E172)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product is the date shown on the
container and outer package of the product in the country of
origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C. Store in the original package.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister packs of 4 tablets contained in an outer cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
Any urgent medicinal product or waste should be di