Risedronate Sodium Accord Once a Week 35 mg gastro-resistant tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Risedronate sodium

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

M05BA; M05BA07

INN (International Name):

Risedronate sodium

Dosage:

35 milligram(s)

Pharmaceutical form:

Gastro-resistant tablet

Therapeutic area:

Bisphosphonates; risedronic acid

Authorization status:

Not marketed

Authorization date:

2018-07-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISEDRONATE SODIUM ACCORD ONCE A WEEK 35 MG GASTRO
‐
RESISTANT 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 Gastro-
resistant 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 likely bones to

Summary of Product characteristics

Health Products Regulatory Authority
07 May 2020
CRN009PP0
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Sodium Accord Once a Week 35 mg gastro-resistant tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gastro-resistant tablet contains 35 mg risedronate sodium
(equivalent to 32.5 mg risedronic acid).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant tablet.
Oval, yellow, gastro-resistant tablet with “EC 35” engraved on one
side.
The dimensions of the tablet are as follows: width 13.05 mm, length
5.94 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fractures (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one Optinate Septimum 35 mg
gastro-resistant tablet orally once a week. The tablet
should be taken on the same day each week.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need for continued
treatment should be re‑evaluated periodically based on the benefits
and potential risks of risedronate on an individual patient
basis, particularly after 5 or more years of use.
Special populations
_Elderly_
Of the patients receiving risedronate 35 mg gastro-resistant tablets
in postmenopausal osteoporosis studies, 59% were 65 and
over, while 13 % were 75 and over. No overall differences in safety
and effectiveness were observed between these patients
and younger patients.
_Patients with renal impairment_
No dosage adjustment is required for those patients with mild to
moderate renal impairment. The use of risedronate sodium is
contraindicated in patients with severe renal impairment (creatinine
clearance lower than 30 ml/min) (see sections 4.3 and 5.2).
_Paediatric population_
Risedronate sodium is not recommended for use in children below age 18
due to insufficient data on safety and efficacy (also
see section 5.1).
Method of administration
Risedr