Risedronate Sodium Accord 75 mg Film Coated 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:

75 milligram(s)

Pharmaceutical form:

Film-coated 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 75 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 75 mg
film-coated tablets
but within this leaflet it will be referred to as Risedronate Sodium
Accord.
WHAT IS IN THIS LEAFLET
1.
What Risedronate Sodium Accord is and what it is used for
2.
What you need to know before you take Risedronate Sodium Accord
3.
How to take Risedronate Sodium Accord
4.
Possible side effects
5.
How to store Risedronate Sodium Accord
6.
Contents of the pack and other information
1.
WHAT RISEDRONATE SODIUM ACCORD IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE SODIUM ACCORD IS
Risedronate Sodium Accord 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.
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 RISEDRON

Summary of Product characteristics

Health Products Regulatory Authority
13 May 2020
CRN009PQP
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Sodium Accord 75 mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Film-coated tablet contains 75 mg risedronate sodium, (equivalent
to 69.6 mg risedronic acid).
For the list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Oval pink 11.7 x 5.8 mm film-coated tablet engraved with RSN on one
side and 75 mg on the other.
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 75 mg tablet orally on two
consecutive days a month. The first tablet should be taken
on the same day each month, followed by the second tablet the next
day.
Special populations
_Elderly_
No dosage adjustment is necessary since bioavailability, distribution
and elimination were similar in elderly (>60 years of age)
compared to younger subjects.
This has also been shown in the very elderly, 75 years old and above,
postmenopausal population.
_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 (see
section 5.1).
Method of administration
- The absorption of risedronate sodium is affected by food and
polyvalent cations (see section 4.5), thus to ensure adequate
absorption patients should take Risedronate Sodium Accord 75 mg before
breakfast: at least 30 minutes before the first food,
other medicinal product or drink (other than plain water) of the day.
Plain water is the only drink that should be taken with
Risedronate