Risedronate sodium 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Risedronate sodium

Available from:

Phoenix Healthcare Distribution Ltd

ATC code:

M05BA07

INN (International Name):

Risedronate sodium

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
RISEDRONATE SODIUM 5 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.
WHAT IS IN THIS LEAFLET
:
1.
What Risedronate sodium is and what it is used for
2.
What you need to know before you take Risedronate sodium
3.
How to take Risedronate sodium
4.
Possible side effects
5.
How to store Risedronate sodium
6.
Contents of the pack and other information
1.
WHAT RISEDRONATE SODIUM IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE SODIUM IS
Risedronate sodium 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.
It is more likely that early menopausal women and patients on
long-term steroid treatment get osteoporosis.
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 RISEDRONATE SODIUM IS USED FOR
The treatment of osteoporosis:
•
in postmenopausal women.
The prevention of osteoporosis:
•
in women with

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Risedronate sodium 5mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5mg risedronate sodium (amorphous),
equivalent to
4.64mg risedronic acid.
Excipient:
Each film-coated tablet contains 156.30mg lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Yellow 8.5 mm round, biconvex, film-coated tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of postmenopausal osteoporosis, to reduce the risk of
vertebral fractures.
Treatment of established postmenopausal osteoporosis, to reduce the
risk of hip
fractures. Prevention of osteoporosis in postmenopausal women with
increased risk of
osteoporosis (see section 5.1).
To maintain or increase bone mass in postmenopausal women undergoing
long-term
(more than 3 months), systemic corticosteroid treatment at doses
≥
7.5mg/day
prednisone or equivalent.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended daily dose in adults is one 5mg tablet orally.
Special population
_Elderly: _No dosage adjustment is necessary since bioavailability,
distribution and
elimination were similar in elderly (> 60 years of age) compared to
younger subjects.
_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 18 years of age due to insufficient data on safety and efficacy
(see also section
5.1).
Method of administration
The absorption of Risedronate sodium is affected by food, thus to
ensure adequate
absorption patients should take Risedronate sodium:
•
Before breakfast: At least 30 minutes before the first food, other
medicinal
product or drink (other than plain water), of the day.
In the particular