Risedronate sodium 35mg 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:

35mg

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 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.
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. 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 RISEDRONATE SODIUM IS USED FOR
The treatment of osteoporosis
•
in postmenopausal women, even if osteoporosis is s

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Risedronate sodium 35 mg film-coated tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
35 mg
risedronate
sodium
(amorphous),
equivalent to 32.48 mg risedronic acid.
Excipient with known effect:
Each film-coated tablet contains 153.18 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Orange 9.0 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 (see section 5.1).
Treatment of osteoporosis in men at high risk of fractures (see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The recommended dose in adults is one 35 mg tablet orally once a week.
The
tablet should be taken on the same day each week.
The absorption of risedronate sodium is affected by food, thus to
ensure
adequate absorption, patients should take Risedronate sodium 35 mg:
•
Before breakfast: At least 30 minutes before the first food, other
medicinal
product or drink (other than plain water), of the day.
Patients should be instructed that if a dose is missed, one
Risedronate sodium
35 mg tablet should be taken on the day that the tablet is remembered.
Patients
should then return to taking one tablet once a week on the day the
tablet is
normally taken. Two tablets should not be taken on the same day.
The tablet must be swallowed whole and not sucked or chewed. To aid
delivery of the tablet to the stomach Risedronate sodium is to be
taken while
in an upright position with a glass of plain water (
≥
120 ml). Patients should
not lie down for 30 minutes after taking the tablet (see section 4.4).
Supplemental calcium and vitamin D should be considered if the dietary
intake
is inadequate.
The optimal duration of bisphosphonate treatment for osteoporosis has
not
been establ