Risedronate Aurobindo 5mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

RISEDRONATE SODIUM

Available from:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC code:

M05BA07

INN (International Name):

RISEDRONATE SODIUM 5 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RISEDRONATE SODIUM 5 mg

Prescription type:

POM

Therapeutic area:

DRUGS FOR TREATMENT OF BONE DISEASES

Authorization status:

Authorised

Authorization date:

2011-07-18

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RISEDRONATE AUROBINDO 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. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Risedronate Aurobindo is and what it is used for
2.
What you need to know before you take Risedronate Aurobindo
3.
How to take Risedronate Aurobindo
4.
Possible side effects
5.
How to store Risedronate Aurobindo
6.
Contents of the pack and other information
1.
WHAT RISEDRONATE AUROBINDO IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE AUROBINDO IS
Risedronate Aurobindo 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 is more likely to occur in women who have reached the
menopause early and also in
patients treated long-term with steroids.
The spine, hip and wrist are the most likely bones to break, although
this can happen to any bone in
your body. Osteoporosisrelated 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 AUROBINDO IS USED FOR
The treatment of osteoporosis
•
In
POS

Summary of Product characteristics

Page
1
of
10
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Risedronate Aurobindo 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg risedronate sodium (equivalent
to 4.6 mg risedronic acid).
Excipients with known effect:
Each film-coated tablet contains lactose monohydrate 24.60 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow colored, circular shaped, beveled edge, film-coated biconvex
tablets debossed with ‘X’ on one
side and ‘61’ on the other side.
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
Posology:
The recommended daily dose in adults is one 5 mg tablet orally. 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 instance that before breakfast dosing is not
practical, risedronate sodium can be taken
between meals or in the evening at the same time everyday, with strict
adherence to the following
instructions, to ensure risedronate sodium is taken on an empty
stomach:
•
Between meals: risedronate sodium should be taken at least 2 hours
before and at least 2 hours
after any food, medicinal product or drink (other than plain water).
•
In the evening: risedronate sodium should be taken at least 2 hours
after the last food, medicinal
p