Risedronate Aurobindo 30mg 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 30 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

RISEDRONATE SODIUM 30 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 30 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. 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.
Paget’s disease occurs when this process, called remodeling, happens
too quickly and in a disordered
way. The new bone that is produced is weaker than normal and the
affected bones may become
enlarged, painful and may fracture. Risedronate Aurobindo changes the
bone remodeling process back
to normal, returning the strength to the bone structure.
WHAT RISEDRONATE AUROBINDO IS USED FOR
Treatment of Paget’s disease of the bone (osteitis deformans).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RISEDRONATE AUROBINDO
DO NOT TAKE RISEDRONATE AUROBINDO
•
If you are allergic to risedronate sodium or any of the other
ingredients of this medicine ( listed in
section 6).
•
If your doctor has

Summary of Product characteristics

Page
1
of
8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Risedronate Aurobindo 30 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg risedronate sodium (equivalent
to 27.8 mg risedronic acid).
Excipients with known effect:
Each film-coated tablet contains lactose monohydrate 147.6 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white colored, circular shaped film coated biconvex
tablets debossed with ‘L’ on one side
and ‘30’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of Paget's disease of the bone.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
The recommended daily dose in adults is one 30 mg tablet orally for 2
months. If re-treatment is
considered necessary (at least two months post-treatment), a new
treatment with the same dose and
duration of therapy could be given. 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
product or drink (other than plain water) of the day. Risedronate
sodium should be taken at least
30 minutes before going to bed.
If an occasional dose is missed, risedronate sodium can be taken
before breakfast, between meals, or in
the evening according to