RISEDRONATE AUROBINDO 30 Milligram Film Coated Tablet

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

RISEDRONATE SODIUM

Saatavilla:

Milpharm Limited

ATC-koodi:

M05BA07

INN (Kansainvälinen yleisnimi):

RISEDRONATE SODIUM

Annos:

30 Milligram

Lääkemuoto:

Film Coated Tablet

Prescription tyyppi:

Product subject to prescription which may be renewed (B)

Terapeuttinen alue:

Bisphosphonates

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2011-12-05

Pakkausseloste

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 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 or nurse  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 Y

Valmisteyhteenveto

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 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 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�