RISEDRONATE AUROBINDO 5 Milligram Film Coated Tablet

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

RISEDRONATE SODIUM

Sẵn có từ:

Milpharm Limited

Mã ATC:

M05BA07

INN (Tên quốc tế):

RISEDRONATE SODIUM

Liều dùng:

5 Milligram

Dạng dược phẩm:

Film Coated Tablet

Loại thuốc theo toa:

Product subject to prescription which may be renewed (B)

Khu trị liệu:

Bisphosphonates

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2011-12-05

Tờ rơi thông tin

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. 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. 

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. Osteoporosis related fractures can also cause back pain,
height loss and a curved

Đặc tính sản phẩm

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