RISEDRONATE SODIUM ACTAVIS ONCE WEEKLY 35 Milligram Film Coated Tablet

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

RISEDRONATE SODIUM

متاح من:

Actavis Group PTC ehf

ATC رمز:

M05BA07

INN (الاسم الدولي):

RISEDRONATE SODIUM

جرعة:

35 Milligram

الشكل الصيدلاني:

Film Coated Tablet

نوع الوصفة الطبية :

Product subject to prescription which may be renewed (B)

المجال العلاجي:

Bisphosphonates

الوضع إذن:

Authorised

تاريخ الترخيص:

2010-10-01

نشرة المعلومات

Risedronic acid 35mg tablet leaflet - Ireland
item no: 
print proof no: 
origination date: 
originated by:
revision date:  
revised by: 
dimensions: 
pharmacode:
colours/plates:
approved for print/date
Non Printing Colours
1. Black
2.
3.
4.
5.
6.
1. 
2.
3.
date sent:
supplier:
technically app. date:
min pt size:
TECHNICAL APPROVAL
AAAJ0083
2
09.05.16
jh
20.05.16
jh
Actavis Iceland
170 x 380
8.6
09.05.16
10.05.16
PACKAGE LEAFLET: 
INFORMATION FOR THE PATIENT.
RISEDRONATE SODIUM ACTAVIS ONCE WEEKLY 
35 MG FILM-COATED TABLETS
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 SODIUM ACTAVIS ONCE 
WEEKLY IS AND WHAT IT IS USED FOR
2
  WHAT YOU NEED TO KNOW BEFORE YOU 
TAKE RISEDRONATE SODIUM ACTAVIS ONCE 
WEEKLY 
3
  HOW TO TAKE RISEDRONATE SODIUM ACTAVIS 
ONCE WEEKLY
4
  POSSIBLE SIDE EFFECTS
5
  HOW TO STORE RISEDRONATE SODIUM 
ACTAVIS ONCE WEEKLY
6
  CONTENTS OF THE PACK AND OTHER 
INFORMATION
1
   WHAT RISEDRONATE SODIUM ACTAVIS ONCE 
WEEKLY IS AND WHAT IT IS USED FOR
WHAT RISEDRONATE SODIUM ACTAVIS ONCE 
WEEKLY IS
Risedronate sodium Actavis Once Weekly 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 condit

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Risedronate Sodium Actavis once weekly 35mg 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.
Excipients 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, 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).
Risedronate Sodium Actavis once weekly 35 mg is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 Actavis once weekly 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 Actavis once weekly 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 tabl