Actonel Plus Ca & D 35mg film-coated Tablets + 1000mg/880IU effervescent granules

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

CALCIUM, COLECALCIFEROL, RISEDRONATE SODIUM

から入手可能:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATCコード:

M05BB02

INN（国際名）:

CALCIUM 1000 mg COLECALCIFEROL 880 µg RISEDRONATE SODIUM 35 mg

医薬品形態:

FILM-COATED TABLET EFFERVESCENT GRANULES

構図:

CALCIUM 1000 mg COLECALCIFEROL 880 µg RISEDRONATE SODIUM 35 mg

処方タイプ:

POM

治療領域:

DRUGS FOR TREATMENT OF BONE DISEASES

認証ステータス:

Withdrawn

承認日:

2008-02-05

情報リーフレット

LEAFL ET: PAGE 1
SAP-Nr.: 
10001568
Product:  
IS Actonel Combi D 
Sachet small IE WE10
Country: Ireland
Version: 
8
Constructed: 20.09.2014 
s+b/hp
Modifi ed: 
13.11.2014  s+b/khf/hp/hp/hp/hp/

hp/khf
Size: 
210 x 480 mm (80 x 105 mm)
Fontversion: Futura
Smallest font size:  9 pt 
Pages: 1 
of 
2
Colours: PMS 
Black 

■
●
  Techn. Drawing 
(Size, perforation, label, 
Placeholder for Sticker, 
varnish free area)
●
  Colours 
●
  Pharma Code (Laetus), 
Placement 
●
  Code of goods
●
  Version 
●
  Braille
●
  Barcode (EAN, ...)
APPROVED QA-LABEL 
CONTROL
WORD BY WORD CHECKED AND APPROVED BY LOCAL REGULATORY
Datum/Date:
.................................................................  
 Unterschrift/Sign:
...........................................................
.........................................
Replace SAP-No.:
  10000701/
   10001434
MPMS-No.:
98911520-XXX
Diecut
––––––––––––
Reason for change: 
SANOFI -AVENTIS REMOVED, COLLOIDAL ANHYDROUS SILICA
CHILDREN AND ADOLESCENTS
Risedronate sodium is not recommended for use in children 
below 18 due to insuffi cient data on safety and effi cacy.
OTHER MEDICINES AND ACTONEL PLUS CA & D
❍  
_Actonel tablets_
Medicines containing one of the following lessen the effect of the 
Actonel tablet if taken at the same time:
• calcium
• magnesium
• aluminium (for example some indigestion mixtures)
• iron.
Take these medicines at least 30 minutes after your Actonel tablet.
 ❑  _Calcium/vitamin D_
_3_
_ sachets_
Medicines containing calcium/vitamin D
3
 are known to interfere 
with the following:
• digitalis (used to treat heart disorders)
• tetracycline antibiotics
• steroids (such as cortisone)
• sodium fl uoride (used to strengthen the tooth enamel)
•  thiazide diuretics (used to remove water from the body by 
increasing urine production)
• cholestyramine (used to treat high blood cholesterol levels)
• laxatives (such as paraffi n oil).

製品の特徴

Page 1 of 13 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Actonel Plus Ca & D 35 mg film-coated tablets + 1000 mg / 880 IU effervescent granules  

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each film-coated tablet contains 35 mg risedronate sodium, (equivalent to 32.5 mg risedronic acid). 
Each sachet of effervescent granules contains 1000 mg calcium (as 2500 mg calcium carbonate) and 
22 micrograms (880 IU) colecalciferol (vitamin D
3
). 

Excipients with known effect: 
Each film-coated tablet contains 126.0 mg of lactose monohydrate (equivalent to 119.7 mg lactose). 
Each sachet of effervescent granules contains potassium (163 mg), sucrose (3.6 mg), soya-bean oil (0.7 
mg) and sorbitol (100 mg). 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

_Film-coated tablet_ 
Oval, light-orange, film-coated tablet with RSN on one side and 35 mg on the other. 

_Effervescent granules_ 
White effervescent granules. 

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). 
Actonel Plus Ca & D is only intended for use in assessed patients for whom the amount of calcium and 
vitamin D
3 
included is considered to provide adequate supplementation. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

A weekly unit of Actonel Plus Ca & D consists of 1 Actonel 35 mg film-coated tablet and 6 
calcium/vitamin D
3 
sachets in a box. 

Posology 
The recommended dose in adults is 1 Actonel 35 mg tablet on the first day followed on the next day by 
1 calcium/vitamin D
3 
sache