FOSAVANCE 5600 TABLET

Land: Sydafrika

Språk: engelska

Källa: South African Health Products Regulatory Authority (SAHPRA)

Tillgänglig från:

Organon South Africa (Pty) Ltd

Dos:

See ingredients

Läkemedelsform:

TABLET

Sammansättning:

EACH TABLET CONTAINS ALENDRONATE SODIUM EQUIVALENT TO ALENDRONIC ACID 70,0 mg VITAMIN D 5600,0 iu

Bemyndigande status:

Registered

Tillstånd datum:

2015-11-06

Bipacksedel

Page 1 of 9
PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING FOSAVANCE
5600.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor or your
pharmacist.
•
FOSAVANCE 5600 has been prescribed for you personally and you should
not share your medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
SCHEDULING STATUS
PROPRIETARY NAME AND DOSAGE FORM
FOSAVANCE
®
5600 Tablets
1. WHAT FOSAVANCE 5600 CONTAINS
FOSAVANCE 5600 (alendronate sodium/cholecalciferol) are tablets that
contain the active
ingredients:
•
Alendronate monosodium trihydrate which is equivalent to 70 mg
alendronic acid (anhydrous free
acid) and 140 mcg of cholecalciferol (5600 I.U. of vitamin D
3
).
FOSAVANCE 5600 provide a week’s supply of vitamin D per tablet.
In addition, FOSAVANCE 5600 contain the following inactive
ingredients: Microcrystalline cellulose,
lactose anhydrous, medium chain triglycerides, gelatin, croscarmellose
sodium, sucrose, colloidal
silicon dioxide, magnesium stearate, butylated hydroxytoluene,
modified food starch and sodium
aluminium silicate.
Contains lactose and sucrose.
2.
WHAT FOSAVANCE 5600 IS USED FOR
The alendronate in FOSAVANCE 5600 is a member of a class of
non-hormonal medicines called
bisphosphonates. FOSAVANCE 5600 helps to rebuild bone and makes bone
less likely to fracture.
Vitamin D is an essential nutrient, required for calcium absorption
and healthy bones.
Your doctor has prescribed FOSAVANCE 5600 to treat your osteoporosis
and to help make sure you
get enough vitamin D. This will reduce the risk of developing
fractures.
3.
BEFORE YOU TAKE FOSAVANCE 5600
DO NOT TAKE FOSAVANCE 5600 IF:
•
You are allergic to alendronate or to any of the other ingredients of
FOSAVANCE 5600.
S3
Page 2 of 9
•
You have certain disorders of the oesophagus (the tube that connects
your mouth with your
stomach).
•
You are unable to stand or sit upright for at least 30 minutes.
•
Your doctor has t

Produktens egenskaper

FOSAVANCE 2800 AND FOSAVANCE 5600 TABLETS
APPROVED PACKAGE INSERT
APPROVED BY MCC: 11 JUNE 2015 (REGISTRATION)
_JJ/20090108 _
Page 1 of 13
_Council registration _
Initial:
SCHEDULING STATUS
S3
PROPRIETARY NAME AND DOSAGE FORM
FOSAVANCE

2800
Tablets
FOSAVANCE
™
5600 Tablets
COMPOSITION
Each FOSAVANCE 2800 contains alendronate monosodium salt trihydrate
which is the molar equivalent to 70
mg of free acid, and 70 mcg of cholecalciferol equivalent to 2800 IU
vitamin D
3
.
Each
FOSAVANCE
5600
Tablet
contains
alendronate
monosodium
salt
trihydrate
which
is
the
molar
equivalent to 70 mg alendronic acid (anhydrous free acid), and 140 mcg
of cholecalciferol equivalent to 5600
IU vitamin D
3
.
Excipients: microcrystalline cellulose, lactose anhydrous, medium
chain triglycerides, gelatine, croscarmellose
sodium, sucrose, colloidal silicon dioxide, magnesium stearate,
butylated hydroxytoluene, modified food
starch, and sodium aluminium silicate.
FOSAVANCE 2800 contains sugar in the form of lactose anhydrous (62 mg)
and sucrose (8 mg).
FOSAVANCE 5600 contains sugar in the form of lactose anhydrous (63 mg)
and sucrose (16 mg).
PHARMACOLOGICAL CLASSIFICATION
A.3.2. Connective tissue medicines, non-hormonal preparations.
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Alendronate Sodium
Alendronate sodium is a bisphosphonate that acts as a specific
inhibitor of osteoclast-mediated bone
resorption. Bisphosphonates are synthetic analogues of pyrophosphate
that bind to the hydroxyapatite found

Trademark of Merck & CO., INC., Whitehouse Station., N.J., U.S.A
FOSAVANCE 2800 AND FOSAVANCE 5600 TABLETS
APPROVED PACKAGE INSERT
APPROVED BY MCC: 11 JUNE 2015 (REGISTRATION)
_JJ/20090108 _
Page 2 of 13
_Council registration _
Initial:
in bone.
Cholecalciferol
Cholecalciferol (vitamin D
3
) is a secosterol that is the natural precursor of the
calcium-regulating hormone
calcitriol (1,25-dihydroxyvitamin D
3
).
Vitamin D
3
is converted to 25-hydroxyvitamin D
3
in the liver. Conversion to the active calcium-mobilising
hormone
1,25-d