Natriumrisedronaat Sandoz 75 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

NATRIUMRISEDRONAAT 1-WATER SAMENSTELLING overeenkomend met ; NATRIUMRISEDRONAAT 0-WATER ; SAMENSTELLING overeenkomend met RISEDRONINEZUUR

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

M05BA07

INN (Algemene Internationale Benaming):

NATRIUMRISEDRONAAT 1-WATER COMPOSITION corresponding to ; NATRIUMRISEDRONAAT 0-WATER ; COMPOSITION corresponding to RISEDRONINEZUUR

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; MAÏSZETMEEL, GEPREGELATINEERD ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Risedronic Acid

Product samenvatting:

Hulpstoffen: IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; MAÏSZETMEEL, GEPREGELATINEERD; NATRIUMSTEARYLFUMARAAT; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2011-08-23

Bijsluiter

Sandoz B.V.
Page 1/7
Natriumrisedronaat Sandoz 75 mg, filmomhulde tabletten
RVG 107797
V12
1.3.1.3 Bijsluiter
Mei 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
NATRIUMRISEDRONAAT SANDOZ
® 75 MG, FILMOMHULDE TABLETTEN
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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
WHAT [NATIONALLY COMPLETED NAME] IS
[Nationally completed name] belongs to a group of non-hormonal
medicines called bisphosphonates
that 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.
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 back.
Many patients with osteoporosis have no symptoms and you may not even
have known that you had it.
WHAT [NATIONALLY COMPLETED NAME] IS USED FOR
The t

Productkenmerken

Sandoz B.V.
Page 1/10
Natriumrisedronaat Sandoz 75 mg, filmomhulde tabletten
RVG 107797
V8
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Natriumrisedronaat Sandoz 75 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 75 mg of risedronate sodium,
equivalent to 69.6 mg risedronic acid.
_ _
Excipient with known effect
Each film-coated tablet contains 299.8 mg of lactose monohydrate
(equivalent to 284.8 mg lactose).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Pink, round, biconvex, marked with “R 75” on one side and plain on
the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of osteoporosis in postmenopausal women at increased risk of
fractures (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose in adults is one 75 mg tablet orally on two
consecutive days a month. The first
tablet should be taken on the same day each month, followed by the
second tablet the next day.
The optimal duration of bisphosphonate treatment for osteoporosis has
not been established. The need
for continued treatment should be re-evaluated periodically based on
the benefits and potential risks of
[Nationally completed name] 75mg film-coated tablets on an individual
patient basis, particularly after
5 or more years of use.
The absorption of risedronate sodium is affected by food and
polyvalent cations (see section 4.5), thus
to ensure adequate absorption patients should take the tablet before
breakfast: at least 30 minutes
before the first food, other medicinal product or drink (other than
plain water) of the day. Plain water
is the only drink that should be taken with risedronate 75 mg tablets.
Please note that some mineral
water may have a higher concentration of calcium and therefore should
not be used (see section 5.2).
Patients who miss a dose should be instructed to take one tablet the
morning after th