Tacrolimus Sandoz 0,75 mg, capsules, hard

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TACROLIMUS 1-WATER 0,767 mg/stuk SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER 0,75 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

L04AD02

INN (Algemene Internationale Benaming):

TACROLIMUS 1-WATER 0,767 mg/stuk SAMENSTELLING overeenkomend met ; TACROLIMUS 0-WATER 0,75 mg/stuk

farmaceutische vorm:

Capsule, hard

Samenstelling:

BRILJANTBLAUW FCF (E 133) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tacrolimus

Product samenvatting:

Hulpstoffen: BRILJANTBLAUW FCF (E 133); CROSCARMELLOSE NATRIUM (E 468); GELATINE (E 441); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); TITAANDIOXIDE (E 171); ZWARTE INKT;

Autorisatie datum:

2014-07-10

Bijsluiter

Sandoz B.V.
Page 1
Tacrolimus Sandoz 0,5 mg, 0,75 mg, 1 mg, 2
mg, 5 mg, capsules, hard
RVG 102096/113454/102097/113453/102098
1313-v14
1.3.1.3 Bijsluiter
Mei 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
TACROLIMUS SANDOZ® 0,5 MG, CAPSULES, HARD
TACROLIMUS SANDOZ® 0,75 MG, CAPSULES, HARD
TACROLIMUS SANDOZ® 1 MG, CAPSULES, HARD
TACROLIMUS SANDOZ® 2 MG, CAPSULES, HARD
TACROLIMUS SANDOZ® 5 MG, CAPSULES, HARD
tacrolimus
_ _
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
[Nationally completed name] belongs to a group of medicines called
IMMUNOSUPPRESSANTS
.
Following your organ transplant (e.g. liver, kidney, heart), your
body’s immune system will
try to reject the new organ.
[Nationally completed name] is used to control your body’s immune
response enabling your
body to accept the transplanted organ. [Nationally completed name] is
often used in
combination with other medicines that also suppress the immune system.
You may also be given [Nationally completed name] for an ongoing
rejection of your
transplanted liver, kidney, heart or other organ or if any previous
treatment you were taking
was unable to control this immune response after your tra

Productkenmerken

Sandoz B.V.
Page 1
Tacrolimus Sandoz 0,5 mg, 0,75 mg, 1 mg, 2 mg, 5 mg, capsules, hard
RVG 102096, 113454, 102097, 113453, 102098
1311-v15
1.3.1.1 Summary of Product Characteristics
Mei 2022
1
NAAM VAN HET GENEESMIDDEL
Tacrolimus Sandoz 0,5 mg, capsules, hard
Tacrolimus Sandoz 0,75 mg, capsules, hard
Tacrolimus Sandoz 1 mg, capsules, hard
Tacrolimus Sandoz 2 mg, capsules, hard
Tacrolimus Sandoz 5 mg, capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg of tacrolimus (as tacrolimus
monohydrate).
Excipient with known effect:
Each hard capsule contains 46.1 mg lactose (as monohydrate).
Each hard capsule contains 0.75 mg of tacrolimus (as tacrolimus
monohydrate).
Excipient with known effect:
Each hard capsule contains 69.1 mg lactose (as monohydrate).
Each hard capsule contains 1 mg of tacrolimus (as tacrolimus
monohydrate).
Excipient with known effect:
Each hard capsule contains 45.0 mg lactose (as monohydrate).
Each hard capsule contains 2 mg of tacrolimus (as tacrolimus
monohydrate).
Excipient with known effect:
Each hard capsule contains 90.0 mg lactose (as monohydrate).
Each hard capsule contains 5 mg of tacrolimus (as tacrolimus
monohydrate).
Excipient with known effect:
Each hard capsule contains 225.1 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Sandoz B.V.
Page 2
Tacrolimus Sandoz 0,5 mg, 0,75 mg, 1 mg, 2 mg, 5 mg, capsules, hard
RVG 102096, 113454, 102097, 113453, 102098
1311-v15
1.3.1.1 Summary of Product Characteristics
Mei 2022
Capsule, hard
_0.5 mg hard capsules _
Opaque white and ivory hard gelatin capsule containing white to off-
white powder (length: 14.5 mm).
_0.75 mg hard capsules _
Light green opaque hard gelatin capsule, imprinted in black with 0.75
mg on the cap, containing white
to off-white powder (length: 14.5 mm).
_1 mg hard capsules _
Opaque white and light brown hard gelatin capsule containing white to
off- white powder (length:
14.5 mm).
_2 mg hard capsules _
Dark green opaque capsule, imprinted