Tacrolimus Sandoz
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
08-08-2019
Summary of Product characteristics
(SPC)
03-07-2019
Active ingredient:
Tacrolimus monohydrate 1.022mg equivalent to 1 mg tacrolimus
Available from:
Sandoz New Zealand Limited
INN (International Name):
Tacrolimus monohydrate 1.022 mg (= 1 mg tacrolimus)
Dosage:
1 mg
Pharmaceutical form:
Capsule
Composition:
Active: Tacrolimus monohydrate 1.022mg equivalent to 1 mg tacrolimus Excipient: Croscarmellose sodium Hypromellose Capsugel white/brown G4ICS000510 Lactose monohydrate Magnesium stearate
Units in package:
Blister pack, PVC/PE/PVdC/Al, 100 capsules, 100 capsules
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Lek Pharmaceuticals d.d.
Therapeutic indications:
Primary immunosuppression in liver, kidney, pancreas, kidney-pancreas, lung or heart allograft recipients and rescue use in liver, kidney or other solid organ (heart, lung, pancreas or kidneys) transplantation, that has either failed conventional immunosuppressive agents, or where such agents are producing intolerable side effects.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVdC/Al, 100 capsules - 100 capsules - 24 months from date of manufacture stored at or below 30°C 12 months opened stored at or below 25°C. (opened pouch, but still packed in blisters)
Authorization date:
2010-03-01
Patient Information leaflet
Tacrolimus Sandoz® CMI v1.0
1
TACROLIMUS SANDOZ®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TACROLIMUS SANDOZ?
Tacrolimus Sandoz contains the active ingredient tacrolimus
monohydrate.
Tacrolimus Sandoz is used so that your new liver, kidney, lung or
heart will not be attacked or rejected by your body.
For more information, see Section 1. Why am I using Tacrolimus Sandoz?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TACROLIMUS SANDOZ?
Do not use if you have ever had an allergic reaction to Tacrolimus
Sandoz, macrolide antibiotics, or any of the ingredients
listed at the end of the CMI. Tacrolimus Sandoz and Tacrolimus XR
Sandoz are not interchangeable.
For more information, see Section 2. What should I know before I use
Tacrolimus Sandoz? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Tacrolimus Sandoz and affect how it
works.
Tell your doctor of pharmacist if you are taking any other medicines,
including any medicines, vitamins or supplements that
you buy without a prescription from your pharmacy, supermarket or
health food shop.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TACROLIMUS SANDOZ?
•
Tacrolimus Sandoz capsules should be taken in two doses (e.g. morning
or evening) each day.
•
Tacrolimus Sandoz capsules should be taken at least 1 hour before or 2
to 3 hours after a meal preferably with water and
not grapefruit juice.
More instructions can be found in Section 4. How do I use Tacrolimus
Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TACROLIMUS SANDOZ?
THINGS YOU
SHOULD DO
•
Tell your doctor if you become pregnant while taking Tacrolimus
Sandoz.
•
Tacrolimus Sandoz suppresses your immune system by lowering your
body’s immune defence system.
This increases your risk of skin cancer and other cancers while taking
Tacrolimu
Read the complete document
Summary of Product characteristics
230717-Tacrolimus Sandoz-ds
Page 1 of 20
NEW ZEALAND DATA SHEET
TACROLIMUS SANDOZ CAPSULES (TACROLIMUS)
1.
PRODUCT NAME
Tacrolimus
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tacrolimus Sandoz 0.5 mg: Each capsule contains tacrolimus 0.5 mg (as
monohydrate).
Tacrolimus Sandoz 0.75 mg: Each capsule contains tacrolimus 0.75 mg
(as monohydrate).
Tacrolimus Sandoz 1 mg: Each capsule contains tacrolimus 1 mg (as
monohydrate).
Tacrolimus Sandoz 2 mg: Each capsule contains tacrolimus 2 mg (as
monohydrate).
Tacrolimus Sandoz 5 mg: Each capsule contains tacrolimus 5 mg (as
monohydrate).
For the full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Tacrolimus Sandoz 0.5 mg: White to off-white powder filled in size
“4” capsule with white
coloured opaque body and ivory coloured cap.
Tacrolimus Sandoz 0.75 mg: White to off-white powder filled in size
“4” capsule with light
green opaque body and cap, imprinted in black with 0.75 mg on cap.
Tacrolimus Sandoz 1 mg: White to off-white powder filled in size
“4” capsule with white
coloured opaque body and light brown coloured cap.
Tacrolimus Sandoz 2 mg: White to off-white powder filled in size
“4” capsule with dark green
opaque body and cap, imprinted in black with 2 mg on cap.
Tacrolimus Sandoz 5 mg: White to off-white powder filled in size
“3” capsule with white
coloured opaque body and Swedish orange coloured cap.
_Not all strengths may be marketed in New Zealand. _
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Primary immunosuppression in liver, kidney, pancreas, kidney-pancreas,
lung or heart allograft
recipients and rescue use in liver, kidney or other solid organ
(heart, lung, pancreas or kidney-
pancreas) transplantation, that has either failed conventional
immunosuppressive agents, or
where such agents are producing intolerable side effects.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_ADULTS _
The dosage recommendations given below for oral administration should
act as a guideline.
Tacrolimus doses should be adjusted according to
Read the complete document
