CYCLOSPORIN SANDOZ ciclosporin 100mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

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Patient Information leaflet (PIL)

06-05-2021

Summary of Product characteristics (SPC)

06-05-2021

Public Assessment Report (PAR)

28-11-2017

Active ingredient:

ciclosporin, Quantity: 100 mg

Available from:

Novartis Pharmaceuticals Australia Pty Ltd

INN (International Name):

ciclosporin

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: propylene glycol; iron oxide black; titanium dioxide; corn glycerides; dl-alpha-tocopherol; glycerol; Gelatin; ethanol; PEG-40 hydrogenated castor oil; hypromellose; purified water; isopropyl alcohol; cochineal; aluminium chloride; sodium hydroxide

Administration route:

Oral

Units in package:

30 Capsules, 60 Capsules, 50 Capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cyclosporin Sandoz is indicated as an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation. For induction and/or maintenance of remission in the nephrotic syndrome. Cyclosporin is not a first-line agent. Its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see Precautions). For the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective. In patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with the quality of life. For the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate. Careful monitoring of all cyclosporin-treated patients is mandatory. Cyclosporin should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see "Precautions").

Product summary:

Visual Identification: blue-grey oblong soft gelatin capsules imprinted in red with "NVR 100mg".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2012-06-14

Patient Information leaflet

CYCLOSPORIN SANDOZ
®
_ciclosporin_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cyclosporin Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Cyclosporin
Sandoz against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CYCLOSPORIN
SANDOZ IS USED FOR
Cyclosporin Sandoz is used for
people who have had a kidney, heart
or liver transplant, to prevent the
body from rejecting the new organ. It
does this by blocking the
development of special cells which
would normally attack the
transplanted tissue.
Cyclosporin Sandoz is also used to
treat several other conditions which
are thought to be caused by a
problem with the immune system:
•
a kidney disease called nephrotic
syndrome
•
severe cases of rheumatoid
arthritis (a disease, affecting the
joints with pain and swelling)
•
severe cases of:
-
psoriasis (a skin disease with
thickened patches of red skin,
often with silvery scales)
-
atopic dermatitis (skin allergies).
Cyclosporin Sandoz contains the
active ingredient, cyclosporin. It
belongs to a group of medicines
called immuno-suppressive agents.
These medicines help to control your
body's immune system.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your d

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Summary of Product characteristics

Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION
CYCLOSPORIN SANDOZ
 CAPSULES (CICLOSPORIN)
1
NAME OF THE MEDICINE
Ciclosporin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ciclosporin is poorly soluble in water (0.004% w/w) and n-hexane, but
is very soluble in other
organic solvents and in lipids.
Each Cyclosporin Sandoz 25 mg capsule contains 25 mg ciclosporin.
Each Cyclosporin Sandoz 50 mg capsule contains 50 mg ciclosporin.
Each Cyclosporin Sandoz 100 mg capsule contains 100 mg ciclosporin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
25 mg: blue-grey oval soft gelatin capsules imprinted in red with "NVR
25 mg".
50 mg: yellow-white oblong soft gelatin capsules imprinted in red with
"NVR 50 mg".
100 mg: blue-grey oblong soft gelatin capsules imprinted in red with
"NVR 100 mg".
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Cyclosporin Sandoz is indicated:
•
As an immunosuppressive agent for the prevention of graft rejection
following kidney,
liver and heart allogeneic transplantation.
•
For induction and/or maintenance of remission in the nephrotic
syndrome. Ciclosporin
is not a first-line agent. Its use should be restricted to occasions
when steroids and
cytostatic drugs have failed, or are not tolerated, or are considered
inappropriate, and
when renal function is unimpaired (see Section 4.4 Special warnings
and precautions
for use).
•
For the treatment of severe, active rheumatoid arthritis in patients
for whom classical
slow-acting
antirheumatic
agents
(including
methotrexate)
are
inappropriate
or
ineffective.
•
In patients with severe psoriasis in whom conventional therapy is
ineffective or
inappropriate and the disease has caused a significant interference
with quality of life.
•
For the treatment of severe atopic dermatitis when other treatment is
ineffective or
inappropriate.
_CAREFUL MONITORING OF ALL CICLOSPORIN-TREATED PATIENTS IS MANDATORY.
CICLOSPORIN SHOULD ONLY _
_BE USED BY MEDICAL PRACTITIONERS WHO ARE EXPERIENCED IN THE USE OF
IMMUNOSUPPR

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