APO-CICLOSPORIN ciclosporin 25 mg soft capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ciclosporin, Quantity: 25 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: Gelatin; iron oxide black; polysorbate 20; purified water; ethyl lactate; sorbitan oleate; titanium dioxide; PEG-40 hydrogenated castor oil; glycerol; tricaprin; lecithin

Administration route:

Oral

Units in package:

60, 30, 50

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Ciclosporin 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 immunosuppressive therapy (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

Product summary:

Visual Identification: Grey oval soft gelatin capsules; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-02-09

Patient Information leaflet

APO-CICLOSPORIN
1
APO-CICLOSPORIN
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 APO-CICLOSPORIN?
APO-CICLOSPORIN contains the active ingredient ciclosporin.
APO-CICLOSPORIN is used for people who have had a kidney,
heart or liver transplant, to prevent the body from rejecting the new
organ. APO-CICLOSPORIN is also used to treat several
other conditions which are thought to be caused by a problem with the
immune system: kidney disease (nephrotic syndrome),
severe case of rheumatoid arthritis, severe case of psoriasis or
atopic dermatitis.
For more information, see Section 1. Why am I using APO-CICLOSPORIN?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE APO-CICLOSPORIN?
Do not use if you have ever had an allergic reaction to ciclosporin or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
APO-CICLOSPORIN?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with APO-CICLOSPORIN and affect how it
works.
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 APO-CICLOSPORIN?
•
Follow all directions given to you by your doctor and pharmacist
carefully.
•
The dose of APO-CICLOSPORIN is worked out for each person. It will
depend on how much you weigh, what condition is
being treated, how well APO-CICLOSPORIN works for you, and whether you
have any side effects from this medicine.
•
Swallow the capsules whole with a full glass of water. Do not chew the
capsules.
More instructions can be found in Section 4. How do I use
APO-CICLOSPORIN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING APO-CICLOSPORIN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
APO-CICLOSPORIN
(Ciclosporin) CAPSULES
1
NAME OF THE MEDICINE
Ciclosporin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APO-CICLOSPORIN capsules are intended for oral administration. Each
capsule contains either
25mg, 50mg or 100mg ciclosporin as the active ingredient.
Ciclosporin is poorly soluble in water (0.004% w/w) and n-hexane but
is very soluble in other organic
solvents and in lipids.
APO-CICLOSPORIN is a microemulsion pre-concentrate formulation of
ciclosporin. When mixed with
water (either in the form of gastric fluid or a beverage),
APO-CICLOSPORIN immediately forms a
microemulsion which facilitates the gastrointestinal absorption of
ciclosporin
Each tablet contains sulfites and soya bean products.
EXCIPIENTS WITH KNOWN EFFECT:
Ethyl lactate (28.0% w/w). Ethyl lactate rapidly metabolises to
ethanol and lactic acid. An oral dosage
that provides 100mg of ciclosporin would thus result in concomitant
oral administration of 129mg of
ethanol.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
APO-CICLOSPORIN CAPSULES
25 mg: Grey soft gelatin capsules filled with an oily liquid solution
with imprinting “DX 25mg”
50 mg: Grey soft gelatin capsules filled with an oily liquid solution
with imprinting “DX 50mg”
100 mg: Grey soft gelatin capsules filled with an oily liquid solution
with imprinting “DX 100mg”
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
APO-CICLOSPORIN is indicated:
•
As an immunosuppressive agent for the prevention of graft rejection
following kidney, liver
and heart allogeneic transplantation.
2
•
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