CYCLOSPORIN SANDOZ ciclosporin 100mg capsule blister pack

Main information

  • Trade name:
  • CYCLOSPORIN SANDOZ ciclosporin 100mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CYCLOSPORIN SANDOZ ciclosporin 100mg capsule blister pack
    Australia
  • Language:
  • English

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization status:
  • Registered
  • Authorization number:
  • 186361
  • Last update:
  • 22-05-2019

Public Assessment Report

Public Summary

Summary for ARTG Entry:

186361

CYCLOSPORIN SANDOZ ciclosporin 100mg capsules blister pack

ARTG entry for

Medicine Registered

Sponsor

Sandoz Pty Ltd

Postal Address

54 Waterloo Road,Macquarie Park, NSW, 2113

Australia

ARTG Start Date

14/06/2012

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. CYCLOSPORIN SANDOZ ciclosporin 100mg capsule blister pack

Product Type

Single Medicine Product

Effective date

7/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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").

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

Al/Al

24 Months

Store below 25

degrees Celsius

Not recorded

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

30 capsules

(S4) Prescription Only Medicine

60 capsules

(S4) Prescription Only Medicine

50 capsules

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Capsule, soft

Route of Administration

Oral

Visual Identification

blue-grey oblong soft gelatin capsules imprinted in red with "NVR 100mg".

Active Ingredients

ciclosporin

100 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 02:55:00 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Cyclosporin Sandoz

®

cyclosporin

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.

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 doctor may have prescribed it

for another reason.

Cyclosporin Sandoz is only available

with a doctor's prescription. It is not

addictive.

Before you take

Cyclosporin Sandoz

When you must not take it

Do not take Cyclosporin Sandoz if

you have ever had an allergic

reaction to cyclosporin, the active

ingredient in Cyclosporin Sandoz,

or to any of the other ingredients

listed at the end of this leaflet.

Symptoms of an allergic reaction

may include hives or an itchy skin

rash, swelling of the face, lips or

tongue, faintness, wheezing or

troubled breathing.

If you think you may be allergic to

Cyclosporin Sandoz, ask your

doctor for advice.

Do not take Cyclosporin Sandoz

after the expiry date printed on the

pack or if the packaging is torn or

shows signs of tampering.

In that case, return it to your

pharmacist.

Do not give Cyclosporin Sandoz to

a child under 16 years of age to

treat severe rheumatoid arthritis,

psoriasis or atopic dermatitis.

There is not enough information to

recommend its use for these diseases

in children under 16 years of age.

However, Cyclosporin Sandoz can be

used in children younger than 16 who

have had an organ transplant or who

have nephrotic syndrome.

Before you start to take it

If you have been prescribed

Cyclosporin Sandoz for nephrotic

syndrome, rheumatoid arthritis,

psoriasis or atopic dermatitis, tell

your doctor if you also have any of

these health problems/medical

conditions:

high blood pressure that is not

controlled

any uncontrolled infection

a poorly functioning immune

system

problems with your kidneys or

liver

severe heart, lung or blood vessel

disease

any type of cancer, including skin

cancer.

Your doctor may not want you to

take Cyclosporin Sandoz or may

want to take special precautions if

you have any of these conditions.

If you are being treated with

Cyclosporin Sandoz for psoriasis

or atopic dermatitis, you should

not concurrently receive UVB-rays

or phototherapy.

CYCLOSPORIN SANDOZ

Tell your doctor if you are

pregnant or intend to become

pregnant.

Experience with Cyclosporin Sandoz

in pregnancy is very limited. The use

of immunosuppressant medicines,

including cyclosporin, during

pregnancy has been shown to

increase the risk of problems in the

mother and the unborn child. If it is

necessary for you to take this

medicine, your doctor will discuss

with you the benefits and risks of

taking it during pregnancy.

Tell your doctor if you are breast-

feeding.

Breast-feeding is not recommended

since cyclosporin, the active

ingredient in Cyclosporin Sandoz,

passes into breast milk and may

affect your baby.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you buy without a

prescription from a pharmacy,

supermarket or health food shop.

Many other medicines may be

affected by Cyclosporin Sandoz or

they may affect how well

Cyclosporin Sandoz works. This

includes:

St John's wort, an ingredient in

many medicines that you can buy

without a prescription from a

pharmacy, health food shop or

supermarket

methotrexate, a medicine to treat

severe rheumatoid arthritis, some

types of cancers, and psoriasis

antibacterial amino glycoside-

type agents (e.g. gentamicin,

tobramycin)

antifungal agents containing

amphotericin B

antibacterial agents containing

ciprofloxacin

cytostatics containing melphalan

agents used to treat urinary tract

infection containing trimethoprim

medicines used to treat pain (non-

steroid anti-inflammatory drugs,

e.g. diclofenac)

acid secretion inhibitors of the

H2-receptor antagonist type (e.g.

cimetidine, ranitidine) , which are

used to reduce the amount of acid

in your stomach

other drugs which may affect the

kidneys

antibacterial agents of the

macrolide type (e.g.

clarithromycin, azithromycin,

erythromycin)

antifungal agents of the azole

type (e.g. fluconazole,

itraconazole, ketoconazole,

voriconazole) or terbinafine

oral contraceptives

(Levonorgestrel and

Norethisterone)

protease inhibitors, used to treat

or prevent infections caused by

viruses

imatinib, a medicine used to treat

some cancers

anthracycline anticancer

medicines, such as doxorubicin

certain blood pressure reducing

agents of the calcium antagonist

type (e.g. nifedipine, amlodipine,

verapamil, diltiazem,

amiodarone) or of the endothelin

receptor antagonist type (e.g.

bosentan, ambrisentan)

certain anticonvulsives, used to

prevent fits or seizures (e.g.

carbamazepine, phenytoin)

digoxin, a medicine used to treat

heart failure

colchicine, used to treat gout

disease with painful, swollen

joints

HMG-CoA reductase inhibitors

(statins), or fibric acid

derivatives, which are used to

treat high cholesterol

prednisolone, a corticosteroid

used to treat inflammatory

diseases such as arthritis, asthma,

colitis

etoposide, used to treat cancer

repaglinide, used to treat Type II

diabetes

aliskiren, used to treat high blood

pressure

potassium sparing drugs or

potassium containing drugs

triclopidine (a medicine that is

used after a stroke)

octreotide, a medicine used to

treat excess growth hormone,

relieve the symptoms of certain

types of cancer, or having surgery

on the pancreas

orlistat, used to help with weight

loss

danazol, a medicine used to treat

menstrual disorders

allopurinol, a medicine used to

treat gout (a disease with painful,

swollen joints caused by uric acid

crystals)

metoclopramide, a medicine used

to stop prevent nausea and

vomiting

cholic acid and derivatives, which

are used to treat gallstones

tacrolimus, everolimus, or

sirolimus, which are medicines

that lower your immunity

dabigatran, an anticoagulant

medicine used to prevent stroke.

You may need to take different

amounts of your medicines or you

may need to take different medicines.

Your doctor and pharmacist have

more information on medicines to be

careful with or avoid while taking

Cyclosporin Sandoz.

If you have not told your doctor

about any of these things, tell him/

her before you take Cyclosporin

Sandoz.

How to take

Cyclosporin Sandoz

Follow all directions given to you

by your doctor and pharmacist

carefully.

CYCLOSPORIN SANDOZ

These instructions may differ from

the information contained in this

leaflet.

If you do not understand the

instructions on the label, ask your

doctor or pharmacist for help.

If you are changing from

Sandimmun

®

to Cyclosporin

Sandoz

Some patients who have been

prescribed Cyclosporin Sandoz

would have taken Sandimmun in the

past. Like Cyclosporin Sandoz,

Sandimmun contains the medicine,

cyclosporin. Cyclosporin Sandoz,

however, is designed to improve the

way cyclosporin gets into your

bloodstream. Because of this, your

dose of Cyclosporin Sandoz may

eventually be less than the dose of

Sandimmun you used to take.

If you are changing from Sandimmun

to Cyclosporin Sandoz, your doctor

will perform some extra blood tests

and then decide whether to change

your dose of Cyclosporin Sandoz.

Do not change from Cyclosporin

Sandoz to Sandimmun or from

Sandimmun to Cyclosporin Sandoz

unless it is under the strict

supervision of your doctor.

Do not take Cyclosporin Sandoz

and Sandimmun at the same time.

How much to take

The dose of Cyclosporin Sandoz is

worked out for each person. It will

depend on how much you weigh,

what condition is being treated, how

well Cyclosporin Sandoz works for

you, and whether you have any side

effects from this medicine. Your dose

may be changed from time to time.

How to take it

Do not remove the capsules from

the foil blister pack until you are

ready to take them.

Swallow the capsules whole with

a full glass of water.

Do not chew them.

When to take it

Always take Cyclosporin Sandoz

twice a day. It is best to take the

doses 12 hours apart if possible.

Take them at about the same time

each day.

Taking your doses 12 hours apart and

at the same time each day will have

the best effect. It will also help you

remember when to take them.

How long to take it

Keep taking this medicine for as

long as your doctor recommends.

The length of treatment will depend

on what medical condition you have.

For transplant patients:

You will need to take one or more

immunosuppressant medicines for as

long as you have the transplanted

organ.

For nephrotic syndrome:

You may take Cyclosporin Sandoz

for 3 months to start with. If it helps

your condition, your doctor may

decide to continue Cyclosporin

Sandoz treatment for as long as it

helps you and does not cause serious

side effects.

For severe rheumatoid arthritis:

You will usually take Cyclosporin

Sandoz for 3 months to start with. It

may take this long to know whether

Cyclosporin Sandoz will help your

condition. If Cyclosporin Sandoz is

effective, your doctor may then lower

the dose and you will continue

treatment at the lowest dose that is

suitable for you.

For severe psoriasis:

You will usually take Cyclosporin

Sandoz for up to 6 weeks to start

with. If your condition improves,

your doctor may want you to

continue treatment at the lowest

effective dose. You can only expect

to benefit from this medicine while

you continue to take it.

For severe atopic dermatitis:

You will usually take Cyclosporin

Sandoz for up to 8 weeks to start

with. Once your condition has

improved, the dose may be slowly

reduced, and in some cases, may

even be stopped. Once you have

stopped taking Cyclosporin Sandoz,

your condition is likely to return,

although this may take several weeks

or months. Your doctor may then

want you to start taking Cyclosporin

Sandoz again.

If you forget to take it

If it is almost time for your next

dose, skip the dose you missed and

take the next dose when you are

meant to.

Otherwise, take it as soon as you

remember, and then go back to

taking it as you would normally.

Do not take a double dose to make

up for the one that you missed.

This may increase the chance of you

getting an unwanted side effect.

If you miss more than one dose,

contact your doctor as soon as

possible.

If you have trouble remembering

when to take your medicine, ask

your pharmacist for some hints.

If you take too much

(Overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(telephone number 13 11 26), or go

to Accident and Emergency at

your nearest hospital if you think

that you or anyone else may have

taken too much Cyclosporin

Sandoz. Do this even if there are no

signs of discomfort or poisoning.

Keep the telephone numbers for

these places handy.

While you are taking

Cyclosporin Sandoz

Things you must do

Take Cyclosporin Sandoz exactly

as your doctor has prescribed.

You must take this medicine

exactly as prescribed so that it will

CYCLOSPORIN SANDOZ

work properly and to prevent

unwanted side effects.

Make sure that you keep all of

your doctor's appointments and

have any tests done that are

ordered by your doctor.

Your doctor may ask you to have

tests from time to time to check how

well your kidneys and liver are

working. It may be necessary to

measure the amount of cyclosporin,

as well as the levels of other

chemicals (eg. potassium) in your

blood. Your blood pressure will also

be checked regularly.

Avoid eating large amounts of

foods that are high in potassium.

In some people taking Cyclosporin

Sandoz, the amount of potassium in

the blood can increase (called

hyperkalaemia). The amount of

potassium in the blood can also be

increased by eating certain foods.

Your doctor can tell you which foods

to avoid.

If you become pregnant while

taking Cyclosporin Sandoz, tell

your doctor.

Your doctor can discuss with you the

risks of taking it while you are

pregnant.

If you develop lumps anywhere on/

in your body, or develop any

moles, or you notice changes in

existing moles, tell your doctor.

This may be an early sign of a

cancer. Immunosuppressant

medicines, including Cyclosporin

Sandoz, may increase the risk of

developing certain cancers, including

skin cancer and lymphoma (cancer of

the lymphatic system).

Limit your exposure to sunlight

and UV light. If you go out in the

sun, wear a hat, appropriate

protective clothing and a sunscreen

with a high protection factor.

This will help to prevent the

development of skin cancer.

If you have psoriasis or atopic

dermatitis, you must be especially

careful about developing skin

cancer. Visit your skin specialist

regularly for check-ups.

Take special care of your teeth and

gums.

If you experience any symptoms of

infection (e.g. fever, sore throat),

inform your doctor immediately.

People taking immunosuppressant

medicines are at a greater risk of

getting infections. Taking good care

of your teeth and gums will help to

prevent dental and mouth infections.

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking Cyclosporin Sandoz.

Tell any other doctor, dentist or

pharmacist who treats you that

you are taking Cyclosporin

Sandoz.

Things you must not do

Do not take Cyclosporin Sandoz

with grapefruit or grapefruit juice

since this can influence

Cyclosporin Sandoz's effects.

Do not have any vaccinations

without first checking with your

doctor.

Some vaccines may be less effective

or they may cause unwanted side

effects while you are taking

Cyclosporin Sandoz.

Do not give this medicine to anyone

else even if their condition seems

similar to yours.

Do not take it to treat any other

complaints unless your doctor tells

you to.

Things to be careful of

Be careful driving, operating

machinery or doing jobs that

require you to be alert while you

are taking Cyclosporin Sandoz

until you know how it affects you.

This medicine can cause tiredness,

lack of energy or confusion in some

people. If you have any of these

symptoms, do not drive or do

anything else that could be

dangerous.

Cyclosporin Sandoz soft gelatin

capsules contain alcohol (ethanol).

The capsules contain 11.8 vol. %

alcohol, i.e. up to 500 mg per dose in

the transplantation indications

equivalent to 12.6 mL beer, 5 mL

wine per dose. Alcohol may be

harmful for those suffering from

alcoholism, epilepsy, brain injury or

liver disease as well as for pregnant

or breast-feeding women and

children.

Like other medicines that dampen the

immune system, cyclosporin may

influence your body's ability to fight

against infection and may cause

tumours or other malignancies,

particularly of the skin.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

Cyclosporin Sandoz, even if you do

not think it is connected with the

medicine.

All medicines can have side effects.

Sometimes they are serious, but most

of the time they are not. You may

need medical treatment if you get

some of the side effects. Your doctor

may be able to relieve some of the

side effects of Cyclosporin Sandoz

by lowering the dose.

If you are over 65 years old, you

should be especially careful while

taking this medicine. Report any

side effects promptly to your

doctor.

As people grow older, they are more

likely to get side effects from

medicines.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

CYCLOSPORIN SANDOZ

tiredness, lack of energy

burning feeling in hands and feet,

usually during the first week of

treatment

excessive growth of body and

facial hair

overgrown, thickened, swollen or

bleeding gums

stomach upset, including nausea

(feeling sick), vomiting, loss of

appetite, diarrhoea, stomach

cramps, stomach ulcer

tremor (shaking)

headache, including migraine

sensitivity to light

weight loss or gain

feeling depressed (sad)

flushing of face, acne, darkening

of skin

painful menstrual periods or lack

of periods

increase in size of breasts in

males and females

muscle cramps, tenderness or

weakness

blocked or stuffy nose

pain of lower extremities.

The above side effects are not usually

serious.

Tell your doctor immediately if

you notice any of the following:

fever (temperature above 37°C)

constant "flu-like" symptoms

such as chills, sore throat, aching

joints, swollen glands, or any

other signs of infection

unusual bleeding or bruising

signs of allergy such as rash,

itching or hives on the skin;

swelling of the face, lips, tongue

or other part of the body;

shortness of breath, wheezing or

troubled breathing

new lumps or moles, or changes

to existing moles, anywhere on

the body

swelling of the eyelids, hands or

feet due to excess fluid

a change in the amount of urine

passed or in the number of times

you urinate, pain on urinating,

bloody or smelly urine

yellowing of the skin and/or eyes

(jaundice) often accompanied by

generally feeling unwell (for

example, tiredness, lack of

energy, loss of appetite, nausea

and vomiting, pain in the

abdomen)

severe pain or tenderness in the

stomach or abdomen

vomiting blood or material that

looks like coffee grounds; black

sticky bowel motions or bloody

diarrhoea

unusual tiredness or weakness,

which may be accompanied by

dizziness, spots before the eyes,

shortness of breath and pale skin

numbness or "pins and needles"

in the hands and feet

a disturbance in brain function

which may cause a variety of

symptoms, including personality

changes, confusion,

disorientation, agitation, inability

to sleep, decreased

responsiveness, weakness and

loss of coordination in arms and

legs with or without abnormal

speech or eye movements,

seizures (fits), clumsiness,

memory loss, difficulty speaking

or understanding what others say,

visual hallucinations (seeing

things that are not there) or other

problems with vision, coma,

paralysis of part or all of the

body, stiff neck

buzzing or ringing in the ears,

difficulty hearing.

The above are serious side effects

that need medical attention.

Some side effects may not give you

any symptoms and can only be

found when tests are done. Some of

these side effects include:

changes in kidney or liver

function, or liver injury (with or

without yellow eyes or skin)

raised blood pressure

increase in the amount of

potassium or cholesterol in the

blood

decrease in the amount of

magnesium in the blood

increase in the amount of uric

acid in the blood, which can lead

to gout

increase in blood sugar

low white blood cell count

low levels of red blood cells

low levels of platelets in the

blood.

Your doctor will make sure that tests

are done regularly to watch for these

side effects.

Tell your doctor if you notice

anything else that is making you

feel unwell.

If you notice any other side effects

not mentioned in this leaflet, please

inform your doctor or pharmacist.

Other side effects not listed here may

happen in some people.

After using

Cyclosporin Sandoz

Storage

Keep your capsules in the foil

blister pack until it is time to take

them. If you take the capsules out

of the blister pack, they will not

keep well.

Store the pack in a cool dry place

where the temperature stays

below 25°C.

Keep the medicine where children

cannot reach it.

A locked cupboard at least one-and-

a-half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

taking Cyclosporin Sandoz or it

has passed its expiry date, ask your

pharmacist what to do with any

medicine you have left over.

CYCLOSPORIN SANDOZ

Product description

What it looks like

25 mg:

blue-grey, oval, soft gelatin capsules,

printed in red with the "NVR" and

"25 mg;" in foil blister packs of 30.

50 mg:

yellow-white, oblong, soft gelatin

capsules, printed in red with the

"NVR" and "50 mg;" in foil blister

packs of 30.

100 mg:

blue-grey, oblong, soft gelatin

capsules, printed in red with the

"NVR" and "100 mg;" in foil blister

packs of 30.

Ingredients

Cyclosporin Sandoz capsules contain

25 mg, 50 mg or 100 mg of

cyclosporin. The capsules also

contain:

dl-alpha-tocopherol

alcohol

propylene glycol

corn glycerides

polyoxyl PEG-40 hydrogenated

castor oil.

Cyclosporin Sandoz capsule shells

contain:

gelatin

propylene glycol

glycerol (E422)

titanium dioxide (E171)

iron oxide black (E172) (25 mg &

100 mg capsule shells only).

The printing ink on the capsules

contains:

carmoisine (E120)

aluminium chloride

sodium hydroxide

hypromellose (E464).

Supplier

Sandoz Pty Ltd

ABN 60 075 449 553

54 Waterloo Road

Macquarie Park NSW 2113

Australia

Tel: 1800 634 500

Australian Registration Numbers:

25 mg capsule: AUST R 186358

50 mg capsule: AUST R 186359

100 mg capsule: AUST R 186361

This leaflet was revised in August

2015.

CYCLOSPORIN SANDOZ