Cyclosporin Sandoz

ciclosporin


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 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 ciclosporin, 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.

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 ciclosporin, 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 ciclosporin, 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

mycophenolate sodium or mofetil, which are medicines that lower your immunity

eltrombopag, medicine to stimulate the formation of new platelets in the blood.

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.

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, ciclosporin. Cyclosporin Sandoz, however, is designed to improve the way ciclosporin 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 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 ciclosporin, 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, ciclosporin 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:

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 30°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.

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 ciclosporin. 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).

Sponsor

Novartis Pharmaceuticals Australia Pty Limited

ABN 18 004 244 160

54 Waterloo Road

Macquarie Park NSW 2113

Australia

Telephone 1 800 671 203

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 October 2022.

(cic171022c.doc) based on PI (cic171022i.doc)

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