Pacrolim

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NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Tacrolimus (as monohydrate)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about PACROLIM. 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 PACROLIM against the benefits this medicine is expected to have for you.

If you have any concerns about using PACROLIM ask your doctor or pharmacist.

Keep this leaflet with your medicine. You may need to read it again.

What PACROLIM is used for

You have been given a new transplanted liver or kidney, lung or heart from another person because your own was no longer healthy. Your body recognises that this new organ is different from your organs and will try to reject it by attacking it in the same way that it would attack germs that enter your body. This could make you become ill again. PACROLIM stops this attack; it is very important to take PACROLIM given to you by your doctor regularly so that your new liver, kidney, lung or heart will not be attacked or rejected.

If you have been taking other medicines for this purpose, but are still feeling unwell, your doctor may change your treatment and begin giving you PACROLIM.

PACROLIM contains the active ingredient tacrolimus, which is an immunosuppressive agent.

Your doctor may have prescribed PACROLIM for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take PACROLIM

When you must not use it

Do not use PACROLIM if

• you have an allergy to tacrolimus, other macrolides (these are antibiotics of the erythromycin family - trade names are Eryc, EES, Klacid, Zithromax, Rulide and Biaxsig) or any of the ingredients contained in the capsules. See ‘Product Description’ at the end of this leaflet for a list of ingredients.

Do not use PACROLIM if the packaging is torn or shows signs of tampering. Do not use PACROLIM beyond the expiry date (month and year) printed on the pack.

Before you start to use it

You must tell your doctor if

you are pregnant or planning to become pregnant

you are using oral contraceptives

you are breast feeding

you are receiving cyclosporin immunosuppressive therapy.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking or are given PACROLIM.

Your doctor will advise you whether or not to take PACROLIM or if you need to adjust the dose or adapt your treatment.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop.

This is particularly important for PACROLIM because there are some specific medicines that could alter PACROLIM's effectiveness and safety.

Among these medicines is the herbal preparation St John's Wort (Hypericum perforatum) which is capable of decreasing tacrolimus blood levels.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

Effects on driving and operating machinery

PACROLIM may cause visual or nervous disturbances. If affected, do not drive or operate machinery.

Effects of food and alcohol

Food reduces the absorption of PACROLIM so the capsules should be taken at least 1 hour before a meal.

Using PACROLIM

How much to take

You can only get PACROLIM from your doctor. Your dose will be calculated according to your weight, age, and medical condition. As your health and the function of your new liver or kidney, lung or heart can be affected by how much medicine you take, it is normal that your doctor collects samples of blood and urine at regular intervals. This is in order to test whether your medicine requires adjustment.

PACROLIM should be taken in two doses (e.g. morning and evening). Take the capsule from the blister pack and swallow it whole with plenty of water. Do not use grapefruit juice, grapefruit juice contains substances that interfere with the action of PACROLIM.

How to take it

PACROLIM capsules should be taken at least 1 hour before a meal.

You must never change the dose yourself even if you are feeling better. It is very important that you keep taking this medicine so that your body will not reject your new liver kidney, lung or heart.

If you accidentally take a larger dose than recommended, tell your doctor immediately.

If you do not understand the instructions provided with this medicine, ask your doctor or pharmacist for help.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you have missed more than one dose, or are not sure what to do, check with your doctor or pharmacist.

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 for advice, or go to Accident and Emergency at your nearest hospital.

Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Poisons Information Centre telephone numbers:

Australia: 13 11 26

New Zealand: 0800 POISON or 0800 764 766

Keep these telephone numbers handy.

While you are taking PACROLIM

Things you must do

Always follow your doctor's instructions carefully

Tell your doctor if you become pregnant while taking PACROLIM

If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking PACROLIM.

PACROLIM suppress your immune system by lowering your body's immune defence system. This increases your risk of skin cancer and other cancers while taking PACROLIM. Always protect yourself from the sun, wear sunscreen, a hat and protective clothing.

Things you must not do

Do not take PACROLIM to treat any other complaint unless your doctor says so.

Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Side effects

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. 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 experience any of the following:

tiredness, lack of energy

stomach upset, including nausea (feeling sick), vomiting, loss of appetite, diarrhoea, stomach cramps

tremor (shaking)

headache

feeling depressed (sad)

sleeping difficulties

blurred vision or sensitive to light

muscle cramps, tenderness or weakness.

Tell your doctor immediately if you notice any of the following as you may need urgent medical care:

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

fever

diabetes / increased blood sugar

swelling, numbness or tingling (pins and needles) in your hands and feet

constant "flu-like" symptoms such as chills, sore throat, aching joints, swollen glands, or any other signs of infection

unusual bleeding or bruising

high blood pressure

palpitations, abnormal heart rhythms, chest pain

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, or other kidney problems.

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)

symptoms of anaemia, such as shortness of breath, tiredness or dizziness

seizures (fits)

buzzing or ringing in the ears, difficulty hearing

Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.

After using PACROLIM

Storage

The blister strips should be kept in a dry place and the capsules should be left in the blister until required for use.

Store below 25°C.

Store in the original container.

Keep your medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres (1.5 m) above the ground is a good place to store medicines.

Do not store PACROLIM, or any other medicine, in the bathroom or near a sink. Do not leave medicines in the car or on window sills. Heat and dampness can destroy some medicines.

Disposal

If your doctor tells you to stop taking PACROLIM capsules, or your medicine has passed its expiry date, ask your pharmacist what to do with any medicine which may be left over.

Product description

What it looks like

PACROLIM capsules 0.5 mg are light yellow / light yellow hard gelatin capsules, size “4” imprinted with “TCR” on cap & “ABZ 0.5” on body containing white to off white granular powder is presented in aluminium/aluminium blister in a carton containing 10, 50 or 100 capsules.

PACROLIM capsules 1 mg are white / white hard gelatin capsules, size “4” imprinted with “TCR” on cap & “ABZ 1” on body containing white to off white granular powder is presented in aluminium/aluminium blister in a carton containing 10, 50 or 100 capsules.

PACROLIM capsules 5 mg are pink / pink hard gelatin capsules, size “4” imprinted with “TCR” on cap & “ABZ 5” on body containing white to off white granular powder is presented in aluminium/aluminium blister in a carton containing 10, 50 or 100 capsules.

Ingredients

PACROLIM 0.5 mg capsule contains 0.5 mg Tacrolimus (as monohydrate) as the active ingredient.

PACROLIM 1 mg capsule contains 1 mg Tacrolimus (as monohydrate) as the active ingredient.

PACROLIM 5 mg capsule contains 5 mg Tacrolimus (as monohydrate) as the active ingredient.

PACROLIM capsules also contain hypromellose, croscarmellose sodium, lactose anhydrous and magnesium stearate.

The capsule shell contains gelatin, water-purified and titanium dioxide and a dye (iron oxide yellow (E172) for 0.5 mg capsules and iron oxide red (E172) for 5 mg capsules).

The capsules also have a trace of TekPrint SW-9008 black ink (ARPING Number: 2328), which contains shellac, propylene glycol, ammonia, iron oxide black and potassium hydroxide.

PACROLIM contains sugars as lactose.