Tacrolimus APOTEX

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

Contains the active ingredient tacrolimus
Consumer Medicine Information

What is in this leaflet

Read this leaflet carefully before taking your medicine.
This leaflet answers some common questions about Tacrolimus APOTEX Capsules. 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 Tacrolimus APOTEX against the benefits this medicine is expected to have for you.
If you have any concerns about using Tacrolimus APOTEX ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.

What this medicine 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. Tacrolimus APOTEX stops this attack; it is very important to take Tacrolimus APOTEX 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 Tacrolimus APOTEX.
Tacrolimus APOTEX contains the active ingredient tacrolimus, which is an immunosuppressive agent.
Your doctor may have prescribed Tacrolimus APOTEX for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take this medicine

When you must not take it

Do not take this medicine 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.
the packaging is torn or shows signs of tampering.
Do not use Tacrolimus APOTEX beyond the expiry date (month and year) printed on the pack.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1. you are pregnant or planning to become pregnant

2. you are using oral contraceptives

3. you are breast feeding

4. 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 Tacrolimus APOTEX.
Your doctor will advise you whether or not to take Tacrolimus APOTEX 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 Tacrolimus APOTEX because there are some specific medicines that could alter Tacrolimus APOTEX 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
Tacrolimus APOTEX may cause visual or nervous disturbances. If affected, do not drive or operate machinery.
Effects of food and alcohol
Food reduces the absorption of Tacrolimus APOTEX so the capsules should be taken at least 1 hour before a meal.

How to take this medicine

How much to take

You can only get Tacrolimus APOTEX 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.
Tacrolimus APOTEX 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 Tacrolimus APOTEX.

How to take it

Tacrolimus APOTEX 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.

How long to take it for

Continue taking your medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.

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)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively, go to the Accident and Emergency department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are taking this medicine

Things you must do

Tell your doctor that you are taking this medicine if:
Always follow your doctor's instructions carefully
Tell your doctor if you become pregnant while taking Tacrolimus APOTEX
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking Tacrolimus APOTEX.
Tacrolimus APOTEX suppress your immune system by lowering your body's immune defence system. This increases your risk of skin cancer and other cancers while taking Tacrolimus APOTEX. Always protect yourself from the sun, wear sunscreen, a hat and protective clothing.

Things you must not do

Do not take Tacrolimus APOTEX 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.

Possible 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 notice 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 as soon as possible if you notice any of the following.
These may be serious side effects and you may need medical attention:
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.

Storage and disposal

Storage

Use all the capsules within 12 months of opening the aluminium wrapper.
Keep Tacrolimus APOTEX Capsules in the blisters until it is time to take them.
Keep Tacrolimus APOTEX Capsules in a cool dry place where the temperature is below 25°C.
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 Tacrolimus APOTEX, 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 Tacrolimus APOTEX 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 Tacrolimus APOTEX Capsules look like

Tacrolimus APOTEX capsules 0.5 mg are white to off white powder filled in size '5' yellow coloured cap/yellow coloured body hard gelatin capsule printed with "0.5 mg" on cap and "Tacro" on body with red ink.
Packed in blister sheets of ten capsules and sealed in an aluminium wrapper (Pack size 100 capsules).
 
Tacrolimus APOTEX 1 mg capsules are White to off white powder filled in size '5' white coloured cap/white coloured body hard gelatin capsule printed with "1 mg" on cap and "Tacro" on body with red ink.
Packed in blister sheets of ten capsules and sealed in an aluminium wrapper (Pack size 100 capsules).
 
Tacrolimus APOTEX 5 mg capsules are White to off white powder filled in size '4' greyish red coloured cap/ greyish red coloured body hard gelatin capsule printed with "5 mg" on cap and "Tacro" on body with white ink.
Packed in blister sheets of ten capsules and sealed in an aluminium wrapper (Pack size 50 capsules).
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each capsule contains 0.5 mg, 1 mg or 5 mg of tacrolimus as the active ingredient.
It also contains the following inactive ingredients:
hypromellose
croscarmellose sodium
lactose anhydrous
magnesium stearate
The 0.5 mg and 1 mg capsules are printed with TekPrint SB-1033 Red Ink, the 5 mg capsules with TekPrint SW-0012 White ink.
The capsule shells contain gelatin, water, titanium dioxide, sodium lauryl sulfate, iron oxide yellow (0.5 mg capsules), and iron oxide red (5 mg capsules).
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Australian Registration Numbers

Tacrolimus APOTEX 0.5 mg capsules (blister pack): AUST R 209273
Tacrolimus APOTEX 1 mg capsules (blister pack): AUST R 209275
Tacrolimus APOTEX 5 mg capsules (blister pack): AUST R 209269

Sponsor

PHARMACOR PTY LIMITED
Suite 501, 7 Oaks Avenue Dee Why NSW 2099 Australia

Distributor

Apotex Pty. Ltd.
16 Giffnock Avenue Macquarie Park NSW 2113
This leaflet was last updated in:
June 2017