Tacrolimus (as monohydrate)
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about TACROGRAF 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 TACROGRAF against the benefits this medicine is expected to have for you.
If you have any concerns about using TACROGRAF ask your doctor or pharmacist.
Keep this leaflet with your medicine. You may need to read it again.
What TACROGRAF 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. TACROGRAF stops this attack; it is very important to take TACROGRAF 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 TACROGRAF.
TACROGRAF is an immunosuppressive agent.
Your doctor may have prescribed TACROGRAF for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Before you use TACROGRAF
When you must not use it
Do not use TACROGRAF if you have an allergy to TACROGRAF, 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.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongueor other parts of the body
- rash, itching or hives on the skin
Do not use TACROGRAF if the packaging is torn or shows signs of tampering. Do not use TACROGRAF 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 TACROGRAF.
Your doctor will advise you whether or not to take TACROGRAF 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 TACROGRAF because there are some specific medicines that could alter TACROGRAF'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
TACROGRAF may cause visual or nervous disturbances. If affected, do not drive or operate machinery.
Effects of food and alcohol
Food reduces the absorption of TACROGRAF so the capsules should be taken at least 1 hour before a meal.
How much to take
You can only get TACROGRAF 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.
The total daily amount should be divided and taken in two doses (e.g. morning and evening). Swallow the capsule whole with plenty of water. Do not use grapefruit juice, grapefruit juice contains substances that interfere with the action of TACROGRAF.
How to take it
TACROGRAF 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 have taken too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 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.
While you are taking TACROGRAF
Things you must do
Always follow your doctor's instructions carefully
Tell your doctor if you become pregnant while taking TACROGRAF
If you are about to start taking a new medicine, tell your doctor and pharmacist that you are taking TACROGRAF.
TACROGRAF suppress your immune system by lowering your body's immune defence system. This increases your risk of skin cancer and other cancers while taking TACROGRAF. Always protect yourself from the sun, wear sunscreen, a hat and protective clothing.
Things you must not do
Do not take TACROGRAF 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.
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)
- 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
- 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, abnorma
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 TACROGRAF
Keep TACROGRAF Capsules in the original pack until it is time to take them.
Keep TACROGRAF 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 TACROGRAF, 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.
If your doctor tells you to stop taking TACROGRAF Capsules, or your medicine has passed its expiry date, ask your pharmacist what to do with any medicine which may be left over.
What it looks like
TACROGRAF 0.5mg hard gelatin capsules have a red opaque cap and red opaque body, printed SAL on cap and 720 on body in black ink.
Each capsule contains tacrolimus monohydrate equivalent to tacrolimus 0.5mg. The excipients are hypromellose, lactose monohydrate, croscarmellose and magnesium stearate.
The capsule is composed of gelatin, water, sodium lauryl sulfate, brilliant blue FCF, allura red AC and TekPrint SW-9008 black ink.
The capsules are available in bottles of 100’s.
TACROGRAF 1mg hard gelatin capsules have a green opaque cap and green opaque body, printed SAL on cap and 721 on body in black ink.
Each capsule contains tacrolimus monohydrate equivalent to tacrolimus 1mg. The excipients are hypromellose, lactose monohydrate, croscarmellose and magnesium stearate.
The capsule is composed of gelatin, water, sodium lauryl sulfate, brilliant blue FCF, iron oxide yellow, titanium dioxide and TekPrint SW-9008 black ink.
The capsules are available in bottles of 100’s.
TACROGRAF 5mg hard gelatin capsules have a teal opaque cap and teal opaque body, printed SAL on cap and 722 on body in black ink.
Each capsule contains tacrolimus monohydrate equivalent to tacrolimus 5mg . The excipients are hypromellose, lactose monohydrate, croscarmellose and magnesium stearate.
The capsule is composed of gelatin, water, sodium lauryl sulfate, brilliant blue FCF, phloxine B, titanium dioxide, quinoline yellow and TekPrint SW-9008 black ink.
The capsules are available in bottles of 50’s.
TACROGRAF hard gelatin capsules contain the active tacrolimus and excipients hypromellose, croscarmellose sodium, lactose monohydrate, and magnesium stearate.
The capsules are gluten free.
Australian Registration Numbers
0.5mg – AUST R 167286 bottle
1mg – AUST R 167288 bottle
5mg – AUST R 167289 bottle
Arrow Pharma Pty Ltd
15-17 Chapel St
Cremorne VIC 3121
This leaflet was prepared in August 2018.
Published by MIMS October 2018