PHARMACOR MYCOPHENOLATE 500

PHARMACOR MYCOPHENOLATE 500

Active ingredient(s): MYCOPHENOLATE MOFETIL

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Consumer Medicine Information (CMI)

This leaflet provides important information about using PHARMACOR MYCOPHENOLATE 500. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PHARMACOR MYCOPHENOLATE 500.

Where to find information in this leaflet:

1. Why am I using PHARMACOR MYCOPHENOLATE 500?
2. What should I know before I use PHARMACOR MYCOPHENOLATE 500?
3. What if I am taking other medicines?
4. How do I use PHARMACOR MYCOPHENOLATE 500?
5. What should I know while using PHARMACOR MYCOPHENOLATE 500?
6. Are there any side effects?
7. Product details

1. Why am I using PHARMACOR MYCOPHENOLATE 500?

PHARMACOR MYCOPHENOLATE 500 contains the active ingredient mycophenolate mofetil.

PHARMACOR MYCOPHENOLATE 500 is used to treat a Immunosuppressants are used to prevent the rejection of a transplanted organ and work by stopping your immune system from reacting to the transplanted organ.

There are many different types of medicines used to prevent rejection of a transplanted organ.

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.

This medicine is not addictive. This medicine is available only with a doctor’s prescription.

2. WHAT SHOULD I KNOW BEFORE I USE PHARMACOR MYCOPHENOLATE 500?

Warnings

• Do not use PHARMACOR MYCOPHENOLATE 500 if you are allergic to it, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.
• Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
• If you are breastfeeding, it may pass into human breast milk and could cause serious side effects in your baby if you breastfeed.
• You must use two reliable forms of contraception at the same time before beginning Tablets therapy, during therapy and for at least six weeks after stopping Tablets, unless you are not sexually active.
• If you are not sure whether you should start taking this medicine, talk to your doctor.
• Do not take this medicine 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.

Check with your doctor if you:

• You are pregnant or plan to become pregnant
• if you are a woman of child bearing potential, you must have two negative pregnancy tests 8-10 days apart just prior to starting treatment with PHARMACOR MYCOPHENOLATE 500.
• repeat pregnancy tests will be performed during routine followup visits with your doctor.
• you are breast feeding or plan to breast feed
• you are a sexually active man
• you are recommended to use condoms during treatment and for 90 days after stopping treatment, even if you have had a vasectomy.
• your female partner(s) are recommended to use reliable contraception while you are being treated with PHARMACOR MYCOPHENOLATE 500 and for 90 days after you have stopped receiving PHARMACOR MYCOPHENOLATE 500.
• You should not donate semen while you are being treated with PHARMACOR MYCOPHENOLATE 500 and for 90 days after you have stopped receiving PHARMACOR MYCOPHENOLATE 500.
• You should not donate blood while you are being treated with PHARMACOR MYCOPHENOLATE 500.
• you have any other health problems, especially the following:
  – a history of sun spots or skin cancers
  – a history of low blood counts of neutrophils (a type of white blood cell)
  – a history of serious stomach or bowel problems (such as ulceration or bleeding)
  – rare diseases due to a deficiency of the HGPRT enzyme such as Lesch-Nyhan or Kelley-Seegmiller Syndrome
  – kidney disease
  – phenylketonuria. You may not be able to take PHARMACOR MYCOPHENOLATE 500 Tablets oral suspension as it is a source of phenylalanine
  – you have allergies to any other medicines, foods, preservatives or dyes

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the risks and benefits involved.

3. What if I am taking other medicines?

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

Some medicines may interfere with PHARMACOR MYCOPHENOLATE 500 and affect how it works. These include:

• azathioprine, tacrolimus and sirolimus, medicines used to suppress the immune system which can be used to prevent organ rejection after a transplant
• acyclovir, ganciclovir,valaciclovir or valganciclovir, medicines used to treat certain viral infections
• isavuconazole, a medicine used to treat fungal infections
• antacids, medicines used to treat heartburn and indigestion
• cholestyramine, a medicine used to treat high cholesterol
• ciprofloxacin, amoxicillin plus calvulanic acid, norfloxacin plus metronidazole and rifampicin, medicines used to treat infections
• iron supplements, medicines used to treat low iron levels in the blood
• certain vaccines, (especially live vaccines), medicines that work by causing your body to produce its own protection against an infectious disease
• proton-pump inhibitors, medicines used to treat indigestion and stomach ulcers such as lansoprazole and pantoprazole
• calcium-free phosphate binders (such as sevelamer), medicines used to treat high phosphate levels in the blood Their effectiveness may be reduced while taking

Your doctor and pharmacist have more information.

If you have not told your doctor about any of these things, tell him/ her before you start taking this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PHARMACOR MYCOPHENOLATE 500.

4. HOW DO I USE PHARMACOR MYCOPHENOLATE 500?

How much to take

• Take PHARMACOR MYCOPHENOLATE 500 exactly as your doctor has prescribed.
• Your doctor will tell you how many PHARMACOR MYCOPHENOLATE 500 to take each day.
• The dose to prevent organ rejection is usually 1g to 1.5 g in the morning and 1 g to 1.5 g at night (2 g to 3 g per day) depending on which organ has been transplanted.
• Your doctor may adjust your dose depending on your response.
• Follow the instructions provided and use defereasirox until your doctor tells you to stop.

When to take PHARMACOR MYCOPHENOLATE 500

It is best to take doses of PHARMACOR MYCOPHENOLATE 500 approximately 12 hours apart.

Take your medicine at about the same time each day.

Taking PHARMACOR MYCOPHENOLATE 500 at the same time each day will have the best effect. It will also help you remember when to take it.

How to take PHARMACOR MYCOPHENOLATE 500

• Swallow the tablets whole with a full glass of water.
  Do not crush tablets or open or crush capsules. If a capsule breaks open accidentally, wash any powder off your skin with soap and water.
• The film-coated tablets should not be taken with a high fat meal.
• If you cannot swallow the tablets whole, you can crush them. Then sprinkle all of it onto soft food like yogurt or apple sauce (apple puree). You should then eat it all immediately. Do not keep any to have later.

If you forget to use PHARMACOR MYCOPHENOLATE 500

PHARMACOR MYCOPHENOLATE 500 should be used regularly at the same time each day. 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 dose that you missed. This may increase the chance of you getting an unwanted side effect. If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

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 use too much PHARMACOR MYCOPHENOLATE 500

If you think that you have used too much PHARMACOR MYCOPHENOLATE 500 you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. WHAT SHOULD I KNOW WHILE USING PHARMACOR MYCOPHENOLATE 500?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking PHARMACOR MYCOPHENOLATE 500.

Your eyesight and hearing may be tested during treatment as a precautionary measure.

If you become pregnant while taking this medicine, tell your doctor immediately. It may affect your developing baby. Your doctor will discuss the risks and benefits of continuing treatment in this case.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you are a woman of child bearing potential, you must use two reliable forms of contraception at the same time before beginning PHARMACOR MYCOPHENOLATE 500 therapy, during therapy and for at least six weeks after stopping PHARMACOR MYCOPHENOLATE 500, unless you are not sexually active.

If you are a sexually active male, you are recommended to use condoms during treatment and for 90 days after stopping treatment, even if you have had a vasectomy.

Your female partner(s) are recommended to use reliable contraception while you are being treated with PHARMACOR MYCOPHENOLATE 500 and for 90 days after you have stopped receiving PHARMACOR MYCOPHENOLATE 500

Call your doctor straight away if you:

• Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
• Tell your doctor if you feel your medicine is not helping your condition. Be sure to keep all of your appointments with your doctor so that your progress can be checked.
• Your doctor will need to give you regular blood tests.
  Wear protective clothing and broad-spectrum sunscreen when outdoors. Medicines that prevent the rejection of transplanted organs can increase the risk of skin cancers.

Remind any doctor, dentist or pharmacist you visit that you are using PHARMACOR MYCOPHENOLATE 500.

Things you should not do

• Do not stop taking PHARMACOR MYCOPHENOLATE 500 or change the dose without first checking with your doctor.
• Do not use PHARMACOR MYCOPHENOLATE 500 to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else, even if they have the same condition as you.
• Do not let yourself run out of medicine over the weekend or on holidays.
• Do not crush PHARMACOR MYCOPHENOLATE 500
• Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting with a pharmacist.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PHARMACOR MYCOPHENOLATE 500 affects you.

PHARMACOR MYCOPHENOLATE 500 may cause affects you or if you experience somnolence, confusion, dizziness, tremor or hypotension. It may affect your ability to drive a car or operate machinery.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

• Keep your medicine in the original container until it is time to take it.
• Store below 25°C. Protected from light.
• Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects	What to do
diarrhoea, constipation, nausea (feeling sick), vomiting or Indigestion stomach, chest or back pain headache urinary infections	Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects	What to do
Any of the following symptoms which may be signs of of other infections: fevers, chills, sore throat, ulcers of the mouth, abdominal pain or bloody stools. unexpected bruising or bleeding signs of anaemia such as excessive tiredness, dizziness or looking pale swelling of the hands, ankles or feet, lymph nodes hypersensitivity breathing difficulties, pain in the chest, chronic cough with blood.	Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effect you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What PHARMACOR MYCOPHENOLATE 500 contains

Active ingredient (main ingredient)	Mycophenolate mofetil
Other ingredients (inactive ingredients)	croscarmellose sodium povidone microcrystalline cellulose(avicel 102) magnesium stearate instacoat ICG-U-10130 GREY
Potential allergens	No

Do not take this medicine if you are allergic to any of these ingredients.

What PHARMACOR MYCOPHENOLATE 500 looks like

PHARMACOR MYCOPHENOLATE 500: Lavender coloured caplet shaped biconvex film coated tablets debossed with ‘265’ on one side and plain on other side.

PHARMACOR MYCOPHENOLATE 500 available in a PVC/PVDC-Al blister pack of 10’s, 30’s, 50’s, 100’s, 150’s, and 300’s Tablets.

Australian Register Number:

PHARMACOR MYCOPHENOLATE 500: Blister pack: 363772

Who distributes PHARMACOR MYCOPHENOLATE 500

Pharmacor Pty Ltd.
CHATSWOOD, NSW 2067,
Australia

This leaflet was prepared in 04/2022.