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Ceptolate

Capsules and Tablets

contains the active ingredient mycophenolate mofetil
CONSUMER MEDICINE INFORMATION

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Ceptolate. It does not contain all the information that is known about Ceptolate. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What Ceptolate is used for

Ceptolate contains the active ingredient mycophenolate mofetil.
Ceptolate belongs to a group of medicines called immunosuppressants.
Immunosuppressants are used to prevent rejection of transplanted organs, and work by stopping your immune system from reacting to the transplanted organ.
There are many different types of medicines used to prevent transplant rejection.
Ceptolate may be used together with other medicines known as cyclosporin and corticosteroids.
Your doctor, however, may have prescribed Ceptolate for another purpose.
Ask your doctor if you have any questions about why Ceptolate has been prescribed for you.
This medicine is available only with a doctor's prescription.
There is no evidence that Ceptolate is addictive.
This medicine is only available with a prescription.

Before you take Ceptolate

When you must not take it

Do not take Ceptolate if:

1. you have had an allergic reaction to Ceptolate or any ingredients listed at the end of this leaflet.

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, hives on the skin.

2. you are pregnant

Ceptolate is harmful to an unborn baby when taken by a pregnant woman.
there have cases of miscarriage and severe birth defects reported when patients have taken Ceptolate during pregnancy.
You must tell your doctor if you are pregnant or plan to become pregnant.

3. you are breastfeeding

Ceptolate may pass into human breast milk and could cause serious side effects in your baby if you breastfeed.

4. you are a woman who could become pregnant and you are not using two reliable forms of contraception

You must use two reliable forms of contraception at the same time before beginning Ceptolate therapy, during therapy and for at least six weeks after stopping Ceptolate, unless you are not sexually active.

5. the package is torn or shows signs of tampering.

6. the expiry date (EXP) printed on the pack has passed.

If you take this medicine after the expiry date has passed, it may not work as well.
If you are not sure if you should be taking Ceptolate, talk to your doctor.

Before you start to take it

Tell your doctor if:

1. 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 Ceptolate.
repeat pregnancy tests will be performed during routine follow-up visits with your doctor.

2. you are breast-feeding or plan to breast-feed

3. 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 Ceptolate and for 90 days after you have stopped receiving Ceptoplate.

4. 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 ulcers or bleeding)
rare diseases due to a deficiency of the HGPRT enzyme such as Lesch-Nyhan or Kelley-Seegmiller syndrome.
kidney disease.

5. you are allergic to any other medicines, foods, dyes or preservatives.

If you have not told your doctor about any of the above, tell them before you start taking Ceptolate.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you have bought without a prescription from a pharmacy, supermarket or health food shop.
Some medicines may interfere with Ceptolate. These medicines include:
aciclovir or ganciclovir, medicines used to treat viral infections
antacids, medicines used to treat heartburn and indigestion
azathioprine and tacrolimus, medicines used to suppress the immune system
calcium-free phosphate binders (such as sevelamer), medicines used to treat high phosphate levels in the blood
certain vaccines, medicines that work by causing your body to produce its own protection against an infectious disease
cholestyramine, a medicine used to treat high cholesterol levels in the blood
iron supplements, medicines used to treat low iron levels in the blood
norfloxacin plus metronidazole and amoxicillin plus clavulanic acid, combination antibiotics used to treat infections
Proton-pump inhibitors, used to treat indigestion and stomach ulcers, such as lansoprazole and pantoprazole
rifampicin and ciprofloxacin, medicines used to treat infections
sirolimus, a medicine used to prevent organ rejection after a transplant.
These medicines may be affected by Ceptolate, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking Ceptolate.
Ask your doctor or pharmacist if you are not sure about this list of medicines.

How to take Ceptolate

Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.

How much to take

Take Ceptolate exactly as your doctor has prescribed.
Your doctor will tell you how many Ceptolate tablets or capsules, to take each day.
Ceptolate Capsules and Tablets:
Adults
The dose to prevent organ rejection is usually 1 g 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.
Children
For renal transplant only.
For children 2 to 18 years of age, the dose to prevent rejection is dependent on your child's height and weight. The maximum dose is usually 1 g in the morning and 1 g at night (2 g daily).
Your doctor may adjust your dose depending on your response.

How to take it

Swallow the capsules or tablets whole with a glass of water.
If the capsule breaks open accidentally, wash off any powder thoroughly with soap and water.

When to take it

It is best to take doses approximately 12 hours apart. Your dose can be taken with or without food.
Taking your medicine at the same time each day will have the best effect. It will also help you remember when to take your Ceptolate.

How long to take it for

Ceptolate should be taken every day. It is important to keep taking Ceptolate to ensure your new transplant keeps working properly.
Continue taking Ceptolate until your doctor tells you to stop.

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.
Otherwise, take it as soon as you remember and then go back to taking it as you would normally.
Do not double a dose to make up for one you have missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering your dose, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor, or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Ceptolate. Do this even if there are no signs of discomfort or poisoning.
Keep telephone numbers for these places handy.
If you are not sure what to do, contact your doctor or pharmacist.

While you are taking Ceptolate

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking Ceptolate.
Tell your doctor if you become pregnant while taking Ceptolate.
It is important to take effective contraceptive measures four weeks before you commence taking Ceptolate, while you are taking Ceptolate and for six weeks after you stop taking Ceptolate.
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 a broad-spectrum sunscreen when outdoors.
Medicines that prevent rejection of transplants can increase the risk of skin cancers.

Things you must not do

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

Things to be careful of

Be careful driving or operating machinery until you know how Ceptolate affects you.
However, Ceptolate is not expected to affect your ability to drive a car or operate machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Ceptolate.
Ceptolate helps most people who have transplants but it may have unwanted side effects in a few people.
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 of the side effects.
To stop you rejecting your organ, transplant medications reduce your body's own defence mechanisms. This means your body will not be as good at fighting infection. People taking Ceptolate therefore develop more infections than usual.
Patients who receive immunosuppressant medicines may also have a small increase in their risk of developing some types of cancer. You should discuss this with your doctor.
If you are over 65 years of age you may have an increased chance of getting side effects.
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:
diarrhoea, constipation, nausea (feeling sick) or indigestion
stomach, chest, back or other pain
headache
urinary infections.
These are the more common side effects of Ceptolate. Mostly these are mild.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
signs of other infections e.g. fevers, chills, sore throat or ulcers of the mouth
unexpected bruising or bleeding
signs of anaemia such as excessive tiredness, dizziness or looking pale.
swelling of the hands, ankles or feet
These are serious side effects. You may need urgent medical attention. Serious side effects are rare.
Ask your doctor or pharmacist if you don't understand anything in this list.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

After taking Ceptolate

Storage

Keep your capsules or tablets in the blister pack until it is time to take them.
If you take the capsules or tablets out of the blister, they may not keep well.
Keep your capsules or tablets in a cool dry place where the temperature stays below 25°C.
Do not store Ceptolate capsules or tablets, or any other medicine, in a bathroom or near a sink. Do not leave your medicine in the car or on window sills.
Always keep the capsules or tablets away from direct light and keep the capsules away from moisture.
Light will cause Ceptolate tablets to fade.
Keep it where young 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 this medicine or the expiry date has passed ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Ceptolate Capsules:
Oblong capsules, caramel on one end and lavender on the other, printed with black ink MYLAN over 2250 on both the cap and body.
Available in blister packs of 50.
Ceptolate Tablets:
Light pink film coated, oval, biconvex, beveled edge tablets debossed with MYLAN on one side of the tablet and 472 on the other side reverse.
Available in blister packs of 50.

Ingredients

Ceptolate Capsules:
Each capsule contains 250 mg of mycophenolate mofetil.
Inactive ingredients:
The capsule fill contains
microcrystalline cellulose
pregelatinised maize starch
silicon dioxide
magnesium stearate
sodium lauryl sulfate
croscarmellose sodium.
The capsule shell contains
gelatin
sodium lauryl sulfate
shellac
ammonium hydroxide
sorbitan monolaurate
Empty Hard Gelatin Capsule Size 1 Lavender Op/Caramel OP G1HCSA00612 (ARTG No 106636).
The dyes in the capsule shell are
indigo carmine (132)
iron oxide red (172)
titanium dioxide (171)
iron oxide yellow (172)
iron oxide black (172)
OPACODE monogramming ink S-1-17822 Black (ARTG No. 12390)
OPACODE monogramming ink S-1-17823 Black (ARTG No. 12108).
Ceptolate capsules are gluten and lactose free.
Ceptolate Tablets:
Each tablet contains 500 mg of mycophenolate mofetil.
Inactive ingredients:
microcrystalline cellulose
pregelatinised maize starch
povidone
silicon dioxide
magnesium stearate
sodium lauryl sulfate
croscarmellose sodium
OPADRY II Complete Film Coating System 85F94410 Pink (ARTG No. 106325).
Ceptolate tablets are gluten and lactose free.

Sponsor

Ceptolate is sponsored in Australia by:
Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au
 
Australian registration numbers:
Ceptolate 250 mg capsules - AUST R 165766
Ceptolate 500 mg tablets -
AUST R 163308
 
This leaflet was prepared on
12 December 2015.
 
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