Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about taking this medicine,
speak to your doctor or pharmacist.
1. Why am I taking CYSTAGON?
CYSTAGON contains the active ingredient mercaptamine (cysteamine) bitartrate. CYSTAGON
is used to manage nephropathic cystinosis, in children and adults.
For more information, see Section
1. Why am I taking CYSTAGON? in the full CMI.
2. What should I know before I take CYSTAGON?
Do not take if you have ever had an allergic reaction to mercaptamine, penicillamine,
or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I take CYSTAGON? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with CYSTAGON and affect how it works.
4. How do I take CYSTAGON?
The dose of CYSTAGON is based on your weight.
5. What should I know while taking CYSTAGON?
Things you or your child should do
|
Remind any doctor, dentist or pharmacist you visit that you are taking CYSTAGON.
Take adequate precautions when using this medicine in children, especially those at
risk of the medicine entering their airways or lungs.
Keep all of your doctor's appointments so that your progress can be checked.
Follow your doctor's advice about tests that are needed to find out if any unwanted
serious side effects are occurring. The tests are very important because serious side
effects can occur.
|
Things you should not do
|
Do not take CYSTAGON 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 stop taking your medicine or change the dosage without checking with your doctor.
|
Driving or using machines
|
Be careful driving or operating machinery until you know how CYSTAGON affects you.
This medicine may cause drowsiness or tiredness in some people.
|
Looking after your medicine
|
Store below 25°C in a cool dry place away from moisture, heat or sunlight.
Keep your capsules in the bottle until it is time to take them.
Keep CYSTAGON where young children cannot reach it.
|
6. Are there any side effects?
Less serious side effects include nausea, vomiting, loss of appetite, diarrhoea, drowsiness,
rash, unpleasant breath odour, fever or feel tired or fatigued.
Serious side effects include stomach pain, loss of appetite, throwing up blood, seizures,
depression, excessive sleepiness, low white blood cell count, abnormal liver function
headache, dizziness, double vision, blurry vision, loss of vision, pain behind the
eye or pain with eye movement, skin lesions, bone lesions or joint problems.
Please note this is not a complete list of possible side effects.
Active ingredient:
mercaptamine (cysteamine) bitartrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about taking CYSTAGON. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about taking CYSTAGON.
Where to find information in this leaflet:
1. Why am I taking CYSTAGON?
CYSTAGON contains the active ingredient mercaptamine (cysteamine).
CYSTAGON is used to manage nephropathic cystinosis, in children and adults.
Nephropathic cystinosis is a rare inherited disorder characterised by the build-up
of cystine in organs such as kidneys. Cystine build up causes kidney damage and excretion
of excess amounts of glucose, proteins and electrolytes.
Cystinosis can be detected by measuring the amount of cystine in while blood cells
and other body cells. The results of cystinosis are slow body growth, weak bones and
progressive kidney failure.
Mercaptamine (cysteamine) works by reacting with cystine so that the cystine level
in cells is decreased.
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.
2. What should I know before I take CYSTAGON?
Warnings
Do not take CYSTAGON if:
you are allergic to mercaptamine, penicillamine, or any of the ingredients listed
at the end of this leaflet.
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.
Always check the ingredients to make sure you can take this medicine.
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
have allergies to any other medicines, foods, preservatives or dyes
take any medicines for any other condition
have or have ever had any of the following medical conditions
:
a skin rash or any bone problems
a history of seizures, exhaustion, depression or other nervous system problems
stomach or intestinal problems including ulcers or bleeding
blood problems.
If you have not told your doctor about any of the above, tell them before you start
taking CYSTAGON.
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
Tell your doctor if you are pregnant or plan to become pregnant or if you are breastfeeding
or plan to breastfeed.
Your doctor can discuss with you the risks or 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.
Tell your doctor or pharmacist if you are taking an electrolyte replacement supplement.
Replacement of electrolytes (like potassium) is still required during therapy with
CYSTAGON capsules.
Your doctor or pharmacist will have more information on medicines to be careful with
or avoid while 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 CYSTAGON.
4. How do I take CYSTAGON?
Follow all directions given to you or your child by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
How much to take
The dose of CYSTAGON is based on your weight.
The initial dose for both children and adults is 200 mg to 300 mg/m2/day given in four divided doses.
This dose will increase over a period of 4 to 6 weeks as directed by your doctor to
a maintenance dose:
for children up to 12 years: 1.3 g /m2/day.
for patients over 12 years and 50 kg body weight: 2 g/day.
Do not give the whole CYSTAGON capsule to children under six years or age because
they may not be able to swallow it and they may choke. For those who are unable to
swallow the capsules whole, the capsule may be opened and the contents sprinkled on
food or mixed in formula.
Ask your doctor for full instructions.
When to take CYSTAGON
Take CYSTAGON at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How long to take CYSTAGON
Continue taking your medicine for as long as your doctor tells you.
If you forget to take CYSTAGON
If it is less than 2 hours before 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 your medicine
as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.
If you take too much CYSTAGON
If you think that you or anyone else has taken too much CYSTAGON, urgent medical attention
may be needed.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, 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.
Symptoms of an overdose may include vomiting, dehydration, feeling of tiredness, drowsiness,
lack of energy or heart attack.
5. What should I know while taking CYSTAGON?
Things you or your child should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking CYSTAGON.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
Take adequate precautions when using this medicine in children, especially those at
risk of the medicine entering their airways or lungs.
Your medical treatment will include, in addition to CYSTAGON, one or more supplements
to replace important electrolytes lost through the kidneys. It is important to take
or give these supplements exactly as instructed. If a dose of one of these supplements
is missed, do not take extra doses to make up for the missed dose. If several doses
of the supplements are missed or weakness or drowsiness develops, call your doctor
for instructions.
Keep all of your doctor's appointments so that your progress can be checked.
Regular blood tests to measure the amount of cystine present inside white blood cells
are necessary to help determine the correct dose of CYSTAGON.
Regular blood and urine tests are also necessary to measure the levels or various
important electrolytes to help your doctor correctly adjust the dose of these supplements.
Follow your doctor' s advice about tests that are needed to find out if any unwanted
serious side effects are occurring. The tests are very important because serious side
effects can occur. Ask your doctor to explain the warning signs of the serious side
effects.
Things you or your child should not do
Do not take CYSTAGON to treat any other complaints unless your doctor tells you to.
Do not give CYSTAGON to anyone else, even if they have the same condition as you.
Do not stop taking CYSTAGON or change the dose without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how CYSTAGON
affects you.
This medicine may cause drowsiness or tiredness in some people. If you have any of
these symptoms, do not drive, operate machinery or do anything else that could be
dangerous.
Children should be careful when riding bicycles or climbing trees.
If you feel light-headed, dizzy or faint when getting out of bed or standing up, get
up slowly.
Looking after your medicine
Keep your capsules in the bottle until it is time to take them.
If you take your capsules out of the bottle they may not keep well.
Store below 25°C.
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.
Heat, cold and dampness can destroy some medicines.
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.
Getting rid of any unwanted medicine
If you no longer need to take this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not take 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
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
or your child 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 effects 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 CYSTAGON contains
Active ingredient
(main ingredient)
|
mercaptamine free base as mercaptamine bitartrate 50 mg or 150 mg per capsule
|
Other ingredients
(inactive ingredients)
|
microcystralline cellulose
pregelatinised maize starch
magnesium stearate
sodium lauryl sulfate
silicon dioxide
croscarmellose sodium
titanium dioxide
gelatin
The printing ink on the capsules contains the following inactive ingredients:
shellac
ethanol
iron oxide black
butan-1-ol
propylene glycol
isopropyl alcohol
sulfuric acid
strong ammonia solution
|
Do not take this medicine if you are allergic to any of these ingredients.
What CYSTAGON looks like
CYSTAGON 50 mg capsules are white, opaque capsules printed with "CYSTA 50" on the
body and "MYLAN" on the cap (AUST R 60451).
CYSTAGON 150 mg capsules are white, opaque capsules printed with "CYSTA 150" on the
body and "MYLAN" on the cap (AUST R 60452).
CYSTAGON 50 mg and 150 mg capsules are available in bottles of 500 capsules.
Who distributes CYSTAGON
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in October 2024.
CYSTAGON® is a Viatris company trade mark
CYSTAGON_cmi\Oct24/00