Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I using Xadago®?
Xadago® contains the active ingredient safinamide. Xadago® is used to treat Parkinson’s
disease. It is taken when levodopa on its own (or with other medicines) does not control
the symptoms of Parkinson’s Disease.
2. What should I know before I use Xadago®?
Do not use if you have ever had an allergic reaction to Xadago® or any of the ingredients
listed at the end of the CMI, if you are taking, or have recently taken a monoamine
oxidase inhibitor (MAOI) or Pethidine, or if you have a serious liver problem or disease
or a condition which may affect your eyes
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.
3. What if I am taking other medicines?
Some medicines may interfere with Xadago® and affect how it works.
4. How do I use Xadago®?
Follow all directions given to you by your doctor or pharmacist carefully.
Take one tablet each day, or as told by your doctor.
5. What should I know while using Xadago®?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Xadago®
Tell your doctor immediately if you become pregnant
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Things you should not do
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Do not stop using this medicine suddenly without checking with your doctor.
Do not start taking any other medicine without first talking to your doctor.
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Driving or using machines
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Be careful driving or operating machinery until you know how Xadago® affects you.
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Looking after your medicine
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Store in a cool, dry place, below 30°C.
Keep Xadago® tablets in the blister pack until it is time to take them, and out of
reach of children.
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6. Are there any side effects?
Common side effects include dizziness on standing up, especially when getting up from
a sitting or lying position, dizziness or light-headedness, nausea (feeling sick),
accidental injury (e.g. falls), sleepiness, trouble sleeping (insomnia), headache,
uncontrolled sudden movements (dyskinesia), and cloudiness in your eye or vision changes.
Serious side effects include unusual urges or behaviours, obsessive thoughts, allergic
reactions, serotonin syndrome. For more information, including what to do if you have
any side effects, see Section
6. Are there any side effects? in the full CMI.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
Sulfinomide
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Xadago®. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about Xadago®.
Where to find information in this leaflet:
1. Why am I using Xadago®?
Xadago®
is used to treat Parkinsons disease. It is taken when levodopa on its own (or with other medicines) does not control
the symptoms of Parkinson’s Disease.
Xadago® contains the active ingredient Safinamide. Xadago® is a prescription medicine called monoamine oxidase inhibitors (MAOIs). It contains
an active ingredient called safinamide.
Parkinson's disease is a condition of the brain that mainly affects movement. The
three main symptoms of Parkinson's disease are:
Shaking (tremor)
Muscle stiffness
Slow and unsteady movement.
The symptoms of Parkinson's disease are caused by a lack of dopamine. Dopamine is
a natural substance that is made in the brain and helps with movement. Xadago® works
by increasing the level of dopamine in the brain. This decreases the symptoms of Parkinson's
disease.
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. Xadago® is not addictive.
2. What should I know before I use Xadago®?
Warnings
Do not use Xadago® if:
You are allergic to safinamide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Symptoms of an allergic reaction may include:
asthma, wheezing or coughing, shortness of breath
swelling of the face, lips, tongue which may cause difficulty in swallowing or breathing
hives, itching or skin rash
stomach ache, fever, chills, nausea and vomiting, fainting.
you are taking, or have recently taken, any of the following:
a monoamine oxidase inhibitor (MAOI),which are a group of medicines that can be used
to treat Parkinson’s Disease, depression and some other conditions.
Pethidine, a strong pain killer.
you have:
a serious liver problem or disease
a condition which may affect your eyes such as:
albinism: a lack of pigment in your skin and eyes
retinal degeneration: a loss of cells from the light sensitive layer at the back
of the eye
uveitis: inflammation inside of the eye
an inherited vision disorder
severe, progressive vision loss due to diabetes
Check with your doctor if you:
Have allergies to any medicines or other substances such as, foods, preservatives
or dyes.
Are pregnant or intend to become pregnant.
Are breast-feeding or planning to breast-feed.
Have any other medical conditions such as liver problems or disease.
Have or have had problems with your eyes or have a family history of retinal disease.
Take any medicines for any other condition
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.
Pregnancy and breastfeeding
Tell your doctor if you are pregnant or intend to become pregnant.
Xadago® should not be used if you are pregnant or planning to become pregnant.
Tell your doctor if you are breast-feeding or planning to breast-feed.
Xadago® should not be used while breast-feeding.
Children
There is not enough information to recommend the use of this medicine for children
under the age of 18 years.
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 Xadago® and affect how it works.
Do not take Xadago® if you are taking, or have recently taken, any of the following:
A monoamine oxidase inhibitor (MAOI), which are a group of medicines that can be used
to treat Parkinson’s Disease, depression and some other conditions.
Pethidine, a strong pain killer.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Xadago®.
4. How do I use Xadago®?
How much to take
The usually starting does is one 50mg tablet each day. After two weeks, the dosage
may be increased to one 100mg tablet each day.
Your doctor will tell you the dose that you should take.
Only take the amount that your doctor tells you to.
When to take Xadago®
Take your Xadago® tablet at about the same time every day.
Take it at the same time that you take your other Parkinson’s medication.
How to take Xadago®
Xadago® tablets should be swallowed whole and washed down with a glass of water.
Xadago® can be taken before, with or after eating food.
If you forget to use Xadago®
Skip the dose that you missed. Take the next dose at the usual time the next day.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
How long to take Xadago®
Do not stop taking this medicine without first checking with your doctor.
Talk with your doctor about how long you should take Xadago®. You may need to take
it for a long time.
If you use too much Xadago®
If you think that you have used too much Xadago®, 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 Xadago®?
Things you should do
Call your doctor straight away if you:
you become pregnant.
Remind any doctor, dentist or pharmacist you visit that you are using Xadago®.
Things you should not do
Do not start taking any other medicine including any that you can buy without a prescription
from your pharmacy, supermarket, health food shop, naturopath or herbalist, without
first talking to your doctor.
Do not stop taking this medicine without checking with your doctor.
Your doctor may want you to gradually reduce the amount you are taking before stopping
completely.
Do not give Xadago® to anyone else, even if they have the same condition as you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Xadago®
affects you.
As with some other Parkinson’s disease medications, Xadago® may make you feel sleepy,
dizzy or lightheaded.
If you have any of symptoms, do not drive, operate machinery or do anything else that
could be dangerous.
Looking after your medicine
Store in a cool, dry place, below 30°C.
Keep Xadago® tablets in the blister pack until it is time to take them.
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 windowsills.
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
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 affects 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 Xadago® contains
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Active ingredient
(main ingredient)
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Safinamide
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Other ingredients
(inactive ingredients)
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Microcrystalline cellulose
Crospovidone
Magnesium stearate
Colloidal anhydrous silica
Opadry complete film coating system 02F59058 Clear
Candurin Orange amber
Candurin Gold sheen
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Potential allergens
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None.
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Do not take this medicine if you are allergic to any of these ingredients.
What Xadago® looks like
Xadago® 50 mg tablets are orange to copper, round, biconcave, immediate release, film-coated
tablets (7 mm diameter) with metallic gloss and “50” embossed on one side, supplied
in boxes of 10 and 30 tablets (AUST R 292145).
Xadago® 100 mg tablets are orange to copper, round, biconcave, immediate release,
film-coated tablets (9 mm diameter) with metallic gloss and “100” embossed on one
side, supplied in boxes of 10 and 30 tablets (AUST R 292144).
Not all pack sizes may be available.
Who distributes Xadago®
Xadago® is supplied in Australia by:
Clinect Pty Ltd
120 - 132 Atlantic Drive
Keysborough VIC 3173
Australia
Customer enquiries: 1800 899 005
Sponsor:
Atnahs Pharma Australia Pty Ltd
Level 10
10 Shelley Street
Sydney, NSW, 2000
Australia
This leaflet was prepared in March 2025.