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.
1. Why am I using FINGOLIMOD-TEVA?
FINGOLIMOD-TEVA contains the active ingredient fingolimod hydrochloride. FINGOLIMOD-TEVA
is used in adults, children and adolescents (10 years of age and above) to treat relapsing
forms of multiple sclerosis (MS).
For more information, see Section
1. Why am I using FINGOLIMOD-TEVA? in the full CMI.
2. What should I know before I use FINGOLIMOD-TEVA?
Do not use if you have ever had an allergic reaction to FINGOLIMOD-TEVA 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 use FINGOLIMOD-TEVA? in the full CMI.
3. What if I am taking other medicines?
4. How do I use FINGOLIMOD-TEVA?
The usual dose for adults and children weighing over 40 kg is one capsule per day
(0.5 mg of fingolimod).
The usual dose for children weighing 40 kg or less is one 0.25 mg capsule per day.
5. What should I know while using FINGOLIMOD-TEVA?
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using FINGOLIMOD-TEVA.
Avoid becoming pregnant while taking FINGOLIMOD-TEVA
Tell your doctor about any changes in your vision
|
Things you should not do
|
You should not receive certain types of vaccines (live attenuated vaccines) during
and for up to 2 months after treatment with this medicine
|
Driving or using machines
|
Your doctor will tell you whether your illness allows you to drive vehicles and use
machines safely.
FINGOLIMOD-TEVA is not expected to have an influence on your ability to drive and
use machines.
|
Looking after your medicine
|
Store it in a cool dry place where the temperature stays below 25°C and away from
moisture, heat or sunlight.
|
6. Are there any side effects?
Common side effects include: flu related symptoms (tiredness, chills, sore throat, fever), sinusitis, headache,
diarrhoea, back pain, cough, weight loss.
Serious side effects include: slow heartbeat (bradycardia) or irregular heartbeat; pneumonia with symptoms such
as fever, cough, difficulty breathing; shadows or blind spot in the centre of your
vision, blurred vision, problems seeing colours or details; bleeding or bruising more
easily than normal (thrombocytopenia).
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 in Australia. 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):
Fingolimod hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using FINGOLIMOD-TEVA. 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 FINGOLIMOD-TEVA.
Where to find information in this leaflet:
1. Why am I using FINGOLIMOD-TEVA?
FINGOLIMOD-TEVA contains the active ingredient fingolimod hydrochloride. FINGOLIMOD-TEVA belongs to a group of medicines known as sphingosine 1-phosphate
(S1-P) receptor modulators. FINGOLIMOD-TEVA can alter the way the body's immune system works and is used in adults,
children and adolescents (10 years of age and above) to treat relapsing forms of multiple
sclerosis (MS).
MS is a long-term condition that affects the central nervous system (CNS), particularly
how the brain and spinal cord work. In MS, inflammation destroys the protective cover
around the nerves (called myelin) and stops the nerves from working properly.
The cause of MS is unknown but it is thought that an abnormal response by the body's
immune system plays an important part in the process which damages the CNS.
This medicine slows down the progression of physical disability and decreases the
number of flare-ups (relapses) in patients with relapsing MS.
FINGOLIMOD-TEVA helps to fight against attacks on myelin by the immune system by affecting
the ability of some white blood cells to move freely within the body and by stopping
the cells that cause inflammation from reaching the brain. This reduces nerve damage
caused by MS.
FINGOLIMOD-TEVA may also have a direct and beneficial effect on certain brain cells
(neural cells) involved in repairing or slowing down the damage of MS.
Ask your doctor if you have any questions about how FINGOLIMOD-TEVA works or why this
medicine has been prescribed for you or your child.
2. What should I know before I use FINGOLIMOD-TEVA?
Warnings
Do not use FINGOLIMOD-TEVA if:
you are allergic to fingolimod, 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.
any other similar medicines (such as medicines of the same class or with a similar
structure
have had a heart attack, unstable angina, stroke or warning stroke or certain types
of heart failure in the last 6 months
have certain types of irregular or abnormal heartbeat (arrhythmia)
are taking or have recently taken medicine for irregular heartbeat such as quinidine,
disopyramide, amiodarone or sotalol (due to a possible added effect on irregular heartbeat).
Check with your doctor if you:
have allergies to any other medicines, foods, dyes or preservatives. Your doctor will
want to know if you are prone to allergies.
have any of the following medical conditions:
a lowered immune response (due to a disease or medicines that suppress the immune
system). See section
3 What if I am taking other medicines? You may get infections more easily or an infection you already have may get worse.
problems with your liver. FINGOLIMOD-TEVA may affect your liver function.
have an infection. Infections can be serious and sometimes life-threatening. Before
you start taking FINGOLIMOD-TEVA, your doctor will confirm whether you have enough
white blood cells (these fight infections) in your blood.
take any medicines for any other condition
plan to receive a vaccine. You should not receive certain types of vaccines (called
"live attenuated vaccines") during and up to 2 months after treatment with FINGOLIMOD-TEVA
(see section
3 What if I am taking other medicines?).
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 intend to become pregnant.
You should avoid becoming pregnant while taking FINGOLIMOD-TEVA or in the two months
after you stop taking it because FINGOLIMOD-TEVA may harm your unborn baby.
If you become pregnant while taking FINGOLIMOD-TEVA, tell your doctor without delay.
You and your doctor will decide what is best for you and your baby.
You should not breast-feed while you are taking FINGOLIMOD-TEVA.
FINGOLIMOD-TEVA can pass into breast milk and there is a risk of serious side effects
for a breast-fed baby.
Children
FINGOLIMOD-TEVA is used in children and adolescents (10 years of age and above) to
treat relapsing-multiple sclerosis.
FINGOLIMOD-TEVA has not been studied in children under 10 years of age.
Elderly
Experience with FINGOLIMOD-TEVA in older people (more than 65 years old) is limited.
Heart conditions
Checking the health of your heart is, important. If any of the following applies to
you, your doctor may decide not to use FINGOLIMOD-TEVA:
irregular or abnormal heartbeat
severe heart disease
uncontrolled high blood pressure
history of stroke or other diseases related to blood vessels in the brain
severe breathing difficulties when asleep (sleep apnoea that is not treated)
heart rhythm disturbances (called QTc prolongation or abnormal ECG heart tracing)
or the risk of these disturbances
slow heart rate or if you have a history of sudden loss of consciousness (fainting).
Your doctor may decide not to use FINGOLIMOD-TEVA or may refer you first to a cardiologist
for further advice before commencing your first dose of FINGOLIMOD-TEVA.
If your doctor thinks that FINGOLIMOD-TEVA is appropriate for you, he/she may refer
you first to a cardiologist (doctor specialised in heart disease). You may also be
monitored overnight by a health care professional after taking the first dose of FINGOLIMOD-TEVA.
Vaccination
Tell your doctor if you have never had chickenpox or have no record of vaccination
against chickenpox.
Your doctor will test your status of the antibody against this virus and may decide
to vaccinate you (if you do not have antibodies to this virus).
In this case you will start FINGOLIMOD-TEVA treatment one month after the full course
of the vaccination is completed.
Children or adolescents (10 years of age and above) need to have completed their vaccination
schedule before starting treatment with FINGOLIMOD-TEVA.
Vaccination against human papilloma virus (HPV) is recommended. If you are female,
your doctor will also recommend HPV screening.
Monitoring and required tests
You will have a blood test to check your liver function before and during treatment
with FINGOLIMOD-TEVA and until two months after stopping treatment. If liver problems
are detected your doctor may decide to discontinue treatment.
A skin examination is recommended before you start and at regular intervals during
treatment. Your doctor will decide what to do if skin problems are noticed.
An eye examination before you start treatment and at regular intervals afterwards
is recommended if you have or have had one of the following conditions:
visual disturbances or other signs of swelling in the central vision area at the back
of the eye (a condition known as macular oedema)
inflammation or infection of the eye (uveitis)
diabetes.
If you are female, a pregnancy test is recommended to check if you are pregnant.
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 FINGOLIMOD-TEVA and affect how it works. Tell your
doctor if you are taking any of the following:
medicines that slow down heartbeat such as atenolol (a beta blocker); verapamil, diltiazem
or (calcium channel blockers) or ivabradine or digoxin. Your doctor may decide not
to use FINGOLIMOD-TEVA or may refer you first to a cardiologist to switch to medicines
that do not slow your heart rate or to decide how you should be observed after the
first dose of FINGOLIMOD-TEVA
medicines that can cause an abnormal heart rhythm called Torsades de Pointes such
as citalopram, chlorpromazine, haloperidol, methadone or erythromycin
medicines that suppress or modulate the immune system including other medicines used
to treat MS such as beta-interferon, glatiramer acetate, natalizumab, mitozantrone,
dimethyl fumarate, teriflunomide, alemtuzumab or corticosteroids due to a possible
added effect on the immune system
vaccines. If you need to receive a vaccine, seek your doctor's advice first. During
and up to 2 months after treatment with FINGOLIMOD-TEVA, administration of some vaccines
containing live virus (live attenuated vaccines) may result in an infection that the
vaccination is designed to prevent, while others may not work as well.
You may need to take different amounts of your medicines or to take different medicines
while you are taking FINGOLIMOD-TEVA. Your doctor and pharmacist can provide you with
more information.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FINGOLIMOD-TEVA.
4. How do I use FINGOLIMOD-TEVA?
How much to take
Adults
The usual dose is one capsule per day (0.5 mg of fingolimod).
Children and adolescents (10 years of age and above)
The dose depends on the body weight:
Children and adolescents who weigh 40 kg or less: one 0.25 mg capsule per day.*
Children and adolescents with a body weight above 40 kg: one 0.5 mg capsule per day.
*0.25 mg capsules are available in other brands
Children and adolescents who started on one 0.25 mg capsule per day and reach a stable
body weight above 40 kg will be instructed by their doctor to switch to one 0.5 mg
capsule per day. In this case, it is recommended to repeat the first dose observation
period (see below).
Follow the instructions provided and use FINGOLIMOD-TEVA until your doctor tells you
to stop.
When to take FINGOLIMOD-TEVA
FINGOLIMOD-TEVA should be taken 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. It does not matter if you take this medicine before or after
food.
How to take FINGOLIMOD-TEVA
Swallow the FINGOLIMOD-TEVA capsule with a glass of water.
FINGOLIMOD-TEVA can be taken with or without food.
Continue taking your medicine for as long as your doctor tells you to.
Your doctor will check your progress to make sure the medicine is working and will
discuss with you how long your treatment should continue.
Do not stop taking FINGOLIMOD-TEVA unless your doctor tells you to.
Your symptoms may return or become worse if you stop the treatment. Tell your doctor
if you have worsening of MS symptoms after stopping FINGOLIMOD-TEVA.
FINGOLIMOD-TEVA will stay in your body for up to 2 months after you stop taking it.
Your white blood cell count (lymphocyte count) may also remain low during this time
and the side effects described in this leaflet may still occur.
If you stop taking FINGOLIMOD-TEVA:
for 1 day or more during the first 2 weeks of treatment, or
for more than 7 days during weeks 3 and 4 of treatment, or
for more than 2 weeks after your first month of FINGOLIMOD-TEVA treatment, the initial
effect on your heart rate may occur again.
If you restart FINGOLIMOD-TEVA therapy after a break, your doctor may decide to monitor
your heart rate and blood pressure every hour, to run ECGs, or to monitor you overnight.
First Dose Precaution
Because FINGOLIMOD-TEVA may have a short-term effect on your heart rate when you take
the first dose (or when children/adolescents switch from the 0.25 mg capsule to the
0.5 mg capsule), you will be required to have the health of your heart checked:
before your first dose of FINGOLIMOD-TEVA
6 hours after taking your first dose of FINGOLIMOD-TEVA, and
if you start FINGOLIMOD-TEVA again after a break from therapy (depending on how long
the break is and how long you have been receiving FINGOLIMOD-TEVA treatment).
You will need to stay at the doctor's office or clinic for 6 hours after taking the
first dose of FINGOLIMOD-TEVA (or after taking the first dose of 0.5 mg when your
child switches from the 0.25 mg capsule daily dose) so that your heart rate and blood
pressure can be checked each hour. Your doctor will also check and record the electrical
activity of your heart (using a test called an ECG), and check your heart rhythm.
Tell your doctor if you feel dizzy, tired, or are conscious of your heartbeat.
At the end of the 6-hour observation period, you will be required to have a second
ECG.
In case of unusual ECG or slow heart rate at the end of the 6-hour observation period,
you may be observed for longer and overnight if necessary. In this case, the same
observation process that took place for your first dose of FINGOLIMOD-TEVA will also
apply for your second dose.
At the beginning of treatment, FINGOLIMOD-TEVA can cause the heart rate to slow down
in some patients. If your heart rate slows down after your first dose, you may feel
dizzy or tired or be consciously aware of your heartbeat. If your heart rate slows
down too much or your blood pressure drops, you may need treatment without delay.
Slow heart rate usually returns to normal within one month.
FINGOLIMOD-TEVA can also cause an irregular heartbeat in some patients, especially
after the first dose. Irregular heartbeat usually returns to normal in less than one
day.
If you forget to use FINGOLIMOD-TEVA
FINGOLIMOD-TEVA 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 your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you miss a dose during the first 2 weeks call your doctor right away.
Your doctor may decide to observe you at the time you take the next dose.
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.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much FINGOLIMOD-TEVA
If you think that you have used too much FINGOLIMOD-TEVA, 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.
You may need urgent medical attention. Your doctor may decide to observe you with
hourly heart rate and blood pressure measurements, run ECGs, and he/she may decide
to monitor you overnight.
Symptoms of an overdose may include:
swelling in hands or feet
tingling or numbness in hands or feet
muscle pain
fever.
5. What should I know while using FINGOLIMOD-TEVA?
Things you should do
You should avoid becoming pregnant while taking FINGOLIMOD-TEVA or in the two months
after you stop taking it because FINGOLIMOD-TEVA may harm your unborn baby.
Talk to your doctor about the associated risk. Talk with your doctor about reliable
methods of birth control that you should use during treatment and for 2 months after
you stop treatment.
If you become pregnant while taking this medicine, tell your doctor immediately.
FINGOLIMOD-TEVA should not be taken if you are pregnant.
Tell your doctor about any changes in your vision, especially if:
the centre of your vision gets blurry or has shadows
if you develop a blind spot in the centre of your vision
if you have problems seeing colours or fine detail.
FINGOLIMOD-TEVA may cause macular oedema uncommonly (swelling of a small area at the
back of the eye). When this side effect does occur, it usually happens in the first
4 months of treatment. Your chance of developing macular oedema is higher if you have
diabetes or have had an inflammation of the eye called uveitis. It can cause some
of the same vision symptoms as an MS attack (optic neuritis).
Your doctor should carry out regular skin examinations during your treatment with
FINGOLIMOD-TEVA. Limit your exposure to the sun and UV rays by wearing appropriate
protective clothing and regularly applying sunscreen with a high degree of UV protection.
This will help minimise your risk of developing skin cancers.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor will do regular checks to help prevent you from having side effects from
the medicine. This includes blood tests to check your liver function and regular skin
checks.
Call your doctor straight away if you:
think you have an infection, have fever, or feel like you have the flu. You may get
infections more easily while you are taking FINGOLIMOD-TEVA and for up to 2 months
after you stop taking it. Any infection that you already have may get worse. Infections
can be serious and sometimes life threatening.
notice any skin nodules (e.g. shiny pearly nodules), patches or open sores that do
not heal within weeks. Skin cancers have been reported in MS patients treated with
FINGOLIMOD-TEVA. Symptoms may include abnormal growth or changes of skin tissue (e.g.
unusual moles) which may change in colour, shape or size over time.
notice signs that your MS is getting worse (e.g. weakness or visual change) or if
you notice any new or unusual symptoms. These may be the symptoms of a rare brain
disorder caused by infection called progressive multifocal leukoencephalopathy (PML)
or a condition called tumefactive lesions. Your doctor may organise an MRI scan to
decide if you need to stop taking FINGOLIMOD-TEVA.
think you have an infection; a fever; feel like you
have the flu, or have a headache accompanied by stiff neck, sensitivity to light,
nausea, and/or confusion, or seizures/fits (these may be symptoms of meningitis and/or
encephalitis)
have sudden onset of severe headache, confusion, seizures and vision changes which
are symptoms of a condition called posterior reversible encephalopathy (PRES)
have swelling in your neck, armpits or groin, persistent tiredness, fever, night sweats,
shortness of breath, unexplained weight loss, itchy skin which are symptoms of lymphoma
have unexplained nausea, vomiting, abdominal pain, tiredness, yellowing of the skin
or whites of your eyes, abnormally dark urine. These may be signs of liver injury.
Remind any doctor, dentist or pharmacist you visit that you are using FINGOLIMOD-TEVA.
Things you should not do
You should not receive certain types of vaccines (live attenuated vaccines) during
and for up to 2 months after treatment with this medicine (see section
3 What if I am taking other medicines?).
Do not give this medicine to anyone else, even if their condition seems similar to
yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Driving or using machines
Your doctor will tell you whether your illness allows you to drive vehicles and use
machines safely.
FINGOLIMOD-TEVA is not expected to have an influence on your ability to drive and
use machines.
Looking after your medicine
Store it in a cool dry place where the temperature stays below 25°C
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.
When to discard your medicine
If your doctor tells you to stop taking this medicine or the expiry date has passed.
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
|
Gut - related:
diarrhoea
weight loss
nausea
Lung - related:
cough
breathlessness
Skin - related:
ringworm, a fungal infection affecting the skin with ring-like red itchy rash
itchy, red, burning rash (eczema)
itchy skin
Flu symptoms such as:
tiredness
chills
sore throat
joint or muscles aching
fever
Pain - related:
muscle or joint pain
feeling of pressure or pain in the cheeks and forehead (sinusitis)
severe headache often together with nausea, vomiting and sensitivity to light (signs
of migraine)
headache
back pain
Vision - related:
blurred vision (see also information on macular oedema below)
Other:
dizziness
weakness
|
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
|
bronchitis with symptoms such as coughing with phlegm, chest pain, fever
shingles or herpes zoster symptoms such as blisters, burning, itching or pain of the
skin, typically on the upper body or face. Other symptoms may be fever and weakness
in the early stages of infection, followed by numbness, itching, and red patches with
severe pain.
fever, cough, difficulty breathing, tiredness, aching joints and muscles which are
signs of infections.
slow heartbeat (bradycardia) or irregular heartbeat
pneumonia with symptoms such as fever, cough, difficulty breathing
shadows or blind spot in the centre of your vision, blurred vision, problems seeing
colours or details which are symptoms of macular oedema (swelling in the central vision
area of the retina at the back of the eye)
moles which may change size, shape, elevation or colour over time, or new moles which
may be symptoms of melanoma, a type of skin cancer usually developing from an unusual
mole (naevus). The moles may itch, bleed or ulcerate.
skin nodules (e.g. shiny pearly nodules), patches or open sores
skin lesions of unusual colour
convulsions, fits (more frequent in children and adolescents than in adults)
bleeding or bruising more easily than normal. This may be due to low level of platelets
(thrombocytopenia).
yellowing of your skin or the whites of your eyes, abnormally dark urine, unexplained
nausea, vomiting, pain on the right side of your stomach area, feeling less hungry
than usual and tiredness, which may be signs of liver injury
worsening of MS symptoms (e.g. weakness or visual changes) which could be signs of
a rare brain disorder caused by infection called progressive multifocal leukoencephalopathy.
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in
swallowing or breathing
sudden onset of rash or hives
sudden onset of severe headache, confusion, seizures and/or vision changes, which
are symptoms of a condition called posterior reversible encephalopathy (PRES)
headache accompanied by stiff neck, sensitivity to light, nausea, and/or confusion
or seizures (fits) which are symptoms of a cryptococcal infection (a type of fungal
infection), including cryptococcal meningitis, or meningitis/encephalits (caused by
herpes or varicella zoster virus).
|
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.
Some side effects may not give you any symptoms and can only be found when tests are
done. These include:
hypertension (FINGOLIMOD-TEVA may cause a mild increase in blood pressure)
higher levels of liver enzymes and/or liver injury
increased level of blood fat (triglycerides)
changes to blood cell counts
abnormal lung function test results starting after one month of treatment, remaining
stable after that and reversible after treatment discontinuation.
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 FINGOLIMOD-TEVA contains
Active ingredient
(main ingredient)
|
Fingolimod hydrochloride
|
Other ingredients
(inactive ingredients)
|
Capsule Content
Pregelatinised maize starch
Sodium lauryl sulfate
Capsule Shell
Iron oxide yellow (E172)
Titanium dioxide (E171)
Gelatin
Printing Ink
TekPrint™ SW-9008 Black Ink
|
Do not take this medicine if you are allergic to any of these ingredients.
What FINGOLIMOD-TEVA looks like
FINGOLIMOD-TEVA is a hard gelatin capsule, size 4, filled with white to off-white
powder, imprinted in black, with "TV 7820" on the yellow capsule cap and "TV 7820"
on the white opaque capsule body (Aust R 384703).
FINGOLIMOD-TEVA is available in packs of 7, 28, 30 and 84. Not all pack sizes may
be marketed.
Who distributes FINGOLIMOD-TEVA
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
Ph: 1800 288 382
This leaflet was prepared in January 2023.