Active ingredient
- teriflunomide
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/13/838/004, EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/005, EU/1/13/838/003.
AUBAGIO 14 mg film-coated tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AUBAGIO 14 mg film-coated tablets
teriflunomide
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What AUBAGIO is and what it is used for
2. What you need to know before you take AUBAGIO
3. How to take AUBAGIO
4. Possible side effects
5. How to store AUBAGIO
6. Contents of the pack and other information
1. What AUBAGIO is and what it is used for
What AUBAGIO is
AUBAGIO contains the active substance teriflunomide which is an immunomodulatory agent and adjusts the immune system to limit its attack on the nervous system.
What AUBAGIO is used for
AUBAGIO is used in adults to treat relapsing - remitting multiple sclerosis (MS).
What multiple sclerosis is
MS is a long-term illness that affects the central nervous system (CNS). The CNS is made up of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (called myelin) around the nerves in the CNS. This loss of myelin is called demyelination. This stops nerves from working properly.
People with relapsing form of multiple sclerosis will have repeated attacks (relapses) of physical symptoms caused by their nerves not working properly.
These symptoms vary from patient to patient but usually involve:
Symptoms may disappear completely after the relapse is over, but over time, some problems may remain between relapses. This can cause physical disabilities that may interfere with your daily activities.
How AUBAGIO works
AUBAGIO helps to protect against attacks on the central nervous system by the immune system by limiting the increase of some white blood cells (lymphocytes). This limits the inflammation that leads to nerve damage in MS.
2. What you need to know before you take AUBAGIO
Do not take AUBAGIO:
If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking AUBAGIO if:
Children and adolescents
AUBAGIO should not be used in children and adolescents under 18 years of age. This is because the effects of the medicine in this age group are not known.
Other medicines and AUBAGIO
Tell your your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following:
Pregnancy and breast-feeding
Do not take AUBAGIO if you are, or think you may be pregnant. If you are pregnant or become pregnant while taking AUBAGIO, the risk of having a baby with birth defects is increased. Women of childbearing potential must not take this medicine without using reliable contraceptive measures.
Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to ensure that most of this medicine has left your body before trying to become pregnant. The elimination of the active substance may take up to 2 years to occur naturally. The time can be reduced to a few weeks by taking certain medicines which speed up removal of AUBAGIO from your body.
In either case it should be confirmed by a blood test that the active substance has been sufficiently removed from your body and you need confirmation from your treating physician that the blood level of AUBAGIO is low enough to allow you to become pregnant.
For further information on the laboratory testing please contact your doctor.
If you suspect that you are pregnant while taking AUBAGIO or in the two years after you have stopped treatment, you must contact your doctor immediately for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove AUBAGIO rapidly and sufficiently from your body, as this may decrease the risk to your baby.
Contraception
You must use an effective method of contraception during and after treatment with AUBAGIO. Teriflunomide remains in your blood for a long time after you stop taking it. Continue to use effective contraception after you stop treatment.
Do not take AUBAGIO when you are breast-feeding, as teriflunomide passes into the breast milk.
Driving and using machines
AUBAGIO might make you feel dizzy which may impair your ability to concentrate and react. If you are affected, do not drive or use machines.
AUBAGIO contains lactose
AUBAGIO contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
AUBAGIO contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take AUBAGIO
Treatment with AUBAGIO will be overseen by a doctor who is experienced in the treatment of multiple sclerosis.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The recommended dose is one film-coated tablet (14 mg) daily.
Route/method of administration
AUBAGIO is for oral use. AUBAGIO is taken every day as a single daily dose at any time of the day.
You should swallow the tablet whole with some water.
AUBAGIO may be taken with or without food.
If you take more AUBAGIO than you should
If you have taken too much AUBAGIO, call your doctor straight away. You may experience side effects similar to those described in section 4 below.
If you forget to take AUBAGIO
Do not take a double dose to make up for a forgotten tablet. Take your next dose at the scheduled time.
If you stop taking AUBAGIO
Do not stop taking AUBAGIO or change your dose without talking to your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine.
Serious side effects
Tell your doctor immediately, if you notice any of the following serious side effects:
Other side effects can occur with the following frequencies
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Not known (frequency cannot be estimated from the available data)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the contact details listed below. By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store AUBAGIO
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, protective sleeve, and wallet after “EXP”. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What AUBAGIO contains
What AUBAGIO looks like and contents of the pack
AUBAGIO 14 mg film-coated tablets (tablets) are pale blue to pastel blue, pentagonal film-coated tablets with imprint on one side (‘14’) and engraved with a corporate logo on the other side.
AUBAGIO is available in cardboard cartons containing:
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in 09/2020
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
R789540
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT
+44 (0)800 035 2525