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Document Details
Generated Narrative: Bundle TEST PURPOSES ONLY - teriflunomide
Language: en
Profile: Bundle - ePI
Final Document at 2022-02-16 13:28:17+0000 by Organization ACME industry for Bundle: identifier = http://ema.europa.eu/identifier#None; type = document; timestamp = 2023-06-27 10:09:22+0000
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Document Content
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Language: en
Profile: Composition (ePI)
identifier: http://ema.europa.eu/identifier
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status: Final
type: Package Leaflet
category: Raw
date: 2022-02-16 13:28:17+0000
author: Organization ACME industry
title: TEST PURPOSES ONLY - teriflunomide
Mode | Time |
Official | 2022-02-16 13:28:17+0000 |
What is in this leaflet
What Teriflunomide Accord is Teriflunomide Accord contains the active substance teriflunomide which is an immunomodulatory agent and adjusts the immune system to limit its attack on the nervous system.
What Teriflunomide Accord is used for Teriflunomide Accord is used in adults and in children and adolescents (10 years of age and older) 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 Teriflunomide Accord works Teriflunomide Accord 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.
Do not take Teriflunomide Accord:
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 Teriflunomide Accord if:
Respiratory reactions Tell your doctor if you have unexplained cough and dyspnoea (shortness of breath). Your doctor may perform additional tests
Children and adolescents Teriflunomide Accord is not intended for use in children under 10 years of age, as it has not been studied in MS patients in this age group.
The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:
Other medicines and Teriflunomide Accord Tell 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 Teriflunomide Accord if you are or think you may be pregnant. If you are pregnant or become pregnant while taking Teriflunomide Accord, 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. If your daughter reaches menses while taking Teriflunomide Accord, you should inform the doctor, who will provide specialist counselling regarding contraception and the potential risks in case of pregnancy.
Tell your doctor if you plan to become pregnant after stopping treatment with Teriflunomide Accord, 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 teriflunomide 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 teriflunomide 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 Teriflunomide Accord or in the two years after you have stopped treatment, you must discontinue Teriflunomide Accord and 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 teriflunomide 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 Teriflunomide Accord. 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 Teriflunomide Accord when you are breast-feeding, as teriflunomide passes into the breast milk.
Driving and using machines Teriflunomide Accord might make you feel dizzy which may impair your ability to concentrate and react. If you are affected, do not drive or use machines.
Teriflunomide Accord contains lactose Teriflunomide Accord 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.
Teriflunomide Accord contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially sodium-free .
Treatment with Teriflunomide Accord 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.
Adults The recommended dose is one 14 mg tablet daily.
Children and adolescents (10 years of age and above) The dose depends on body weight:
7 mg tablets are not available under this tradename and another medicine with teriflunomide should be taken in this case.
Children and adolescents who reach a stable body weight above 40 kg will be instructed by their doctor to switch to one 14 mg tablet daily.
Route/method of administration Teriflunomide Accord is for oral use. Teriflunomide Accord is taken every day as a single dose at any time of the day. You should swallow the tablet whole with some water. Teriflunomide Accord may be taken with or without food.
If you take more Teriflunomide Accord than you should If you have taken too much Teriflunomide Accord, call your doctor straight away. You may experience side effects similar to those described in section 4 below.
If you forget to take Teriflunomide Accord 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 Teriflunomide Accord Do not stop taking Teriflunomide Accord 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.
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
Some side effects could be or could become serious, if you experience any of these, tell your doctor immediately.
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):
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)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Children (10 years of age and above) and adolescents The side effects listed above also apply to children and adolescents. The following additional information is important for children, adolescents, and their caregivers:
Common (may affect up to 1 in 10 people)
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 after EXP . The expiry date refers to the last day of that month.
This medicinal product 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.
What Teriflunomide Accord contains
What Teriflunomide Accord looks like and contents of the pack Teriflunomide Accord 14 mg film-coated tablets (tablets) are blue colored, pentagonal shaped, film coated tablets, debossed with T2 on one side and plain on other side.
Teriflunomide Accord is available in cartons containing:
Not all pack sizes may be marketed.
Marketing Authorisation Holder Accord Healthcare S.L.U. World Trade Center,
Moll De Barcelona s/n,
Edifici Est, 6a Planta,
Barcelona, 08039, Spain Manufacturer Accord Healthcare Polska Sp. z.o.o. ul.Lutomierska 50, 95-200, Pabianice, Poland
Accord Healthcare B.V. Winthontlaan 200,
3526 KV Utrecht, Netherlands
Pharmadox Healthcare Ltd. KW20A Kordin Industrial Park, Paola PLA 3000, Malta
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
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