Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Teriflunomida contains the active ingredient teriflunomida, which is an immunomodulator agent that adjusts the immune system to limit its attack on the nervous system.
Teriflunomida is used in adults and in children and adolescents (10 years of age and older) to treat relapsing-remitting multiple sclerosis (EM).
Multiple sclerosis is a long-term disease that affects the central nervous system (CNS). The CNS is formed by the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (myelin) that surrounds the CNS nerves. This loss of myelin is called demyelination. This makes the nerves stop functioning properly.
People who suffer from the relapsing form of multiple sclerosis will have repeated (recurrent) attacks of physical symptoms caused by the improper functioning of the nerves. These symptoms vary from patient to patient, but usually include:
The symptoms may disappear completely after the recurrence but, over time, some problems may remain. This can cause physical disabilities that can interfere with daily activities.
Teriflunomida helps to protect against attacks in the central nervous system by the immune system, limiting the growth of some white blood cells (lymphocytes). This limits the inflammation that causes nerve damage in MS.
In case of doubt, ask your doctor or pharmacist before taking this medication.
Consult your doctor or pharmacist before starting to take teriflunomida if:
Inform your doctor if you have cough and shortness of breath without explanation. Your doctor may perform additional tests.
Teriflunomida is not indicated for use in children under 10 years of age, as it has not been studied in patients with EM in this age group.
The warnings and precautions listed above also apply to children. The following information is important for children and their caregivers:
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications.
Especially, inform your doctor or pharmacist if you are taking any of the following medications:
Do nottake teriflunomida if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking teriflunomida, you will have an increased risk of having a baby with birth defects.
Women of childbearing age should not take this medication unless they are using reliable contraceptive methods.
If your daughter starts menstruating while taking teriflunomida, she should inform her doctor, who will provide specialized advice on contraceptive methods and the potential risks in case of pregnancy.
Inform your doctor if you plan to become pregnant after stopping treatment with teriflunomida, as you need to ensure that most of this medication has been eliminated from your body before trying to become pregnant. The elimination of the active ingredient naturally may take up to 2 years. This time period can be reduced to a few weeks by taking certain medications to accelerate the elimination of teriflunomida from your body.
In any case, you need your doctor to confirm, from a blood test, that the level of active ingredient in your blood is low enough for you to become pregnant.
For more information on laboratory tests, contact your doctor.
If you suspect you are pregnant while taking teriflunomida or in the two years following treatment, you should stop teriflunomida and contact your doctor immediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may suggest a treatment with certain medications to eliminate teriflunomida from your body quickly, as this may reduce the risk to your baby.
Contraception
You should use an effective contraceptive method during and after treatment with teriflunomida. Follow the instructions below:
Do not take teriflunomida during breastfeeding as teriflunomida passes into breast milk.
Teriflunomida may cause dizziness, which may affect your ability to concentrate and react. If you are affected, do not drive or operate machinery.
If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.
This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".
A healthcare professional with experience in treating multiple sclerosis will oversee treatment with teriflunomida.
Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.
The recommended dose is one 14 mg tablet per day.
The dose depends on body weight:
Your doctor will instruct children and adolescents who reach a stable body weight greater than 40 kg to switch to one 14 mg tablet per day.
Form/via of administration
This medication is administered orally. Teriflunomida is taken once a day in a single daily dose at any time of the day.
The tablet should be swallowed whole with water. This medication can be taken with or without food.
If you have taken too much teriflunomida, call your doctor immediately. You may experience adverse effects similar to those described in section 4 (below).
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.
Do not take a double dose to compensate for the missed doses. Take your next dose at your usual time.
Do not interrupt treatment or change the dose of teriflunomida without consulting your doctor first. If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects may occur with this medicine.
Some side effects can be severe, if you experience any of these, inform your doctor immediately.Inform your doctor immediately.
Frequent(may affect up to 1 in 10 people)
Uncommon(may affect up to 1 in 100 people)
Frequency not known(the frequency cannot be estimated with the available data)
Other side effectsmay occur with the following frequencies:
Very frequent(may affect more than 1 in 10 people)
Frequent(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 patients)
Frequency not known(the frequency cannot be estimated with the available data)
The previously listed side effects also apply to children and adolescents. The following additional information is important for children, adolescents, and their caregivers:
Frequent(may affect up to 1 in 10 people)
If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and the blister pack after “CAD”. The expiration date is the last day of the month indicated.
This medication does not require special conditions for conservation.
Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.
Composition of Teriflunomida Kern Pharma
Tablet core: lactose monohydrate, cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A) (from potato), hydroxypropylcellulose, magnesium stearate, sodium hydroxide, anhydrous colloidal silica.
Tablet coating: hypromellose, titanium dioxide (E-171), triacetin, indigo carmine (E-132), and talc.
Appearance of the product and contents of the packaging
The film-coated tablets, with a light blue or pale blue color, have a pentagonal shape, are biconvex, and are engraved with "14" on one side and are flat on the other side. Tablet dimensions: 7.4 mm.
The film-coated tablets are available in single-dose PVC/PCTFE/aluminum or aluminum/aluminum blisters in carton boxes containing 28 tablets.
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa – Barcelona
Spain
Responsible for manufacturing:
Pharmacare Premium Ltd.
HHF003 Hal Far Industrial Estate,
Hal Far Birzebbugia, BBG3000,
Malta
or
Genepharm S.A.
18th km Marathonos Ave,
Pallini Attiki, 15351,
Greece
The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.
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