Teriflunomide Accord: detailed information

Package leaflet: Information for the patient

Teriflunomide Accord 7 mg film-coated tablets, 14 mg film-coated tablets

teriflunomide
Read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Teriflunomide Accord is and what it is used for
What you need to know before taking Teriflunomide Accord
How to take Teriflunomide Accord
Possible side effects
How to store Teriflunomide Accord
Contents of the pack and other information

1. What Teriflunomide Accord is and what it is used for

What Teriflunomide Accord is
Teriflunomide Accord contains the active substance teriflunomide, which is an immunomodulatory agent and modulates the immune system to limit its attacks on the nervous system.

What Teriflunomide Accord is used for
Teriflunomide Accord is used in adults, children, and adolescents (aged 10 years and older) for the treatment of relapsing-remitting multiple sclerosis (MS).

What is multiple sclerosis
MS is a long-term disease affecting the central nervous system (CNS), which consists of the brain and spinal cord. In multiple sclerosis, inflammation destroys the protective sheath (called myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination and prevents nerves from functioning properly.

People with relapsing forms of multiple sclerosis experience repeated attacks (relapses) of physical symptoms caused by improper nerve function. These symptoms vary from patient to patient but generally include:

difficulty walking
visual problems
balance problems.

Symptoms may completely disappear after a relapse, but over time some problems may persist between relapses. This can lead to physical disability that may interfere with daily activities.

How Teriflunomide Accord works
Teriflunomide Accord helps protect the central nervous system from attacks by the immune system by limiting the increase of certain white blood cells (lymphocytes). This reduces the inflammation that causes nerve damage characteristic of MS.

2. What you need to know before taking Teriflunomide Accord

Do not take Teriflunomide Accord:

if you are allergic to teriflunomide or to any of the other ingredients of this medicine (listed in section 6),
if you have developed a severe skin rash or skin peeling, blistering, and/or mouth sores after taking teriflunomide or leflunomide,
if you have severe liver problems,
if you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
if you have any serious condition affecting the immune system (e.g. acquired immunodeficiency syndrome (AIDS)),
if you have any severe bone marrow disorder or if you have low levels of red blood cells, white blood cells, or platelets in your blood,
if you have a serious infection,
if you have severe kidney problems requiring dialysis,
if you have very low levels of protein in your blood (hypoproteinemia). If in doubt, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions
Talk to your doctor or pharmacist before taking Teriflunomide Accord if:

you have liver problems and/or consume large amounts of alcohol. Your doctor will request blood tests before and during treatment to monitor liver function. If blood test results indicate liver problems, your doctor may ask you to stop treatment with Teriflunomide Accord. See section 4.
you have high blood pressure (hypertension), whether controlled by medication or not. Teriflunomide Accord may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly thereafter. See section 4.
you have an infection. Before starting Teriflunomide Accord, your doctor will check that your white blood cell and platelet counts are adequate. Since Teriflunomide Accord reduces the number of white blood cells in the blood, this may affect your ability to fight infections. If you suspect you have an infection, your doctor may perform blood tests to monitor white blood cells. Viral infections caused by herpes viruses, including oral herpes or herpes zoster (shingles), may occur during treatment with teriflunomide. In some cases, serious complications may arise. You must inform your doctor immediately if you suspect any symptoms of a herpes virus infection. See section 4.
you have severe skin reactions.
you have respiratory symptoms.
you experience weakness, numbness, or pain in your hands or feet.
you need to receive a vaccination.
you are taking leflunomide together with Teriflunomide Accord.
you are switching to or from treatment with Teriflunomide Accord. You will need a specific blood test (calcium level). Falsely low calcium levels may be observed.

Respiratory reactions
Inform your doctor if you develop unexplained cough or shortness of breath (dyspnea). Your doctor may perform further investigations.

Children and adolescents
Teriflunomide Accord is not recommended for children under 10 years of age, as it has not been studied in pediatric patients with MS in this age group.
The warnings and precautions listed above also apply to children. The following information is important for children and those caring for them:

Pancreatitis (inflammation of the pancreas) has been observed in patients taking teriflunomide. Your child’s doctor may perform blood tests if pancreatitis is suspected.

Other medicines and Teriflunomide Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

leflunomide, methotrexate, and other medicines that affect the immune system (commonly called immunosuppressants or immunomodulators)
rifampicin (a medicine used to treat tuberculosis and other infections)
carbamazepine, phenobarbital, phenytoin for epilepsy
St. John’s wort (a herbal medicine for depression)
repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
duloxetine for depression, urinary incontinence, or kidney problems in diabetics
alosetron for managing severe diarrhea
theophylline for asthma
tizanidine, a muscle relaxant
warfarin, an anticoagulant used to thin the blood (i.e. make it more fluid) to prevent blood clots
oral contraceptives (containing ethinylestradiol and levonorgestrel)
cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
indomethacin, ketoprofen for pain or inflammation
furosemide for heart conditions
cimetidine for reducing gastric acid
zidovudine for HIV infection
rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)
sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
colestyramine for high cholesterol or relief of itching in liver diseases
activated charcoal to reduce absorption of medicines or other substances.

Pregnancy and breastfeeding
Do not take Teriflunomide Accord if you are pregnant or suspect you may be pregnant. If you become pregnant while taking Teriflunomide Accord, the risk of birth defects in the baby increases. Women of childbearing potential must not take this medicine without using reliable contraceptive methods.
If your daughter starts menstruating while taking Teriflunomide Accord, inform your doctor, who will provide specialist advice regarding contraception and potential risks in case of pregnancy.
Inform your doctor if you plan to become pregnant after stopping treatment with Teriflunomide Accord, because you must ensure that most of the medicine has been eliminated from your body before planning a pregnancy. Elimination of the active substance may take up to 2 years naturally. This period can be reduced to a few weeks by taking certain medicines that accelerate the elimination of Teriflunomide Accord from the body.
In any case, blood testing must confirm that the active substance has been sufficiently eliminated from your body, and you must wait for confirmation from your doctor that teriflunomide blood levels are low enough to allow pregnancy.
For further information on laboratory tests, consult your doctor.
If you suspect pregnancy while taking Teriflunomide Accord or within two years after stopping treatment, you must stop taking Teriflunomide Accord and contact your doctor immediately for a pregnancy test. If pregnancy is confirmed, your doctor may recommend treatment with specific medicines to rapidly and sufficiently eliminate teriflunomide from your body, as this may reduce the risk to the fetus.

Contraception
You must use an effective method of contraception during and after treatment with Teriflunomide Accord. Teriflunomide remains in the blood for a long time after stopping treatment. Continue using effective contraception after stopping treatment.

Continue until teriflunomide blood levels are sufficiently low. Your doctor will monitor these levels.
Discuss with your doctor the most suitable contraceptive method for you and if any change in contraception is needed.

Do not take Teriflunomide Accord if you are breastfeeding, as teriflunomide passes into breast milk.

Driving and using machines
Teriflunomide Accord may cause dizziness, which could impair your ability to concentrate and react. Do not drive or operate machinery if you experience this symptom.

Teriflunomide Accord contains lactose
Teriflunomide Accord contains lactose (a type of sugar). If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.

Teriflunomide Accord contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Teriflunomide Accord

Treatment with Teriflunomide Accord must be supervised by a physician experienced in the
treatment of multiple sclerosis.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor.
Adults
The recommended dose is one 14 mg tablet per day.
Children and adolescents (aged 10 years and older)
The dose depends on body weight:

Children with body weight above 40 kg: one 14 mg tablet per day.
Children with body weight less than or equal to 40 kg: one 7 mg tablet per day.

Children and adolescents who reach a stable body weight above 40 kg will be instructed by their physician to switch to one 14 mg tablet per day.
Route/method of administration
Teriflunomide Accord is for oral use. Teriflunomide Accord is taken daily as a single daily dose at any time of the day.
The tablet should be swallowed 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, contact your doctor immediately. You may experience adverse 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 the missed tablet. Take the next dose at the scheduled time.
If you stop treatment with Teriflunomide Accord
Do not stop using Teriflunomide Accord or change the dose without first discussing it with your
doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with this medicine.
Serious side effects
Some side effects may be or may become serious. Contact your doctor immediately if you notice any of
the following serious side effects.
Common (may affect up to 1 in 10 people)

Inflammation of the pancreas which may include symptoms such as abdominal pain, nausea or vomiting (frequency is common in paediatric patients and uncommon in adult patients).

Uncommon (may affect up to 1 in 100 people)

Allergic reactions which may include symptoms such as rash, hives, swelling of the lips, tongue or face, or sudden breathing difficulties
Severe skin reactions which may include symptoms such as rash, blisters, fever, or mouth ulcers
Severe infections or sepsis (a type of infection that may be life-threatening) which may include symptoms such as high fever, shaking, chills, reduced urine output, or confusion
Inflammation of the lungs which may include symptoms such as shortness of breath or persistent cough

Not known (frequency cannot be estimated from the available data)

Severe liver diseases which may include symptoms such as yellowing of the skin or whites of the eyes, darker than normal urine, unexplained nausea and vomiting, or abdominal pain

Other side effects may occur with the following frequencies
Very common (may affect more than 1 in 10 people):

Headache
Diarrhoea, nausea
Increased ALT (elevated levels of certain liver enzymes in the blood) detected by blood tests
Hair thinning

Common (may affect up to 1 in 10 people):

Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, cystitis, viral gastroenteritis, dental infection, laryngitis, fungal foot infection
Herpes virus infections, including oral herpes and herpes zoster (shingles), with symptoms such as blisters, burning, itching, numbness or pain of the skin, usually on one side of the upper body or face, and other symptoms such as fever and weakness
Laboratory tests: decreased number of red blood cells (anaemia), changes in liver function tests and white blood cell counts (see section 2), and increases in a muscle enzyme (creatine phosphokinase)
Mild allergic reactions
Feeling anxious
Tingling, weakness, numbness, burning, prickling or pain in the lower back or legs (sciatica); numbness, tingling or pain in the hands and fingers (carpal tunnel syndrome)
Awareness of your heartbeat
Increased blood pressure
Vomiting, toothache, upper abdominal pain
Rash, acne
Tendon, joint, bone pain, muscle pain (musculoskeletal pain)
Need to urinate more often than usual
Heavy menstrual periods
Pain
Lack of energy or feeling weak (asthenia)
Weight loss

Uncommon (may affect up to 1 in 100 people):

Decreased number of platelets (mild thrombocytopenia)
Increased sensitivity, particularly of the skin; stabbing or pulsating pain in one or more nerves, nerve problems in arms or legs (peripheral neuropathy)
Nail disorders, severe skin reactions
Post-traumatic pain
Psoriasis
Inflammation of the mouth/lips
Abnormal levels of fats (lipids) in the blood
Inflammation of the colon (colitis)

Rare (may affect up to 1 in 1,000 people):
Inflammation or damage to the liver
Not known (frequency cannot be estimated from the available data):

Increased blood pressure in the lungs

Children (aged 10 years and older) and adolescents
The side effects listed above also apply to children and adolescents. The following additional information is important for children, adolescents, and those caring for them:
Common (may affect up to 1 in 10 people)

Inflammation of the pancreas

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Teriflunomide Accord

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 medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Teriflunomide Accord contains
Teriflunomide Accord 7 mg film-coated tablets

The active substance is teriflunomide. Each tablet contains 7 mg of teriflunomide.
The other components are monohydrate lactose, maize starch, microcrystalline cellulose, sodium starch glycolate, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol (E1521), indigo carmine – aluminium lake (E132), iron oxide yellow (E172).

Teriflunomide Accord 14 mg film-coated tablets

The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
The other components are monohydrate lactose, maize starch, microcrystalline cellulose, sodium starch glycolate, hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica, hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol (E1521), indigo carmine – aluminium lake (E132).

Description of the appearance of Teriflunomide Accord and contents of the pack
Teriflunomide Accord 7 mg film-coated tablets
Teriflunomide Accord 7 mg film-coated tablets (tablets) are film-coated tablets, light greenish-grey to slightly greenish-blue in colour, hexagonal in shape, with the imprint “T1” on one side and smooth on the other.
Teriflunomide Accord is available in cardboard boxes containing:

14, 28, 84 and 98 tablets in aluminium-aluminium blisters;
14x1, 28x1, 84x1 and 98x1 tablets in perforated aluminium-aluminium unit dose blisters.

Teriflunomide Accord 14 mg film-coated tablets
Teriflunomide Accord 14 mg film-coated tablets are film-coated tablets, blue in colour, pentagonal in shape, with the imprint “T2” on one side and smooth on the other.
Teriflunomide Accord is available in cardboard boxes containing:

28 and 84 tablets in aluminium-aluminium blisters;
28x1 and 84x1 tablets in perforated aluminium-aluminium unit dose blisters.

Not all pack sizes may be marketed.
Marketing Authorization Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll De Barcelona s/n,
Edifici Est, 6th Floor,
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, The Netherlands
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LX / MT /
NL / NO / PL / PT / RO / SE / SI / SK / UK (NI)
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu