Patient Information Leaflet

Teriflunomida Accord 14 mg Film-Coated Tablets

teriflunomida

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as 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 others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

What is Teriflunomida Accord

Teriflunomida Accord contains the active ingredient teriflunomida, which is an immunomodulator agent that adjusts the immune system to limit its attack on the nervous system.

What is Teriflunomida Accord used for

Teriflunomida Accord is used in adults and in children and adolescents (from 10 years of age) to treat relapsing-remitting multiple sclerosis (MS).

What is multiple sclerosis

MS is a long-term disease that affects the central nervous system (CNS). The CNS is formed by the brain and spinal cord. In MS, inflammation destroys the protective sheath (myelin) that surrounds the nerves of the CNS. This loss of myelin is called demyelination. This makes the nerves stop functioning correctly.

People who suffer from the relapsing form of MS will have repeated attacks (recurrences) of the physical symptoms caused by the inadequate functioning of the nerves. These symptoms vary from patient to patient, but usually include:

• difficulty walking
• vision problems
• balance problems.

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.

How Teriflunomida Accord works

Teriflunomida Accord 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.

Do not take Teriflunomida Accord:

• if you are allergic to teriflunomida or any of the other components of this medication (listed in section 6),
• if you have ever developed a severe skin rash or peeling of the skin, blisters, and/or ulcers in the mouth after taking teriflunomida or leflunomida,
• if you have severe liver problems,
• if you are pregnant, think you may be pregnant, or are breastfeeding,
• if you have a severe condition that affects the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have severe problems with the bone marrow or if you have a low number of white blood cells, red blood cells, or platelets in the blood or a reduced number of platelets,
• if you have a severe infection,
• if you have severe kidney problems that require dialysis,
• if you have a very low level of proteins in the blood (hypoproteinemia),

In case of doubt, ask your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Teriflunomida Accord if:

• you have liver problems and/or if you drink large amounts of alcohol. Your doctor may perform blood tests to check the functioning of your liver before treatment and during treatment. If the test results indicate a liver problem, your doctor may interrupt the treatment with Teriflunomida Accord. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated to control it.
• Teriflunomida Accord may cause an increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. See section 4.
• you have an infection. Before you start taking Teriflunomida Accord, your doctor will ensure that you have enough white blood cells and platelets in the blood. Since Teriflunomida Accord reduces the number of white blood cells in the blood, this may affect your ability to fight off the infection. Your doctor may perform blood tests to check your white blood cells if they suspect you have an infection. See section 4.
• you have severe skin reactions.
• you have respiratory symptoms.
• you have weakness, numbness, and pain in your hands and feet.
• you are planning to be vaccinated.
• you are taking leflunomida with Teriflunomida Accord.
• you are changing medication from or to Teriflunomida Accord.
• you are scheduled to have a specific blood test (calcium level). A false decrease in calcium levels may be detected.

Respiratory reactions

Inform your doctor if you have cough and shortness of breath without explanation. Your doctor may perform additional tests.

Children and adolescents

Teriflunomida Accord 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:

• inflammation of the pancreas has been observed in patients receiving teriflunomida. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medications and Teriflunomida Accord

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:

• leflunomida, methotrexate, and other medications that affect the immune system (often referred to as immunodepressants or immunomodulators)
• rifampicin (a medication used to treat tuberculosis and other infections)
• carbamazepine, phenobarbital, phenytoin for epilepsy
• hypericum (a plant-based medication for depression)
• repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes
• daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer
• duloxetine for depression, incontinence, or kidney disease in diabetics
• alosetron for severe diarrhea
• theophylline for asthma
• tizanidine, a muscle relaxant
• warfarin, an anticoagulant to thin the blood (make it more fluid) and prevent clots
• oral contraceptives (ethinylestradiol, levonorgestrel)
• cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections
• indomethacin, ketoprofen for pain or inflammation
• furosemide for heart disease
• cimetidine to reduce stomach acid
• zidovudine for AIDS
• rosuvastatin, simvastatin, atorvastatin, pravastatin for high cholesterol (high cholesterol)
• sulfasalazine for inflammatory bowel disease or rheumatoid arthritis
• cholestyramine for high cholesterol or relief of itching in liver disease
• activated charcoal to reduce the absorption of medications or other substances.

Pregnancy and breastfeeding

Do nottake Teriflunomida Accord if you are pregnant or think you may bepregnant. If you are pregnant or become pregnant while taking Teriflunomida Accord, 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 Accord, she should inform her doctor, who will give her specialized advice on contraceptive methods and the possible risks in case of pregnancy.

Inform your doctor if you plan to become pregnant after interrupting treatment with Teriflunomida Accord, as you need to ensure that most of this medication has been eliminated from your body before attempting to become pregnant. The natural elimination of the active ingredient may take up to 2 years. This period of time can be reduced to a few weeks by taking certain medications to accelerate the elimination of teriflunomida from the body.

In any case, you need your doctor to confirm, from a blood test, that the level of active ingredient in the 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 Accord or in the two years following completion of treatment, you should interrupt Teriflunomida Accord and contact your doctorimmediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may recommend a treatment with certain medications to eliminate teriflunomida from the body quickly and effectively, as this may reduce the risk to your baby.

Contraception

You must use an effective contraceptive method during and after treatment with Teriflunomida Accord. Teriflunomida remains in the blood for a long period after stopping treatment. Continue to use contraceptive methods after interrupting treatment.

• Continue to do so until the levels of teriflunomida in the blood are low enough (your doctor will check).
• Consult your doctor about the best contraceptive method for you and if you need to change methods.

Do not take Teriflunomida Accord during breastfeeding as teriflunomida passes into breast milk.

Driving and operating machinery

Teriflunomida Accord may cause dizziness, which may affect your ability to concentrate and react. If you are affected, do not drive or operate machinery.

Teriflunomida Accord contains lactose

Teriflunomida Accord contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Teriflunomida Accord contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

A doctor with experience in treating multiple sclerosis will supervise treatment with Teriflunomida Accord.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (10 years of age and older)

The dose depends on body weight:

• children with a body weight greater than 40 kg: 14 mg once a day.
• children with a body weight less than or equal to 40 kg: 7 mg once a day.

This brand does not have 7 mg tablets, so in this case, another medication with teriflunomida must be used.

Your doctor will instruct children and adolescents to change to a 14 mg tablet per day once they reach a stable body weight greater than 40 kg.

Form/administration route

Teriflunomida Accord is administered orally. Teriflunomida Accord is taken once a day in a single daily dose at any time of the day.

The tablet should be swallowed whole with water.

Teriflunomida Accord can be taken with or without food.

If you take more Teriflunomida Accord than you should

If you have taken too much Teriflunomida Accord, call your doctor immediately. You may experience adverse effects similar to those described in section 4 (below).

If you forget to take Teriflunomida Accord

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Teriflunomida Accord

Do not stop treatment or change the dose of Teriflunomida Accord 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.

Severe side effects

Some side effects can be serious, or even life-threatening. If you experience any of these, inform your doctor immediately.Inform your doctor immediately.

Common(may affect up to 1 in 10 people)

• Pancreatitis, which may include symptoms such as abdominal pain, nausea, or vomiting (common in pediatric patients and rare 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 difficulty breathing
• Severe skin reactions, which may include symptoms such as skin rash, blisters, fever, or mouth ulcers
• Severe infections or sepsis (a type of infection that can be potentially life-threatening), which may include symptoms such as high fever, chills, decreased urine output, or confusion
• Pneumonia, which may include symptoms such as shortness of breath or persistent cough

Frequency not known(the frequency cannot be estimated with the available data)

• Severe liver disease, which may include symptoms such as yellowing of the skin or eyes, dark urine, unexplained nausea and vomiting, or abdominal pain.

Other side effectsmay occur with the following frequencies:

Very common(may affect more than 1 in 10 people)

• Headache
• Diarrhea, feeling of illness
• Increased ALT (elevation of certain liver enzymes in the blood) in laboratory tests
• Thinning of hair

Common(may affect up to 1 in 10 people)

• Common cold, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat, and difficulty swallowing, cystitis, viral gastroenteritis, oral herpes, dental infection, laryngitis, fungal infection of the foot
• Laboratory values: a decrease in the number of red blood cells (anemia), changes in the liver and white blood cells in laboratory tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Anxiety
• Needle-like sensations, weakness, numbness, tingling, or pain in the lower back or leg (sciatica); numbness, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Feeling of illness (vomiting), toothache, upper abdominal pain
• Rash, acne
• Tendon, joint, or bone pain (musculoskeletal pain)
• Increased frequency of urination
• Heavy periods
• Pain
• Lack of energy or weakness (asthenia)
• Weight loss

Uncommon(may affect up to 1 in 100 people)

• Leukopenia (a decrease in the number of white blood cells)
• Increased sensitivity, especially in the skin; stabbing or pulsating pain in one or more nerves; nerve problems in arms and legs (peripheral neuropathy)
• Changes in nails, severe skin reactions
• Post-traumatic pain
• Poriasis
• Inflammation of the mouth/lips
• Abnormal lipid levels in the blood
• Colitis (inflammation of the colon)

Rare(may affect up to 1 in 1,000 patients)

• Hepatitis (inflammation of the liver) or liver damage

Frequency not known(the frequency cannot be estimated with the available data)

• Pulmonary hypertension

Children (10 years of age and older) and adolescents

The previously listed side effects 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)

• Pancreatitis

Reporting side effects

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. 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 after "CAD" and “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Teriflunomida Accord

• The active ingredient is teriflunomida. Each tablet contains 14 mg of teriflunomida.
• The other components are lactose monohydrate, cornstarch, microcrystalline cellulose, sodium glycolate starch, hydroxypropyl cellulose, magnesium stearate, anhydrous colloidal silica, hypromellose (E464), titanium dioxide (E171), talc (E553b), macrogol (E1521), and aluminium lake carmine indigo (E132).

Appearance of the product and content of the container

Teriflunomida Accord 14 mg film-coated tablets are pentagonal film-coated tablets, blue in color, engraved with “T2” on one face; the other face is smooth.

Teriflunomida Accordis available in cartons containing:

• 28 and 84 tablets in aluminium/aluminium blisters;
• 28x1 and 84x1 tablets in perforated single-dose aluminium/aluminium blisters.

Only some container sizes may be commercially available.

Marketing Authorization Holder:

Accord Healthcare S.L.U.

World Trade Center,

Moll De Barcelona s/n,

Edifici Est, 6th Floor,

Barcelona, 08039

Spain

Responsible for Manufacturing:

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

Last review date of this leaflet:

The detailed information on this medicine is available on the European Medicines Agency website:http://www.ema.europa.eu.