Prescribing Information for the Patient

AUBAGIO 7 mg Film-Coated Tablets

AUBAGIO 14 mg Film-Coated Tablets

teriflunomida

Read this entire prescribing information carefully before starting to take this medication, as it contains important information for you.

• Keep this prescribing information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prescribing information. See section 4.

AUBAGIO 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 AUBAGIO used for

AUBAGIO is used in adults and in children and adolescents (10 years of age and older) 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 covering (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 AUBAGIO works

AUBAGIO helps to protect against attacks on 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 AUBAGIO:

• 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 arepregnant, think you may be, or are breastfeeding,
• if you have a severe condition that affects the immune system, for example, acquired immunodeficiency syndrome (AIDS),
• if you have severe bone marrow problems or if you have a low number of white blood cells, red blood cells, or platelets in your 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 your blood (hypoproteinemia),

Ask your doctor or pharmacist before taking this medication if you are unsure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take AUBAGIO if:

• you have liver problems and/or if you drink large amounts of alcohol. Your doctor may perform blood tests to check your liver function before treatment and during treatment. If the test results indicate a liver problem, your doctor may interrupt treatment with AUBAGIO. See section 4.
• you have high blood pressure (hypertension), whether or not you are being treated to control it. AUBAGIO 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 starting to take AUBAGIO, your doctor will ensure that you have enough white blood cells and platelets in your blood. Since AUBAGIO reduces the number of white blood cells in your 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 that you have any infection. With teriflunomida treatment, you may develop viral infections, including oral herpes or herpes zoster (shingles). In some cases, serious complications have occurred. Inform your doctor immediately if you suspect that you have any symptoms of a viral herpes 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 going to be vaccinated.
• you are taking leflunomida with AUBAGIO.
• your medication is being changed from or to AUBAGIO.
• 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

AUBAGIO 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:

-pancreatitis has been observed in patients receiving teriflunomida. Your child's doctor may perform blood tests if they suspect pancreatitis.

Other medications and AUBAGIO

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, urinary 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 itching in liver disease
• activated charcoal to reduce the absorption of medications or other substances.

Pregnancy and breastfeeding

Do nottake AUBAGIO if you are pregnant or think you may bepregnant. If you are pregnant or become pregnant while taking AUBAGIO, 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.

Inform your doctor if your daughter has her first menstrual period while taking AUBAGIO. Your doctor will give you 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 AUBAGIO, 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 time period can be reduced to a few weeks by taking certain medications to accelerate the elimination of AUBAGIO from your body.

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 that you are pregnant while taking AUBAGIO or in the 2 years following the end of treatment, you must interrupt AUBAGIO and contact your doctorimmediatelyto perform a pregnancy test. If the test confirms pregnancy, your doctor may recommend treatment with certain medications to eliminate AUBAGIO from your body quickly and sufficiently, as this may reduce the risk to your baby.

Contraception

You must use an effective contraceptive method during and after treatment with AUBAGIO. Teriflunomida remains in your blood for a long time after you stop taking it. Continue to use contraceptive methods after interrupting treatment.

• Continue to do so until the levels of AUBAGIO in your 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 AUBAGIO during breastfeeding as teriflunomida passes into breast milk.

Driving and operating machines

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

AUBAGIO contains lactose

AUBAGIO 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.

AUBAGIO contains sodium

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

A healthcare professional experienced in treating multiple sclerosis will oversee treatment with AUBAGIO.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Adults

The recommended dose is one 14 mg tablet per day.

Children and adolescents (10 years of age and above)

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.

Your doctor will instruct children and adolescents who reach a stable body weight above 40 kg to switch to one 14 mg tablet per day.

Form/administration route

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

The tablet should be swallowed whole with water.

AUBAGIO can be taken with or without food.

If you take more AUBAGIO than you should

If you have taken too much AUBAGIO, call your doctor immediately. You may experience adverse 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 the missed dose.

If you interrupt treatment with AUBAGIO

Do not stop treatment or change the dose of AUBAGIO 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 may cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine.

Severe side effects

Some side effects may be severe, if you experience any of these, inform your doctor immediately.Inform your doctor immediately.

Common(may affect up to 1 in 10 people)

• Pancreatitis that may include symptoms of 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 that may include symptoms of rash, hives, swelling of lips, tongue, or face, or sudden difficulty breathing
• Severe skin reactions that may include symptoms of skin rash, blisters, fever, or ulcers in your mouth
• Severe infections or sepsis (a type of infection that can be potentially fatal) that may include symptoms such as high fever, chills, decreased urine flow, or confusion
• Pneumonia that 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 that may include symptoms such as yellowing of the skin or eyes, darker urine than normal, nausea, and vomiting without explanation, 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 (increase in certain liver enzymes in the blood) in tests
• Thinner 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, dental infection, laryngitis, fungal infection of the foot
• Herpes virus infections, including oral herpes and shingles (zoster) with symptoms such as blisters, burning, itching, numbness, or pain in the skin, usually on one side of the upper body or face, and other symptoms, such as fever and weakness
• Laboratory values: a decrease in the number of red blood cells (anemia), changes in the liver and white blood cells in tests (see section 2), as well as elevations in a muscle enzyme (creatine phosphokinase)
• Mild allergic reactions
• Anxiety
• Needle-like sensations, feeling of weakness, numbness, tingling, or pain in the lower back or leg (sciatica); feeling of numbness, burning, tingling, or pain in hands and fingers (carpal tunnel syndrome)
• Palpitations
• Increased blood pressure
• Feeling of illness (vomiting), toothache, pain in the upper abdominal region
• Rash, acne
• Pain in tendons, joints, bones, muscle pain (musculoskeletal pain)
• Urinating more frequently than normal
• Heavy periods
• Pain
• Lack of energy or weakness (asthenia)
• Weight loss

Uncommon(may affect up to 1 in 100 people)

• Decrease in the number of platelets (mild thrombocytopenia)
• 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)

• Liver inflammation or 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 are side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for 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 case after "CAD". 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 AUBAGIO

The active ingredient is teriflunomide.

AUBAGIO 7 mg film-coated tablets

-Each tablet contains 7 mg of teriflunomide.

-The other components are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, aluminium lake carmine (E132) and yellow iron oxide (E172) (see section 2 “AUBAGIO contains lactose”).

AUBAGIO 14 mg film-coated tablets

• Each tablet contains14mg of teriflunomide.
• The other components are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, aluminium lake carmine (E132) (see section 2 “AUBAGIO contains lactose”).

Appearance of the product and contents of the pack

AUBAGIO 7 mg film-coated tablets

The film-coated tablets are light blue-green to pale blue-green in colour, hexagonal in shape, engraved with ('7') on one side and a corporate logo on the other side.

AUBAGIO 7 mg film-coated tablets are available in cartons containing 28 tablets in a blister pack.

AUBAGIO 14 mg film-coated tablets

The film-coated tablets are pale blue or pale blue in colour, pentagonal in shape, engraved with ('14') on one side and a corporate logo on the other side.

AUBAGIO 14 mg film-coated tablets are available in cartons containing:

• 14, 28, 84 and 98 tablets in blister packs;
• 10x1 tablet in perforated unit dose blisters.

Only some pack sizes may be marketed.

Marketing authorisation holder:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer:

Opella Healthcare International SAS

56, Route de Choisy

60200 Compiègne

France

Sanofi Winthrop Industrie

30-36, avenue Gustave Eiffel

37100 Tours

France

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Date of the last revision of this leaflet:

Other sources of information

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

You can also find a copy of the leaflet and patient card with safety information in the QR code mentioned below.

Inclusion of the QR code +www.qr-aubagio-sanofi.eu