Aubagio ® 14 mg Film-Coated Tablets

AUBAGIO contains the active substance teriflunomide which is an immunomodulatory agent and adjusts the immune system to limit its attack on the nervous system. AUBAGIO is used in adults to treat relapsing forms of multiple sclerosis (MS).

AUBAGIO does not cure MS, but it helps to reduce the number of relapses and to slow down the progression of physical disabilities due to MS.

Do not take AUBAGIO:

• If you are hypersensitive (allergic) to teriflunomide or leflunomide, or any of the other ingredients of AUBAGIO (listed in section 6).
• If you have severe liver problems.
• If you are taking leflunomide (used for rheumatoid arthritis).
• If you are a woman who is pregnant or planning to become pregnant or if you are able to become pregnant and not using effective birth control methods.
• If you are breastfeeding.

Warnings and precautions

Tell your doctor or health care provider before taking AUBAGIO:

• If you have liver problems. During the treatment your doctor will periodically request blood tests to monitor your liver function. If your test results indicate a problem with your liver, you may have to interrupt treatment with AUBAGIO. If you notice yellowing of your skin or the whites of your eyes, abnormal darkening of your urine or unexplained nausea and vomiting, tell your doctor immediately. Your risk of liver problems may be higher if you take other medicines that also affect your liver (see section 4).
• If you have high blood pressure (hypertension) and whether it is controlled with medicines or not, AUBAGIO can cause your blood pressure to increase. Therefore, your doctor will check your blood pressure before you start taking AUBAGIO and regularly thereafter.
• If you suffer from a serious problem which affects your immune system.
• If you have an infection. Before you take AUBAGIO, your doctor will make sure you have enough white blood cells and platelets in your blood. As AUBAGIO decreases the number of white cells in the blood, this may affect your ability to fight the infection and the infection may get worse. Your doctor may do blood tests to check your white blood cells if you think you have an infection.
• If you develop a serious infection while you are taking AUBAGIO or have symptoms such as fever, or flu symptoms, call your doctor right away.
• If you plan to get vaccinated.
• If you have severe skin reactions or if you develop serious skin reactions or mouth ulcers during treatment (see section 4).
• If you have weakness, numbness and pain in the hands and feet.
• If you have or develop respiratory symptoms (e.g. coughing or difficulty breathing).
• If you are lactose intolerant.
• If you develop symptoms of severe skin reactions (skin rash, including flu-like symptoms, fever, swollen lymph nodes, peeling or blistering of your mouth, nose, eyes or genitals). These are serious reactions which may be fatal if not treated immediately (see section 4).

Children and adolescents

AUBAGIO is not intended to be used in children and adolescents below 18 years old as it has not been studied in MS patients below 18 years old.

Other medicines and AUBAGIO

Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.) Tell your doctor especially if you are taking any of the following medicines:

• leflunomide for rheumatoid arthritis. Leflunomide must not be taken with AUBAGIO (see Do not take AUBAGIO, above)
• ciclosporin and methotrexate, and other medicines that affect the immune system (often called immunosuppressants or immunomodulators)
• rifampicin for tuberculosis

Do not share medicines prescribed for you with any other person. Your treatment with AUBAGIO will be overseen by a doctor who is experienced in the treatment of multiple sclerosis. Always take AUBAGIO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The usual dose is one tablet per day. You should swallow the tablet whole with some water. AUBAGIO may be taken with or without food.

Use in children and adolescents: AUBAGIO is not intended to be used in children and adolescents below 18 years old (see Warnings and precautions above).

If you take more AUBAGIO than you should

In the event of an overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take this leaflet and the remaining tablets with you so the doctor will know what you have taken. You may experience side effects similar to those described in section 4 below.

If you forget to take AUBAGIO

If you forget to take a dose of AUBAGIO, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue to take your next tablet at the usual time. Do not take a double dose to make up for a forgotten tablet.

If you stop taking AUBAGIO

Do not stop taking AUBAGIO or change your dose without talking to your doctor first. If you have any further questions on the use of AUBAGIO, ask your doctor, nurse or pharmacist.

AUBAGIO can have side effects. Not all side effects reported for AUBAGIO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking AUBAGIO, please consult your health care provider for advice.

If any of the following happens, stop taking AUBAGIO and tell your doctor immediately or go to the casualty department at your nearest hospital:

Frequency unknown:

• severe allergic reactions which might include symptoms of rash, hives, swelling of lips, tongue or face or sudden difficulty breathing or fainting
• severe skin reactions which might include symptoms of skin rash, pain, flu-like symptoms, fever, peeling or blistering of your mouth, nose, eyes or genitals. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to AUBAGIO. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Frequent:

• severe infections or sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion
• serious liver disease which might include symptoms of yellowing of your skin or the whites of your eyes, darker urine than normal, unexplained nausea and vomiting, or abdominal pain.

Frequency unknown:

• inflammation of the lungs which might include symptoms of shortness of breath or persistent cough
• inflammation of your pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea or vomiting. These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent:

• influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, sore throat and discomfort when swallowing, bladder infection, viral gastroenteritis, oral herpes, tooth infection, laryngitis, fungal infection of the foot
• headache
• feeling weak, pins and needles, numbness, tingling or pain in the lower back or leg (sciatica); feeling numb, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome); increased feeling or sensitivity, especially in the skin; stabbing or throbbing pain along one or more nerves
• diarrhoea, feeling sick (nausea), being sick (vomiting), upper abdominal (stomach) pain, toothache
• hair thinning
• rash or itching
• acne
• abnormal blood test results, increase in the liver enzymes (AST, ALT and GGT) which shows changes in the way the liver is working; a decrease in the number of red blood cells (anaemia) and a decrease in white blood cells (this may increase the risk of infection)
• decreased weight
• mild allergic reactions (such as seasonal allergy)
• feeling anxious
• increase in blood pressure
• fast or throbbing heartbeat
• pain of the joints, bones or muscle pain (musculoskeletal pain)
• frequent urge to urinate
• heavy menstrual periods
• pain and post-traumatic pain.

Frequency unknown:

• painful sores with swelling and redness inside the mouth
• colitis (inflammation of the large intestine [the colon])
• psoriasis (long-term [chronic] scaling disease of the skin which may include raised bumps on the skin or affect your nails)
• nail disorders.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

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 report any side effects directly to Sanofi’s Pharmacovigilance Unit at [email protected] (email) or 011 256 3700 (tel). You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8

Store all medicines out of reach of children. Do not use after the expiry date which is stated on the carton, protective sleeve, and blister. The expiry date refers to the last day of that month. Store at or below 30 °C. Keep the blister in wallet/carton until required for use. Do not dispose of unused medicines in drains, sewerage systems or household waste. Return all unused medicine to your pharmacist.