Teriflunomide Film-Coated Tablets

TERIFLUNOMIDE 14 TEVA contains the active substance teriflunomide which is an immunomodulatory medicine and adjusts the immune system to limit its attack on the nervous system. TERIFLUNOMIDE 14 TEVA is used for the treatment of adult patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of relapses and to delay the accumulation of physical disability.

Do not take TERIFLUNOMIDE 14 TEVA:

• if you are hypersensitive (allergic) to teriflunomide or any of the other ingredients of TERIFLUNOMIDE 14 TEVA (listed in section 6)
• if you have severe liver problems
• if you are using leflunomide (used to treat rheumatoid arthritis and psoriatic arthritis)
• if you are pregnant, think you may be pregnant, or are breastfeeding
• if you suffer from a serious problem which affects your immune system e.g. acquired immunodeficiency syndrome (AIDS)
• if you have a serious problem with your bone marrow, or if you have low numbers of red or white cells in your blood or a reduced number of blood platelets
• if you are suffering from a serious infection
• if you have severe kidney problems which require dialysis
• if you have very low levels of proteins in your blood (hypoproteinaemia).

Warnings and precautions:

Take special care with TERIFLUNOMIDE 14 TEVA:

• if you have liver problems and/or if you drink large amounts of alcohol. Your doctor will carry out blood tests before and during treatment to check how well your liver is working. If your test results show a problem with your liver, your doctor may stop your treatment with TERIFLUNOMIDE 14 TEVA. Please read section 4.
• if you have high blood pressure (hypertension) whether it is controlled with medicines or not. TERIFLUNOMIDE 14 TEVA can cause an increase in blood pressure. Your doctor will check your blood pressure before the start of treatment and regularly thereafter. Please read section 4.

Do not share medicines prescribed for you with any other person. Always take TERIFLUNOMIDE 14 TEVA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose. The recommended dose of TERIFLUNOMIDE 14 TEVA is 14 mg orally once daily. The film-coated tablet should be swallowed whole with some water.

Use in children and adolescents: TERIFLUNOMIDE 14 TEVA 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. Your doctor will tell you how long your treatment with TERIFLUNOMIDE 14 TEVA will last. Do not stop treatment early. If you have the impression that the effect of TERIFLUNOMIDE 14 TEVA is too strong or too weak, tell your doctor or pharmacist.

If you take more TERIFLUNOMIDE 14 TEVA than you should: In the event of overdosage, consult your doctor or pharmacist without delay. If neither is available, contact the nearest hospital or poison centre.

If you forget to take a dose of TERIFLUNOMIDE 14 TEVA: Do not take a double dose to make up for forgotten individual doses. If you stop taking TERIFLUNOMIDE 14 TEVA: Do not stop taking TERIFLUNOMIDE 14 TEVA or change your dose without talking to your doctor first.

TERIFLUNOMIDE 14 TEVA can have side effects. Not all side effects reported for TERIFLUNOMIDE 14 TEVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TERIFLUNOMIDE 14 TEVA, please consult your doctor, pharmacist or other healthcare provider for advice.

If any of the following happens, stop taking TERIFLUNOMIDE 14 TEVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting (dizziness).

These are all very serious side effects. If you have them, you may have had a serious reaction to TERIFLUNOMIDE 14 TEVA. 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 side effects:

• influenza (a common viral infection that includes fever and muscle aches)
• upper respiratory tract infection
• urinary tract infection
• bronchitis (inflammation of the lining of the bronchial tubes)
• sinusitis (a condition where the cavities around the nasal passages become inflamed)
• pharyngitis (a sore throat)
• cystitis (inflammation of the bladder)
• viral gastroenteritis (intestinal infection)
• Herpes virus infections, including oral herpes and herpes zoster
• tooth infection
• laryngitis (inflammation of your voice box)
• tinea pedis (fungal infection that begins between the toes)
• neutropenia (an abnormally low count of a type of white blood cells)
• a decrease in the number of red blood cells (anaemia)
• paraesthesia (pins-and-needles in the arms, hands, legs or feet)
• palpitations (sensation that the heart is racing, pounding, fluttering or skipping a beat)
• increase in ALT (increase in blood levels of certain hepatic enzymes)
• increased gamma glutamyl transferase (GGT) increase (liver enzyme)
• aspartate aminotransferase increase (liver enzyme)
• decrease in neutrophil count (type of white blood cell)
• white blood cell count decrease
• blood creatine phosphokinase increased (indication of kidney function)
• high blood pressure.

Less frequent side effects:

• decrease in the number of blood platelets (mild thrombocytopenia)
• increased feeling or sensitivity, especially in the skin; stabbing or throbbing pain along one or more nerves, problems in the nerves of the arms or legs (peripheral neuropathy)
• post-traumatic pain.
• neuralgia (pain that travels along the length of a nerve)
• inflammation of the colon characterised by discomfort and pain in the abdomen
• severe skin reactions which might include symptoms of skin rash, blistering, or ulcers in your mouth.

Frequency not known:

• 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
• inflammation of the lungs which might include symptoms of shortness of breath or persistent cough
• high blood pressure in the arteries of the lungs
• inflammation of the pancreas which might include symptoms of severe pain in the upper abdominal area that may also be felt in your back, nausea, or vomiting
• painful swelling and sores inside the mouth (stomatitis)
• 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

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

Frequent side effects:

• mild allergic reactions
• seasonal allergy
• anxiety
• headache
• pins and needles, feeling weak, numb, tingling or pain in the lower back or leg (sciatica)
• feeling numb, burning, tingling or pain in the hands and fingers (carpal tunnel syndrome)
• diarrhoea
• nausea
• upper abdominal pain
• vomiting
• toothache
• hair loss from the scalp or elsewhere on the body (alopecia)
• acne
• musculoskeletal pain (pain of the bones, muscles, ligaments, tendons and nerves)
• pain in a muscle or group of muscles
• joint pain
• needing to urinate more often than usual
• heavy or prolonged vaginal bleedings
• pain
• asthenia (decrease muscle strength)
• weight loss.

Less frequent side effects:

• nail disorders

Frequency not known:

• abnormal levels cholesterol or fats (lipids) in the blood.

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

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. 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. By reporting side effects, you can help provide more information on the safety of this medicine.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C. Keep the blisters in the outer carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).