Teritemso 14 mg Film-Coated Tablets

TERITEMSO contains the active substance teriflunomide which is an immunomodulatory medicine and adjusts the immune system to limit its attack on the nervous system.

TERITEMSO 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 TERITEMSO:

• if you are hypersensitive (allergic) to teriflunomide or any of the other ingredients of TERITEMSO (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 a woman of childbearing potential and you are not on reliable contraception.
• if you are pregnant, think you may be pregnant, or if you are breastfeeding your baby.
• 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 TERITEMSO:

• 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 TERITEMSO. Please read section 4.
• if you have hypoproteinaemia, e.g. in nephrotic syndrome (a kidney disorder that causes your body to pass too much protein in your urine).
• if you have high blood pressure (hypertension) whether it is controlled with medicines or not. TERITEMSO 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.
• if you have an infection before you start treatment or when you developed an infection during treatment. Before you take TERITEMSO, your doctor will make sure you have enough white blood cells and platelets in your blood. As TERITEMSO decreases the number of white cells in the blood this may affect your ability to fight the infection. Your doctor may do blood tests to check your white blood cells if you think you have an infection. Please read section 4.
• if you have respiratory symptoms.
• if you have pre-existing anaemia, leukopenia, and/or thrombocytopenia or impaired bone marrow function.
• if you have severe skin reactions.
• if you are due for a vaccination.
• if you are using any other immunosuppressants (often called immunomodulators) or antineoplastic medicine (usually used to treat cancer).
• if you are switching to or from TERITEMSO.
• if you are due to have a specific blood test (calcium level). Falsely low levels of calcium can be detected.

Children and adolescents

TERITEMSO should not be used in children and adolescents under 18 years of age. This is because the effects of TERITEMSO in this age group are not known.

Other medicines and TERITEMSO

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Tell your doctor if you are taking any of the following medicines:

• Rifampicin (to treat tuberculosis).
• Carbamazepine (to treat epilepsy and neuropathic pain).
• Phenobarbitone (to treat epilepsy).
• Phenytoin (to treat epilepsy).
• St. John’s Wort (to treat mild to moderate depression, nervousness, tiredness, poor appetite and trouble sleeping).
• Cholestyramine (to treat cholesterol).
• Activated charcoal (to treat drug overdose or poisoning).
• Repaglinide and nateglinide (to treat diabetes).
• Paclitaxel (to treat cancer).
• Pioglitazone or rosiglitazone (to treat diabetes)
• Oral contraceptives: 0,03 mg ethinylestradiol and 0,15 mg levonorgestrel.
• Duloxetine (to treat major depressive disorder, generalized anxiety disorder, fibromyalgia, and neuropathic pain).
• Alosetron (used for the management of severe diarrhoea-predominant irritable bowel syndrome in women only).
• Theophylline (to treat chronic obstructive pulmonary disease and asthma).
• Tizanidine (to treat muscle spasticity due to spinal cord injury or multiple sclerosis).
• Warfarin (to treat blood clots such as deep vein thrombosis and pulmonary embolism and to prevent stroke in people who have atrial fibrillation, valvular heart disease or artificial heart valves).
• Cefaclor (to treat certain bacterial infections such as pneumonia and ear infections).
• Benzylpenicillin (to treat bacterial infections).
• Ciprofloxacin (to treat bacterial infections).
• Indomethacin (a nonsteroidal anti-inflammatory drug commonly used to reduce fever, pain, stiffness, and swelling from inflammation).
• Ketoprofen (to treat pain or fever).
• Furosemide (to treat fluid build-up due to heart failure, liver scarring, or kidney disease).
• Cimetidine (to treat heartburn or peptic ulcers).
• Methotrexate (to treat cancer, autoimmune diseases, ectopic pregnancy, and for medical abortions).
• Zidovudine (used to prevent and treat HIV/AIDS).
• Rosuvastatin (to treat cholesterol).
• Topotecan (to treat ovarian cancer, lung cancer and other cancer types).
• Sulfasalazine (to treat rheumatoid arthritis).
• Daunorubicin (to treat acute myeloid leukaemia, acute lymphocytic leukaemia, chronic myelogenous leukaemia, and Kaposi's sarcoma).
• Doxorubicin (to treat breast cancer, bladder cancer, Kaposi's sarcoma, lymphoma, and acute lymphocytic leukaemia).
• Simvastatin (to treat cholesterol).
• Atorvastatin (to treat cholesterol).
• Pravastatin (to treat cholesterol).

Do not share medicines prescribed for you with any other person.

Always take TERITEMSO exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are not sure.

The treatment should be initiated and supervised by a doctor experienced in multiple sclerosis.

Your doctor will decide on your starting dose. The recommended dose of TERITEMSO is 14 mg orally once daily.

The film-coated tablet should be swallowed whole with some water.

Use in children and adolescents:

TERITEMSO 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 TERITEMSO will last. Do not stop treatment early. If you have the impression that the effect of TERITEMSO is too strong or too weak, tell your doctor or pharmacist.

If you take more TERITEMSO 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 a dose of TERITEMSO

Do not take a double dose to make up for forgotten individual doses.

If you stop taking TERITEMSO

Do not stop taking TERITEMSO or change your dose without talking to your doctor first.

TERITEMSO can have side effects.

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

If any of the following happens, stop taking TERITEMSO 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 TERITEMSO. 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),
• oral herpes (infection with the herpes simplex virus around the border of the lips),
• tooth infection,
• laryngitis (inflammation of your voice box),
• tinea pedis (a fungal infection that begins between the toes),
• neutropenia (an abnormally low count of a type of white blood cells),
• anaemia (a lack of red blood cells in the blood),
• paraesthesia (pins-and-needles in the arms, hands, legs or feet),
• neuralgia (pain that travel along the length of a nerve),
• palpitations (sensation that the heart is racing, pounding, fluttering or skipping a beat),
• alanine aminotransferase (ALT) increase (liver enzyme),
• gamma glutamyl transferase (GGT) increase (liver enzyme),
• aspartate aminotransferase increase (liver enzyme),
• neutrophil count decrease (type of white blood cell),
• white blood cell count decrease,
• blood creatine phosphokinase increased (indication of kidney function).

Less frequent side effects

• mild thrombocytopenia (low platelet count),
• peripheral neuropathy (weakness, numbness and pain in your hands or feet) due to nerve damage),
• post-traumatic pain.

Frequency not known:

• severe infections including sepsis (a potentially life-threatening type of infection) which might include symptoms of high fever, shaking, chills, reduced urine flow, or confusion
• pancreatitis (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,
• stomatitis (painful swelling and sores inside the mouth),
• acute hepatitis (inflammation of the liver) 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,
• interstitial lung disease (inflammation of the lungs which might include symptoms of shortness of breath or persistent cough),
• severe skin reactions
• psoriasis (including pustular)

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,
• sciatica (pain radiating along the sciatic nerve, which runs down one or both legs from the lower back),
• carpal tunnel syndrome (a numbness and tingling in the hand and arm caused by a pinched nerve in the wrist),
• hyperaesthesia (excessive physical sensitivity, especially of the skin),
• hypertension (high blood pressure),
• diarrhoea,
• nausea,
• upper abdominal pain,
• vomiting,
• toothache,
• alopecia (hair loss from the scalp or elsewhere on the body),
• acne,
• musculoskeletal pain (pain of the bones, muscles, ligaments, tendons and nerves),
• myalgia (pain in a muscle or group of muscles),
• arthralgia (pain in a joint),
• pollakiuria (the need to urinate more often than usual),
• menorrhagia (heavy or prolonged vaginal bleeding),
• pain,
• asthenia (decrease muscle strength),
• weight loss.

Less frequent side effects

• nail disorders.

Frequency not known:

• dyslipidaemia (abnormal elevated cholesterol or fats 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. 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.

Store in the original package.

Keep the container in the outer carton

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).