Teriflunomide Adco 14 mg Film-Coated Tablets

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

• if you are hypersensitive (allergic) to teriflunomide or any of the other ingredients of TERIFLUNOMIDE ADCO (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 TERIFLUNOMIDE ADCO:

• 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 ADCO. 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. TERIFLUNOMIDE ADCO 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 TERIFLUNOMIDE ADCO, your doctor will make sure you have enough white blood cells and platelets in your blood. As TERIFLUNOMIDE ADCO 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 TERIFLUNOMIDE ADCO.
• if you are due to have a specific blood test (calcium level). Falsely low levels of calcium can be detected.

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

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

Do not share medicines prescribed for you with any other person. Always take TERIFLUNOMIDE ADCO 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 TERIFLUNOMIDE ADCO is 14 mg orally once daily. The film-coated tablet should be swallowed whole with some water.
Use in children and adolescents: TERIFLUNOMIDE ADCO 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 ADCO will last. Do not stop treatment early. If you have the impression that the effect of TERIFLUNOMIDE ADCO is too strong or too weak, tell your doctor or pharmacist.
If you take more TERIFLUNOMIDE ADCO 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 TERIFLUNOMIDE ADCO
Do not take a double dose to make up for forgotten individual doses. If you stop taking TERIFLUNOMIDE ADCO, do not stop taking TERIFLUNOMIDE ADCO or change your dose without talking to your doctor first.

TERIFLUNOMIDE ADCO can have side effects. Not all side effects reported for TERIFLUNOMIDE ADCO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TERIFLUNOMIDE ADCO, please consult your doctor, pharmacist or other healthcare provider for advice.
If any of the following happens, stop taking TERIFLUNOMIDE ADCO 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).

• 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).

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

• 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)

• 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.

• nail disorders.

• dyslipidaemia (abnormal elevated cholesterol or fats in the blood).

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).