Do not take AUBAMIDE if you:
- you are allergic (hypersensitive) to teriflunomide, leflunomide or any other ingredients of AUBAMIDE (see section 6)
- have severe liver problems
- are taking leflunomide
- are a woman who is planning on becoming pregnant or is pregnant
- have a possibility of becoming pregnant but not using effective birth control methods
- you are a mother breastfeeding their babies.
If you become pregnant while taking AUBAMIDE stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking this medicine AUBAMIDE by using suitable contraceptive measures.
Warnings and precautions
Talk to you doctor or pharmacist before taking AUBAMIDE:
- if you have liver problems and / or you drink large amounts of alcohol
- if you have high blood pressure (hypertension) and whether it is controlled or not with medicines
- if you suffer from a serious infection or a serious problem affecting your immune system
- if you are planning on getting vaccinated
Liver function tests: You should not take AUBAMIDE if you have severe liver problems. AUBAMIDE may cause abnormal liver function tests results.
If you notice your skin and whites of your eyes becoming yellow, abnormal darkening of the urine or unexplained nausea and vomiting inform your doctor immediately. If you have any of these symptoms after starting treatment on AUBAMIDE, tell your doctor immediately. During the treatment period your doctor will regularly request to do blood tests to monitor your liver function. If your test results indicate a problem with your liver, your treatment with AUBAMIDE may have to be interrupted.
High blood pressure AUBAMIDE may cause a rise in blood pressure, your doctor should test your blood pressure levels before initiating treatment on AUBAMIDE and during treatment with AUBAMIDE.
Infections You may get infections more easily while taking AUBAMIDE. Any existing infections may get become worse. Infections can be serious and potentially life-threatening. If you suspect you have an infection, have fever, or feel like you have the flu, call your doctor immediately.
Blood count AUBAMIDE decreases the number of certain blood cells in your blood. If you require to have any blood tests taken, notify the doctor that you are taking AUBAMIDE. Otherwise, it may not be possible for the doctor to interpret the results of the test. Before you begin treatment on AUBAMIDE, your doctor will confirm whether you have enough of certain blood cells in your blood and may want to check regularly.
Children and adolescents:
AUBAMIDE, is not recommended for use in children and adolescents below 18 years old since it has not been studied in MS patients below 18 years old. If any of the above applies to you (or if you are not sure): check with your doctor or pharmacist before you start taking any dose of AUBAMIDE.
Interstitial lung disease
Interstitial lung disease (ILD) has been reported with teriflunomide treatment. ILD and worsening of existing ILD have been reported during treatment with leflunomide. The risk is higher in patients who had a history of ILD when treated with leflunomide. ILD may happen at any time during treatment and shows in different ways. ILD may be fatal. New or worsening lung symptoms, such as persistent cough and difficulty breathing, may be a reason for stopping of the treatment and for further investigation, where appropriate.
Peripheral neuropathy (nerve damage)
Cases of nerve damage have been reported in patients taking AUBAMIDE. In most patients, this condition becomes better after stopping treatment with teriflunomide. However, in some patients the nerve damage stopped, and some patients had ongoing symptoms. If a patient taking AUBAMIDE develops peripheral neuropathy, consider stopping AUBAMIDE treatment.
Other medicines and AUBAMIDE
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor if you are taking any of the following:
- medicines that affect the immune system (also called immunosuppressants or immunomodulators) such as ciclosporin and methotrexate
- rifampicin used for tuberculosis
- carbamazepine, phenobarbitone, phenytoin (medicines used for epilepsy)
- St John’s wort – a herbal medicine used for depression
- repaglinide, pioglitazone, rosiglitazone used for diabetes
- paclitaxel, daunorubicin, doxorubicin, topotecan used for treating cancer
- duloxetine used for depression
- ethinylestradiol and levonorgestrel used as oral contraceptives
- theophylline (medicines used for asthma and other lung disease)
- tizanidine (used for muscle spasms)
- warfarin (used for blood clots)
- cefaclor, penicillin, ciprofloxacin (used as antibiotics)
- indomethacin, ketoprofen, used for pain and inflammation
- furosemide (used for high blood pressure)
- cimetidine (used for ulcers)
- zidovudine (used for viral infections)
- rosuvastatin, simvastatin, atorvastatin, pravastatin used for controlling high cholesterol
- sulfasalazine (used for treatment of bowel disease)
- leflunomide (used for rheumatoid arthritis).
If you get admitted into a hospital or receive treatment for another condition, inform your doctor or pharmacist that you are taking AUBAMIDE.
Pregnancy, breast-feeding and fertility
You should not become pregnant while taking AUBAMIDE. AUBAMIDE remains in your blood for a long time even after you have stopped taking it, hence you should continue using effective contraceptive methods until your AUBAMIDE blood levels have been tested to be sufficiently low. Talk to your doctor about effective and reliable methods of birth control that you should use while on treatment with AUBAMIDE. If you become pregnant or suspect a pregnancy during treatment with AUBAMIDE or within two years after you have stopped taking it and have not taken certain medicines to help remove AUBAMIDE from your blood, you must call your doctor immediately for a pregnancy test. Should the pregnancy test confirm a pregnancy, your doctor might suggest treatment with certain medication to accelerate the removal of AUBAMIDE from the body, as this may reduce the potential risk to your baby.
Do not take AUBAMIDE if you are breastfeeding as teriflunomide may pass into the breast milk. If you are breastfeeding or pregnant, suspecting you may be pregnant or planning on having a baby, talk to your doctor or pharmacist for advice before taking AUBAMIDE.
Driving and using machines
AUBAMIDE may cause dizziness and affect the ability to concentrate properly. In such cases, patients should refrain from driving and using machines.
AUBAMIDE and (sugar) lactose If you have been informed by your doctor that you have an intolerance to some sugars (e.g lactose), you should contact your doctor before taking AUBAMIDE.
