14 mg film-coated tablets
1. What AUBAGIO is and what it is used for
AUBAGIO contains the active substance teriflunomide, which is an immunomodulatory agent and regulates the immune system to limit its attack on the nervous system.
What AUBAGIO is used for
AUBAGIO is used in adults for the treatment of relapsing multiple sclerosis (MS).
What multiple sclerosis is
MS is a long-term disease that affects the central nervous system ( CNS ). The CNS is made up of the brain and spinal cord. In MS, an inflammation destroys the protective sheath (called myelin), which surrounds the nerves in the CNS . This loss of myelin is called demyelination. It prevents the nerves from functioning normally.
People with relapsing multiple sclerosis have repeated attacks ( relapses ) of physical symptoms caused by their nerves not functioning properly. Symptoms vary between patients, but usually include:
- difficulty walking
- vision problems
- balance problem.
The symptoms may disappear completely when the relapse is over, but over time, some problems may persist between relapses . This can cause physical disability that can interfere with daily activities.
How AUBAGIO works
AUBAGIO helps protect the central nervous system from attack by the immune system, by limiting the growth of certain white blood cells ( lymphocytes ). This limits inflammation which leads to nerve damage in MS.
What you need to know before taking AUBAGIO
Do not take AUBAGIO:
- if you are allergic to teriflunomide or any of the other ingredients of this medicine (listed in section 6),
- if you have severe liver disease,
- if you are pregnant, think you may be pregnant or breast-feeding,
- if you suffer from a serious problem affecting your immune system (eg Acquired Immune Deficiency Syndrome ( AIDS ),
- if the function of your bone marrow is severely impaired or if you have a low number of red or white blood cells or a reduced number of platelets,
- if you have a serious infection,
- if you have a kidney disease that requires dialysis,
- if you have very low levels of protein in your blood (hypoproteinemia).
If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and cautions
Talk to your doctor or pharmacist before taking AUBAGIO if:
- you have liver problems and/or if you drink large amounts of alcohol. Your doctor will take blood samples before and during treatment to check how well your liver is working. If your test results show problems with your liver, your doctor may discontinue treatment with AUBAGIO. Read section 4.
- you have high blood pressure ( hypertension ), whether this is controlled with medication or not. AUBAGIO may cause a slight increase in blood pressure. Your doctor will check your blood pressure before starting treatment and regularly during treatment. Read section 4.
- you have an infection. Before taking AUBAGIO, your doctor will check that you have enough white blood cells and platelets. Because AUBAGIO reduces the number of white blood cells, it can affect your ability to fight infection . Your doctor may take blood samples to check your white blood cells if you think you have an infection. Read section 4.
- you get severe skin reactions.
- you have or get respiratory symptoms.
- you feel weakness, numbness, and pain in your hands and feet.
- you should be vaccinated.
- you are taking leflunomide with AUBAGIO.
- you switch to or from AUBAGIO.
- you are lactose intolerant.
- you should take a specific blood test (calcium level). Measurements can show falsely low calcium levels.
Children and young people
AUBAGIO should not be used by children and adolescents under 18 years of age. This is because the effects of the drug in this age group are not known.
Other medicines and AUBAGIO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines.
In particular, tell your doctor or pharmacist if you are taking any of the following:
- leflunomide, methotrexate, and other medicines that affect the immune system (often called immunosuppressants or immunomodulators )
- rifampicin (a medicine used to treat tuberculosis and other infections )
- carbamazepine, phenobarbital, or phenytoin in epilepsy
- St. John’s wort (herbal remedy for depression)
- repaglinide, pioglitazone, nateglinide, or rosiglitazone in diabetes
- daunorubicin, doxorubicin, paclitaxel, or topotecan in cancer
- duloxetine in depression, urinary incontinence, or kidney disease in diabetes
- alosetron in severe diarrhea
- theophylline in asthma
- tizanidine, a muscle relaxant
- warfarin, an anticoagulant used to make the blood thinner to avoid blood clots
- oral contraceptives (containing Ethinyl estradiol and levonorgestrel)
- cefaclor, benzylpenicillin, ciprofloxacin at infection s
- indomethacin, ketoprofen for pain or inflammation
- furosemide in heart disease
- cimetidine to reduce stomach acid
- zidovudine, HIV – infection
- rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia(high cholesterol )
- sulfasalazine in inflammatory bowel disease or rheumatoid arthritis
- cholestyramine in high cholesterol or as an antipruritic agent in liver disease
- activated carbon to reduce the absorption of drugs or other substances
Pregnancy and breastfeeding
Do not take AUBAGIO if you are pregnant or think you may be pregnant. If you are pregnant or become pregnant while taking AUBAGIO, the risk of birth defects is increased. Women of childbearing potential must not take this medicine without using a reliable contraceptive.
Tell your doctor if you are planning to become pregnant after stopping treatment with AUBAGIO, as most of this medicine must have disappeared from your body before trying to conceive. The excretion of the active substance can take up to 2 years naturally. The time can be shortened to a few weeks by taking special drugs that speed up the excretion of AUBAGIO from your body.
In both cases, a blood test must check whether the active substance has been excreted sufficiently from your body and the doctor must determine that the amount of AUBAGIO is low enough in the blood for you to become pregnant.
Contact your doctor for more information about the laboratory samples.
If you suspect you are pregnant while taking AUBAGIO, or within two years of stopping treatment, you must contact a doctor immediately for a pregnancy test. If the test confirms that you are pregnant, your doctor may suggest treatment with special medicines, so that AUBAGIO is removed more quickly and sufficiently from your body, as this may reduce the risks to your baby.
You must use an effective contraceptive during and after treatment with AUBAGIO. Teriflunomide remains in your blood long after you stop taking it. Continue to use an effective contraceptive after stopping treatment.
- Continue doing this until the amount of AUBAGIO in your blood is low enough – your doctor will check this.
- Talk to your doctor about the best method of contraception for you and when changing contraceptives.
Do not take AUBAGIO while breast-feeding, as teriflunomide passes into breast milk.
Driving and using machines
AUBAGIO can make you dizzy, and it can impair your ability to concentrate and react. If this happens, do not drive or use machines.
AUBAGIO contains lactose
AUBAGIO contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
AUBAGIO contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
3. How to take AUBAGIO
Treatment with AUBAGIO will be supervised by a doctor who has experience in the treatment of MS.
Always use this medicine exactly as your doctor has told you. Consult your doctor if you are unsure.
The recommended dose is 14 mg daily.
AUBAGIO is taken daily as a single dose at any time of the day.
The tablet should be swallowed whole with a little water.
AUBAGIO can be taken with or without food.
If you use more AUBAGIO than you should
Contact a doctor immediately if you have taken too much AUBAGIO. You may experience side effects similar to those mentioned in section 4 below.
If you forget to take AUBAGIO
Do not take a double dose to make up for a forgotten tablet. Take the next dose when you normally take it.
If you stop taking AUBAGIO
Do not stop taking AUBAGIO or change your dose without first talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine.
Serious adverse events are
Talk immediately to your doctor if you notice any of the following serious side effects:
- allergic reactions that may include symptoms such as rash, hives, swollen lips, tongue or face, or sudden difficulty breathing
- severe skin reactions that may include symptoms such as rash, blisters, or sores in the mouth
- severe infection or sepsis (a potentially life-threatening type of infection) that may include symptoms such as high fever, tremors, chills, decreased urine flow, or confusion
- severe liver disease that may include symptoms such as yellowing of the skin or whites of the eyes, darker-than-normal urine, unexplained nausea or vomiting, or abdominal pain
- inflammation of the lungs which may include symptoms such as shortness of breath or persistent cough
- inflammation of the pancreas which may include symptoms such as severe pain in the upper abdominal area which may also be felt in the back, nausea or vomiting
Other side effects are can occur with the following frequencies:
Very common (may affect more than 1 in 10 people):
- Diarrhea, malaise
- Elevated ALT (elevated blood levels of certain liver enzymes) as shown by tests
- Hair thinning
Common (may affect up to 1 in 10 people):
- Influenza, upper respiratory infection, urinary tract infections, bronchitis ( bronchitis ), sinusitis ( sinusitis ), sore throat and pain on swallowing, bladder infection ( cystitis ) caused viral gastrointestinal infection, cold sores, tooth infection, stämbandskatarr ( laryngitis ), athlete’s foot
- Laboratory values: Decreased red blood cell count ( anemia ), altered liver and white blood cell test results (see section 2), as well as elevated muscle enzyme levels (creatinine phosphokinase), have been observed
- Mild allergic reactions
- Feeling anxious
- Tingling, feeling of weakness, numbness, tingling or pain in the lower back or leg (sciatica), numbness, burning or tingling sensation, pain in hands and fingers ( carpal tunnel syndrome )
- High blood pressure
- Nausea (vomiting), toothache, pain in the upper abdomen.
- Skin rash, acne
- Pain in tendons, joints, legs, muscle aches (musculoskeletal pain),
- Need to throw water more often than normal
- Abundant menstruation
- Lack of energy or feeling of weakness ( asthenia )
- Weight loss
Uncommon (may affect up to 1 in 100 people):
- Decreased platelet count (mild thrombocytopenia )
- Increased sensitivity, especially in the skin, stabbing or throbbing pain along one or more nerves, problems with the nerves in the arms or legs ( peripheral neuropathy )
- Nail diseases
- Post-traumatic pain
No known frequency (cannot be calculated from the available data)
- Severe infection (including sepsis (blood poisoning))
- Severe allergic reactions (including anaphylaxis)
- Lung reaction (interstitial lung disease, ILD)
- Inflammation of the liver, pancreas, or mouth/lips
- Severe skin reactions
- Abnormal levels of fat ( lipid s) in the blood
Reporting of side effects
If you get any 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 directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information
5. How to store AUBAGIO
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, cap, or blister after “EXP.” The expiry date will be the last day of that month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
- The active substance is teriflunomide. Each tablet contains 14 mg of teriflunomide.
- The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, sodium starch glycolate (type A), hydroxypropyl cellulose, magnesium stearate, hypromellose, titanium dioxide (E171), talc, macrogol 8000, indigotin/indigo carmine (E132).
What the medicine looks like and the contents of the pack
AUBAGIO 14 mg film-coated tablets (tablets) are pale blue to pastel blue, five-sided film-coated tablets debossed on one side (“14”) and engraved with the company logo on the other side.
AUBAGIO is available in cartons containing:
- 14, 28, 84, and 98 tablets in folding packs with integrated aluminum blisters;
- 10 x 1 tablets in aluminum single-dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
54, rue La Boétie
Sanofi Winthrop Industrie
56, route de Choisy au Bac
Sanofi Winthrop Industry
30-36, Gustave Eiffel Avenue
Contact the representative of the marketing authorization holder to find out more about this medicine
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