Aubagio 14 mg 28 Tablets
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- AUBAGIO contains the active substance teriflunomide, which is an immunomodulatory drug and regulates the immune system to limit its attack on the nervous system.
What Aubagio is used against:
- AUBAGIO is used in adults and in children and adolescents (10 years and older) to treat relapsing multiple sclerosis ( MS ).
What multiple sclerosis is:
- MS is a long-term disease that affects the central nervous system ( CNS ).
- The CNS consists of the brain and spinal cord. In multiple sclerosis , inflammation destroys the protective layer (called myelin) around the nerves in the CNS .
- This destruction of myelin is called demyelination.
- This prevents the nerves from working properly.
- People with relapsing multiple sclerosis will have repeated attacks (exacerbation) with physical symptoms caused by the nerves not working properly.
These symptoms vary from patient to patient, but usually include:
- Difficulty walking
- Vision problems
- Problems with balance
- Symptoms may disappear completely when the attack is over, but over time some problems may persist between attacks. This can cause physical impairment that can affect your daily activities.
How AUBAGIO works:
- AUBAGIO helps protect the central nervous system from attacks by the immune system by limiting the increase of some white blood cells (lymphocytes). This limits the inflammation that leads to nerve damage in MS .
How To Use:
- A doctor experienced in the treatment of multiple sclerosis will supervise treatment with AUBAGIO.
- Always use this medicine exactly as your doctor has told you.
- Contact a doctor if you are unsure.
- The recommended dose is one 14 mg tablet daily.
Children and young people (10 years and over):
The dose depends on body weight:
- Children weighing more than 40 kg: one 14 mg tablet daily.
- Children weighing less than or equal to 40 kg: one 7 mg tablet daily.
- Children and adolescents who achieve a stable body weight above 40 kg will be instructed by their doctor to switch to one 14 mg tablet daily
Method of administration:
- AUBAGIO is for oral use (taken by mouth).
- AUBAGIO is taken every day as a single dose at any time of the day.
You should swallow the tablet whole with a little water.
AUBAGIO can be taken with or without food.
If you take too much AUBAGIO:
- If you have taken too much AUBAGIO, contact your doctor immediately.
- You may experience side effects such as those described in section 4 below.
If you have forgotten to take AUBAGIO:
- You should not take a double dose to replace a forgotten tablet.
- Take the next dose as scheduled.
If you stop treatment with AUBAGIO:
- Do not stop treatment or change the dose of AUBAGIO without consulting your doctor first.
- Ask your doctor or pharmacist if you have any questions about the use of this medicine.
Warnings and precautions:
Do not use AUBAGIO:
- If you are allergic to teriflunomide or any of the other ingredients of this medicine.
- If you have had severe skin rash or skin peeling, blisters and/or sores in the mouth after taking teriflunomide or leflunomide.
- If you have severe liver problems.
- If you are pregnant , think you may be pregnant or are breastfeeding.
- If you have a serious disorder that affects your immune system, e.g. Acquired immunodeficiency syndrome (AIDS).
- If you have serious problems with your bone marrow, or if you have a low number of red or white blood cells or a reduced number of platelets.
- If you suffer from a serious infection.
- If you have serious kidney problems that require dialysis.
- If you have very low levels of proteins in your blood (hypoproteinaemia).
- If you are not sure, talk to your doctor or pharmacist before using this medicine.
Talk to your doctor or pharmacist before using AUBAGIO if:
- You have liver problems and/or consume significant amounts of alcohol.
- Your doctor will take blood tests before and during treatment to check how well your liver is working.
- If the results of the tests show a problem with your liver, your doctor may stop treatment with AUBAGIO.
- You have high blood pressure ( hypertension ), regardless of whether it is controlled with drugs or not. AUBAGIO may cause increased blood pressure.
- The doctor will check your blood pressure before starting treatment and regularly thereafter.
- You have an infection.
- Before you take AUBAGIO, your doctor will check that there are enough white blood cells and platelets in your blood.
- As AUBAGIO reduces the number of white blood cells in the blood, this will affect your ability to fight the infection .
- The doctor can take blood tests to check your white blood cells if you think you have an infection.
- You have severe skin reactions.
- You have respiratory symptoms.
- You feel weak, numb or have pain in your hands and feet.
- You must take a vaccine.
- You are taking leflunomide with AUBAGIO.
- You switch to or from AUBAGIO.
- You will take a special blood test (measurement of calcium value). Falsely low calcium values may occur.
- Talk to a doctor if you experience unexplained coughing or shortness of breath ( dyspnoea ).
- The doctor can carry out additional examinations.
Children and youth:
- AUBAGIO is not intended for use in children under 10 years of age, as it has not been studied in MS patients in this age group.
- The warnings and precautions listed above also apply to children.
The following information is important for children and their carers:
- Inflammation of the pancreas has been observed in patients receiving teriflunomide.
- Your child's doctor may take blood tests if they suspect inflammation of the pancreas.
Pregnancy and breastfeeding:
- Do not take AUBAGIO if you are, or think you may be, pregnant .
- If you are pregnant, or become pregnant while taking AUBAGIO, there is an increased risk of having a child with a congenital malformation.
- Women who may become pregnant must not take this medicine without using effective contraception.
If your daughter menstruates while taking AUBAGIO, you should inform the doctor, who will provide advice on contraception and the potential risks of pregnancy.
- Tell your doctor if you plan to become pregnant after stopping treatment with AUBAGIO, as you need to make sure that most of this medicine has left your body before trying to conceive.
- Natural excretion of the active ingredient can take up to two years.
- This time can be reduced to a few weeks by taking certain medicines that allow AUBAGIO to be removed from the body more quickly.
In any case, it should be confirmed with a blood test that the active substance has been removed from the body to a sufficient extent, and you need confirmation from the attending physician that the level of AUBAGIO in the blood is low enough for you to become pregnant.
- For more information about laboratory tests, contact your doctor.
- If you suspect that you are pregnant while taking AUBAGIO, or in the next two years after you stop taking AUBAGIO, you must stop using AUBAGIO and contact your doctor immediately for a pregnancy test.
- If the test confirms that you are pregnant, the doctor may suggest treatment with certain medicines to remove AUBAGIO quickly and sufficiently from the body, as this may reduce the risk to the baby.
- You must use safe contraception during and after treatment with AUBAGIO.
- Teriflunomide stays in your blood for a long time after you stop taking it.
- Continue to use effective contraception after you stop treatment.
- Do this until the level of AUBAGIO in the blood is low enough - the doctor will check this.
- Talk to the doctor about which method of contraception is best for you, and whether you need to change contraception.
Do not take AUBAGIO if you are breast-feeding, as teriflunomide passes into breast milk.
Driving and using machines:
- AUBAGIO can make you dizzy, which can affect your ability to concentrate and react.
- If this applies to you, you should not drive or use machines.
- The active substance is teriflunomide.
AUBAGIO 14 mg film-coated tablets:
- Each tablet contains 14 mg of teriflunomide
- Manufacturer: Aubagio
- Product form: Tablets
- Ingredients: Teriflunomide