Dosage form:

0.23, 0.46 and 0.92 mg capsules, for oral use

What is Zeponim used for?

ZEPONIM is a prescription medicine used to treat:

• adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome (CIS), relapsing-remitting disease (RRMS), and active secondary progressive disease (SPMS).
• adults with moderately to severely active ulcerative colitis (UC).

It is not known if Zeponim is safe and effective in children.

What do I need to tell my doctor BEFORE I take Zeponim ?

Do not take Zeponim :

• if you are allergic to ozanimod or any of the other ingredients of this medicine;
• if your healthcare professional has told you that you have a severely weakened immune system;
• if you have had a heart attack, angina, stroke or mini-stroke (Transient Ischemic Attack – TIA), or certain types of severe heart failure in the last 6 months;
• if you have certain types of irregular or abnormal heartbeats (arrhythmia) – your doctor will check your heart before starting treatment;
• if you have severe infection such as hepatitis or tuberculosis;
• if you have cancer;
• if you have severe liver problems;
• if you are pregnant or a woman of childbearing potential not using effective contraception.

Talk to your doctor or pharmacist before taking Zeponim if:

• you have a slow heart rate or you are taking or have recently taken medicines that slow your heart rate (such as beta blockers or calcium channel blockers);
• you have untreated severe breathing problems when you sleep (severe sleep apnea);
• you have problems with your liver;
• you have an infection;
• you have low levels of a type of white blood cell – called lymphocytes;
• you have never had, or are not sure if you have had chickenpox;
• you have recently had or are planning to have a vaccination;
• you or others notice worsening of your MS symptoms as well as any new or unfamiliar symptoms;
• you have ever had problems with your vision or other symptoms of build-up of fluid in the central area of the retina called the macula (a condition called macular oedema);
• you have inflammation of the eye (uveitis);
• you have diabetes (which can cause problems with your eyes);
• you have severe lung disease (pulmonary fibrosis or chronic obstructive pulmonary disease);

What are some things I need to know or do while I take Zeponim ?

• Before you start taking Zeponim , your doctor will check your heart using an electrocardiogram (ECG). If you have certain heart conditions your doctor will monitor you for at least the first 6 hours after your first dose.
• As ZEPONIM can increase your blood pressure, your doctor may want to check your blood pressure regularly.
• During treatment with Zeponim , if you develop unexplained nausea, vomiting, pain on the right side of the stomach area (abdominal pain), tiredness, loss of appetite, yellowing of your skin or the whites of your eyes (jaundice) and/or dark urine, speak to your doctor straight away. These symptoms may be due to a problem with your liver. Before, during and after the treatment, your doctor will request blood tests to monitor your liver function. If your test results indicate a problem with your liver you may have to interrupt treatment with Zeponim .
• While you are taking Zeponim (and for up to 3 months after you stop taking it), you may get infections more easily. Any infection that you already have may get worse. Talk to your doctor if you develop an infection.
• During treatment with Zeponim , if you develop disturbance of vision, progressive weakness, clumsiness, memory loss or confusion, or if you have MS and you think your disease is getting progressively worse, speak to your doctor straight away.
• During treatment with Zeponim , if you develop a severe headache, feel confused, or have seizures and loss of vision, speak to your doctor straight away.
• As Zeponim may increase the risk of skin cancer, you should limit your exposure to sun light and UV (ultraviolet) light, by wearing protective clothing and applying regular sunscreen (with high sun protection factor).
• Women of childbearing potential: If used during pregnancy, Zeponim can harm the unborn baby. Before you start treatment with ZEPONIM, your doctor will explain the risk to you and ask you to do a pregnancy test in order to ensure that you are not pregnant. You must use effective contraception during treatment and for 3 months after stopping treatment.

If any of these apply to you, tell your doctor or pharmacist before taking ZEPONIM:

• Worsening of MS after stopping Zeponim treatment: Tell your doctor straight away if you think your MS worsens after you have stopped treatment with Zeponim .
• Children and adolescents: Do not give this medicine to children and adolescents aged under 18 years. This is because Zeponim has not been studied in children and adolescents.
• Other medicines and Zeponim : Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because ZEPONIM can affect the way some other medicines work. Also, some other medicines can affect the way Zeponim works.

    In particular, before taking Zeponim , tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:

• medicines which suppress or modulate your immune system (e.g., ciclosporin)
• medicines used to treat MS, such as alemtuzumab, beta interferon, dimethyl fumarate, glatiramer acetate, mitoxantrone, natalizumab or teriflunomide
• medicines used to treat ulcerative colitis, such as azathioprine and 6-mercaptopurine
• gemfibrozil to reduce levels of fats or cholesterol in the blood
• clopidogrel, medicine used to prevent blood clots
• rifampicin, an antibiotic for treating tuberculosis and other serious infections
• medicines called monoamine oxidase inhibitors for treating depression (e.g., phenelzine) or Parkinson’s disease (e.g., selegiline)
• medicines that slow your heart rate (such as beta-blockers or calcium channel blockers)
• Driving and using machines: Zeponim has no or negligible influence on your ability to drive and use machines.

What are some other side effects of this drug?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or pharmacist if you notice any of the following side effects:

• Very common: may affect more than 1 in 10 people
  • infections of the nose or nostrils, nasal cavity, mouth, throat (pharynx), or voice box (larynx) caused by viruses
  • increased liver enzyme levels in blood tests (a sign of liver problems)
• Common: may affect up to 1 in 10 people
  • urinary tract infections
  • increase in blood pressure
  • swelling especially of the ankles and feet, due to fluid retention (peripheral oedema)
  • drop in blood pressure
  • nausea, upper abdominal pain
  • low level of a type of white blood cell – called lymphocytes
• Uncommon: may affect up to 1 in 100 people
  • herpes zoster (shingles)
  • low back pain, joint pain
  • headache
  • fever

How is Zeponim best taken?

You will receive a 7-day starter pack. You must start Zeponim by slowly increasing doses over the first week. Follow the dose schedule in the table below. This may reduce the risk of slowing of the heart rate.

Days 1-4	Take 0.23 mg 1 time a day
Days 5-7	Take 0.46 mg 1 time a day
Days 8 and thereafter	Take 0.92 mg 1 time a day, or as directed by your healthcare provider

• Take Zeponim exactly as your healthcare provider tells you to take it.
• Swallow Zeponim capsules whole.
• Take Zeponim with or without food.
• Do not stop taking Zeponim without talking with your healthcare provider first.
• Do not skip a dose.
• Start taking Zeponim with a 7-day starter pack.

What do I do if I miss a dose?

If you forget to take Zeponim :

• If you forget a dose of Zeponim , take it as soon as you remember. However, if you forget the dose for the whole day skip the missed dose and take the next dose at your usual time.
• Do not take a double dose to make up for a forgotten dose.
• If you miss one or more doses during the first 14 days of starting Zeponim , talk to your doctor about how to re-start your treatment.

If you stop taking ZEPONIM:

• Do not stop taking Zeponim without talking to your doctor first.
• Talk to your doctor about how to re-start your treatment if you have stopped taking Zeponim :
  • for 1 day or more during the first 14 days of treatment
  • for more than 7 consecutive days between day 15 and day 28 of treatment
  • for more than 14 consecutive days after day 28 of treatment.

You will need to start the ‘treatment initiation pack’ again.

How do I store Zeponim ?

• 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 blister and carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Do not use this medicine if you notice any damage or signs of tampering with the pack.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the