Ponvory 2 mg Film-Coated Tablets

What PONVORY is

PONVORY contains the active substance ponesimod.

What PONVORY is used for

PONVORY is used to treat adults with ‘Relapsing forms of Multiple Sclerosis’ (RMS) with active disease.

What is multiple sclerosis

Multiple Sclerosis (MS) affects the nerves in the brain and spinal cord (the ‘central nervous system’).

• In MS, the body’s defence system (immune system) does not work properly.
• The immune system attacks a protective layer around nerve cells (called myelin sheath) – this causes inflammation.
• This breakdown of the myelin sheath properly (called demyelination). stops the nerves from working properly.

Symptoms of MS depend on which part of the brain and spinal cord are affected. This can include problems with walking and balance, weakness, numbness, double vision and blurring, poor coordination, and bladder problems. Symptoms of a relapse may disappear completely when the relapse is over – but some problems may remain.

Do not take PONVORY if:

• you are allergic to ponesimod or to any of the other ingredients.
• the doctor has advised you that you have a weak immune system.
• you have severe active or chronic infection.
• you have active cancer
• you have moderate or severe liver disease
• you have had a heart attack, chest pain called unstable angina, stroke or mini stroke (transient ischaemic attack can be called TIA), or certain types of heart failure in the last 6 months.
• if you have certain types of heart block or irregular or abnormal heartbeat (‘arrhythmia’) unless you have a pacemaker.
• you are pregnant or a woman of childbearing potential not using highly effective contraception.

Do not take PONVORY if any of the above apply to you. If you are not sure if you have any of these conditions, talk to your doctor before taking PONVORY.

Warnings and precautions

Talk to your doctor before taking PONVORY if:

• you have an irregular or abnormal heartbeat
• you have slow heart rate
• you have ever had a stroke or other diseases related to blood vessels in the brain
• you have ever suddenly passed out or fainted (syncope)
• you have a fever or infection
• you are unable to fight infections – due to a disease or taking medicines that weaken your immune system.
• you have never had chickenpox or have received the vaccine for chickenpox. Your doctor may do a blood test for chickenpox virus. You may need to get the full course of vaccine for chickenpox and then wait 1 month before you start taking PONVORY.
• you have breathing problems
• you have liver problems
• you have diabetes
• you have eye problems – especially an inflammation of the eye called ‘uveitis’
• you have high blood pressure.

If any of the above apply to you (or you are not sure), talk to your doctor before taking PONVORY.

Do not share medicines prescribed for you with any other person.

Always take PONVORY exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how long your treatment with PONVORY will last. Do not stop treatment early because your symptoms may return. If you have the impression that the effect of PONVORY is too strong or too weak, tell your doctor or pharmacist.

The recommended treatment dose of PONVORY 20 mg per day is reached by slowly increasing the dose as instructed in the 14-day Starter Pack.

How to take

• Take PONVORY exactly as your doctor tells you. Do not change your dose or stop taking PONVORY unless your doctor tells you to.
• Take only 1 tablet each day. To help you remember to take your medicine you should take it at the same time each day.
• Swallow the tablet whole
• Take with or without food.

Starter Pack (14-day)

Only start your treatment with PONVORY using the Starter Pack.

The purpose of the starter pack is to reduce any side effects due to slowing your heart rate at the start of the treatment.

Write down the date you start taking the medicine.

Follow this 14-day treatment schedule.

Starter Pack Day Daily Dose

• Day 1 2 mg
• Day 2 2 mg
• Day 3 3 mg
• Day 4 3 mg
• Day 5 4 mg
• Day 6 4 mg
• Day 7 5 mg
• Day 8 6 mg
• Day 9 7 mg
• Day 10 8 mg
• Day 11 9 mg
• Day 12 10 mg
• Day 13 10 mg
• Day 14 10 mg

Not all side effects reported for PONVORY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking PONVORY, please consult your health care provider for advice.

If any of the following happens, stop taking / using PONVORY and tell your doctor immediately or go to the casualty department at your nearest hospital:

Frequent side-effects

• urinary tract infection
• bronchitis
• flu (influenza)
• viral infection of nose, throat, or chest (viral respiratory tract infection)
• viral infection
• herpes zoster virus infection (shingles)
• lung infection (pneumonia)
• spinning sensation (vertigo)
• fever (pyrexia)

Less Frequent side effects

• slow heart beat (bradycardia)

These are all very serious side effects. If you have them, you may have had a serious reaction to PONVORY. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects

• infection of the nose, sinuses, or throat (nasopharyngitis, respiratory tract infection)
• increased level of liver enzymes in the blood (a sign of liver problems)
• low number of a type of white blood cell, called lymphocytes (lymphopenia)
• high blood pressure (hypertension)
• back pain
• feeling very tired (fatigue)
• feeling dizzy
• being short of breath (dyspnoea)
• high level of cholesterol in the blood (hypercholesterolaemia)
• joint pain (arthralgia)
• arm or leg pain

Less Frequent side effects

• high level of potassium in the blood (hyperkalaemia)
• swollen joint
• dry mouth

Other possible side effects

Potential risk of skin cancer. As PONVORY may increase the risk of skin cancer, you should limit your exposure to sunlight and UV (ultraviolet) light, by wearing protective clothing and regularly applying sunscreen with high sun protection factor.

Tell your doctor if you notice any of the above side effects. These are not all the possible side effects of PONVORY. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist. If you get side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form,” found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . reporting side effects, you can help provide more information on the safety of PONVORY.

• Store all medicines out of reach of children.

• Store at or below 30 °C

• Store in the original package / container

• Do not use this medicine after the expiry date which is stated on the carton and blister foil after EXP. The expiry date refers to the last day of that month.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).