Prospect: information for the patient

Ponvory 2 mg film-coated tablets

Ponvory 3 mg film-coated tablets

Ponvory 4 mg film-coated tablets

Ponvory 5 mg film-coated tablets

Ponvory 6 mg film-coated tablets

Ponvory 7 mg film-coated tablets

Ponvory 8 mg film-coated tablets

Ponvory 9 mg film-coated tablets

Ponvory 10 mg film-coated tablets

Ponvory 20 mg film-coated tablets

ponesimod

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this prospect. See section 4.

What is Ponvory

Ponvory contains the active ingredient ponesimod. Ponesimod belongs to a group of medicines called sphingosine-1-phosphate receptor modulators (S1P).

What is Ponvory used for

Ponvory is used to treat adults with relapsing forms of multiple sclerosis (RM) with active disease. Active disease in RM is when there are relapses or when MRI results show signs of inflammation.

What is multiple sclerosis

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

In MS, the immune system (one of the body's main defense systems) does not work correctly. The immune system attacks a protective covering of nerve cells called the myelin sheath, causing inflammation. This break in the myelin sheath (known as demyelination) prevents nerves from functioning correctly.

The symptoms of MS depend on which parts of the brain and spinal cord are affected. They may include problems walking and maintaining balance, weakness, numbness, double vision and blurred vision, poor coordination, and bladder problems.

Relapse symptoms may disappear completely when the relapse has passed, but it is possible that some problems will persist.

How Ponvory works

Ponvory reduces circulating lymphocytes, which are white blood cells that are involved in the immune system. To do this, it keeps them in lymphoid organs (lymph nodes). This means that there are fewer lymphocytes available to attack the myelin sheath that surrounds the nerves in the brain and spinal cord.

By reducing nerve damage in MS patients, the number of relapses (reoccurrences) is reduced, and the progression of the disease is delayed.

Do not take Ponvory if

• You are allergic to ponesimod or any of the other ingredients in this medicine (listed in section 6)
• Your doctor has told you that you have a severely weakened immune system
• You have had a heart attack, unstable angina (chest pain), stroke or transient ischaemic attack (TIA) or certain types of heart failure in the last 6 months
• You have certain types of heart block (abnormal heart rhythm on an ECG, usually with slow heartbeats) or irregular or abnormal heartbeats (arrhythmia), unless you have a pacemaker
• You have an active severe infection or an active chronic infection
• You have an active cancer
• You have moderate to severe liver problems
• You are pregnant or are a woman of childbearing potential who is not using an effective contraceptive method

If you are unsure about any of these conditions, consult your doctor before starting Ponvory.

Warnings and precautions

Consult your doctor before starting Ponvory if:

• You have irregular, abnormal or slow heartbeats
• You have ever had a stroke or other diseases related to blood vessels in the brain
• You have ever fainted or had a sudden loss of consciousness (syncope)
• You have a fever or an infection
• You have an immune system that does not work properly, due to a disease or because you are taking medicines that weaken your immune system
• You have never had chickenpox or have not received a chickenpox vaccine. Your doctor may perform a blood test to detect the chickenpox virus. You may need to undergo a complete course of chickenpox vaccination and then wait 1 month before starting Ponvory
• You have respiratory problems (such as severe respiratory disease, pulmonary fibrosis or chronic obstructive pulmonary disease)
• You have liver problems
• You have diabetes. The risk of developing macular edema (see below) is higher in patients with diabetes
• You have eye problems, especially uveitis (inflammation of the eye)
• You have high blood pressure

If you are in any of the above cases (or are unsure), consult your doctor before starting Ponvory.

Inform your doctor immediately if you notice any of the following side effects while taking Ponvory:

Low heart rate(bradycardia or bradyarrhythmia)

Ponvory may lower your heart rate, especially after taking your first dose. An electrocardiogram (ECG) should be performed before taking your first dose of Ponvory, or before restarting Ponvory after a treatment interruption.

• If you are at high risk of experiencing side effects due to a decrease in your heart rate, your doctor may monitor your heart rate and blood pressure for at least 4 hours after administering your first dose of Ponvory.
• You will also have an ECG at the end of the 4 hours. If you still have a very low or decreasing heart rate, it may be necessary to monitor you until it resolves.

Infections

Ponvory may increase your risk of severe infections that can be life-threatening. Ponvory reduces the number of lymphocytes in your blood. These cells fight infections. In general, the number of these cells will return to normal within a week after stopping treatment. Your doctor should review your blood cell count in a recent blood test before starting Ponvory.

Inform your doctor immediately if you have any of the following symptoms of an infection during treatment with Ponvory or during the week after your last dose of Ponvory:

• Fever
• Fatigue
• Generalised body pain
• Chills
• Nausea
• Vomiting
• Headache with fever, neck stiffness, sensitivity to light, nausea, confusion (these may be symptoms of meningitis, an infection of the layer that covers your brain and spinal cord)

Macular edema

Ponvory may cause a problem with your vision called macular edema (accumulation of fluid in the back of the eye (retina) that can cause changes in vision, including blindness).

The symptoms of macular edema may be similar to the visual symptoms of a relapse of MS (called optic neuritis). At first, there may be no symptoms. Make sure to inform your doctor about any changes in your vision. If macular edema occurs, it usually starts within the first 6 months after starting Ponvory.

Your doctor should check your vision before starting Ponvory and also each time you notice changes in your vision during treatment. Your risk of macular edema is higher if you have diabetes or have had uveitis (inflammation of the eye).

Inform your doctor immediately if you notice any of the following:

• Blurred vision or shadows in the center of your visual field
• A blind spot in the center of your visual field
• Sensitivity to light
• Abnormally colored vision (tinted)

Liver problems

Ponvory may cause liver problems. Your doctor should perform blood tests to monitor your liver function before starting Ponvory.

Inform your doctor immediately if you notice any of the following symptoms of liver problems:

• Nausea
• Vomiting
• Abdominal pain
• Fatigue
• Loss of appetite
• Your skin or the white of your eyes turn yellow
• Dark urine

Increased blood pressure

Since Ponvory may increase your blood pressure, your doctor should monitor it periodically during treatment with Ponvory.

Exposure to the sun and sun protection

Since Ponvory may increase the risk of skin cancer, you should limit your exposure to sunlight and ultraviolet (UV) light:

• Wearing protective clothing
• Applying high-factor sunscreen regularly

Respiratory problems

Some people taking Ponvory have difficulty breathing. Inform your doctor immediately if you have new or worsening respiratory problems.

Swelling and narrowing of blood vessels in your brain

The use of medicines similar to Ponvory has caused a condition called SEPR (reversible posterior encephalopathy syndrome). The symptoms of SEPR usually improve when you stop taking Ponvory. However, if left untreated, it may cause a stroke.

Inform your doctor immediately if you notice any of the following symptoms:

• Severe headache
• Sudden confusion
• Sudden loss of vision or other changes in vision
• Seizures

Worsening of multiple sclerosis after stopping Ponvory

When treatment with Ponvory is stopped, MS symptoms may return. They may worsen compared to the situation before or during treatment. Always consult your doctor before stopping Ponvory. Inform your doctor if your MS symptoms worsen after stopping Ponvory.

Children and adolescents

Ponvory has not been studied in children or adolescents, so it is not recommended for use in children or adolescents under 18 years old.

Other medicines and Ponvory

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including prescription medicines, over-the-counter medicines, vitamins and herbal supplements. Inform your doctor especially if you are taking:

• Medicines to control heart rhythm (antiarrhythmics), blood pressure (antihypertensives) or heartbeats (such as calcium channel blockers or beta-blockers that may lower heart rate)
• Medicines that affect your immune system, due to a possible additive effect on your immune system

Vaccines and Ponvory

Inform your doctor if you have recently received a vaccine or if you are planning to receive a vaccine. You should avoid receiving live vaccines during treatment with Ponvory. If you receive a live vaccine, you may contract the infection that the vaccine was intended to prevent. Treatment with Ponvory should be stopped 1 week before and during 4 weeks after administering a live vaccine.

Additionally, other vaccines may not work if administered during treatment with Ponvory.

Pregnancy, contraception and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.

Pregnancy

• Do not use Ponvory during pregnancy. If Ponvory is used during pregnancy, there is a risk of harming the fetus.
• Do not use it if you are trying to become pregnant or are a woman of childbearing potential who is not using an effective contraceptive method.

Women of childbearing potential/contraception in women

If you are a woman of childbearing potential:

• Your doctor will inform you about the risk of harming the fetus before starting treatment with Ponvory, and a pregnancy test should be performed to check that you are not pregnant.
• You should use an effective contraceptive method while taking Ponvory, and also for 1 week after stopping it.

Discuss effective contraceptive methods with your doctor.

If you become pregnant while taking Ponvory, stop taking Ponvory and inform your doctor immediately.

If you become pregnant during the week after stopping Ponvory, talk to your doctor.

Breastfeeding

You should not breastfeed while taking Ponvory. This is to avoid the risk of adverse effects for the baby, as Ponvory may pass into breast milk.

Driving and operating machinery

Ponvory is not expected to affect your ability to drive and operate machinery.

Ponvory contains lactose

Ponvory contains lactose, a type of sugar. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Ponvory contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow the exact administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How to take it

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

Starting treatment package (14 days)

• Onlystart your treatment with Ponvory using the starting treatment package, with which the dose will be gradually increased over 14 days. The purpose of the dose adjustment phase is to reduce any adverse effects due to the decrease in heart rate at the start of treatment.
• Write the date when you start taking the medicine next to day 1 in the Ponvory starting treatment package.
• Follow this 14-day treatment schedule.

Maintenance dose

• Afterfinishing the tablets from the starting treatment package, continue treatment with the maintenance dose of 20 mg.
• Note the date when you start taking the maintenance dose of 20 mg, next to week 1 of the Ponvory 20 mg blister pack.

If you take more Ponvory than you should

If you have taken more Ponvory than you should, inform your doctor immediately or go to the hospital immediately. Bring the medication package and this leaflet with you.

If you forget to take Ponvory

Do not take a double dose to make up for the missed doses.

• If you forget to take up to 3 Ponvory tablets in a row while taking the starting treatment package or the maintenance dose, you can continue treatment by taking the first dose you forgot. Take 1 tablet as soon as you remember, then take 1 tablet a day to continue with the starting treatment package dose or the maintenance dose as planned.
• If you forget to take 4 or more Ponvory tablets in a row while taking the starting treatment package or the maintenance dose, you must restart treatment with a new 14-day starting treatment package. Inform your doctor immediately if you forget 4 or more doses of Ponvory.

Note the date when you start taking the medicine to know if you miss 4 or more consecutive doses.

Do not stop taking Ponvory without first talking to your doctor.

Do not restart treatment with Ponvory after stopping it for 4 or more consecutive days without consulting your doctor. You will need to restart your treatment with a new starting treatment package.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Some side effects may be or may becomeserious

Inform your doctor or pharmacist immediately if you observe any of the side effects listed below, as they may be signs of serious side effects:

Frequent(may affect up to 1 in 10 people)

• Urinary tract infection
• Bronchitis
• Flu (influenza)
• Respiratory viral tract infection
• Viral infection
• Herpes zoster virus infection (shingles)
• Pneumonia
• Dizziness (vertigo)
• Fever (pyrexia)
• Fluid accumulation in the back of the eye (retina) that may cause changes in vision, including blindness (macular edema)
• Seizures (convulsions)

Rare(may affect up to 1 in 100 people)

• Slow heart rate (bradycardia)

Other side effects

Very common(may affect more than 1 in 10 people)

• Common cold, nasal congestion, or throat infection (nasopharyngitis, respiratory tract infection)
• Increased levels of liver enzymes in the blood (a sign of liver problems)
• Low count of a type of white blood cell called lymphocytes (lymphopenia)

Frequent(may affect up to 1 in 10 people)

• High blood pressure (hypertension)
• Back pain
• Feeling very tired (fatigue)
• Dizziness
• Difficulty breathing (dyspnea)
• High cholesterol levels in the blood (hypercholesterolemia)
• Joint pain (arthralgia)
• Pain in arms or legs
• Depression
• Difficulty sleeping (insomnia)
• Cough
• Nasal congestion, sore throat, or sinus infection (rhinitis, pharyngitis, laryngitis, sinusitis)
• Feeling anxious (anxiety)
• Decreased sensation or sensitivity, especially in the skin (hypoesthesia)
• Increased levels of a protein in the blood that may indicate an infection or inflammation (increased levels of C-reactive protein)
• Drowsiness (somnolence)
• Indigestion (dyspepsia)
• Swollen hands, ankles, or feet (peripheral edema)
• Migraine
• Ligament sprain
• Chest discomfort

Rare(may affect up to 1 in 100 people)

• High potassium levels in the blood (hyperkalemia)
• Swollen joints
• Dry mouth

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Ponvory

• The active ingredient is ponesimod.

• The other excipients are:

Core of the tablet

Sodium croscarmellose, monohydrate lactose (see "Ponvory contains lactose"), magnesium stearate, microcrystalline cellulose, Povidone K30, anhydrous colloidal silica, and sodium lauryl sulfate.

Coating of the tablet

Hipromelose 2910, monohydrate lactose, Macrogol 3350, titanium dioxide, and triacetin.

Ponvory 3 mg film-coated tablets

Iron oxide red (E172) and iron oxide yellow (E172)

Ponvory 4 mg film-coated tablets

Iron oxide red (E172) and iron oxide black (E172)

Ponvory 5 mg film-coated tablets

Iron oxide black (E172) and iron oxide yellow (E172)

Ponvory 7 mg film-coated tablets

Iron oxide red (E172) and iron oxide yellow (E172)

Ponvory 8 mg film-coated tablets

Iron oxide red (E172) and iron oxide black (E172)

Ponvory 9 mg film-coated tablets

Iron oxide red (E172), iron oxide black (E172), and iron oxide yellow (E172)

Ponvory 10 mg film-coated tablets

Iron oxide red (E172) and iron oxide yellow (E172)

Ponvory 20 mg film-coated tablets

Iron oxide yellow (E172)

Appearance of the product and contents of the package

Ponvory 2 mg film-coated tablets are white, round, biconvex, film-coated tablets with a diameter of 5 mm, with "2" on one face and an arc on the other face.

Ponvory 3 mg film-coated tablets are red, round, biconvex, film-coated tablets with a diameter of 5 mm, with "3" on one face and an arc on the other face.

Ponvory 4 mg film-coated tablets are purple, round, biconvex, film-coated tablets with a diameter of 5 mm, with "4" on one face and an arc on the other face.

Ponvory 5 mg film-coated tablets are green, round, biconvex, film-coated tablets with a diameter of 8.6 mm, with "5" on one face and an arc and an "A" on the other face.

Ponvory 6 mg film-coated tablets are white, round, biconvex, film-coated tablets with a diameter of 8.6 mm, with "6" on one face and an arc and an "A" on the other face.

Ponvory 7 mg film-coated tablets are red, round, biconvex, film-coated tablets with a diameter of 8.6 mm, with "7" on one face and an arc and an "A" on the other face.

Ponvory 8 mg film-coated tablets are purple, round, biconvex, film-coated tablets with a diameter of 8.6 mm, with "8" on one face and an arc and an "A" on the other face.

Ponvory 9 mg film-coated tablets are brown, round, biconvex, film-coated tablets with a diameter of 8.6 mm, with "9" on one face and an arc and an "A" on the other face.

Ponvory 10 mg film-coated tablets are orange, round, biconvex, film-coated tablets with a diameter of 8.6 mm, with "10" on one face and an arc and an "A" on the other face.

Ponvory 20 mg film-coated tablets are yellow, round, biconvex, film-coated tablets with a diameter of 8.6 mm, with "20" on one face and an arc and an "A" on the other face.

Start of treatment package of Ponvory(blister pack configuration)

Each blister pack of 14 film-coated tablets for a 2-week treatment regimen contains:

2 film-coated tablets of 2 mg

2 film-coated tablets of 3 mg

2 film-coated tablets of 4 mg

1 film-coated tablet of 5 mg

1 film-coated tablet of 6 mg

1 film-coated tablet of 7 mg

1 film-coated tablet of 8 mg

1 film-coated tablet of 9 mg

3 film-coated tablets of 10 mg

Ponvory 20 mg film-coated tablets(maintenance package) (blister pack configuration)

Blister pack with 28 film-coated tablets for a 4-week treatment regimen or multiple blister pack with 84 (3 blister packs of 28) film-coated tablets for a 12-week treatment regimen.

Only some package sizes may be marketed.

Marketing authorization holder

LABORATOIRES JUVISE PHARMACEUTICALS

149 Boulevard Bataille de Stalingrad

69100 Villeurbanne

France

Manufacturer

Janssen Pharmaceutica NV

Turnhoutseweg 30

B-2340 Beerse

Belgium

Last revision date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu