InfoCons Consumer Protection informs you – Velsipity – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start taking this medicine beca use it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor orpharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor orpharmacist .This includes any possible side effects no t listed in this leaflet. See section 4.

In addition to this leaflet, your doctor will give you a patient card, which contains important safety information that you need to be aware of. Keep this patient card with you.

ℹ️ 1. What Velsipity is and what it is used for

Velsipity contains the active substan ce etrasimod, which belongs to a group of medicines known as sphingosine -1-phosphate receptor modulators.

Velsipity is used in adults and adolescents aged 16 years and older for the treatm ent of moderately to severely active ulcerative colitis (UC). Ulcerative colitis is an inflammatory disease of the large bowel .

If you have ulcerative colitis you will first be given other medicines. If you do not respond well enough or cannot take these m edicines, you may be given Velsipity to reduce the signs and symptoms of the disease.

The active substance in Velsipity , etrasimod, prevents lymphocytes (a type of white blood cell) from travelling from the lymph nodes (part of the body’s immune system th at contains lymphocytes) into the blood. These lymphocytes are involved in the inflammation that is linked to the development of ulcerative colitis. By reducing the number of lymphocytes circulating in the blood surrounding the large bowel, etrasimod helps to reduce bowel inflammation and the symptoms associated with the disease.

⚠️ 2. What you need to know before you take Velsipity

Do not take Velsipity

 if you are allergic to etrasimod or any of the other ingredients of this medicine (listed in section 6);  if your healthcare professional has told you that you have a severely weakened immune system ; 38 if you have had a heart attack, unstable angina pectoris (chest pain caused by i nterruptions in the heart’s blood supply that occurs at rest or without an obvious trigger), stroke, transient ischaemic attack (TIA, also known as a mini -stroke) or certain types of severe heart failure in the last 6 months ;  if you have certain types of arrhythmia (irregular or abnormal heartbeat) –your doctor will check your heart before starting treatment ;  if you have a severe active infection or active chronic infection, such as hepatitis (inflammation of the liver) 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 .

Warnings and precautions

Talk to your doctor or, pharmacist before taking Velsipity 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 ever had a stroke or other diseases related to blood vessels in the brain ;  you have problems with your liver ;  you have an infection ;  you have low levels of lymphocytes (a type of white blood cell);  you have recently had or are planning to have a vaccination ;  you have ever had proble ms with your vision or other symptoms of build -up of fluid in the back of the eye ;  you have inflammation of the eye ;  you have diabetes (which can cause problems with your eyes) ;  you have high blood pressure ;  you have severe lung disease, such as pulmonary fibrosis (lung damage with tissue scarring and thickening), asthma or chronic obstructive pulmonary disease (a type of lung disease marked by permanent damage to lung tissues).

Slow heart rate and irregular heart rhythm Before you start taking Velsipity , your doctor will check your heart using an electrocardiogram (ECG ; a test of the heart’s electrical activity ).This is because Velsipity can cause a temporary decrease in heart rate and other heart rhythm disorders when starting treatment. When this happen s, you may feel dizzy or tired or be consciously aware of your heartbeat, or your blood pressure may drop. If these effects are severe, tell your doctor, because you may need treatment right away . If you restart treatment again after stopping for 7or more days in a row , your doctor may re-check your hear t using an ECG.

If you have certain heart conditions ,your doctor will also monitor you for at least the first 4hours after your first dose. Your doctor will ask you to stay at the hospital or clinic for 4hours and will measure your pulse and blood pressure every hour after taking the first dose of Velsipity. You should have an ECG performed before the first dose of Velsipity and after the 4-hour monitoring period. If after the 4-hour period you have a ve ry slow or decreasing heart rate, or if your ECG shows abnormalities, you may need to be monitored for a longer period until these have resolved.

High blood pressure As Velsipity can increase your blood pressure, your doctor may want to check your blood pressure regularly.

Infections Velsipity lowers the levels of white blood cell in your blood (particularly the lymphocyte count).

White blood cells fight infection . While you are taking Velsipity (and for up to about 2weeks after you stop taking it), you may be more likely to get infections ,and any infection that you already have may get worse. Talk to your doctor if you develop an infection. If you think you have an infection, 39have a fever, feel like you have the flu, have shingles or have a headache accompanied by a stiff neck, with sensitivity to light, nausea, rash, and/or confusion or seizures (fits) (these may be symptoms of meningitis and/or encephalitis caused by a fungal or herpes viral infection), contact your doctor straight away, because it could be serious and life -threatening.

Cases of progressive multifocal leukoencephalopathy (PML) have been reported with medicines similar to Velsipity . PML is a rare viral brain infection that may lead to severe disability or death.

PML symptoms include disturbance of vision, progressive weakness, clumsiness, memory loss or confusion. If you develop any of these symptoms, speak to your doctor straight away. Your doctor will consider performing further tests to evaluate this condition and will stop your treatment with Velsipity if PML is confirmed .

Macular oedema Velsipity can cause a problem with your vision called macular oedema ( swelling ofthe macula, the central part of the retina at the back of the eye ).The r isk of developing macular oedema is higher if you have diabetes , uveitis (inflammation of the uvea, the layer beneath the white of the eyeball ), or certain other eye problems. If you have any of these conditions, y our doctor willcheck your vision before you start taking Velsipity and regularly during treatment. If you do not have these conditions, your doctor will check your vision within 3 -4 months after starting treatment. Tell you r doctor about any changes in your vision while on Velsipity.

Call your doctor straight away if you have any of the following:  blurriness or shadows in the centre of your vision;  a blind spot in the centre of your vision;  sensitivity to light;  unusually coloured (tinted) vision.

Cancer Velsipity weakens your immune system. This increases your risk of developing cancers, in particular skin cancers. Skin cancers have been reported with medicines similar to Velsipity . Talk to your doctor straight away if you notice any skin nodules (e.g. ,shiny pearly nodules), patches or open sores that do not heal within weeks. Symptoms of skin cancer may include abnormal growth or changes of skin tissue (e.g. ,unusual moles) with a change in colour, shape ,or size over time. Since there is a risk for 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).

Posterior reversible encephalopathy synd rome (PRES) Posterior reversible encephalopathy syndrome (PRES) is a condition where the brain swells .PRES symptoms include headache, changes in vision, reduced awareness, confusion ,and seizures (fits) . If you develop any of these symptoms, speak to your doctor straight away.

Vaccinations If you need to receive a vaccine, seek your doctor’s advice first. Vaccines may not work as well as they should during your treatment with Velsipity. You are advised to make sure your vaccinations are up-to-date before you start treatment. So -called live vaccines may trigger the infection that they are supposed to prevent and should therefore be given a t least 4 weeks before you start treatment ,or at least 2 weeks after you stop taking Velsipity.

Liver function tests Velsipity may affect your liver function. Tell your doctor straight away if you develop any of the following symptoms : yellowing of your skin or the whites of your eyes, abnormally dark urine (brown coloured), pain on the right side of your stomach area (abdomen), tiredness, feeling less hungry than usual or unexplained nausea and vomiting .

Before, during and after the treatment, your do ctor will request blood tests to monitor your liver function.

40Lung problems Velsipity may have an effect on the lung function. Patients with severe lung problems have a higher chance of developing these side effects.

Other treatments for ulcerative colitis Your doctor will usually advise that you stop other treatments for ulcerative colitis with the exception of corticosteroids (like cortisone), and mesalazine. Some medicines for ulcerative colitis may also be used for other conditions. Tell your doc tor about all other medicines you take .When switching from the previous treatment, because of the risk of additive immunosuppressive effects, the risk of infection may be increased for some time. Do not take any other immunosuppressive products unless you r doctor has told you to do so.

Women of childbearing potential If used during pregnancy, Velsipity can harm the unborn baby. Before you start treatment with Velsipity , 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. Your doctor will give you a patient card which explains why you should not become pregnant while taking Velsipity . It also explains what you should do to avoid becoming pregnant while you are taking Velsipity . You must use effective contraception during treatment and for at least 14days after stopping treatment (see “Pregnancy , contraception, and breast -feeding” in section 2 ).

If any of these apply to you, tell your doctor or pharmacist before taking Velsipity .

Children and adolescents

Do not give this medicine to children and adolescents aged under 16 years. This is because Velsipity has not been studied in this age group.

Other medicines and Velsipity

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Velsipity can affect the way some other medicines work. Also ,some other medicines can affect the way Velsipity works.

In particular, before taking Velsipity , tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines:  Medicines to control your heart rate and blood pressure (beta blocker medicines and calcium chan nel blocker medicines); use of these medicines could strengthen the effect of Velsipity on irregular heartbeat .  Medicines to control your heart rhythm (antiarrhythmics), or heartbeat .  Medicines that affect your immune system; use of these medicines with V elsipity could weaken the immune system .  Vaccines ; if you need to receive a vaccine, talk to your doctor .You should not take Velsipity for at least 2weeks before avaccination .You should not take Velsipity for at least 4weeks after receiving a live vaccine .  Fluconazole (an anti -fungal treatment) and certain other medicines can increase the levels of Velsipity in the blood, which increas esthe risk of side effects with Velsipity . It is recommended that you do not take these while also taking Velsipit yand your doctor will advise you on this .  Rifampicin , enzalutamide, and certain other medicines can decrease the levels of Velsipity in the blood, reducing its effectiveness . It is recommended that you do not take these while also taking Velsipity and you r doctor will advise you on this.

Velsipity may slightly increase the levels of hormones released from some contraceptive pills. You will still be protected from pregnancy, but your chances of side effects from contraceptive pills may be higher . If you have any side effects, talk to your doctor or pharmacist .

41Pregnancy , contraception, and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy and contraception Do not use Velsipity during pregnancy, if you are trying to become pregnant ,or if you are a woman who could become pregnant and you are not using effective contraception. If Velsipity is used during pregnancy, there is a risk of harm to the unborn baby. If you are a woman who could become pregnant, your doctor will inform you about this risk before you start treatment with Velsipity and will ask you to do a pregnancy test in order to ensure that you are not pregnant. You must use effective contraception while taking Velsipity and for at least 14days after you stop taking it. Ask your doctor about reliable methods of contraception.

Your doctor will give you a patient card which explains why you should not become pregnant while taking Velsipity .

If you do become pregnant while taking Velsipity , tell your doctor straight away. Your doctor will likely stop treatment (see “If you stop taking Velsipity ” in section 3) and pre -natal checks will be performed to monitor the health of the unborn baby.

Breast -feeding You should not breast -feed while you are taking Velsipity . This is to avoid a risk of side effects for the baby since Velsipity may pass into breast milk.

Driving and using machines

Velsipity is not expected to have an influence on your ability to drive and use machine s. You may , however, feel dizzy after taking Velsipity . If this happens, do not drive or use machines.

Velsipity contains tartrazine (E102)

The colouring agent in Velsipity contains tartrazine (E102), which may cause allergic reactions.

Velsipity contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet , that is to say essentially ‘sodium – free’.

💊 3. How to take Velsipity

Velsipity will be started under the supervision of a doctor who is experienced in treating ulcerative colitis. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How to take  The recommended dose of Velsipity is one 2 mg tablet taken once daily.  Take Velsipity with food f or the first 3days. After this,you can take Velsipity each day with or without food .  Swallow the tablet whole with water. Do not split, crush ,or chew the tablet before swallowing as it may change how much medicine gets into your body.

Ifyou take more Velsipity than you should If you have taken more Velsipity than you should, call your doctor straight away or go to a hospital straight away. Take the medicine pack and this package leaflet with you.

If you forget to take Velsipity

If youforget to take a dose of Velsipity , take the next dose at your usual time. Do not double the dose .

42If you stop taking Velsipity Do not stop taking Velsipity or change your dose without talking to your doctor first. If your doctor decides to pause your treatment for 7 days or more in a row, the medicine must be taken with food for the first 3 days after you restart taking Velsipity. After that you can take Velsipity with or without food.

If you restart Velsipity afterstopping your treatment for 7 days or more in a row , the effect on heart rate that may be seen when treatment is first started may re -occur and you mayneed to be monitored at the hospital or clinic. Do not restart Velsipity after stopping it for more th an 7 days without seeking advice from your doctor .

Velsipity will stay in your body for up to 14days after you stop taking it. Your white blood cell count (lymphocyte count) may remain low for up to about 2weeks and side effects described in this leaflet may still occur (see “Possible side effects” in section 4) during this period .

If you have any further questions on the use of this medicine, ask your doctor or pharmaci st.

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Tell your doctor or pharmacist immediately if you notice any of the side effects listed below , which could become serious :

Common (may affect up to 1 in 10 people)

 bradycardia (slow heart rate)  hypertension (high blood pressure)  urinary tract infection (infection of the parts of the body that collect and pass out urine)  lower respiratory tract infection (infection of the lower airways or lungs )

Uncommon (may affect up to 1 in 100 people)

 atrioventricular block (a type of heart rhythm disorder)  macular oedema (swelling in the macula, the central part of the retina at the back of the eye)

Other side effects

Tell your doctor or pharmacist immediately if you notice any of the following side effects:

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

 lymphopenia (low levels of lymphocytes, a type of white blood cell)

Common (may affect up to 1 in 10 people)

 hypercholesterolaemia (high blood cholesterol levels)  headache  feeling dizzy  increased liver enzyme levels in blood tests, which can be a sign of problems with your liver function  neutropenia (low levels of neutrophils, a type of whi te blood cell)  visualimpairment

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system 43listed in Appendix V .By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Velsipity

 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 bottle, blister ,and carton after EXP. The expiry date refers to the last day of that month.  This medicine does not require any special temperature storage conditions.  Store in the original package in order to protect from moisture.  Do not use this medicin e 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 environment .

📦 6. Contents of the pack and other information

What Velsipity contains

 The active substance is etrasimod. Each film -coated tablet contains etrasimod arginine

equivalent to 2 mg etrasimod.  Theother excipients are:

Tablet core Magnesium stearate (E470b), mannitol (E421), microcrystalline cellulose (E460i), sodium starch glycolate (Type A) Tablet coating Brilliant blue FCF aluminium lake (E133), indigo carmine aluminium lake (E132), tartrazine aluminium lake (E102), macrogol 4000 (E1521), poly(vinyl alcohol) (E1203), talc (E553b), and titanium dioxide (E171)

What Velsipity looks like and contents of the pack

Velsipity 2mg is agreen, round, film -coated tablet of approximately 6 mm diameter with “ETR” on one side and “2” on the other side.

Pack sizes :  Bottle of 30 film -coated tablets  Blisters of 28 film -coated tablets  Blisters of 98 film -coated tablets Not all pack sizes may be marketed.

Marketing Authorisation Holder

Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Brussels Belgium Manufacturer s Almac Pharma Services (lreland) Limited Finnabair Industrial Estate Dundalk, A91 P9KD Ireland 44Almac Pharma Services Limited Seagoe Industrial Estate Portadown, Craigavon, BT63 5UA United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: +32 (0)2 554 62 11Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4000 България Пфайзер Люксембург САРЛ , Клон България Тел.: +359 2 970 4333Magyarország Pfizer Kft.

Tel.: +36 1 488 37 00 Česká republika Pfizer , spol. s r.o.

Tel: +420 283 004 111Malta Vivian Corporation Ltd.

Tel: +356 21344610 Danmark Pfizer ApS Tlf.: +45 44 20 11 00Nederland Pfizer bv Tel: +31 (0)800 63 34 636 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055 -51000Norge Pfizer AS Tlf: +47 67 52 61 00 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500Österreich Pfizer Corporation Austria Ges.m.b.H.

Tel: +43 (0)1 521 15 -0 Ελλάδα Pfizer Ελλάς A.E.

Τλ: +30 210 6785800Polska Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00 España Pfizer, S.L.

Tel: +34 91 490 99 00Portugal Laborat órios Pfizer, Lda.

Tel: +351 21 423 5500 France Pfizer Tél: +33 (0)1 58 07 34 40România Pfizer Romania S.R.L.

Tel: +40 (0) 21 207 28 00 Hrvatska Pfizer Croatia d.o.o.

Tel: +385 1 3908 777Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel: +386 (0)1 52 11 400 45Ireland Pfizer Healthcare Ireland Unlimited Company Tel: 1800 633 363 (toll free) +44 (0)1304 616161Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: +421 2 3355 5500 Ísland Icepharma hf.

Sími: +354 540 8000Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040 Italia Pfizer S.r.l.

Tel: +39 06 33 18 21Sverige Pfizer AB Tel: +46 (0)8 550 520 00 Kύπρος Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22817690 Latvija Pfizer Luxembourg SARL filiāle Latvijā Tel: +371 670 35 775

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Velsipity (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1790).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.