VELSIPITY 2 мг Фильм-coated таблетки

Содержание инструкции

1. Velsipity 2 mg film-coated tablets
   1. What is Velsipity and what is it used for
   2. What you need to know before taking Velsipity
   3. How to take Velsipity
   4. Possible side effects
   5. How to store Velsipity
   6. Contents of the pack and other information

Velsipity 2 mg film-coated tablets

etrasimod

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, see your doctor or pharmacist. See section 4.

contain important safety information that you need to be aware of. Keep this patient card
with you.

Contents of this leaflet

• 1. What Velsipity is and what it is used for
• 2. What you need to know before you take Velsipity
• 3. How to take Velsipity
• 4. Possible side effects
• 5. How to store Velsipity
• 6. Contents of the pack and other information

1. What is Velsipity and what is it used for

Velsipity contains the active substance 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 over for the treatment
of moderately to severely active ulcerative colitis (UC). Ulcerative colitis is a disease
inflammatory bowel disease of the large intestine. If you have ulcerative colitis, you will first be prescribed other
medicines. If you do not respond well enough or cannot take these medicines, you may be
given Velsipity to reduce the signs and symptoms of the disease.
The active ingredient of Velsipity, etrasimod, prevents lymphocytes (a type of white blood cell) from moving
from the lymph nodes (part of the body's immune system that contains lymphocytes) to the blood. These
lymphocytes are involved in the inflammation related to the development of ulcerative colitis. By reducing the
number of circulating lymphocytes in the blood surrounding the large intestine, etrasimod helps to reduce
intestinal inflammation and symptoms associated with the disease.

2. What you need to know before taking 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 provider has told you that you have a severely weakened immune system;
• if you have had a heart attack, unstable angina pectoris (chest pain caused by interruptions in blood supply to the heart, which occurs at rest or without an obvious trigger), stroke, transient ischemic 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 an active severe infection or an 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 are a woman of childbearing potential who is not using effective contraception.

Warnings and precautions
Talk to your doctor or pharmacist before taking Velsipity if:

• you have a slow heart rate or are taking or have recently taken medicines that slow down the 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 liver problems;
• you have an infection;
• you have low levels of lymphocytes (a type of white blood cells);
• you have recently received or are planning to receive a vaccination;
• you have ever had problems with your vision or other symptoms of fluid buildup in the back of the eye;
• you have inflammation of the eyes;
• you have diabetes (which can cause problems with the eyes);
• you have high blood pressure;
• you have a serious lung disease, such as pulmonary fibrosis (lung damage with scarring and thickening of the tissues), asthma or chronic obstructive pulmonary disease (a type of lung disease characterized by permanent damage to the lung tissue).

Slow heart rate and irregular heart rhythm
Before starting to take Velsipity, your doctor will check your heart using an
electrocardiogram (ECG; a test of the electrical activity of the heart). This is because Velsipity can
cause a temporary decrease in heart rate and other rhythm disturbances
at the beginning of treatment. If this happens, you may feel dizzy or tired, or clearly perceive
your heartbeat, or your blood pressure may drop. If these effects
are severe, tell your doctor because you may need immediate treatment. If you resume
treatment after interrupting it for 7 or more consecutive days, your doctor may recheck your
heart by performing an ECG.
If you suffer from certain heart conditions, your doctor will also monitor you for at least the first 4 hours
after the first dose. Your doctor will ask you to remain in the hospital or clinic for 4 hours and will measure your
heart rate and blood pressure every hour after you have taken the first dose of Velsipity.
You should have an ECG before the first dose of Velsipity and after the 4-hour monitoring period.
If after the 4-hour period you have a very slow or decreasing heart rate or if your
ECG shows abnormalities, you may need to be monitored for a longer period until
these abnormalities resolve.
High blood pressure
Because Velsipity can raise blood pressure, your doctor may want to check you
regularly.
Infections
Velsipity lowers the levels of white blood cells in the blood (especially the count of lymphocytes). White blood cells fight infections. While taking Velsipity (and up to about 2 weeks after
stopping treatment), you may be more likely to get infections and
any infection you already have may worsen. Talk to your doctor if you develop an infection. If
you think you have an infection, have a fever, experience flu-like symptoms, have shingles, or headache accompanied by stiff neck, sensitivity to light, nausea, rash and/or confusion or
seizures (these can be symptoms of meningitis and/or encephalitis caused by
a fungal infection or Herpes virus), contact your doctor immediately, because you may have
a serious and potentially life-threatening condition.
Cases of progressive multifocal leukoencephalopathy (PML) have been reported with medicines similar to
Velsipity. PML is a rare viral infection of the brain that can lead to severe disability or death. The
symptoms of PML include visual disturbances, progressive weakness, clumsiness, memory loss or confusion. If you develop any of these symptoms, contact your
doctor immediately. The doctor will consider performing further tests to assess the
condition and will stop treatment with Velsipity if PML is confirmed
Macular edema
Velsipity can cause an eye problem called macular edema (swelling of the macula, the central part
of the retina in the back of the eye). The risk of developing macular edema is
higher if you have diabetes, uveitis (inflammation of the uvea, the layer under the white of the eye)
or certain other eye problems. If you have any of these conditions, your doctor
will check your vision before starting treatment with 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 your doctor about any changes in your vision while taking Velsipity.
Contact your doctor immediately if you experience any of the following symptoms:

• blurred vision or shadows in the center of your vision;
• a blind spot in the center of your vision;
• sensitivity to light;
• vision with unusual coloration.

Cancer
Velsipity weakens the immune system, increasing the risk of developing cancer, in
particular skin cancer. Skin tumors have been reported with medicines similar to
Velsipity. Contact your doctor immediately if you notice skin nodules (e.g., shiny pearl-like
bumps), spots or open sores that do not heal within a few weeks. The symptoms of skin cancer may include abnormal growth or changes in skin tissue (e.g., unusual moles) with
changing color, shape or size over time. Because there is a risk of developing skin cancer,
exposure to sunlight and UV (ultraviolet) rays should be limited, wearing
protective clothing and regularly applying sunscreen (with a high sun protection factor).
Reversible posterior encephalopathy syndrome (PRES)
Reversible posterior encephalopathy syndrome (PRES) is a condition in which the brain
swells. The symptoms of PRES include headache, changes in vision, decreased awareness,
confusion and seizures. If you develop these symptoms, contact your
doctor immediately.
Vaccinations
If you need to receive a vaccine, talk to your doctor first. During treatment with
Velsipity, vaccines may not be as effective as expected. You should make sure your
vaccinations are up to date before starting treatment. So-called live vaccines can
trigger the infection they are supposed to prevent and therefore should be administered at least
4 weeks before starting treatment, or at least 2 weeks after stopping Velsipity.
Liver function tests
Velsipity can affect liver function. Immediately inform your doctor if you develop any
of the following symptoms: yellowing of the skin or whites of the eyes, unusually dark urine (brown in color), pain in the upper right side of the abdomen, fatigue, loss of appetite or unexplained nausea and vomiting.
Before, during and after treatment, your doctor will request blood tests to monitor
liver function.
Lung problems
Velsipity can affect lung function. Patients with serious lung problems are more likely to develop these side effects.
Other treatments for ulcerative colitis
Your doctor will usually advise you to stop other treatments for ulcerative colitis except for
corticosteroids (such as cortisone) and mesalazine. Some medicines for ulcerative colitis may
also be used for other conditions. Tell your doctor about all other medicines you are taking.
When switching from a previous treatment, due to the risk of additive immunosuppressive effects
the risk of infection may increase for a certain period. Do not take other immunosuppressant products unless directed by your doctor.
Women of childbearing potential
If used during pregnancy, Velsipity can harm the fetus. Before starting treatment with
Velsipity, your doctor will explain the risks and ask you to take a pregnancy test to make sure
you are not pregnant. Your doctor will give you a patient card explaining why you should not become
pregnant while taking Velsipity. It also explains what you need to do to avoid pregnancy during
treatment with Velsipity. You must use effective contraception during treatment and
for at least 14 days after stopping treatment (see “Pregnancy, contraception and
breastfeeding” in section 2).
If any of these applies to you, tell your doctor or pharmacist before taking
Velsipity.

Children and adolescents
Do not give this medicine to children and adolescents under 16 years of age, 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 how other medicines work.
Also, some other medicines can affect how 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 heart rate and blood pressure (beta-blockers and calcium channel blockers); using these medicines may increase the effect of Velsipity on irregular heartbeat;
• medicines to control heart rhythm (antiarrhythmics) or heartbeat;
• medicines that affect the immune system; using these medicines with Velsipity may weaken the immune system;
• vaccines; if you need to receive a vaccine, talk to your doctor. You should not take Velsipity for at least 2 weeks before a vaccination. You should not take Velsipity for at least 4 weeks after receiving a live vaccine;
• fluconazole (an antifungal treatment) and some other medicines can increase the levels of Velsipity in the blood, increasing the risk of side effects with Velsipity. It is recommended not to take them during treatment with Velsipity; your doctor will provide guidance on this.
• rifampicin, enzalutamide and some other medicines can reduce the levels of Velsipity in the blood, reducing its effectiveness. It is recommended not to take them during treatment with Velsipity; your doctor will provide guidance on this.

Velsipity can slightly increase the levels of hormones released by some birth control pills. You will
still be protected from pregnancy, but the possibility of side effects of birth control pills
may increase. If you experience any side effect, talk to your doctor or
pharmacist.

Pregnancy, contraception and breastfeeding
If you are pregnant, suspect you might be pregnant, are trying to become pregnant or are breastfeeding,
ask your doctor for advice before taking this medicine.
Pregnancy and contraception
Do not use Velsipity if you are pregnant, are trying to become pregnant, or are a woman
who could become pregnant and is not using effective contraception. If Velsipity is
used during pregnancy, there is a risk of harm to the fetus. If you are a woman who could
become pregnant, your doctor will inform you of this risk before starting treatment with Velsipity and will
ask you to take a pregnancy test to make sure you are not pregnant. You must use
effective contraception during taking Velsipity and for at least 14 days after
stopping treatment. Ask your doctor about reliable methods of contraception.
Your doctor will give you a patient card explaining why you should not become
pregnant while taking Velsipity.
If you become pregnant while taking Velsipity, tell your doctor immediately. Your doctor will probably
stop the treatment (see “If you stop taking Velsipity” in
section 3) and prenatal checks will be performed to monitor the health of the fetus.
Breastfeeding
You should not breastfeed while taking Velsipity. This is to avoid the risk of side
effects for the baby, as Velsipity can pass into breast milk.

Driving and using machines
Velsipity is not expected to affect your ability to drive and operate machines.
However, you may feel dizzy after taking Velsipity. If this happens, do not drive or operate
machines.

Velsipity contains tartrazine (E102)
The coloring agent in Velsipity contains tartrazine (E102), which can cause allergic reactions.

Velsipity contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially
“sodium-free”.

3. How to take Velsipity

Treatment with Velsipity will be initiated under the supervision of a doctor experienced in the treatment
of ulcerative colitis. Take this medicine following the doctor's instructions exactly at all times.
If you have any doubts, consult your doctor or pharmacist.

How to take the medicine

• The recommended dose of Velsipity is one 2 mg tablet taken once a day.
• Take Velsipity with food for the first 3 days. Afterwards, you can take Velsipity every day with or without food.
• Swallow the tablet whole with water. Do not split, crush or chew the tablet before swallowing, as this could change the amount of medicine absorbed by the body.

If you take more Velsipity than you should
If you have taken more Velsipity than you should, call your doctor immediately or go to

If you forget to take Velsipity

• If you forget a dose of Velsipity, 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 the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Velsipity
Do not stop taking Velsipity or change the dose without first talking to your doctor. If the
doctor decides to discontinue treatment for 7 consecutive days or for a longer period, once you resume taking Velsipity, the medicine must be taken with food for the first
3 days. Afterwards, you can take Velsipity with or without food.
If you resume treatment with Velsipity after interrupting it for 7 or more consecutive days, the effect
on heart rate that may have been observed at the beginning of treatment could
reappear and you may need to be monitored in hospital or clinic. Do not
resume treatment with Velsipity after interrupting it for more than 7 days without seeking advice
from your doctor.
Velsipity will remain in your body for up to 14 days after you stop taking it. The white blood cell count (lymphocyte count) may remain low for about 2 weeks and the undesirable effects
described in this leaflet may continue to occur (see “Possible side effects” in
section 4) during this period.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

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 following side effects
listed below, which could become serious:

Common(may affect up to 1 in 10 people)

• bradycardia (slow heartbeat)
• hypertension (high blood pressure)
• urinary tract infection (infection of the parts of the body that collect and expel 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 edema (swelling in the macula, the central part of the retina in 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)

• hypercholesterolemia (high levels of cholesterol in the blood)
• headache
• feeling of dizziness
• increased levels of liver enzymes in blood tests (which can be a sign of liver problems)
• neutropenia (low levels of neutrophils, a type of white blood cell)
• impaired vision

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
listed in Annex 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 “Scad.”. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage temperature.
• Store in the original packaging to protect the medicine from moisture.
• Do not use this medicine if you notice any damage or signs of tampering with the packaging.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Velsipity contains

• The active ingredient is etrasimod. Each film-coated tablet contains etrasimod arginine equivalent to 2 mg of etrasimod.
• The other 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), polyvinyl
alcohol (E1203), talc (E553b) and titanium dioxide (E171)

Description of Velsipity and contents of the pack
Velsipity 2 mg is a round, film-coated tablet of green colour, approximately 6 mm in
diameter, with the inscription “ETR” on one side and the inscription “2” on the other side.
Pack sizes:

• Bottle of 30 film-coated tablets
• Blister pack of 28 film-coated tablets
• Blister pack 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

Manufacturers
Almac Pharma Services (Ireland) Limited
Finnabair Industrial Estate
Dundalk, A91 P9KD
Ireland
Almac Pharma Services Limited
Seagoe Industrial Estate
Portadown, Craigavon, BT63 5UA
United Kingdom
For further information on this medicinal product, contact the local representative of the
Marketing Authorisation Holder:

België/Belgique/Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

България
Пфайзер Люксембург САРЛ, Клон
България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: +36 1 488 37 00

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τ  λ: +30 210 6785800

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

España
Pfizer, S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: +386 (0)1 52 11 400

Irlanda
Pfizer Healthcare Ireland
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Kύπρος
Pfizer Ελλάς A.E. (Cyprus Branch)
Tηλ: +357 22817690

United Kingdom (Northern Ireland)
Pfizer Limited
Tel: +44 (0) 1304 616161

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

Other sources of information
More detailed information on this medicinal product is available on the European Medicines
Agency website, https://www.ema.europa.eu .