SOTYKTU 6 мг Фильм-coated таблетка

Содержание инструкции

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

SOTYKTU 6 mg film-coated tablets

deucravacitinib

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 medicine. 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, pharmacist or nurse.
• 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is SOTYKTU and what it is used for

What is SOTYKTU
SOTYKTU contains the active substance deucravacitinib, which belongs to a group of medicines
called tyrosine kinase 2 (TYK2) inhibitors that help to reduce inflammation associated with
psoriasis.

What is SOTYKTU used for
SOTYKTU is used for the treatment of adults with “plaque psoriasis” from moderate to severe, an
inflammatory condition that affects the skin, which can cause red, scaly, thick, itchy and painful
patches on the skin and can also affect the scalp and nails, hands and feet.

How does SOTYKTU work
SOTYKTU works by selectively blocking the activity of an enzyme called TYK2 (tyrosine kinase 2),
which is involved in the inflammatory process. By reducing the activity of this enzyme, SOTYKTU can
help to control the inflammation associated with plaque psoriasis and therefore reduce the signs
(skin dryness, cracking, flaking, scaling or shedding, redness and bleeding) and therefore can help
to reduce the symptoms of this condition, such as itching, pain, burning, stinging pain and skin
tightness.
It has also been shown that SOTYKTU improves the quality of life of patients with psoriasis. This
means that the impact of this condition on daily activities, relationships and other factors
should be less than before.

2. What you need to know before you take SOTYKTU

Do not take SOTYKTU

• if you are allergic to deucravacitinib or any of the other ingredients of this medicine (listed in section 6)
• if you have an infection, including active tuberculosis (TB), which your doctor considers important.

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

• if you currently have an infection that does not resolve or continues to recur;
• if you have or have had tuberculosis (TB);
• if you have cancer, because your doctor will need to decide if you can still take SOTYKTU;
• if you have heart problems or medical conditions that increase the likelihood of developing heart disease - it is not clear if SOTYKTU increases the risk of heart disease;
• if you have had or are at risk of developing blood clots in the veins of the legs (deep vein thrombosis) or in the lungs (pulmonary embolism). Tell your doctor if you experience painful swelling in the legs, chest pain or shortness of breath, as these may be signs of blood clots in the veins. It is not clear if SOTYKTU increases the risk of blood clots;
• if you have recently received or are planning to receive a vaccination.

If you are not sure if any of the above conditions apply to you, talk to your doctor, pharmacist or
nurse before using SOTYKTU.

Children and adolescents
The use of SOTYKTU is not recommendedin children and adolescents under 18 years of age,
because it has not been evaluated in this age group.

Other medicines and SOTYKTU
Tell your doctor or pharmacist:

• if you are taking, have recently taken or might take any other medicines;
• if you have recently received or are planning to receive a vaccination. While using SOTYKTU, you should not receive certain types of vaccines (live vaccines).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor for advice before taking this medicine. This is because it is not known if
this medicine may have effects on the baby.

Driving and using machines
SOTYKTU is not expected to affect your ability to drive or use machines.

SOTYKTU contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact them before taking
this medicine.

SOTYKTU contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
‘sodium-free’.

3. How to take SOTYKTU

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
The recommended dose is 6 mg each day. The tablet must be swallowed whole and can be taken with or without food. Do not crush, cut or chew the tablets.
Your doctor will decide how long you need to use SOTYKTU.
If your condition does not improve after six months of treatment, contact your doctor.

If you take more SOTYKTU than you should
If you take more SOTYKTU than you should, contact your doctor as soon as possible. You may experience some of the undesirable effects listed in section 4.

If you forget to take SOTYKTU
If you forget to take SOTYKTU, simply take the normal dose the next day. Do not take a double dose to make up for a missed tablet.

If you stop taking SOTYKTU
Do not stop taking SOTYKTU without talking to your doctor first. If you stop treatment, the symptoms of psoriasis may return.
If you have any further questions on the use of 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.

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

• upper respiratory tract infections (nose and throat) with symptoms such as sore throat and nasal congestion

Common(may affect up to 1 in 10 people)

• viral infection of the mouth (such as cold sores)
• increased level in the blood of an enzyme called creatine phosphokinase (CPK)
• mouth ulcers
• acne-like skin rashes
• inflammation of the hair follicles

Uncommon(may affect up to 1 in 100 people)

• shingles ( herpes zoster)

Reporting of side effects
If you get any side effects, talk to your doctor, nurse or pharmacist. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help to
provide more information on the safety of this medicine.

5. How to store SOTYKTU

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 the package after
Expiry Date/EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if you notice that the tablets are damaged or if there are 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 SOTYKTU contains
The active ingredient is deucravacitinib. Each film-coated tablet contains 6 mg of
deucravacitinib.
The other ingredients are

• tablet core: hypromellose acetate succinate, anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, hydrated colloidal silica and magnesium stearate
• film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), yellow iron oxide (E172).

Description of the appearance of SOTYKTU and contents of the pack
SOTYKTU is a round, biconvex, pink film-coated tablet, with the inscriptions
“BMS 895” and “6 mg” printed on two lines on one side and no inscription on the other side.
The film-coated tablets are supplied in blisters with or without a calendar containing 7 or
14 tablets.
Each pack contains 7, 14, 28 or 84 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Manufacturer
Swords Laboratories Unlimited Company
T/A Bristol-Myers Squibb Pharmaceutical Operations
External Manufacturing
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15, D15 T867
Ireland

Belgique/België/Belgien
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Lietuva
Swixx Biopharma UAB
Tel: + 370 52 369140
[email protected]

България
Swixx Biopharma EOOD
Teл.: + 359 2 4942 480
[email protected]

Luxembourg/Luxemburg
N.V. Bristol-Myers Squibb Belgium S.A.
Tél/Tel: + 32 2 352 76 11
[email protected]

Česká republika
Bristol-Myers Squibb spol. s r.o.
Tel: + 420 221 016 111
[email protected]

Magyarország
Bristol-Myers Squibb Kft.
Tel.: + 36 1 301 9797
[email protected]

Danmark
Bristol-Myers Squibb Denmark
Tlf: + 45 45 93 05 06
[email protected]

Malta
A.M. Mangion Ltd
Tel: + 356 23976333
[email protected]

Deutschland
Bristol-Myers Squibb GmbH & Co. KGaA
Tel: 0800 0752002 (+ 49 89 121 42 350)
[email protected]

Nederland
Bristol-Myers Squibb B.V.
Tel: + 31 (0)30 300 2222
[email protected]

Eesti
Swixx Biopharma OÜ
Tel: + 372 640 1030
[email protected]

Norge
Bristol-Myers Squibb Norway AS
Tlf: + 47 67 55 53 50
[email protected]

Ελλάδα
Bristol-Myers Squibb A.E.
Τηλ: + 30 210 6074300
[email protected]

Österreich
Bristol-Myers Squibb GesmbH
Tel: + 43 1 60 14 30
[email protected]

España
Bristol-Myers Squibb, S.A.
Tel: + 34 91 456 53 00
[email protected]

Polska
Bristol-Myers Squibb Polska Sp. z o.o.
Tel.: + 48 22 2606400
[email protected]

France
Bristol-Myers Squibb SAS
Tél: + 33 (0)1 58 83 84 96
[email protected]

Portugal
Bristol-Myers Squibb Farmacêutica Portuguesa,
S.A.
Tel: + 351 21 440 70 00
[email protected]

Hrvatska
[email protected]

România
Bristol-Myers Squibb Marketing Services S.R.L.
Tel: + 40 (0)21 272 16 19
[email protected]

Ireland
Bristol-Myers Squibb Pharmaceuticals uc
Tel: 1 800 749 749 (+ 353 (0)1 483 3625)
[email protected]

Slovenija
Swixx Biopharma d.o.o.
Tel: + 386 1 2355 100
[email protected]

Ísland
Vistor hf.
Sími: + 354 535 7000
[email protected]
[email protected]

Slovenská republika
Swixx Biopharma s.r.o.
Tel: + 421 2 20833 600
[email protected]

Italia
Bristol-Myers Squibb S.r.l.
Tel: + 39 06 50 39 61
[email protected]

Suomi/Finland
Oy Bristol-Myers Squibb (Finland) Ab
Puh/Tel: + 358 9 251 21 230
[email protected]

Κύπρος
Bristol-Myers Squibb A.E.
Τηλ: 800 92666 (+ 30 210 6074300)
[email protected]

Sverige
Bristol-Myers Squibb Aktiebolag
Tel: + 46 8 704 71 00
[email protected]

Latvija
Swixx Biopharma SIA
Tel: + 371 66164750
[email protected]

United Kingdom (Northern Ireland)
Bristol-Myers Squibb Pharmaceutical Limited
Tel: +44 (0)800 731 1736
[email protected]

Other sources of information
More detailed information about this medicine is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .