Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - sotyktu

Document Subject

Generated Narrative: MedicinalProductDefinition mp8ff5d67e0b7de732bda1082340f24212

identifier: http://ema.europa.eu/identifier/EU/1/23/1718/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: SOTYKTU 6 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8ff5d67e0b7de732bda1082340f24212

identifier: http://ema.europa.eu/identifier/EU/1/23/1718/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - sotyktu

Attesters

What is in 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

What SOTYKTU is 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 SOTYKTU is used for SOTYKTU is used to treat adults with moderate to severe plaque psoriasis , an inflammatory condition affecting the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails, hands, and feet.

How SOTYKTU works SOTYKTU works by selectively blocking the activity of an enzyme called TYK2 (tyrosine kinase 2) which is involved in the process of inflammation. By reducing the activity of this enzyme, SOTYKTU can help to control the inflammation associated with plaque psoriasis and thereby reduce the signs (skin dryness, cracking, scaling, shedding, or flaking, redness and bleeding) and can therefore help to reduce symptoms such as itching, pain, burning, stinging, and skin tightness of this condition.

SOTYKTU has also been shown to improve the quality of life in patients with psoriasis. This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.

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 thinks is important.

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

• if you currently have an infection that does not go away or that keeps coming back
• if you have or have ever had tuberculosis (TB)
• if you have cancer, because your doctor will have to decide if you can still be given SOTYKTU
• if you have heart problems or medical conditions that make you more likely to develop heart disease - it is not clear if SOTYKTU increases the risk of heart disease
• if you have had or are at risk of blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism). Tell your doctor if you get a painful swollen leg, chest pain, or shortness of breath as these can be signs of blood clots in the veins. It is not clear if SOTYKTU increases the risk of blood clots
• if you have recently had or plan to have a vaccination.

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

Children and adolescents SOTYKTU is not recommended for 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 recently had or plan to have a vaccination. You should not be given certain types of vaccines (live vaccines) while using SOTYKTU.

Pregnancy 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. This is because it is not known how this medicine will affect the baby.

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

SOTYKTU contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

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

The recommended dose is 6 mg taken every day. The tablet should be swallowed whole and can be taken either with or without food. Do not crush, cut, or chew the tablets.

Your doctor will decide for how long you need to use SOTYKTU.

If your condition has not improved after six months of treatment, talk to your doctor.

If you take more SOTYKTU than you should If you have taken more SOTYKTU than you should, talk to your doctor as soon as possible. You may get some of the side effects listed in section 4. If you forget to take SOTYKTU If you forgot to take SOTYKTU, just take the normal dose the next day. Do not take a double dose to make up for a forgotten tablet.

If you stop taking SOTYKTU Do not stop taking SOTYKTU without talking to your doctor first. If you stop treatment, symptoms of psoriasis may come back.

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

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 (nose and throat) infections with symptoms such as sore throat and stuffy nose

Common (may affect up to 1 in 10 people)

• viral infection of the mouth (such as cold sores)
• an increase in the level of an enzyme in your blood called creatine phosphokinase (CPK)
• sores in mouth
• acne-like rashes
• inflammation of 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 carton after EXP . The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use this medicine if you notice the tablets are damaged or there are signs of tampering with the medicine packaging.

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.

What SOTYKTU contains The active substance is deucravacitinib. Each film-coated tablet contains 6 mg of deucravacitinib.

The other ingredients are

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

What SOTYKTU looks like and contents of the pack SOTYKTU is a pink, round, biconvex, film-coated tablet printed with BMS 895 and 6 mg on one side, in two lines, plain on the other side.

The film-coated tablets are provided in calendar or non-calendar blisters 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 Blanchardstown Corporate Park 2 Dublin 15, D15 TIreland

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

For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder:

Belgique/Belgi /Belgien N.V. Bristol-Myers Squibb Belgium S.A. T l/Tel: + 32 2 352 76 medicalinfo.belgium@bms.com

Lietuva Swixx Biopharma UAB Tel: + 370 52 369medinfo.lithuania@swixxbiopharma.com

Swixx Biopharma EOOD Te .: + 359 2 4942 medinfo.bulgaria@swixxbiopharma.com

Luxembourg/Luxemburg N.V. Bristol-Myers Squibb Belgium S.A. T l/Tel: + 32 2 352 76 medicalinfo.belgium@bms.com

esk republika Bristol-Myers Squibb spol. s r.o. Tel: + 420 221 016 medinfo.czech@bms.com

Magyarorsz g Bristol-Myers Squibb Kft. Tel.: + 36 1 301 9Medinfo.hungary@bms.com

Danmark Bristol-Myers Squibb Denmark Tlf: + 45 45 93 05 medinfo.denmark@bms.com

Malta A.M. Mangion Ltd Tel: + 356 23976pv@ammangion.com

Deutschland Bristol-Myers Squibb GmbH & Co. KGaA Tel: 0800 0752002 (+ 49 89 121 42 350) medwiss.info@bms.com

Nederland Bristol-Myers Squibb B.V. Tel: + 31 (0)30 300 2medischeafdeling@bms.com

Eesti Swixx Biopharma O
Tel: + 372 640 1medinfo.estonia@swixxbiopharma.com

Norge Bristol-Myers Squibb Norway Ltd. Tlf: + 47 67 55 53 medinfo.norway@bms.com

Bristol-Myers Squibb A.E. : + 30 210 6074medinfo.greece@bms.com

sterreich Bristol-Myers Squibb GesmbH Tel: + 43 1 60 14 medinfo.austria@bms.com

Espa a Bristol-Myers Squibb, S.A. Tel: + 34 91 456 53 informacion.medica@bms.com

Polska Bristol-Myers Squibb Polska Sp. z o.o. Tel.: + 48 22 2606informacja.medyczna@bms.com

France Bristol-Myers Squibb SAS T l: + 33 (0)1 58 83 84 infomed@bms.com

Portugal Bristol-Myers Squibb Farmac utica Portuguesa, S.A. Tel: + 351 21 440 70 portugal.medinfo@bms.com

Hrvatska Swixx Biopharma d.o.o. Tel: + 385 1 2078 medinfo.croatia@swixxbiopharma.com

Rom nia Bristol-Myers Squibb Marketing Services S.R.L. Tel: + 40 (0)21 272 16 medinfo.romania@bms.com

Ireland Bristol-Myers Squibb Pharmaceuticals uc Tel: 1 800 749 749 (+ 353 (0)1 483 3625) medical.information@bms.com

Slovenija Swixx Biopharma d.o.o. Tel: + 386 1 2355 medinfo.slovenia@swixxbiopharma.com

sland Vistor hf. S mi: + 354 535 7vistor@vistor.is medical.information@bms.com

Slovensk republika Swixx Biopharma s.r.o. Tel: + 421 2 20833 medinfo.slovakia@swixxbiopharma.com
Italia Bristol-Myers Squibb S.r.l. Tel: + 39 06 50 39 medicalinformation.italia@bms.com

Suomi/Finland Oy Bristol-Myers Squibb (Finland) Ab Puh/Tel: + 358 9 251 21 medinfo.finland@bms.com

Bristol-Myers Squibb A.E. : 800 92666 (+ 30 210 6074300) medinfo.greece@bms.com

Sverige Bristol-Myers Squibb Aktiebolag Tel: + 46 8 704 71 medinfo.sweden@bms.com

Latvija Swixx Biopharma SIA Tel: + 371 66164medinfo.latvia@swixxbiopharma.com

United Kingdom (Northern Ireland) Bristol-Myers Squibb Pharmaceutical Limited Tel: +44 (0)800 731 1medical.information@bms.com

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: