Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - cosentyx

Document Subject

Generated Narrative: MedicinalProductDefinition mp61ceafb9e1df8e2286f86826be123eb9

identifier: http://ema.europa.eu/identifier/EU/1/14/980/012-013

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Cosentyx 75 mg solution for injection in pre-filled syringe

type: Full name

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part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-61ceafb9e1df8e2286f86826be123eb9

identifier: http://ema.europa.eu/identifier/EU/1/14/980/012-013

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - cosentyx

Attesters

What is in this leaflet

1. What Cosentyx is and what it is used for
2. What you need to know before you (or your child) use Cosentyx
3. How to use Cosentyx
4. Possible side effects
5. How to store Cosentyx
6. Contents of the pack and other information

Cosentyx contains the active substance secukinumab. Secukinumab is a monoclonal antibody which belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by neutralising the activity of a protein called IL-17A, which is present at increased levels in diseases such as psoriasis, psoriatic arthritis and axial spondyloarthritis.

Cosentyx is used for the treatment of the following inflammatory diseases:

• Paediatric plaque psoriasis
• Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis

Paediatric plaque psoriasis Cosentyx is used to treat a skin condition called plaque psoriasis , which causes inflammation affecting the skin. Cosentyx reduces the inflammation and other symptoms of the disease. Cosentyx is used in adolescents and children (6 years of age and older) with moderate to severe plaque psoriasis.

Using Cosentyx in plaque psoriasis will benefit you (or your child) by leading to improvements of skin clearance and reducing symptoms such as scaling, itching and pain.

Juvenile idiopathic arthritis, including enthesitis-related arthritis and juvenile psoriatic arthritis Cosentyx is used in patients (6 years of age and older) to treat conditions of the juvenile idiopathic arthritis categories called enthesitis-related arthritis and juvenile psoriatic arthritis . These conditions are inflammatory diseases affecting the joints and the places where tendons join the bone.

Using Cosentyx in enthesitis-related arthritis and juvenile psoriatic arthritis will benefit you (or your child) by reducing the symptoms and improving your (or your child s) physical function.

Do not use Cosentyx:

• if you (or your child) are allergic to secukinumab or any of the other ingredients of this medicine (listed in section 6). If you think you (or your child) may be allergic, ask your doctor for advice before using Cosentyx.
• if you (or your child) have an active infection which your doctor thinks is important.

Warnings and precautions Talk to your doctor, nurse or pharmacist before using Cosentyx:

• if you (or your child) currently have an infection.
• if you (or your child) have long-term or repeated infections.
• if you (or your child) have tuberculosis.
• if you (or your child) have ever had an allergic reaction to latex.
• if you (or your child) have an inflammatory disease affecting the gut called Crohn s disease.
• if you (or your child) have an inflammation of the large intestine called ulcerative colitis.
• if you (or your child) have recently had a vaccination or are due to have a vaccination during treatment with Cosentyx.
• if you (or your child) are receiving any other treatment for psoriasis, such as another immunosuppressant or phototherapy with ultraviolet (UV) light.

Inflammatory bowel disease (Crohn s disease or ulcerative colitis) Stop using Cosentyx and tell your doctor or seek medical help immediately if you (or your child) notice abdominal cramps and pain, diarrhoea, weight loss, blood in the stool or any other signs of bowel problems.

Look out for infections and allergic reactions Cosentyx can potentially cause serious side effects, including infections and allergic reactions. You must look out for signs of these conditions while you (or your child) are taking Cosentyx.

Stop using Cosentyx and tell your doctor or seek medical help immediately if you (or your child) notice any signs indicating a possible serious infection or an allergic reaction. Such signs are listed under Serious side effects in section 4. Children and adolescents Cosentyx is not recommended for children younger than 6 years of age with plaque psoriasis because it has not been studied in this age group.

Cosentyx is not recommended for children younger than 6 years of age with juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis).

Cosentyx is not recommended for children and adolescents (under 18 years of age) in other indications because it has not been studied in this age group.

Other medicines and Cosentyx Tell your doctor or pharmacist:

• if you (or your child) are taking, have recently taken or might take any other medicines.
• if you (or your child) have recently had or are due to have a vaccination. You (or your child) should not be given certain types of vaccines (live vaccines) while using Cosentyx.

Pregnancy, breast-feeding and fertility

• It is preferable to avoid the use of Cosentyx in pregnancy. The effects of this medicine in pregnant women are not known. If you (or your child) are of childbearing potential, you (or your child) are advised to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for at least 20 weeks after the last Cosentyx dose. Talk to your doctor if you (or your child) are pregnant, may be pregnant or are planning to have a baby.
• Talk to your doctor if you (or your child) are breast-feeding or are planning to breast-feed. You and your doctor should decide if you (or your child) will breast-feed or use Cosentyx. You (or your child) should not do both. After using Cosentyx you (or your child) should not breast-feed for at least 20 weeks after the last dose.

Driving and using machines Cosentyx is unlikely to influence your ability to drive and use machines.

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

Cosentyx is given via injection under the skin (known as a subcutaneous injection). You and the doctor should decide if, after proper training, you should inject Cosentyx yourself or a caregiver should give the injection.

It is important not to try to inject Cosentyx before being trained by your doctor, nurse or pharmacist.

For detailed instructions on how to inject Cosentyx, see Instructions for use of Cosentyx 75 mg pre-filled syringe at the end of this leaflet.

Instructions for use can also be found via the following QR code and web site: QR code to be included
www.cosentyx.eu

How much Cosentyx is given and for how long Your doctor will decide how much Cosentyx you (or your child) need and for how long.

Paediatric plaque psoriasis (children aged 6 years and older)

• The recommended dose is based on body weight as follows: * Weight below 25 kg: 75 mg by subcutaneous injection. * Weight 25 kg or above and below 50 kg: 75 mg by subcutaneous injection. * Weight 50 kg or above: 150 mg by subcutaneous injection. Your doctor may increase the dose to 300 mg.
• Each 75 mg dose is given as one injection of 75 mg. Other dosage forms/strengths may be available for administration of the 150 mg and 300 mg doses.

After the first dose you (or your child) will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Juvenile idiopathic arthritis (enthesitis-related arthritis and juvenile psoriatic arthritis)

• The recommended dose is based on body weight as follows: * Weight below 50 kg: 75 mg by subcutaneous injection. * Weight 50 kg or above: 150 mg by subcutaneous injection.
• Each 75 mg dose is given as one injection of 75 mg. Other dosage forms/strengths may be available for administration of the 150 mg dose.

After the first dose you (or your child) will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.

Cosentyx is for long-term treatment. Your doctor will regularly monitor your (or your child s) condition to check that the treatment is having the desired effect.

If you use more Cosentyx than you should If you (or your child) have received more Cosentyx than you (they) should or the dose has been administered sooner than according to your doctor s prescription, inform your doctor.

If you forget to use Cosentyx If you have forgotten to inject a dose of Cosentyx, inject the next dose as soon as you (or your child) remember. Then talk to your doctor to discuss when you should inject the next dose.

If you (or your child) stop using Cosentyx It is not dangerous to stop using Cosentyx. However, if you stop, your (or your child s) psoriasis symptoms may come back.

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

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

Serious side effects Stop using Cosentyx and tell your doctor or seek medical help immediately if you (or you child) get any of the following side effects:

Possible serious infection - the signs may include:

• fever, flu-like symptoms, night sweats
• feeling tired or short of breath, cough which will not go away
• warm, red and painful skin, or a painful skin rash with blisters
• burning sensation when passing urine.

Serious allergic reaction - the signs may include:

• difficulty breathing or swallowing
• low blood pressure, which can cause dizziness or light-headedness
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps. Your doctor will decide if and when you (or your child) may restart the treatment.

Other side effects Most of the following side effects are mild to moderate. If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.

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

• upper respiratory tract infections with symptoms such as sore throat and stuffy nose (nasopharyngitis, rhinitis)

Common (may affect up to 1 in 10 people):

• cold sores (oral herpes)
• diarrhoea
• runny nose (rhinorrhoea)
• headache
• nausea
• fatigue

Uncommon (may affect up to 1 in 100 people):

• oral thrush (oral candidiasis)
• signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections (neutropenia)
• infection of the external ear (otitis externa)
• discharge from the eye with itching, redness and swelling (conjunctivitis)
• itchy rash (urticaria)
• lower respiratory tract infections
• abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems)
• small, itchy blisters on the palms of hands, soles of feet and edges of the fingers and toes (dyshidrotic eczema)
• athlete s foot (tinea pedis)

Rare (may affect up to 1 in 1 000 people):

• severe allergic reaction with shock (anaphylactic reaction)
• redness and shedding of skin over a larger area of the body, which may be itchy or painful (exfoliative dermatitis)
• inflammation of small blood vessels, which can lead to a skin rash with small red or purple bumps (vasculitis)

Not known (frequency cannot be estimated from the available data):

• fungal infections of the skin and mucous membranes (including oesophageal candidiasis)
• painful swelling and skin ulceration (pyoderma gangrenosum)

Reporting of side effects If you (or your child) get any side effects, talk to your doctor, pharmacist or nurse. 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 outer box or the label on the syringe after EXP .
• if the liquid contains easily visible particles, is cloudy or is distinctly brown.

Store the syringe sealed in its box to protect from light. Store in the refrigerator between 2 C and 8 C. Do not freeze. Do not shake. If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room temperature, not above 30 C.

This medicine is for single use only.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Cosentyx contains

• The active substance is secukinumab. Each pre-filled syringe contains 75 mg secukinumab.
• The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80 and water for injections.

What Cosentyx looks like and contents of the pack Cosentyx solution for injection is a clear liquid. Its colour may vary from colourless to slightly yellow. Cosentyx 75 mg solution for injection in pre-filled syringe is available in unit packs containing 1 pre-filled syringe and in multipacks containing 3 (3 packs of 1) pre-filled syringes. Not all pack sizes may be marketed.

Marketing Authorisation Holder Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland

Manufacturer Novartis Pharma GmbH Roonstra e 90429 Nuremberg Germany

Sandoz GmbH Biochemiestrasse 6336 Langkampfen Austria

Novartis Pharmaceutical Manufacturing GmbH Biochemiestrasse 6336 Langkampfen Austria

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

Belgi /Belgique/Belgien Novartis Pharma N.V. T l/Tel: +32 2 246 16 Lietuva SIA Novartis Baltics Lietuvos filialas Tel: +370 5 269 16
Novartis Bulgaria EOOD : +359 2 489 98 Luxembourg/Luxemburg Novartis Pharma N.V. T l/Tel: +32 2 246 16 esk republika Novartis s.r.o. Tel: +420 225 775 Magyarorsz g Novartis Hung ria Kft. Tel.: +36 1 457 65 Danmark Novartis Healthcare A/S Tlf: +45 39 16 84 Malta Novartis Pharma Services Inc. Tel: +356 2122 2Deutschland Novartis Pharma GmbH Tel: +49 911 273 0

Nederland Novartis Pharma B.V. Tel: +31 88 04 52 Eesti SIA Novartis Baltics Eesti filiaal Tel: +372 66 30 Norge Novartis Norge AS Tlf: +47 23 05 20
Novartis (Hellas) A.E.B.E. : +30 210 281 17 sterreich Novartis Pharma GmbH Tel: +43 1 86 6Espa a Novartis Farmac utica, S.A. Tel: +34 93 306 42 Polska Novartis Poland Sp. z o.o. Tel.: +48 22 375 4France Novartis Pharma S.A.S. T l: +33 1 55 47 66 Portugal Novartis Farma - Produtos Farmac uticos, S.A. Tel: +351 21 000 8Hrvatska Novartis Hrvatska d.o.o. Tel. +385 1 6274 Rom nia Novartis Pharma Services Romania SRL Tel: +40 21 31299 Ireland Novartis Ireland Limited Tel: +353 1 260 12 Slovenija Novartis Pharma Services Inc. Tel: +386 1 300 75 sland Vistor hf. S mi: +354 535 7Slovensk republika Novartis Slovakia s.r.o. Tel: +421 2 5542 5Italia Novartis Farma S.p.A. Tel: +39 02 96 54 1 Suomi/Finland Novartis Finland Oy Puh/Tel: +358 (0)10 6133
Novartis Pharma Services Inc. : +357 22 690 Sverige Novartis Sverige AB Tel: +46 8 732 32 Latvija SIA Novartis Baltics Tel: +371 67 887 United Kingdom (Northern Ireland) Novartis Ireland Limited Tel: +44 1276 698This leaflet was last revised in

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