Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - otezla

Document Subject

Generated Narrative: MedicinalProductDefinition mp8e4b99b58ac1302c60e1a3d75920f33f

identifier: http://ema.europa.eu/identifier/EU/1/14/981/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Otezla 10 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-8e4b99b58ac1302c60e1a3d75920f33f

identifier: http://ema.europa.eu/identifier/EU/1/14/981/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - otezla

Attesters

What is in this leaflet

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

What Otezla is

Otezla contains the active substance apremilast . This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.

What Otezla is used for

Otezla is used to treat adults with the following conditions:

• Active psoriatic arthritis - if you cannot use another type of medicine called Disease-Modifying Antirheumatic Drugs (DMARDs) or when you have tried one of these medicines and it did not work.
• Moderate to severe chronic plaque psoriasis - if you cannot use one of the following treatments or when you have tried one of these treatments and it did not work:

• phototherapy - a treatment where certain areas of skin are exposed to ultraviolet light
• systemic therapy - a treatment that affects the entire body rather than just one local area, such as ciclosporin , methotrexate or psoralen .

• Beh et s disease (BD) - to treat the mouth ulcers which is a common problem for people with this illness.

What psoriatic arthritis is

Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.

What plaque psoriasis is

Psoriasis is an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails.

What Beh et s disease is

Beh et s disease is a rare type of inflammatory disease which affects many parts of the body. The most common problem is mouth ulcers.

How Otezla works

Psoriatic arthritis, psoriasis and Beh et s disease are usually lifelong conditions and there is currently no cure. Otezla works by reducing the activity of an enzyme in the body called phosphodiesterase 4 , which is involved in the process of inflammation. By reducing the activity of this enzyme, Otezla can help to control the inflammation associated with psoriatic arthritis, psoriasis and Beh et s disease, and thereby reduce the signs and symptoms of these conditions.

In psoriatic arthritis, treatment with Otezla results in an improvement in swollen and painful joints, and can improve your general physical function.

In psoriasis, treatment with Otezla results in a reduction in psoriatic skin plaques and other signs and symptoms of the disease.

In Beh et s disease, treatment with Otezla reduces the number of mouth ulcers and can stop them completely. It can also reduce the associated pain.

Otezla has also been shown to improve the quality of life in patients with psoriasis, psoriatic arthritis or Beh et s disease. 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 Otezla:

• if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you may be pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before taking Otezla.

Depression and suicidal thoughts

Tell your doctor before starting Otezla if you have depression which is getting worse with thoughts of suicide.

You or your caregiver should also tell your doctor straight away of any changes in behaviour or mood, feelings of depression and of any suicidal thoughts you may have after taking Otezla.

Severe kidney problems

If you have severe kidney problems, your dose will be different see section 3. If you are underweight

Talk to your doctor while taking Otezla if you lose weight without meaning to.

Gut problems

If you experience severe diarrhoea, nausea, or vomiting, you should talk to your doctor.

Children and adolescents

Otezla has not been studied in children and adolescents, therefore it is not recommended for use in children and adolescents aged 17 years and under.

Other medicines and Otezla

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Otezla can affect the way some other medicines work. Also some other medicines can affect the way Otezla works.

In particular, tell your doctor or pharmacist before taking Otezla if you are taking any of the following medicines:

• rifampicin an antibiotic used for tuberculosis
• phenytoin, phenobarbital and carbamazepine - medicines used in the treatment of seizures or epilepsy
• St John s Wort a herbal medicine for mild anxiety and depression.

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 or pharmacist for advice before taking this medicine. There is little information about the effects of Otezla in pregnancy. You should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Otezla.
It is not known if this medicine passes into human milk. You should not use Otezla while breast- feeding.

Driving and using machines

Otezla has no effect on the ability to drive and use machines.

Otezla contains lactose

Otezla contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

How much to take

• When you first start taking Otezla, you will receive a treatment initiation pack which contains all the doses as listed in the table below.
• The treatment initiation pack is clearly labelled to make sure you take the correct tablet at the correct time.
• Your treatment will start at a lower dose and will gradually be increased over the first 6 days of treatment.
• The treatment initiation pack will also contain enough tablets for another 8 days at the recommended dose (days 7 to 14).
• The recommended dose of Otezla is 30 mg twice a day after the titration phase is complete - one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food.
• This is a total daily dose of 60 mg. By the end of day 6 you will have reached this recommended dose.
• Once the recommended dose has been reached, you will only get the 30 mg tablet strength in your prescribed packs. You will only ever need to go through this stage of gradually increasing your dose once even if you re-start treatment.

People with severe kidney problems

If you have severe kidney problems then the recommended dose of Otezla is 30 mg once a day (morning dose). Your doctor will talk to you about how to increase your dose when you first start taking Otezla.

How and when to take Otezla

• Otezla is for oral use.
• Swallow the tablets whole, preferably with water.
• You can take the tablets either with or without food.
• Take Otezla at about the same time each day, one tablet in the morning and one tablet in the evening.

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

If you take more Otezla than you should

If you take more Otezla than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you.

If you forget to take Otezla

• If you miss a dose of Otezla, take it as soon as you remember. If it is close to the time for your next dose, just skip the missed dose. Take the next dose at your regular time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Otezla

• You should continue taking Otezla until your doctor tells you to stop.
• Do not stop taking Otezla without talking to your doctor first. Day Morning Dose Evening Dose Total Daily Dose Day 1 10 mg (pink) Do not take a dose 10 mg Day 2 10 mg (pink) 10 mg (pink) 20 mg Day 3 10 mg (pink) 20 mg (brown) 30 mg Day 4 20 mg (brown) 20 mg (brown) 40 mg Day 5 20 mg (brown) 30 mg (beige) 50 mg Day 6 onwards 30 mg (beige) 30 mg (beige) 60 mg 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.

Serious side effects depression and suicidal thoughts

Tell your doctor straight away about any changes in behaviour or mood, feelings of depression, thoughts of suicide or suicidal behaviour (this is uncommon).

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

• diarrhoea
• nausea
• headache
• upper respiratory tract infections such as cold, runny nose, sinus infection

Common side effects (may affect up to 1 in 10 people)

• cough
• back pain
• vomiting
• feeling tired
• stomach pain
• loss of appetite
• frequent bowel movements
• difficulty sleeping (insomnia)
• indigestion or heartburn
• inflammation and swelling of the tubes in your lungs (bronchitis)
• common cold (nasopharyngitis)
• depression
• migraine
• tension headache

Uncommon side effects (may affect up to 1 in 100 people)

• rash
• hives (urticaria)
• weight loss
• allergic reaction
• bleeding in the bowel or in the stomach
• suicidal ideation or behaviour

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

• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)

If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting. If your gut problems become severe, you should talk to your doctor.

Reporting of side effects

If you 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 blister or on the wallet or on the carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 30 C.
• Do not use this medicine if you notice any damage or signs of tampering to 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 Otezla contains

The active substance is apremilast.

• Otezla 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
• Otezla 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
• Otezla 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.

The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate, croscarmellose sodium and magnesium stearate.

• The film-coating contains poly (vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide red (E172).
• The 20 mg film-coated tablet also contains iron oxide yellow (E172).
• The 30 mg film-coated tablet also contains iron oxide yellow (E172) and iron oxide black (E172).

What Otezla looks like and contents of the pack

The Otezla 10 mg film-coated tablet is a pink, diamond shaped film-coated tablet with APR
engraved on one side and 10 on the opposite side. The Otezla 20 mg film-coated tablet is a brown, diamond shaped film-coated tablet with APR
engraved on one side and 20 on the opposite side. The Otezla 30 mg film-coated tablet is a beige, diamond shaped film-coated tablet with APR
engraved on one side and 30 on the opposite side.

Pack sizes

• The treatment initiation pack is a folding wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4 x 20 mg tablets and 19 x 30 mg tablets.
• The one-month standard pack contains 56 x 30 mg film-coated tablets.
• The three-month standard pack contains 168 x 30 mg film-coated tablets.

Marketing Authorisation Holder and Manufacturer Amgen Europe B.V. Minervum 74817 ZK Breda The Netherlands

Marketing Authorisation Holder Amgen Europe B.V. Minervum 74817 ZK Breda The Netherlands

Manufacturer Amgen NV Telecomlaan 5-7 1831 Diegem Belgium

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

Belgi /Belgique/Belgien s.a. Amgen n.v. Tel/T l: +32 (0)2 7752Lietuva Amgen Switzerland AG Vilniaus filialas Tel: +370 5 219 7

.: +359 (0)2 424 7Luxembourg/Luxemburg s.a. Amgen
Belgique/Belgien Tel/T l: +32 (0)2 7752 esk republika Amgen s.r.o. Tel: +420 221 773 Magyarorsz g Amgen Kft. Tel.: +36 1 35 44 Danmark Amgen, filial af Amgen AB, Sverige Tlf: +45 39617Malta Amgen B.V. The Netherlands Tel: +31 (0)76 5732Deutschland AMGEN GmbH Tel: +49 89 1490Nederland Amgen B.V. Tel: +31 (0)76 5732Eesti Amgen Switzerland AG Vilniaus filialas Tel: +372 586 09Norge Amgen AB Tel: +47 23308
Amgen . . .
: +30 210 3447 sterreich Amgen GmbH
Tel: +43 (0)1 50 Espa a Amgen S.A. Tel: +34 93 600 18 Polska Amgen Biotechnologia Sp. z o.o. Tel.: +48 22 581 3France Amgen S.A.S. T l: +33 (0)9 69 363 Portugal Amgen Biofarmac utica, Lda. Tel: +351 21 4220Hrvatska Amgen d.o.o. Tel: +385 (0)1 562 57 Rom nia Amgen Rom nia SRL Tel: +4021 527 3Ireland Amgen Ireland Limited Tel: +353 1 8527Slovenija AMGEN zdravila d.o.o. Tel: +386 (0)1 585 1 sland Vistor hf. S mi: +354 535 7Slovensk republika Amgen Slovakia s.r.o. Tel: +421 2 321 114 Italia Amgen S.r.l. Tel: +39 02 6241Suomi/Finland Amgen AB, sivuliike Suomessa/Amgen AB, filial i Finland Puh/Tel: +358 (0)9 54900K
C.A. Papaellinas Ltd : +357 22741 Sverige Amgen AB
Tel: +46 (0)8 6951Latvija Amgen Switzerland AG R gas fili le Tel: +371 257 25United Kingdom (Northern Ireland) Amgen Limited Tel: +44 (0)1223 420This leaflet was last revised in

Other sources of information

Detailed and updated information on this medicine is available by scanning the QR code on the outer packaging with a smartphone. The same information is also available on the following URL:
www.otezla-eu-pil.com.

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