Package Insert: Information for the Patient

Otezla 10Film-Coated Tablets

Otezla 20Film-Coated Tablets

Otezla 30Film-Coated Tablets

apremilast

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section4.

What is Otezla

Otezla contains the active ingredient “apremilast”. It belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.

What is Otezla used for

Otezla is used to treat adults with the following diseases:

• Active psoriatic arthritis:if you cannot use another type of medicine called “Disease-Modifying Antirheumatic Drugs” (DMARDs) or when you have already tried one of these medicines and it did not work.
• Chronic moderate to severe plaque psoriasis:if you cannot use one of the following treatments or when you have already tried one of these treatments and it did not work:
• • phototherapy: a treatment in which certain areas of the skin are exposed to ultraviolet light
  • systemic treatment: a treatment that acts throughout the body instead of a localized area, such as “ciclosporina”, “metotrexate”, or “psoralen”.
• Behçet's disease (BD) - to treat mouth ulcers, a common problem in people with this disease.

Otezla is used to treat children and adolescents aged 6years or older and weighing at least 20kg with the following condition:

• Chronic moderate to severe plaque psoriasis:if your doctor considers it appropriate for you to take a systemic treatment like Otezla.

What is psoriatic arthritis

Psiatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, an inflammatory skin disease.

What is plaque psoriasis

Poriasis is an inflammatory skin disease,which can produce red, scaly, thickened, itchy, or painful lesions on the skin, and can also affect the scalp and nails.

What is Behçet's disease

Behçet's disease is a rare inflammatory disease that affects many parts of the body. The most common problem is mouth ulcers.

How does Otezla work

Psiatic arthritis, psoriasis, and Behçet's disease are generally chronic diseases that currently have no cure. Otezla works by reducing the activity of an enzyme in the body called “phosphodiesterase 4”, which is involved in the inflammatory process. By reducing the activity of this enzyme, Otezla can help control the inflammation associated withpsoriatic arthritis, psoriasisand Behçet's diseaseand, in this way, reduce the symptoms and signs of these diseases.

In adults with psoriatic arthritis, Otezla treatment improves inflamed and painful joints and can improve overall physical function.

In adults and in children and adolescents aged 6years or older and weighing at least 20kg with psoriasis, Otezla treatment reduces psoriasis plaques on the skin and other symptoms of the disease.

In adults with Behçet's disease, Otezla treatment reduces the number of mouth ulcers and can make them disappear completely. It can also reduce associated pain.

Otezla has also shown that it improves the quality of life of adult and pediatric patients with psoriasis, adult patients with psoriatic arthritis, and adult patients with Behçet's disease. This means that the impact of your disease on daily activities, relationships, and other factors should be less than before.

Do not take Otezla

Warnings and precautions

Consult your doctor or pharmacist before starting to take Otezla.

Depression and suicidal thoughts

Inform your doctor before starting treatment with Otezla if you have depression that may worsen with suicidal thoughts.

You or your caregiver must also inform your doctor immediately if there is any change in behavior or mood, feelings of depression, and any suicidal thoughts you may have after taking Otezla.

Severe kidney problems

If you have severe kidney problems, the dose will be different, see section 3.

If you have a low body weight

Talk to your doctor while taking Otezla if you unintentionally lose weight.

Gastrointestinal problems

If you experience severe diarrhea, nausea, or vomiting, inform your doctor.

Children and adolescents

Otezla is not recommended for use in children with plaque psoriasis of moderate to severe severity and who are less than 6years old or weigh less than 20kg, as it has not been studied in these age and weight groups.

Otezla is not recommended for use in children and adolescents under 18years old in other indications, as the safety and efficacy have not been established in this age group.

Other medications and Otezla

Inform your doctor or pharmacistif you are taking, have taken recently, or may need to take any other medication.This includes medications obtained without a prescription and herbal medications. This is because Otezla may affect the way other medications work. Additionally, some medications may affect the way Otezla works.

Specifically, inform your doctor or pharmacist before starting to take Otezla if you are taking any of the following medications:

• rifampicin: an antibiotic used to treat tuberculosis;
• phenytoin, phenobarbital, and carbamazepine: medications used to treat seizures or epilepsy;
• St. John's Wort: a herbal medication used to treat mild anxiety and depression.

Pregnancy and breastfeeding

Do not take Otezla if you are pregnant or think you may be.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is limited information on the effects of Otezladuring pregnancy. Do not become pregnant while taking this medication andmust use effective birth control methodsduring treatment with Otezla.

The safety of Otezlain breastfeeding women is unknown. Otezlashould not be used while breastfeeding.

Driving and operating machinery

The influence ofOtezlaon the ability to drive and operate machinery is negligible.

Otezla contains lactose

Otezla contains lactose (a type of sugar). If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

• When you start taking Otezla for the first time, you will receive a "starting treatment package" that contains enough tablets for a total of two weeks of treatment
• The "starting treatment package" is clearly labeled to ensure you take the correct dose at the correct time
• Your treatment will start at a lower dose and gradually increase during the first week of treatment (escalation phase)
• The "starting treatment package" will also contain enough tablets for another week at the recommended dose
• Once you reach the recommended dose, the prescribed packages will contain only single-dose tablets
• You will only have to go through the process of gradually increasing the dose once, even if you have to restart treatment

Adults

• The recommended dose of Otezla for adult patients is 30mg twice a day after completing the escalation phase, as shown in the table below, a dose of 30mg in the morning and a dose of 30mg at night, approximately every 12hours, with or without food. This makes a total daily dose of 60mg.

Children and adolescents 6 years or older

• The dose of Otezla will be based on body weight

For patients with a weight of 20kg or less than 50kg:the recommended dose of Otezla is 20mg twice a day after completing the escalation phase, as shown in the table below, a dose of 20mg in the morning and a dose of 20mg at night, approximately every 12hours, with or without food. This makes a total daily dose of 40mg.

For patients with a weight of 50 kg or more:the recommended dose of Otezla is 30mg twice a day after completing the escalation phase (the same as the adult dose), as shown in the table below, a dose of 30mg in the morning and a dose of 30mg at night, approximately every 12hours, with or without food. This makes a total daily dose of 60mg.

Patients with severe kidney problems

If you are an adult with severe kidney problems, then the recommended dose of Otezla is 30mgonce a day (morning dose).

For children and adolescents 6 years or older with severe renal insufficiency, the recommended dose of Otezla is 30mgonce a day (morning dose)for patients with a weight of 50 kg or more, and 20mgonce a day (evening dose)for children with a weight of 20kg to less than 50kg.

Your doctor will tell you how to increase the dose when you start taking Otezla for the first time. Your doctor may advise you to take only the morning dose that applies to your case as shown in the table above (for adults or for children/adolescents) and skip the evening dose.

How and when to take Otezla

• Otezla is taken orally
• Swallow the tablets whole, preferably with water
• You can take the tablets with or without food
• Take Otezla approximately at the same time each day, one tablet in the morning and one tablet at night

If you do not improve your disease after six months of treatment, consult your doctor.

If you take more Otezla than you should

If you take more Otezla than you should, consult a doctor or go to the hospital immediately. Bring the medication package and the leaflet with you.

If you forget to take Otezla

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

If you interrupt treatment with Otezla

• You must continue taking Otezla until your doctor tells you to stop.
• Do not stop taking Otezla without consulting your doctor first.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects, depression, and suicidal thoughts

Inform your doctor immediately if you notice any changes in behavior and mood, feelings of depression, suicidal thoughts, or suicidal behavior (this is rare).

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

• diarrhea
• nausea
• headaches, migraines, or tension headaches
• upper respiratory tract infections such as the common cold, runny nose, or sinusitis

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

• cough
• back pain
• vomiting
• fatigue
• stomach pain
• loss of appetite
• more frequent bowel movements
• difficulty sleeping (insomnia)
• indigestion or stomach burning
• inflammation and swelling of the airways (bronchitis)
• common cold (nasopharyngitis)
• depression
• migraine
• tension headache

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

• skin rash
• hives
• weight loss
• allergic reaction
• bleeding in the intestine or stomach
• suicidal ideation or behavior

Side effects not known(the frequency cannot be estimated from the available data)

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

If you are 65years or older, you may be at a higher risk of experiencing severe diarrhea, nausea, and vomiting. If your intestinal problems become severe, you should speak with your doctor.

Reporting side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directlythrough the national notification system included in Appendix V.

By reporting side effects, you can contribute to providing more information about the safety of the medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the blister pack or on the carton or on the box after CAD/EXP. The expiration date is the last day of the month indicated.
• Do not storeat a temperature above 30°C.
• Do not use this medication if you observe any deterioration or signs of manipulation of the medication container.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition ofOtezla

The active ingredient is apremilast.

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

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

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

Appearance of the product and contents of the pack

Otezla 10mg film-coated tablet is a film-coated tablet with a rhomboid shape, pink in color, with “APR” engraved on one face and “10” on the other face.

Otezla 20mg film-coated tablet is a film-coated tablet with a rhomboid shape, brown in color, with “APR” engraved on one face and “20” on the other face.

Otezla 30mg film-coated tablet is a film-coated tablet with a rhomboid shape, beige in color, with “APR” engraved on one face and “30” on the other face.

Starting pack sizes

The starting pack sizes are collapsible boxes containing:

• 27film-coated tablets: 4film-coated tablets of 10mg and 23film-coated tablets of 20mg

• 27film-coated tablets: 4film-coated tablets of 10mg, 4film-coated tablets of 20mg and 19film-coated tablets of 30mg

Pack sizes with Otezla 20mg film-coated tablets

• The standard pack for one month contains 56film-coated tablets of 20mg.

Pack sizes with Otezla 30mg film-coated tablets

• The standard pack for one month contains 56film-coated tablets of 30mg.
• The standard pack for three months contains 168film-coated tablets of 30mg.

Marketing authorisation holder and responsible person for manufacturing

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing authorisation holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Responsible person for manufacturing

Celgene Distribution B.V.

Winthontlaan 6 N

3526 KV Utrecht

Netherlands

Responsible person for manufacturing

Amgen NV

Telecomlaan 5-7

1831 Diegem

Belgium

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet:

Other sources of information

You can access detailed and updated information about this medicine by scanning the QR code included in the outer packaging with your smartphone. You can also access this information on the following website:www.otezla-eu-pil.com.

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.