OTEZLA 10 mg, 20 mg, 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Otezla 10mg film-coated tablets

Otezla 20mg film-coated tablets

Otezla 30mg film-coated tablets

apremilast

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you..

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Otezla and what is it used for

What is Otezla

Otezla contains the active substance “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 other types of medicines called “Disease-Modifying Antirheumatic Drugs” (DMARDs) or when you have already tried one of these medicines and it has not worked.
• 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 has not worked:
• • phototherapy: a treatment where certain areas of the skin are exposed to ultraviolet light
  • systemic treatment: a treatment that acts on the whole body instead of a localized area, such as “ciclosporin”, “methotrexate”, or “psoralen”.
• Behçet's disease (BD) - to treat oral ulcers, a common problem in people with this disease.

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

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

What is psoriatic arthritis

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

What is plaque psoriasis

Psoriasis is an inflammatory disease of the skin, 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 type of inflammatory disease that affects many parts of the body. The most common problem is oral ulcers.

How Otezla works

Psoriatic arthritis, psoriasis, and Behçet's disease are usually 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 with psoriatic arthritis, psoriasis, and Behçet's disease, and thus reduce the signs and symptoms of these diseases.

In adults with psoriatic arthritis, treatment with Otezla results in an improvement in inflamed and painful joints and can improve overall physical function.

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

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

Otezla has also been shown to improve 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.

2. What you need to know before you take Otezla

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

Consult your doctor or pharmacist before starting treatment with Otezla.

Depression and suicidal thoughts

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

You or your caregiver should also inform your doctor immediately of 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 weight below normal

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

Gastrointestinal problems

If you suffer from severe diarrhea, nausea, or vomiting, you should inform your doctor.

Children and adolescents

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

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

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 may affect the way other medicines work. Also, some medicines may affect the way Otezla works.

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

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

Pregnancy and breastfeeding

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

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

There is limited information on the effects of Otezla during pregnancy. You should not become pregnant while taking this medicine and should use effective contraceptive methods during treatment with Otezla.

It is not known whether this medicine passes into breast milk. Otezla should not be used while breastfeeding.

Driving and using machines

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

Otezla contains lactose

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

3. How to take Otezla

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

• When you start taking Otezla for the first time, you will receive a “treatment initiation pack” that contains enough tablets for a total of two weeks of treatment.
• The “treatment initiation pack” is clearly labeled to ensure you take the correct dose at the correct time.
• Your treatment will start at a lower dose and will gradually increase over the first week of treatment (titration phase).
• The “treatment initiation pack” will also contain enough tablets for another week at the recommended dose.
• Once the recommended dose is reached, the prescribed packs will contain only single-dose tablets.
• You will only need to go through the dose escalation process once, even if you need to restart treatment.

Adults

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

Children and adolescents from 6 years old

• The dose of Otezla will be based on body weight.

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

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

Patient with severe kidney problems

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

In children and adolescents from 6 years old with severe kidney impairment, the recommended dose of Otezla is 30 mg once a day (morning dose)for patients with a weight of at least 50 kg, and 20 mg once a day (evening dose)for children with a weight of 20 kg to less than 50 kg.

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 in the evening.

If your disease does not improve 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 a hospital immediately. 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 possible. If it is close to the time of your next dose, skip the missed dose. Take your next dose at the usual time.
• Do not take a double dose to make up for missed doses.

If you stop taking Otezla

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

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.

Severe side effects, depression, and suicidal thoughts

Tell your doctor immediately if you experience any change in behavior or mood, feelings of depression, or suicidal thoughts or behaviors (this is uncommon).

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

• diarrhea
• nausea
• headache, migraine, or tension headache
• upper respiratory tract infections such as cold, runny nose, sinus infection (sinusitis)

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

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

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

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

Unknown 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 cause difficulty breathing or swallowing)

If you are 65 years old or more, you may have a higher risk of suffering from diarrhea, nausea, and vomiting. If your gastrointestinal problems become severe, you should talk to your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Otezla

• 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 carton after CAD/EXP. The expiry date is the last day of the month stated.
• Do not store above 30°C.
• Do not use this medicine if you notice any deterioration or signs of tampering with the medicine packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition ofOtezla

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 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, and red iron oxide (E172).
• The 20 mg film-coated tablet also contains yellow iron oxide (E172).
• The 30 mg film-coated tablet also contains yellow iron oxide (E172) and black iron oxide (E172).

Appearance and packaging of the product

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

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

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

Package sizes for initiation of treatment

The starter packs are foldable boxes containing:

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

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

Package sizes with Otezla 20 mg tablets

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

Package sizes with Otezla 30 mg tablets

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

Marketing authorisation holder and manufacturer

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Marketing authorisation holder

Amgen Europe B.V.

Minervum 7061

4817 ZK Breda

Netherlands

Manufacturer

Celgene Distribution B.V.

Winthontlaan 6 N

3526 KV Utrecht

Netherlands

Manufacturer

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:

Date of last revision of this leaflet:

Other sources of information

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the outer packaging with your smartphone. You can also access this information at the following internet address: www.otezla-eu-pil.com.

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