OTEZLA 10 mg/20 mg /30 Mg Film-Coated Tablets

Зміст інструкції

1. Otezla 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets
   1. What is Otezla and what is it used for
   2. What you need to know before taking Otezla
   3. How to take Otezla
   4. Possible side effects
   5. How to store Otezla
   6. Package contents and other information

Otezla 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets

apremilast

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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

1. What is Otezla and what is it used for

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

What is Otezla used for
Otezla is used for the treatment of adults suffering from the following diseases:

• Active psoriatic arthritis- if another type of medicines called “disease-modifying antirheumatic drugs” (DMARDs) cannot be used, or if treatment with one of these medicines has been attempted, but has not been effective.
• Moderate to severe chronic plaque psoriasis- if one of the following treatments cannot be used, or if one of these treatments has been attempted, but has not been effective:
• phototherapy - a treatment in which certain areas of the skin are exposed to ultraviolet light
• systemic therapy - a treatment that affects the whole body rather than just an area, such as “cyclosporine”, “methotrexate” or “psoralene”.
• Behçet’s disease (BD)- for the treatment of mouth ulcers which is a common problem for people with this disease.

Otezla is used for the treatment of children and adolescents aged 6 years and over and weighing
at least 20 kg, with the following conditions:

• Moderate to severe plaque psoriasis- if the doctor decides that systemic therapy such as Otezla is appropriate for them.

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 that can cause red, scaly, thick, itchy and painful patches on the skin and which 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 mouth ulcers.

How does Otezla work
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong diseases and
for which there is currently no cure. Otezla works by reducing the activity of an enzyme present
in the body, called “phosphodiesterase 4”, which is involved in the inflammatory process. By reducing
the activity of this enzyme, Otezla can help to control the inflammation associated with psoriatic
arthritis, psoriasis and Behçet’s disease and thus alleviate the signs and symptoms of these
clinical conditions.
In adults with psoriatic arthritis, treatment with Otezla produces an improvement in swelling and
pain in the joints and can improve overall physical function.
In adults and in children and adolescents aged 6 years and over and weighing at least 20 kg with
psoriasis, treatment with Otezla produces a reduction in psoriatic 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 mouth ulcers and can
stop them completely. It can also reduce the associated pain.
It has also been shown that Otezla 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 the disease on daily activities, relationships and other
factors would be less than before.

2. What you need to know before taking 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 or think you might 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 suffer from depression that is worsening with suicidal thoughts.
You or the person who cares for you should also immediately inform your doctor of any changes in behaviour or mood, feeling of depression and suicidal thoughts that you may experience 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 you are taking Otezla if you lose weight unintentionally.

Intestinal problems
If you develop severe diarrhoea, nausea or vomiting, you should talk to your doctor.

Children and adolescents
Otezla is not recommended for use in children with moderate to severe plaque psoriasis who are under 6 years of age or weigh less than 20 kg, because it has not been studied in this age group and in this weight group.
Otezla is not recommended for use in children and adolescents under 18 years of age for other indications, because 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, including those without a prescription and herbal medicines. This is because Otezla can affect the action of other medicines and other medicines can affect the action of Otezla.
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 to treat seizures or epilepsy
• St John's wort - a herbal medicine for mild anxiety and depression.

Pregnancy and breastfeeding
Do not take Otezla if you are or think you might be pregnant.
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding, ask your doctor or pharmacist for advice before taking 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 contraception during treatment with Otezla.
It is not known whether this medicine passes into breast milk. You should not use Otezla while breastfeeding.

Driving and using machines
Otezla does not affect the ability to drive or operate machinery.

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

3. How to take Otezla

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

Dosage

• When you start taking Otezla, you will receive a “treatment starter pack”, containing a quantity of tablets sufficient for a total of two weeks of treatment.
• The “treatment starter pack” has clear labelling to ensure that you take the right tablet at the right time.
• Treatment will begin with a lower dose, which will be gradually increased during the first week of treatment (ramp-up phase).
• The “treatment starter pack” will also contain enough tablets for another week of treatment at the recommended dose.
• Once the recommended dose is reached, you will only take a single tablet from the prescribed packs.
• You will only need to follow this dose ramp-up phase once, even if you restart treatment after an interruption.

Adults

• The recommended dose of Otezla for adult patients is 30 mg twice a day, once the dose ramp-up phase is completed, as shown in the following table: a 30 mg dose in the morning and a 30 mg dose in the evening, approximately 12 hours apart, with or without food. This corresponds to a total daily dose of 60 mg.

Dose
daily
total
Day 110 mg (pink) Do not take any dose10 mg

Day 210 mg (pink) 10 mg (pink) 20 mg

Day 310 mg (pink) 20 mg (brown) 30 mg

Day 420 mg (brown) 20 mg (brown) 40 mg

Day 520 mg (brown) 30 mg (beige) 50 mg

From day 6
onwards
30 mg (beige) 30 mg (beige) 60 mg

DayMorning doseEvening dose
Children and adolescents aged 6 years and over

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

For patients weighing between 20 kg and less than 50 kg:The recommended dose of Otezla is 20 mg twice a day, once the dose ramp-up phase is completed, as shown in the following table: a 20 mg dose in the morning and a 20 mg dose in the evening, approximately 12 hours apart, with or without food. This corresponds to a total daily dose of 40 mg.

For patients weighing 50 kg or more:The recommended dose of Otezla is 30 mg, twice a day, once the dose ramp-up phase is completed (same dose as adults), as shown in the following table: a 30 mg dose in the morning and a 30 mg dose in the evening, approximately 12 hours apart, with or without food. This corresponds to a total daily dose of 60 mg.

Patients with severe kidney problems
If you are an adult with severe kidney problems, the recommended dose of Otezla is 30 mg once a day
(morning dose).
In children and adolescents aged 6 years and over, with severe kidney impairment, for patients weighing 50 kg or more, the recommended dose of Otezla is 30 mg once a day
(morning dose)and 20 mg once a day (morning dose), for children weighing between 20 kg and less than 50 kg.
Your doctor will explain how to increase the dose when you start treatment with Otezla. Your doctor may advise you to only take the morning dose, shown in the table above, suitable for you (for adults or for children/adolescents) and to skip the evening dose.

How and when to take Otezla

• Otezla is for oral use.
• Swallow the tablets whole, preferably with water.
• You can take the tablets 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 consult your doctor.

If you take more Otezla than you should
If you take more Otezla than you should, consult your doctor or go to hospital immediately. Bring

If you forget to take Otezla

• If you forget to take a dose of Otezla, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose to make up for a missed dose.

If you stop taking Otezla

• Continue to take Otezla until your doctor tells you to stop treatment.
• Do not stop taking Otezla without first consulting your doctor.

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.

Serious side effects - depression and suicidal thoughts
Tell your doctor immediately about any changes in behaviour or mood, feelings of depression, suicidal thoughts or suicidal behaviour (this is uncommon).

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

• diarrhoea
• nausea
• headache
• upper respiratory tract infection 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 airways (bronchitis)
• common cold (nasopharyngitis)
• depression
• migraine
• tension headache

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

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

Side effects with unknown frequency(frequency cannot be estimated from available data):

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

If you are 65 years of age or older you may be more at risk of complications from severe diarrhoea, nausea
and vomiting. If your bowel problems become severe, you should talk to your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system detailed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store 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 the carton after Exp. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Do not use this medicine if you notice damage or signs of tampering with the packaging.

Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Otezla contains
The active ingredient 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 components present in the tablet core are microcrystalline cellulose, lactose
monohydrate, sodium croscarmellose and magnesium stearate.

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

Description of the appearance of Otezla and contents of the pack
The 10 mg film-coated tablet of Otezla is a film-coated tablet in the shape of a
rhombus, pink in colour, with “APR” embossed on one side and “10” on the other side.
The 20 mg film-coated tablet of Otezla is a film-coated tablet in the shape of a
rhombus, brown in colour, with “APR” embossed on one side and “20” on the other side.
The 30 mg film-coated tablet of Otezla is a film-coated tablet in the shape of a
rhombus, beige in colour, with “APR” embossed on one side and “30” on the other side.
Packs for starting treatment
For starting treatment, the folding packs contain:

• 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.

Packs with Otezla 20 mg tablets

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

Packs 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
The Netherlands

Marketing authorisation holder
Amgen Europe B.V.
Minervum 7061
4817 ZK Breda
The Netherlands

Manufacturer
Amgen NV
Telecomlaan 5-7
1831 Diegem
Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
s.a. Amgen n.v.
Tél/Tel: +32 (0)2 7752711

Lietuva
Amgen Switzerland AG Vilniaus filialas
Tel: +370 5 219 7474

България
Амджен България ЕООД
Тел.: +359 (0)2 424 7440

Luxembourg/Luxemburg
s.a. Amgen
Belgique/Belgien
Tél/Tel: +32 (0)2 7752711

Česká republika
Amgen s.r.o.
Tel: +420 221 773 500

Magyarország
Amgen Kft.
Tel.: +36 1 35 44 700

Danmark
Amgen, filial af Amgen AB, Sverige
Tlf: +45 39617500

Malta
Amgen S.r.l
Italy
Tel: +39 02 6241121

Deutschland
Amgen GmbH
Tel.: +49 89 1490960

Nederland
Amgen B.V.
Tel: +31 (0)76 5732500

Eesti
Amgen Switzerland AG Vilniaus filialas
Tel: +372 586 09553

Norge
Amgen AB
Tlf: +47 23308000

Ελλάδα
Amgen Ελλάς Φαρμακευτικά Ε.Π.Ε.
Τηλ: +30 210 3447000

Österreich
Amgen GmbH
Tel: +43 (0)1 50 217

España
Amgen S.A.
Tel: +34 93 600 18 60

Polska
Amgen Biotechnologia Sp. z o.o.
Tel.: +48 22 581 3000

France
Amgen S.A.S.
Tél: +33 (0)9 69 363 363

Portugal
Amgen Biofarmacêutica, Lda.
Tel: +351 21 4220606

Hrvatska
Amgen d.o.o.
Tel: +385 (0)1 562 57 20

România
Amgen România SRL
Tel: +4021 527 3000

Ireland
Amgen Ireland Limited
Tel: +353 1 8527400

Slovenija
AMGEN zdravila d.o.o.
Tel: +386 (0)1 585 1767

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
Amgen Slovakia s.r.o.
Tel: +421 2 321 114 49

Italia
Amgen S.r.l.
Tel: +39 02 6241121

Suomi/Finland
Amgen AB, sivuliike Suomessa/Amgen AB, filial
i Finland
Puh/Tel: +358 (0)9 54900500

Kύπρος
C.A. Papaellinas Ltd
Τηλ: +357 22741 741

Sverige
Amgen AB
Tel: +46 (0)8 6951100

Latvija
Amgen Switzerland AG Rīgas filiāle
Tel: +371 257 25888

United Kingdom (Northern Ireland)
Amgen Limited
Tel: +44 (0)1223 420305

Other sources of information
For detailed and up-to-date information on this medicinal product, scan the QR code
on the secondary packaging with a smartphone. The same information is also available at
the following address: www.otezla-eu-pil.com .
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .