APREMILAST ACCORD

Patient Information Leaflet

Apremilast Accord 10 mg film-coated tablets, 20 mg film-coated tablets, 30 mg film-coated tablets

apremilast
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Apremilast Accord is and what it is used for

What Apremilast Accord is
Apremilast Accord contains the active substance "apremilast". This active substance belongs to a group of medicines called "phosphodiesterase 4 inhibitors", which help reduce inflammation.
What Apremilast Accord is used for
Apremilast Accord is used to treat adults with the following conditions:

• Active psoriatic arthritis – if it is not possible to use another type of medicine called "disease-modifying antirheumatic drugs" (DMARDs), or if treatment with one of these medicines has been tried but was not effective.
• Moderate to severe chronic plaque psoriasis – if the following treatments cannot be used, or if one of these treatments has been tried but was not 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 one area, such as "cyclosporine", "methotrexate", or "psoralen".
• Behçet’s disease (BD) – for the treatment of mouth ulcers, which are a common problem for people with this disease.

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

• Moderate to severe plaque psoriasis – if your doctor determines that it is appropriate for you to take a systemic therapy such as Apremilast.

What psoriatic arthritis is
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory skin disease.
What plaque psoriasis is
Psoriasis is an inflammatory skin disease that can cause red, scaly, thick patches on the skin, which may be itchy and painful, and may also affect the scalp and nails.
What Behçet’s disease is
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 Apremilast Accord works
Psoriatic arthritis, psoriasis, and Behçet’s disease are usually lifelong conditions for which there is currently no cure. Apremilast Accord 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, Apremilast Accord can help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet’s disease, thereby reducing the signs and symptoms of these conditions.
In adults with psoriatic arthritis, treatment with Apremilast Accord leads to improvement in joint swelling and pain and may improve overall physical function.
In adults, and in children and adolescents aged 6 years and older and weighing at least 20 kg with psoriasis, treatment with Apremilast Accord reduces psoriatic skin plaques and other signs and symptoms of the disease.
In adults with Behçet’s disease, treatment with Apremilast Accord reduces the number of mouth ulcers and may stop them completely. It may also reduce associated pain.
Apremilast Accord has also been shown to improve the quality of life in adult and pediatric patients with psoriasis, in adult patients with psoriatic arthritis, and in 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 Apremilast Accord

Do not take Apremilast Accord:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Apremilast Accord.
Depression and suicidal thoughts
Inform your doctor before starting Apremilast Accord if you have depression that is worsening, with suicidal thoughts.
You or the person caring for you must also inform your doctor immediately of any changes in behaviour or mood, feelings of depression, or suicidal thoughts that you may experience after taking Apremilast Accord.
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 Apremilast Accord if you lose weight unintentionally.
Gastrointestinal problems
If you develop severe diarrhoea, nausea or vomiting, you must discuss this with your doctor.
Children and adolescents
Apremilast Accord is not recommended for use in children under 6 years of age or weighing less than 20 kg with moderate to severe plaque psoriasis, as it has not been studied in this age group and body weight category.
Apremilast Accord 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 Apremilast Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription and herbal medicines. This is because Apremilast Accord may affect the action of other medicines and other medicines may affect the action of Apremilast Accord.
In particular, inform your doctor or pharmacist before taking Apremilast Accord 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 (Hypericum perforatum) – a herbal medicine used for mild anxiety and depression.

Pregnancy and breastfeeding
Do not take Apremilast Accord if you are or think you may be pregnant.
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
There is limited information on the effects of Apremilast Accord during pregnancy. You must not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast Accord.
It is not known whether this medicine passes into breast milk. You must not use Apremilast Accord while breastfeeding.
Driving and using machines
Apremilast Accord does not affect the ability to drive or operate machinery.
Apremilast Accord contains lactose
Apremilast Accord contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Apremilast Accord

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

Dosage

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

Adults

• The recommended dose of Apremilast Accord for adult patients is 30 mg twice daily, after completion of the dose escalation phase, as shown in the following table: one 30 mg dose in the morning and one 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
Day Morning dose Evening dose Total daily dose
Day 1 10 mg (pink) No 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
From Day 6 onwards 30 mg (beige) 30 mg (beige) 60 mg

Children and adolescents aged 6 years and older

• The dose of Apremilast Accord will be based on body weight.

For patients weighing 20 kg to less than 50 kg:
The recommended dose of Apremilast Accord is 20 mg twice daily, after completion of the dose escalation phase, as shown in the following table: one 20 mg dose in the morning and one 20 mg dose in the evening, approximately 12 hours apart, with or without food. This corresponds to a total daily dose of 40 mg.

Weight 20 kg to less than 50 kg
Day Morning dose Evening dose Total daily dose
Day 1 10 mg (pink) No 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) 20 mg (brown) 40 mg
From Day 6 onwards 20 mg (brown) 20 mg (brown) 40 mg

For patients weighing 50 kg or more:
The recommended dose of Apremilast Accord is 30 mg twice daily, after completion of the dose escalation phase (same dose as adults), as shown in the following table: one 30 mg dose in the morning and one 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 Apremilast Accord is 30 mg once daily (morning dose).
• In children and adolescents aged 6 years and older with severe renal impairment:
  • For patients weighing 50 kg or more, the recommended dose of Apremilast Accord is 30 mg once daily (morning dose).
  • For children weighing between 20 kg and less than 50 kg, the recommended dose is 20 mg once daily (morning dose).

Your doctor will explain how to increase the dose when starting treatment with Apremilast Accord. Your doctor may advise you to take only the morning dose shown in the appropriate table above (for adults or for children/adolescents) and to skip the evening dose.

How and when to take Apremilast Accord

• Apremilast Accord is for oral use.
• Swallow the tablets whole, preferably with water.
• You may take the tablets with or without food.
• Take Apremilast Accord at approximately 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 Apremilast Accord than you should

If you take more Apremilast Accord than you should, consult your doctor or go to hospital immediately. Take the medicine pack and this leaflet with you.

If you forget to take Apremilast Accord

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

If you stop taking Apremilast Accord

• Continue taking Apremilast Accord until your doctor tells you to stop.
• Do not stop treatment with Apremilast Accord without first consulting your doctor.

If you have any questions about how to use 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 not common).
Very common side effects (may affect more than 1 in 10 people)

• diarrhoea
• nausea
• headache
• upper respiratory tract infections such as colds, runny nose, sinusitis

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 lung airways (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 stomach or intestines
• suicidal thoughts or behaviour

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

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

If you are aged 65 or older, you may be at higher risk of complications from severe diarrhoea, nausea and vomiting. If your bowel problems become severe, you must talk to your doctor.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Apremilast Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack, carton, or box after "Exp". The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Do not use this medicine if you notice any damage or signs of tampering with the packaging.

Do not dispose of any medicine via 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 Apremilast Accord contains
The active substance is apremilast.
Apremilast Accord 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
Apremilast Accord 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
Apremilast Accord 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
The other components in the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, anhydrous colloidal silica and magnesium stearate.

• The film coating contains hypromellose (E464), titanium dioxide (E171), diacetylated monoglycerides (E472a) 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 Apremilast Accord and contents of the pack
The Apremilast Accord 10 mg film-coated tablet is a pink, biconvex, diamond-shaped film-coated tablet, with "A1" engraved on one side and smooth on the other. The tablet size is approximately 8 x 5 mm.
The Apremilast Accord 20 mg film-coated tablet is a brown, biconvex, diamond-shaped film-coated tablet, with "A2" engraved on one side and smooth on the other. The tablet size is approximately 10 x 6 mm.
The Apremilast Accord 30 mg film-coated tablet is a beige, biconvex, diamond-shaped film-coated tablet, with "A3" engraved on one side and smooth on the other. The tablet size is approximately 12 x 6 mm.

Packs for initiation of treatment
For initiation of treatment, the carton packs contain:

• 27 film-coated tablets: 4 tablets x 10 mg and 23 tablets x 20 mg
• 27 film-coated tablets: 4 tablets x 10 mg, 4 tablets x 20 mg and 19 tablets x 30 mg

Packs containing Apremilast Accord 20 mg tablets

• The standard monthly pack contains 56 film-coated tablets x 20 mg or unit-dose perforated blisters of 56 film-coated tablets × 1 × 20 mg.

Packs containing Apremilast Accord 30 mg tablets

• The standard monthly pack contains 56 film-coated 30 mg tablets or divisible unit-dose perforated blisters of 56 x 1 x 30 mg film-coated tablets.
• The standard three-month multi-pack contains 168 film-coated tablets x 30 mg (3 packs of 56).

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est, 6 Planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Polska Sp. z.o.o.
ul. Lutomierska 50,
95-200, Pabianice, Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Accord Healthcare B.V.
Winthontlaan 200,
3526 KV Utrecht, The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
AT / BE / BG / CY / CZ / DE / DK / EE / ES / FI / FR / HR / HU / IE / IS / IT / LT / LV / LU / MT /
NL / NO / PL / PT / RO / SE / SI / SK /
Accord Healthcare S.L.U.
Tel: +34 93 301 00 64
EL
Win Medica Α.Ε.
Tel: +30 210 74 88 821

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu