Apremilast Accord 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Apremilast Accord 10 mg film-coated tablets

Apremilast Accord 20 mg film-coated tablets

Apremilast Accord 30 mg film-coated tablets

apremilast

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

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the 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 adverse 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”. It 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 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.

• Moderate to severe chronic 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 therapy: a treatment that works throughout the body rather than in 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.

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

• Moderate to severe plaque psoriasis: if your doctor considers it appropriate for you to receive systemic therapy such as Apremilast Accord.

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 may cause red, scaly, thickened, itchy or painful lesions on the skin, and can 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 oral ulcers.

How Apremilast Accord works

Psoriatic arthritis, psoriasis, and Behçet’s disease are generally chronic conditions that currently have 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 diseases.

In adults with psoriatic arthritis, treatment with Apremilast Accord improves inflamed and painful joints and may improve overall physical function.

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

In adults with Behçet’s disease, treatment with Apremilast Accord reduces the number of oral ulcers and may cause them to disappear completely. It may also reduce associated pain.

Apremilast Accord has also been shown to improve quality of life in 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 should 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 pregnant or think you might be pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before starting Apremilast Accord.

Depression and suicidal thoughts

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

You or your caregiver should also inform your doctor immediately of any changes in behavior or mood, feelings of depression, or any suicidal thoughts 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 have below-normal body weight

Talk to your doctor while taking Apremilast Accord if you experience unintentional weight loss.

Gastrointestinal problems

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

Children and adolescents

The use of Apremilast Accord is not recommended 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 these age and weight groups.

The use of Apremilast Accord is not recommended 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 need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Apremilast Accord may affect how other medicines work. In addition, some medicines may affect how Apremilast Accord works.

Specifically, inform your doctor or pharmacist before starting 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: a herbal medicine used for mild anxiety and depression.

Pregnancy and breastfeeding

Do not take Apremilast Accord if you are pregnant or think you might be pregnant.

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using 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 effective contraception during treatment with Apremilast Accord.

It is unknown whether this medicine passes into breast milk. Apremilast Accord should not be used while breastfeeding.

Driving and use of machines

Apremilast Accord has no influence on the ability to drive or operate machinery.

Apremilast Accord contains lactose

Apremilast Accord contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Apremilast Accord

Follow exactly the instructions for taking this medicine as given by your doctor. If you are unsure, please consult your doctor or pharmacist again.

How much to take

• When you first start taking Apremilast Accord, you will receive a “starter pack” containing enough tablets for a total of two weeks of treatment.
• The “starter pack” is clearly labeled to ensure you take the correct dose at the correct time.
• Your treatment will begin at a lower dose and will gradually increase during the first week of treatment (titration phase).
• The “starter pack” will also contain enough tablets for an additional week at the recommended dose.
• Once the recommended dose is reached, prescribed packs will contain only single-dose tablets.
• You will only need to go through the gradual dose increase process once, even if you have to restart treatment.

Adults

• The recommended dose of Apremilast Accord for adult patients is 30 mg twice daily 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 results in a total daily dose of 60 mg.

Day	Morning dose	Night dose	Total daily dose
Day 1	10 mg (pink)	Do not take the 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

Children and adolescents 6 years of age and older

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

For patients with a weight from 20 kg to less than 50 kg: the recommended dose of Apremilast Accord is 20 mg twice daily after completing the dose titration 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 results in a total daily dose of 40 mg.

Weight from 20 kg to less than 50 kg
Day	Morning dose	Evening dose	Total daily dose
Day 1	10 mg (pink)	Do not take the 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
Day 6 onwards	20 mg (brown)	20 mg (brown)	40 mg

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

Weight of 50 kg or more
Day	Morning dose	Evening dose	Total daily dose
Day 1	10 mg (pink)	Do not take the 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

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, the recommended dose of Apremilast Accord is 30 mg once daily (morning dose) for patients weighing at least 50 kg, and 20 mg once daily (evening dose) for children weighing 20 kg to less than 50 kg.

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

How and when to take Apremilast Accord

• Apremilast Accord is taken by mouth.
• Swallow the tablets whole, preferably with water.
• You may take the tablets with or without food.
• Take Apremilast Accord approximately at the same time each day, one tablet in the morning and one tablet in the evening.

If your condition does not improve after six months of treatment, consult your doctor.

If you take more Apremilast Accord than you should

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

If you forget to take Apremilast Accord

• If you miss a dose of Apremilast Accord, take it as soon as possible. If it is close to the time for 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 a missed dose.

If you stop taking Apremilast Accord

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

If you have any further questions about 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 everyone gets them.

Serious side effects, depression and suicidal thoughts

Tell your doctor immediately if you experience any changes in behaviour or mood, feelings of depression, or suicidal thoughts or 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 (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 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 stomach or intestines
• suicidal ideation or behaviour
• anxiety
• changes in mood

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 may cause difficulty breathing or swallowing)

If you are 65 years of age or older, you may have a higher risk of developing severe diarrhoea, nausea, and vomiting. If your intestinal problems become severe, you should speak to your doctor.

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 or carton pack or outer box, after EXP. The expiry date refers to the last day of the month indicated.
• This medicine does not require any special storage conditions.
• 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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Apremilast Accord

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 of the tablet core are microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate.

• The coating contains hypromellose (E464), titanium dioxide (E171), diacetylated monoglycerides (E472a), 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).

Appearance of the product and contents of the pack

Apremilast Accord 10 mg film-coated tablet is a biconvex film-coated tablet, diamond-shaped and pink in colour, with "A1" in relief on one side and plain on the other. The approximate size of the tablet is 8 x 5 mm.

Apremilast Accord 20 mg film-coated tablet is a biconvex film-coated tablet, diamond-shaped and brown in colour, with "A2" in relief on one side and plain on the other. The approximate size of the tablet is 10 x 6 mm.

Apremilast Accord 30 mg film-coated tablet is a biconvex film-coated tablet, diamond-shaped and beige in colour, with "A3" in relief on one side and plain on the other. The approximate size of the tablet is 12 x 6 mm.

Pack sizes for treatment initiation

The treatment initiation packs are folding cartons 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.

Pack sizes with Apremilast Accord 20 mg tablets

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

Pack sizes with Apremilast Accord 30 mg tablets

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

Marketing Authorisation Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6a 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

You can request further information regarding this medicinal product by contacting 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 / LX / 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

Date of the most recent revision of this leaflet:

Other sources of information

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