APREMILAST 10 мг/20 мг/30 мг Фильм-coated таблетки

Содержание инструкции

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

Apremilast Accord 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 or pharmacist.
• 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 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 you take 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 is Apremilast Accord and what is it used for

What is Apremilast Accord
Apremilast Accord 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 Apremilast Accord used for
Apremilast Accord 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.

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

• Plaque psoriasis, from moderate to severe - if the doctor decides that systemic therapy such as Apremilast 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 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 Apremilast Accord work
Psoriatic arthritis, psoriasis and Behçet's disease are usually lifelong diseases and
for which there is currently no cure. Apremilast Accord works by reducing the activity of an
enzyme present in the body, called “phosphodiesterase 4”, which is involved in the process of
inflammation. By reducing the activity of this enzyme, Apremilast Accord 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 Apremilast Accord produces an improvement
in swelling and pain in the joints and can improve overall physical function.
In adults and children and adolescents aged 6 years and over and weighing at least 20 kg
with psoriasis, treatment with Apremilast Accord 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 Apremilast Accord reduces the number of mouth ulcers
and may stop them completely. It can also reduce associated pain.
Apremilast Accord has also been shown to improve the quality of life of adult and pediatric patients
affected by psoriasis, adult patients affected by psoriatic arthritis and adult patients affected
by 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 you take Apremilast Accord

Do not take Apremilast Accord:

• 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 may be pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before taking Apremilast Accord.

Depression and suicidal thoughts
Tell your doctor before starting Apremilast Accord 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, feelings of depression and 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 you are taking Apremilast Accord if you lose weight unintentionally.

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

Children and adolescents
Apremilast Accord is not recommended for use in children with plaque psoriasis, from moderate to
severe, under 6 years of age or weighing less than 20 kg, because it has not been studied in this age group
and in this weight group.
Apremilast Accord 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 Apremilast Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription and herbal medicines. This
is because Apremilast Accord can affect the action of other medicines and other medicines can affect
the action of Apremilast Accord.
In particular, tell 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 in the treatment of seizures or epilepsy
• St John's Wort (hypericum perforatum) - an herbal medicine 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 are pregnant, are planning to become pregnant or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
There is limited information on the effects of Apremilast Accord during pregnancy. You should not start
a pregnancy while taking this medicine and should use effective contraception
during treatment with Apremilast Accord.
It is not known whether this medicine passes into breast milk. You should not use Apremilast Accord during
breastfeeding.

Driving and using machines
Apremilast Accord does not affect the ability to drive vehicles or use machines.

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

3. How to take Apremilast Accord

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your doctor or pharmacist.

Dosage to be taken

• When you start taking Apremilast Accord, you will receive a “treatment start pack”, an amount of tablets sufficient for a total of two weeks of treatment.
• The “treatment start pack” has clear labeling to ensure 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 start 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 Apremilast Accord 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
total
daily
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 Apremilast Accord will be based on body weight.

For patients weighing between 20 kg and less than 50 kg:
The recommended dose of Apremilast Accord is 20 mg twice a day, once the 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.

Weight between 20 kg and less than 50 kg
Day
Morning doseEvening dose
Total daily dose
Day 110 mg (pink)

Do not take any
dose
10 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) 20 mg (brown) 40 mg

From day 6 onwards20 mg (brown) 20 mg (brown) 40 mg

For patients with a body weight of 50 kg or more:
The recommended dose of Apremilast Accord is 30 mg, twice a day, once the 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 Apremilast Accord 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 Apremilast Accord 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 Apremilast Accord. Your doctor may advise you to take only 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 Apremilast Accord

• Apremilast Accord is for oral use.
• Swallow the tablets whole, preferably with water.
• You can take the tablets with or without food.
• Take Apremilast Accord 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 Apremilast Accord than you should
If you take more Apremilast Accord than you should, consult your doctor or go to hospital

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 the 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 missed dose.

If you stop taking Apremilast Accord

• Continue to take Apremilast Accord until your doctor tells you to stop treatment.
• Do not stop taking Apremilast Accord 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 will experience them.

Serious side effects - depression and suicidal thoughts
Immediately inform your doctor of 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, 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 airways (bronchitis)
• common cold (nasopharyngitis)
• depression
• migraine
• muscle tension headache

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

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

Side effects with unknown frequency(frequency cannot be estimated based on 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 or pharmacist. 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 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 the carton or the box after Scad. The expiry date refers to the last day of that month.
• This medicine does not require any particular precautions for storage.
• 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 Apremilast Accord contains
The active ingredient 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 ingredients present in the tablet core are microcrystalline cellulose, lactose
monohydrate, sodium croscarmellose, anhydrous colloidal silicon dioxide and magnesium stearate.

• The film coating contains hypromellose (E464), titanium dioxide (E171), acetylated monoglycerides (E472a) and iron oxide red (E172).
• The 20 mg film-coated tablets also contain iron oxide yellow (E172).
• The 30 mg film-coated tablets also contain iron oxide yellow (E172) and iron oxide black (E172).

Description of the appearance of Apremilast Accord and package contents
The 10 mg film-coated tablet of Apremilast Accord is a film-coated tablet with a
rhomboid shape, pink in color, biconvex, with “A1” imprinted on one side and smooth on the other side. The
tablet size is approximately 8 x 5 mm.
The 20 mg film-coated tablet of Apremilast Accord is a film-coated tablet with a
rhomboid shape, brown in color, biconvex with “A2” imprinted on one side and smooth on the other side.
The tablet size is approximately 10 x 6 mm.
The 30 mg film-coated tablet of Apremilast Accord is a film-coated tablet with a
rhomboid shape, beige in color, biconvex, with “A3” imprinted on one side and smooth on the other side. The
tablet size is approximately 12 x 6 mm.
Packages for starting treatment
For starting treatment, the folding boxes 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

Packages with Apremilast Accord 20 mg tablets

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

Packages with Apremilast Accord 30 mg tablets

• The standard package for one month contains 56 film-coated tablets of 30 mg or divisible perforated blisters for unit dose 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 boxes 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, Netherlands
For further information on this medicine, 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.
Τel: +30 210 74 88 821

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