Package leaflet: Information for the user

Apremilast Aristo, 10 mg, film-coated tablets
Apremilast Aristo, 20 mg, film-coated tablets
Apremilast Aristo, 30 mg, film-coated tablets
apremilast
Please read this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Apremilast Aristo is and what it is used for
Important information before taking Apremilast Aristo
How to take Apremilast Aristo
Possible side effects
How to store Apremilast Aristo
Contents of the pack and other information

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

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

Active psoriatic arthritis – if the patient cannot take another type of medicine known as "disease-modifying antirheumatic drugs (DMARDs)", or if the patient has already tried such medicines but they were ineffective.
Moderate to severe chronic plaque psoriasis – if the patient cannot take one of the following treatments, or if the patient has already tried one of these therapies but they were ineffective:
- Phototherapy – a treatment in which areas of skin are exposed to ultraviolet light.
- Systemic therapy – a treatment that affects the whole body rather than a specific part; examples include medicines containing substances such as "cyclosporine", "methotrexate", or "psoralen".
Behçet’s disease (BD) – to treat oral ulcers, which are a common symptom in people with this condition.

What psoriatic arthritis is
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis, an inflammatory skin condition.
What plaque psoriasis is
Psoriasis is an inflammatory skin disease that can cause red, scaly, thick, itchy, and painful skin lesions; it may also affect the skin of the scalp and nails.
What Behçet’s disease is
Behçet’s disease is a rare inflammatory disorder affecting multiple parts of the body. The most common symptom is oral ulcers.
How Apremilast Aristo works
Psoriatic arthritis, psoriasis, and Behçet’s disease are generally lifelong conditions, as there is currently no cure. Apremilast Aristo works by reducing the activity of an enzyme called "phosphodiesterase 4", which plays a key role in the inflammatory process. By reducing the activity of this enzyme, Apremilast Aristo may help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet’s disease, thereby reducing the signs and symptoms of these conditions.
In psoriatic arthritis, treatment with Apremilast Aristo reduces joint swelling and pain and may improve the patient’s overall physical function.
In psoriasis, treatment with Apremilast Aristo leads to a reduction in psoriatic skin lesions and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Apremilast Aristo reduces the number of oral ulcers and may lead to their complete resolution. It may also relieve associated pain.
Apremilast has also been shown to improve the quality of life in patients with psoriasis, psoriatic arthritis, or Behçet’s disease. This means the impact of the disease on daily activities, relationships with others, and other factors should be less than before.

2. Important information before taking Apremilast Aristo

When not to take Apremilast Aristo

if the patient is allergic to apremilast or any of the other ingredients of this medicine (listed in section 6);
if the woman is pregnant or suspects she may be pregnant.

Warnings and precautions
Before starting treatment with Apremilast Aristo, discuss this with your doctor or pharmacist.
Depression and suicidal thoughts
If the patient suffers from worsening depression with suicidal thoughts, this should be discussed with the doctor before starting treatment with Apremilast Aristo.
The patient or their caregiver should also immediately inform the doctor about any changes in behaviour or mood, feelings of depression, or any suicidal thoughts that occur after taking this medicine.
Severe kidney disease
If the patient has severe kidney disease, the dose will be different – see section 3.
If the patient is underweight
If the patient experiences unintentional weight loss while taking Apremilast Aristo, they should inform their doctor.
Gastrointestinal problems
Inform the doctor if severe diarrhoea, nausea or vomiting occurs.
Children and adolescents
Studies on the use of apremilast in children and adolescents have not been conducted; therefore, this medicine is not recommended for use in children and adolescents under 17 years of age.
Apremilast Aristo and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription and herbal medicines. This is important because Apremilast Aristo may affect the action of other medicines. Likewise, other medicines may affect the action of Apremilast Aristo.
In particular, inform your doctor or pharmacist before starting Apremilast Aristo if the patient is taking any of the following medicines:

rifampicin – an antibiotic used to treat 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
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There are limited data on the use of Apremilast Aristo in pregnant women. Women should not become pregnant during treatment with this medicine and should use an effective method of contraception while taking Apremilast Aristo.
It is not known whether the medicine passes into human milk. Apremilast Aristo should not be used during breastfeeding.
Driving and operating machinery
Apremilast Aristo has no influence on the ability to drive or operate machinery.
Apremilast Aristo contains lactose and sodium
Apremilast Aristo contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
The medicine contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the product is considered "sodium-free".

3. How to take Apremilast Aristo

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.

Recommended dose of the medicine

If the patient is starting treatment with Apremilast Aristo for the first time, they will receive a "starting set" containing all the doses listed in the table below.
The "starting set" is clearly labeled to ensure that the patient takes the correct tablet at the correct time.
Treatment will begin with the lowest dose, which will be gradually increased over the first 6 days of treatment.
The "starting set" also includes tablets at the recommended dose for the following 8 days (days 7 to 14).
After completion of the dose-titration period, the recommended dose of Apremilast Aristo is 30 mg twice daily—one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart—with or without food.
The total daily dose is 60 mg. The patient will reach the recommended dose by the end of day 6.
Once the recommended dose is achieved, the patient will receive only 30 mg tablets in the prescribed packages. The patient needs to go through this dose-titration phase only once, even if treatment needs to be restarted later.

Day	Morning dose	Evening dose	Total daily dose
Day 1	10 mg (pink tablet)	Do not take a dose of the drug	10 mg
Day 2	10 mg (pink tablet)	10 mg (pink tablet)	20 mg
Day 3	10 mg (pink tablet)	20 mg (orange tablet)	30 mg
Day 4	20 mg (orange tablet)	20 mg (orange tablet)	40 mg
Day 5	20 mg (orange tablet)	30 mg (red-brown tablet)	50 mg
Day 6 and subsequent days	30 mg (red-brown tablet)	30 mg (red-brown tablet)	60 mg

Patients with severe kidney disease
If the patient has severe kidney disease, the recommended dose of Apremilast Aristo is 30 mg once daily (morning dose). Your doctor will inform you how to increase the dose when starting treatment with Apremilast Aristo for the first time.
How and when to take Apremilast Aristo

This medicine is for oral administration.
Tablets should be swallowed whole, preferably with water. Do not crush or split the tablets, as this may affect their properties.
Tablets may be taken with or without food.
This medicine should be taken at the same time each day, one tablet in the morning and one tablet in the evening.

If the patient's condition has not improved after six months, he or she should contact the doctor.
Taking more Apremilast Aristo than prescribed
If the patient takes more Apremilast Aristo than prescribed, he or she should contact a doctor immediately or go to hospital. Bring the packaging and this leaflet with you.
Missing a dose of Apremilast Aristo

If the patient forgets to take a dose of Apremilast Aristo, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should not be taken. Take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Apremilast Aristo

The patient should continue taking Apremilast Aristo until the doctor advises stopping treatment.
Do not stop taking Apremilast Aristo without first consulting your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.
Serious side effects – depression and suicidal thoughts
Inform your doctor immediately about any changes in behaviour or mood, feeling depressed, or having suicidal thoughts or behaviours (these occur not commonly).
Very common side effects (may affect more than 1 in 10 people)

diarrhoea
nausea
headache
upper respiratory tract infections, such as colds, catarrh, sinus infection (infection of the sinuses)

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

cough
back pain
vomiting
feeling tired
abdominal pain
loss of appetite
frequent bowel movements
sleep problems (insomnia)
indigestion or heartburn
inflammation and swelling of the airways in the lungs (bronchitis)
cold (inflammation of the nose and throat)
depression
migraine
tension headache

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

rash
urticaria
weight loss
allergic reaction
bleeding in the intestines or stomach
suicidal thoughts or behaviours

Side effects of 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 lead to difficulty in breathing and swallowing)

In patients aged 65 years and older, there may be an increased risk of complications such as severe diarrhoea, nausea and vomiting. If gastrointestinal problems worsen, inform your doctor.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Apremilast Aristo

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 or the cardboard box
following EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicinal product.
Do not use this medicine if you notice any signs of tampering with the packaging.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Apremilast Aristo contains

The active substance is apremilast.
- Apremilast Aristo 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
- Apremilast Aristo 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
- Apremilast Aristo 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
Other ingredients: For 10 mg
- Tablet core: sodium croscarmellose, lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate
- Coating Opadry 20A240045 Pink: hydroxypropyl cellulose, hypromellose - 6 mPas, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172). Tablets of 30 mg also contain black iron oxide (E172). For 20 mg
- Tablet core: sodium croscarmellose, lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate
- Coating 20A230061 Orange: hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), talc, red iron oxide (E172) and yellow iron oxide (E172). For 30 mg
- Tablet core: sodium croscarmellose, lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate
- Coating Opadry 20A265023 Brown: hydroxypropyl cellulose, hypromellose - 6 mPas, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).

What Apremilast Aristo looks like and contents of the pack
Apremilast Aristo 10 mg film-coated tablet is pink, oblong, with an imprint "10" on one side and smooth on the other, measuring 8 mm in length and 3 mm in width.
Apremilast Aristo 20 mg film-coated tablet is orange, oblong, with an imprint "20" on one side and smooth on the other, measuring 12 mm in length and 6 mm in width.
Apremilast Aristo 30 mg film-coated tablet is red-brown, oblong, with an imprint "30" on one side and smooth on the other, measuring 13 mm in length and 7 mm in width.
Pack sizes

Starter pack: a folding carton containing 27 film-coated tablets: 4 tablets x 10 mg, 4 tablets x 20 mg and 19 tablets x 30 mg in a cardboard box.
Standard one-month pack: 56 film-coated tablets x 30 mg in a cardboard box.
Standard three-month pack: 168 film-coated tablets x 30 mg in a cardboard box.

Marketing Authorisation Holder and Importer
Marketing Authorisation Holder:
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
tel: +48 22 855 40 93
Manufacturer/Importer:
Aristo Pharma GmbH
Wallenroder Str. 8 – 10
13435 Berlin, Germany
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola PLA 3000, Malta
Adalvo Limited
Malta Life Sciences Park,
Building 1, Level 4, Sir Temi Zammit Buildings,
San Gwann, SGN 3000, Malta
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Iceland Apremilast Aristo 10 mg + 20 mg + 30 mg filmuhúðaðar töflur
Apremilast Aristo 30 mg filmuhúðaðar töflur
Poland Apremilast Aristo