Apremilast aristo

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 the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine 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.

Table of contents

1. What Apremilast Aristo is and what it is used for
2. Important information before taking Apremilast Aristo
3. How to take Apremilast Aristo
4. Possible side effects
5. How to store Apremilast Aristo
6. 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 known as
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 – treatment in which skin areas are exposed to ultraviolet light.
  • Systemic therapy – 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 is psoriatic arthritis
Psoriatic arthritis is an inflammatory joint disease, usually associated with psoriasis, an inflammatory
skin condition.
What is plaque psoriasis
Psoriasis is an inflammatory skin disease that may cause red, scaly, thick, itchy, and painful skin lesions; it may also affect the skin of the scalp and nails.
What is Behçet’s disease
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 diseases.
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 reduces 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 reduce 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 reduced compared to 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 inform the doctor immediately 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 during treatment with 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, as well as any medicines they plan to take. This includes medicines available 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 the 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 – 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 is limited data on the use of Apremilast Aristo in pregnant women. Women should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast Aristo.
It is not known whether the medicine passes into human breast milk. Apremilast Aristo should not be used during breastfeeding.
Driving and using machines
Apremilast Aristo has no influence on the ability to drive and use machines.
Apremilast Aristo contains lactose and sodium
Apremilast Aristo contains lactose (a type of sugar). If the patient has been previously diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.
This medicine contains sodium. This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this product is considered "sodium-free".

3. How to take Apremilast Aristo

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

Recommended dosage of the medicine

• If the patient is taking Apremilast Aristo for the first time, they will receive a "starting pack" containing all the doses listed in the table below.
• The "starting pack" is clearly labelled to ensure the patient takes the correct tablet at the correct time.
• Treatment starts with the lowest dose, which will be gradually increased over the first 6 days of treatment.
• The "starting pack" also contains 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 reached, the patient will receive only 30 mg tablets in the prescribed packages. This dose-titration process needs to be completed only once, even if treatment is later restarted.

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 use.
• 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, they should contact their doctor.
Taking more Apremilast Aristo than recommended
If the patient takes more Apremilast Aristo than recommended, they should contact a doctor or go to hospital immediately. The package and this leaflet should be taken along.
If you miss a dose of Apremilast Aristo

• If the patient forgets to take a dose of Apremilast Aristo, they should take it as soon as possible. If it is close to the time of the next dose, the missed dose should not be taken. The next dose should be taken 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 experience 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 occur in more than 1 in 10 patients)

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

Common side effects (may occur in up to 1 in 10 patients)

• cough
• back pain
• vomiting
• feeling tired
• stomach ache
• 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 occur in up to 1 in 100 patients)

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

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 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 intestinal 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, phone: 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 or carton following EXP. The expiry date refers to the last day of the specified month.
No special storage instructions 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging 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 are: For 10 mg
  • Tablet core: sodium croscarmellose, lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate
  • Coating Opadry 20A240045 Pink: hydroxypropylcellulose, hypromellose - 6 mPas, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172). The 30 mg tablets also contain iron oxide black (E172). For 20 mg
  • Tablet core: sodium croscarmellose, lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate
  • Coating 20A230061 Orange: hydroxypropylcellulose, hypromellose, titanium dioxide (E171), talc, iron oxide red (E172) and iron oxide yellow (E172). For 30 mg
  • Tablet core: sodium croscarmellose, lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate
  • Coating Opadry 20A265023 Brown: hydroxypropylcellulose, hypromellose - 6 mPas, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).

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

• The starter pack is 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.
• The standard one-month pack contains 56 film-coated tablets x 30 mg in a cardboard box.
• The standard three-month pack contains 168 film-coated tablets x 30 mg in a cardboard box.

Marketing Authorisation Holder and Manufacturer/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 for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Iceland Apremilast Aristo 10 mg + 20 mg + 30 mg film-coated tablets
Apremilast Aristo 30 mg film-coated tablets
Poland Apremilast Aristo