Apremilast Aristo

Package Leaflet: Information for the User

Apremilast Aristo, 10 mg, coated tablets

Apremilast Aristo, 20 mg, coated tablets

Apremilast Aristo, 30 mg, coated tablets

apremilast

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the package leaflet

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

What is Apremilast Aristo

Apremilast Aristo contains the active substance apremilast. It belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help reduce inflammation.

What is Apremilast Aristo 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 called "disease-modifying antirheumatic drugs (DMARDs)" or if the patient has already tried to take one of these medicines but they did not work.
• Chronic plaque psoriasis of moderate to severe severity -if the patient cannot take one of the following treatments, or if the patient has already tried one of these therapies but they did not work:
• phototherapy - a treatment in which parts of the skin are exposed to ultraviolet light.
• systemic therapy - a treatment that affects the whole body, not just 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 disease.

What is psoriatic arthritis

Psoriatic arthritis is an inflammatory disease of the joints, which is usually accompanied by psoriasis, an inflammatory skin disease.

What is plaque psoriasis

Psoriasis is an inflammatory skin disease that can cause red, scaly, thick, itchy, and painful skin lesions; it can also cause changes in 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 symptom is oral ulcers.

How Apremilast Aristo works

Psoriatic arthritis, psoriasis, and Behçet's disease are usually lifelong diseases, as there is no cure yet. Apremilast Aristo works by reducing the activity of an enzyme called "phosphodiesterase 4", which is involved in the inflammation process. By reducing the activity of this enzyme, Apremilast Aristo can help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet's disease, and thus reduce the signs and symptoms of these diseases.
In psoriatic arthritis, taking Apremilast Aristo results in reduced joint swelling and pain, and may also 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, taking Apremilast Aristo reduces the number of oral ulcers and may cause them to disappear completely. It may also alleviate the associated pain.
It has also been shown that apremilast improves the quality of life of patients with psoriasis, psoriatic arthritis, or Behçet's disease. This means that the impact of the patient's 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 thinks she may be pregnant.

Warnings and precautions

Before starting to take Apremilast Aristo, discuss it with your doctor or pharmacist.

Depression and suicidal thoughts

If the patient has worsening depression with suicidal thoughts, they should discuss it with their doctor before starting to take Apremilast Aristo.
The patient or their caregiver should also immediately inform the doctor about any changes in behavior or mood, feelings of depression, and any suicidal thoughts or behaviors 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 unintended weight loss while taking Apremilast Aristo, they should inform their doctor.

Gastrointestinal problems

The patient should inform their doctor about severe diarrhea, nausea, or vomiting.

Children and adolescents

No studies have been conducted on the use of apremilast in children and adolescents, so this medicine is not recommended for use in children and adolescents under 17 years of age.

Apremilast Aristo and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have 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. Other medicines may also affect the action of Apremilast Aristo.
In particular, the patient should inform their doctor or pharmacist before starting to take Apremilast Aristo if they are 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 to treat mild anxiety and depression.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine.
There are limited data on the use of Apremilast Aristo in pregnant women. Women should not become pregnant while taking this medicine and should use effective contraception during treatment with Apremilast Aristo.
It is not known whether the medicine passes into human 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 diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Apremilast Aristo

This medicine should always be taken exactly as prescribed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist.

Recommended dose of Apremilast Aristo

• If the patient is starting to take Apremilast Aristo for the first time, they will receive a "treatment initiation pack" that contains all the doses as described in the table below.
• The "treatment initiation pack" is designed to ensure that the patient takes the correct tablet at the correct time.
• Treatment will start with the lowest dose, which will be gradually increased over the first 6 days of treatment.
• The "treatment initiation pack" also contains tablets at the recommended dose for the next 8 days (days 7 to 14).
• After completing the dose titration period, the recommended dose of Apremilast Aristo is 30 mg twice a day - one 30 mg dose in the morning and one 30 mg dose in the evening, approximately every 12 hours

with or without food.

• The total daily dose is 60 mg. By the end of day 6, the patient will have reached the recommended dose.
• After reaching the recommended dose, the patient will receive only 30 mg tablets in the prescribed packaging. The patient only needs to go through this dose titration phase once, even if treatment needs to be restarted.

Patient with severe kidney disease

If the patient has severe kidney disease, the recommended dose of Apremilast Aristo is 30 mg once a day (morning dose). The doctor will inform the patient how to increase the dose during the first use of Apremilast Aristo.

How and when to take Apremilast Aristo

• This medicine is intended for oral use.
• The tablets should be swallowed whole, preferably with a glass of water. The tablets should not be crushed or broken, as this may affect their properties.
• The tablets can be taken with or without food.
• This medicine should be taken at the same time every day, one tablet in the morning and one tablet in the evening.

If the patient's condition does not improve after six months, they should contact their doctor.

Taking a higher dose of Apremilast Aristo than recommended

If the patient takes a higher dose of Apremilast Aristo than recommended, they should immediately contact their doctor or go to the hospital. They should take the packaging and this package leaflet with them.

Missing 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 almost time for the next dose, they should not take the missed dose. The next dose should be taken at the scheduled time.
• The patient should not take a double dose to make up for a missed dose.

Stopping treatment with Apremilast Aristo

• The patient should take Apremilast Aristo until their doctor tells them to stop.
• The patient should not stop taking Apremilast Aristo without first consulting their doctor.

If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Apremilast Aristo can cause side effects, although not everybody gets them.

Severe side effects - depression and suicidal thoughts

The patient should immediately inform their doctor about any changes in behavior or mood, feelings of depression, suicidal thoughts, or suicidal behaviors (which occur uncommonly).
Very common side effects(may affect more than 1 in 10 people)

• diarrhea
• nausea
• headache
• upper respiratory tract infections, such as the common cold, runny nose, sinus infection

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)
• 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 gut or stomach
• suicidal thoughts or behaviors

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

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

In patients aged 65 and older, there may be a higher risk of complications such as severe diarrhea, nausea, and vomiting. If gastrointestinal problems worsen, the patient should inform their doctor.

Reporting side effects

If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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 authorization holder.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Apremilast Aristo

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister or carton after EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
Do not use this medicine if you notice any signs of damage to the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will 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 coated tablets: each coated tablet contains 10 mg of apremilast.
• Apremilast Aristo 20 mg coated tablets: each coated tablet contains 20 mg of apremilast.
• Apremilast Aristo 30 mg coated tablets: each coated tablet contains 30 mg of apremilast.
• Other ingredients are: For 10 mg
• tablet core: croscarmellose sodium, 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), 30 mg tablets also contain iron oxide black (E172). For 20 mg
• tablet core: croscarmellose sodium, lactose, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate
• coating 20A230061 Orange: hydroxypropylcellulose, hypromellose, titanium dioxide (E172), talc, iron oxide red (E172), and iron oxide yellow (E172). For 30 mg
• tablet core: croscarmellose sodium, 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, coated tablet is pink, oval, with "10" embossed on one side and smooth on the other side, 8 mm long and 3 mm wide.
Apremilast Aristo, 20 mg, coated tablet is orange, oval, with "20" embossed on one side and smooth on the other side, 12 mm long and 6 mm wide.
Apremilast Aristo, 30 mg, coated tablet is red-brown, oval, with "30" embossed on one side and smooth on the other side, 13 mm long and 7 mm wide.
Pack sizes

• The treatment initiation pack is a folding box containing 27 coated tablets: 4 x 10 mg, 4 x 20 mg, and 19 x 30 mg in a carton.
• The standard pack for one month contains 56 x 30 mg coated tablets in a carton.
• The standard pack for three months contains 168 x 30 mg coated tablets in a carton.

Marketing authorization holder and importer

Marketing authorization holder:

Aristo Pharma Sp. z o.o.
Baletowa 30
02-867 Warsaw
tel: +48 22 855 40 93

Importer:

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 medicine is authorized in the Member States of 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

Date of last revision of the package leaflet: