Apremilast Krka

Leaflet attached to the packaging: patient information

Apremilast Krka, 10 mg, coated tablets

Apremilast Krka, 20 mg, coated tablets

Apremilast Krka, 30 mg, coated tablets

Apremilastum

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Apremilast Krka and what is it used for
• 2. Important information before taking Apremilast Krka
• 3. How to take Apremilast Krka
• 4. Possible side effects
• 5. How to store Apremilast Krka
• 6. Contents of the packaging and other information

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

What is Apremilast Krka

Apremilast Krka contains the active substance "apremilast". It belongs to a group of medicines called phosphodiesterase 4 inhibitors, and its action can help reduce inflammation.

What is Apremilast Krka used for

Apremilast Krka is used to treat adults with the following conditions:

• Active psoriatic arthritis -if the patient cannot take another type of medicine from the group called "disease-modifying antirheumatic drugs (DMARDs)" or if they have tried to take one of these medicines without results.
• Chronic plaque psoriasis of moderate to severe severity -if the patient cannot take one of the following treatments, or if they have tried to take one of these therapies without results:
• phototherapy - treatment in which skin areas are exposed to ultraviolet light.
• systemic treatment - treatment that affects the whole body, not just a specific part; examples include the use of medicines such as "cyclosporine", "methotrexate", or "psoralen".
• Behçet's disease -to treat oral ulcers, which are a common symptom in people with this disease.

What is psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease that 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 does Apremilast Krka work

Psoriatic arthritis, psoriasis, and Behçet's disease are usually lifelong diseases, as there is no cure yet. Apremilast Krka 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 Krka can help control the inflammatory condition associated with psoriatic arthritis, psoriasis, and Behçet's disease, and thus reduce the signs and symptoms of these diseases. In psoriatic arthritis, taking Apremilast Krka results in improved swollen and painful joints and may also improve the patient's overall physical function. In psoriasis, treatment with Apremilast Krka leads to a reduction in psoriatic skin lesions and other signs and symptoms of the disease. In Behçet's disease, taking Apremilast Krka reduces the number of oral ulcers and may cause them to disappear completely. It may also alleviate associated pain. It has also been shown that Apremilast Krka improves the quality of life of patients with psoriasis, psoriatic arthritis, or Behçet's disease. This means reducing the impact of the disease on the patient's daily activities, relationships with others, and other factors, compared to before.

2. Important information before taking Apremilast Krka

When not to take Apremilast Krka

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

Warnings and precautions

Before starting to take Apremilast Krka, the patient should discuss it with their 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 Krka. The patient or their caregiver should also immediately inform the doctor about any changes in behavior or mood, feelings of sadness, and any suicidal thoughts that have occurred after taking Apremilast Krka.

Severe kidney disease

If the patient has severe kidney disease, the dose taken by the patient will be different - see section 3.

In case of underweight

If the patient experiences unintended weight loss while taking Apremilast Krka, they should tell 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 Krka in children and adolescents. Therefore, this medicine is not recommended for use in children and adolescents under 18 years of age.

Apremilast Krka and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. This includes medicines available without a prescription and herbal medicines. This is important because Apremilast Krka may affect the action of other medicines. On the other hand, other medicines may affect the action of Apremilast Krka. In particular, the patient should inform their doctor or pharmacist before starting to take Apremilast Krka 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, breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before taking this medicine. There is limited data on the use of Apremilast Krka in pregnant women. Women should not become pregnant while taking this medicine and should use effective contraception during treatment with Apremilast Krka. It is not known whether the medicine passes into human milk. Apremilast Krka should not be taken during breastfeeding.

Driving and using machines

Apremilast Krka has no effect on the ability to drive and use machines.

Apremilast Krka contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Apremilast Krka

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Recommended dose of Apremilast Krka

• If the patient is taking Apremilast Krka 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 described in detail to ensure that the patient takes the correct tablet at the correct time.
• Treatment will start with a lower 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).
• The recommended dose of Apremilast Krka after the dose titration period 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 reach 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 it is necessary to restart treatment.

Total daily dose

Day 1

10 mg (pink)
Do not take a dose
10 mg

Day 2

10 mg (pink)
10 mg (pink)
20 mg

Day 3

10 mg (pink)
20 mg (orange-brown) 30 mg

Day 4

20 mg (orange-brown) 20 mg (orange-brown) 40 mg

Day 5

20 mg (orange-brown) 30 mg (light brown-purple) 50 mg

Day 6 and subsequent days

30 mg (light brown-purple) 30 mg (light brown-purple) 60 mg

Patients with severe (severe) kidney disease

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

How and when to take Apremilast Krka

• Apremilast Krka is intended for oral administration.
• Tablets should be swallowed whole, preferably with a glass of water.
• Tablets can be taken with or without food.
• Apremilast Krka 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 Krka than recommended

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

Missing a dose of Apremilast Krka

• If the patient forgets to take a dose of Apremilast Krka, they should take it as soon as possible. If it is close to the time of the next dose, they should skip the missed dose and take the next dose at the scheduled time.
• The patient should not take a double dose to make up for the missed dose.

Day Morning dose Evening dose

Stopping treatment with Apremilast Krka

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

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Apremilast Krka 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 sadness, suicidal thoughts, or suicidal behavior (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
• fatigue
• abdominal pain
• loss of appetite
• diarrhea
• sleep disorders (insomnia)
• indigestion or heartburn
• inflammation and swelling of the bronchial tubes (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
• gastrointestinal bleeding
• suicidal thoughts or behavior

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, leading to difficulty breathing and swallowing)

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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:
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 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 the medicine.

5. How to store Apremilast Krka

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 and outer packaging after the word EXP. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Apremilast Krka contains

• The active substance of Apremilast Krka is apremilast. Each coated tablet contains 10 mg or 20 mg or 30 mg of apremilast.
• The other ingredients (excipients) are: Tablet core: mannitol (E421), microcrystalline cellulose, sodium croscarmellose (see section 2 "Apremilast Krka contains sodium") and magnesium stearate (E470b). Tablet coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), talc, iron oxide red (E 172), iron oxide yellow (E 172) - only for 20 mgand 30 mgand iron oxide black (E 172) - only for 30 mg.

What Apremilast Krka looks like and what the packaging contains

Apremilast Krka, 10 mg, coated tablets
Pink, round, biconvex coated tablets with the marking 10 on one side of the tablet. Tablet dimensions: diameter approximately 6 mm.
Apremilast Krka, 20 mg, coated tablets
Orange-brown, round, biconvex coated tablets with the marking 20 on one side of the tablet. Tablet dimensions: diameter approximately 8 mm.
Apremilast Krka, 30 mg, coated tablets
Light brown-purple, round, biconvex coated tablets with the marking 30 on one side of the tablet. Tablet dimensions: diameter approximately 10 mm
Apremilast Krka, 30 mg, coated tablets

• blister pack containing 56 coated tablets, in a cardboard box.
• Treatment initiation pack: Each pack contains 27 coated tablets:
• 4 coated tablets of Apremilast Krka 10 mg
• 4 coated tablets of Apremilast Krka 20 mg
• 19 coated tablets of Apremilast Krka 30 mg

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
tel. 22 57 37 500

Date of last revision of the leaflet: