Apremilast Polpharma

Package Leaflet: Information for the Patient

Apremilast Polpharma, 10 mg, coated tablets

Apremilast Polpharma, 20 mg, coated tablets

Apremilast Polpharma, 30 mg, coated tablets

Apremilast

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• 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 any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

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

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

What is Apremilast Polpharma

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

What is Apremilast Polpharma used for

Apremilast Polpharma is used to treat adult patients 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 taking one of these medicines without improvement.
• Chronic plaque psoriasis of moderate to severe severity -if the patient cannot take one of the following treatments, or if the patient has tried one of these therapies without improvement:
• 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 -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 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 lesions on the skin; 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 Polpharma works

Psoriatic arthritis, psoriasis, and Behçet's disease are usually lifelong diseases, as there is no cure yet. Apremilast Polpharma 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 Polpharma can help control the inflammation associated with psoriatic arthritis, psoriasis, and Behçet's disease, and thereby reduce the signs and symptoms of these diseases.
In psoriatic arthritis, taking Apremilast Polpharma results in reduced joint swelling and pain, and may also improve the patient's overall physical function.
In psoriasis, treatment with Apremilast Polpharma leads to a reduction in psoriatic skin lesions and other signs and symptoms of the disease.
In Behçet's disease, taking Apremilast Polpharma 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 Polpharma 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 Polpharma

When not to take Apremilast Polpharma

• 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 Polpharma, 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 Polpharma.
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 or behaviors that have occurred after taking Apremilast Polpharma.

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 Polpharma, 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 in children and adolescents. Therefore, this medicine is not recommended for use in children and adolescents under 18 years of age.

Apremilast Polpharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take. This includes medicines that can be bought without a prescription and herbal medicines. This is because Apremilast Polpharma may affect the way other medicines work. Other medicines may also affect the way Apremilast Polpharma works.
In particular, the patient should inform their doctor or pharmacist before starting to take Apremilast Polpharma 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 is planning to have a baby, she should ask her doctor or pharmacist for advice before taking this medicine.
There is limited information on the use of Apremilast Polpharma in pregnant women. Women should not become pregnant while taking this medicine and should use effective contraception during treatment with Apremilast Polpharma. It is not known whether the medicine passes into breast milk. Apremilast Polpharma should not be used during breastfeeding.

Driving and using machines

Apremilast Polpharma has no influence on the ability to drive and use machines.

Apremilast Polpharma contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Apremilast Polpharma

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

Recommended dose of Apremilast Polpharma

• If the patient is starting to take Apremilast Polpharma 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 right tablet at the right 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 Polpharma is 30 mg twice a day - 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. 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 they need to restart treatment.

Patients with severe kidney disease

If the patient has severe kidney disease, the recommended dose of Apremilast Polpharma 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 Polpharma.

How and when to take Apremilast Polpharma

• Apremilast Polpharma is intended for oral use.
• The tablets should be swallowed whole, preferably with water.
• The tablets can be taken with or without food.
• Apremilast Polpharma 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 more than the recommended dose of Apremilast Polpharma

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

Missing a dose of Apremilast Polpharma

• If the patient misses a dose of Apremilast Polpharma, 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 Polpharma

• The patient should take Apremilast Polpharma until their doctor tells them to stop.
• The patient should not stop taking Apremilast Polpharma 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 Polpharma 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 behaviors (which occur uncommonly).
Very common(affects more than 1 in 10 people)

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

Common(affects less than 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(affects less than 1 in 100 people)

• rash
• hives
• weight loss
• allergic reaction
• bleeding in the gut or stomach
• suicidal thoughts or behaviors

Frequency not known(frequency cannot be estimated from the available data)

• severe allergic reaction (which can include swelling of the face, lips, mouth, tongue, or throat, which may lead 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 the patient experiences severe gastrointestinal problems, they should tell their doctor.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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, the patient can help provide more information on the safety of this medicine.

5. How to store Apremilast Polpharma

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 treatment initiation pack or on the carton after EXP. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Do not store above 30°C.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
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 Polpharma contains

• The active substance is apremilast.
• Apremilast Polpharma, 10 mg, coated tablets: each coated tablet contains 10 mg of apremilast.
• Apremilast Polpharma, 20 mg, coated tablets: each coated tablet contains 20 mg of apremilast.
• Apremilast Polpharma, 30 mg, coated tablets: each coated tablet contains 30 mg of apremilast.
• The other ingredients are:
• tablet core: mannitol, microcrystalline cellulose (type 102), sodium croscarmellose, magnesium stearate.
• tablet coating: hypromellose 2910 (6 mPas), titanium dioxide (E 171), macrogol 8000, talc (only for 10 mg and 30 mg), yellow iron oxide (E 172) (only for 10 mg and 20 mg), red iron oxide (E 172) (only for 20 mg and 30 mg).

What Apremilast Polpharma looks like and contents of the pack

Apremilast Polpharma, 10 mg, coated tablets
Oval, biconvex, light yellow coated tablets with "10" engraved on one side, 8.0-8.6 mm in length and 4.1-4.7 mm in width.
Apremilast Polpharma, 20 mg, coated tablets
Oval, biconvex, yellow coated tablets with "20" engraved on one side, 10.2-10.8 mm in length and 5.3-5.9 mm in width.
Apremilast Polpharma, 30 mg, coated tablets
Oval, biconvex, light pink to pink coated tablets with "30" engraved on one side, 11.7-12.3 mm in length and 6.1-6.7 mm in width.
Pack sizes

• The treatment initiation pack is a foldable pack containing 27 coated tablets in aluminum/PVC blisters (4 x 10 mg tablets, 4 x 20 mg tablets, and 19 x 30 mg tablets).
• The standard pack contains 28, 56, 112, or 168 coated tablets of 30 mg in aluminum/PVC blisters.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

FARMAPROJECTS S.A.U.
Parc Cientific de Barcelona
C/ Baldiri Reixac, 4/12 i 15
08028 Barcelona
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland: Apremilast Polpharma
Germany: Apremilast 089Pharm

Date of last revision of the leaflet: