APREMILAST ZENTIVA 10mg + 20mg + 30mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Apremilast Zentiva 30 mg film-coated tablets EFG

Apremilast Zentiva 10 mg + 20 mg + 30 mg film-coated tablets EFG(Starter Pack for Treatment Initiation)

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package 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 signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Apremilast Zentiva and what is it used for
2. What you need to know before you take Apremilast Zentiva
3. How to take Apremilast Zentiva
4. Possible side effects
5. Storage of Apremilast Zentiva
6. Package Contents and Further Information

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

What isApremilast Zentiva

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

What Apremilast Zentiva is used for

Apremilast is used to treat adults with the following diseases:

• Active psoriatic arthritis - if you cannot use other types of medicines called “Disease-Modifying Antirheumatic Drugs” (DMARDs) or when you have already tried one of these medicines and it did not work.
• Chronic moderate to severe plaque psoriasis - if you cannot use one of the following treatments or when you have already tried one of these treatments and it did not work:
• • phototherapy - a treatment where certain areas of the skin are exposed to ultraviolet light
  • systemic treatment - a treatment that acts on the whole body instead of a localized area, such as “ciclosporin”, “methotrexate”, or “psoralen”.
• Behçet's disease (BD) - to treat oral ulcers, a common problem in people with this disease.

Apremilast is used to treat children and adolescents from 6 years of age and weighing at least 20 kg with the following condition:

• Moderate to severe plaque psoriasis- if your doctor considers it appropriate for you to take a systemic treatment like apremilast.

What is psoriatic arthritis

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

What is plaque psoriasis

Psoriasis is an inflammatory disease of the skin, which can produce red, scaly, thickened, itchy, or painful lesions on the skin, and can also affect 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 problem is oral ulcers.

How Apremilast Zentiva works

Psoriatic arthritis, psoriasis, and Behçet's disease are usually chronic diseases that currently have no cure. Apremilast works by reducing the activity of an enzyme in the body called “phosphodiesterase 4”, which is involved in the inflammatory process. By reducing the activity of this enzyme, apremilast 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 adults with psoriatic arthritis, treatment with apremilast results in an improvement in inflamed and painful joints and may improve overall physical function.

In adults and in children and adolescents from 6 years of age and weighing at least 20 kg with psoriasis, treatment with apremilast reduces psoriasis plaques on the skin and other signs and symptoms of the disease.

In adults with Behçet's disease, treatment with apremilast reduces the number of oral ulcers and may make them disappear completely. It may also reduce associated pain.

Apremilast has also been shown to improve the quality of life of adult and pediatric patients with psoriasis, adult patients with psoriatic arthritis, and adult patients with Behçet's disease. This means that the impact of your disease on daily activities, relationships, and other factors should be less than before.

2. What you need to know before you take Apremilast Zentiva

Do not takeApremilast Zentiva

• if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or think you may be pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with apremilast.

Depression and suicidal thoughts

Tell your doctor before starting treatment with apremilast if you have depression that may worsen with suicidal thoughts.

You or your caregiver should also immediately inform your doctor of any change in behavior or mood, feelings of depression, and any suicidal thoughts you may have after taking apremilast.

Severe kidney problems

If you have severe kidney problems, the dose will be different - see section 3.

If you have a weight below normal

Talk to your doctor while taking apremilast if you lose weight without wanting to.

Gastrointestinal problems

If you suffer from severe diarrhea, nausea, or vomiting, you should inform your doctor.

Children and adolescents

Apremilast is not recommended for use in children with moderate to severe plaque psoriasis who are under 6 years of age or weigh less than 20 kg, as it has not been studied in these age and weight groups.

Apremilast is not recommended for use in children and adolescents under 18 years of age for other indications, as safety and efficacy have not been established in this age group.

Other medicines and Apremilast Zentiva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because apremilast may affect the way other medicines work. Additionally, some medicines may affect the way apremilast works.

In particular, tell your doctor or pharmacist before starting treatment with apremilast if you are taking any of the following medicines:

• rifampicin - an antibiotic used for tuberculosis;
• phenytoin, phenobarbital, and carbamazepine - medicines used in the treatment of seizures or epilepsy;
• St. John's Wort - a herbal medicine used for mild anxiety and depression.

Pregnancy and breastfeeding

Do not take Apremilast Zentiva if you are pregnant or think you may be pregnant

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

There is limited information on the effects of apremilast during pregnancy. You should not become pregnant while taking this medicine and should use effective contraceptive methods during treatment with apremilast.

It is not known whether this medicine passes into breast milk. Apremilast should not be used while breastfeeding.

Driving and using machines

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

Apremilast Zentiva contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Apremilast Zentiva

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

How much to take

• When you first start taking apremilast, you will receive a “starter pack” that contains enough tablets for a total of two weeks of treatment.
• The “starter pack” is clearly labeled to ensure you take the correct dose at the correct time.
• Your treatment will start at a lower dose and will gradually increase over the first week of treatment (titration phase).
• The “starter pack” will also contain enough tablets for another week at the recommended dose.
• Once you have reached the recommended dose, the prescribed packs will contain only single-dose tablets.
• You will only need to go through the titration process once, even if you need to restart treatment.

Adults

• The recommended dose of apremilast for adult patients is 30 mg twice a day after completing the titration phase, as shown in the table below - a dose of 30 mg in the morning and a dose of 30 mg in the evening, approximately every 12 hours, with or without food. This makes a total daily dose of 60 mg.

Children and adolescents from 6 years of age

• The dose of apremilast will be based on body weight.

For patients weighing from 20 kg to less than 50 kg: the recommended dose of apremilast is 20 mg twice a day after completing the titration phase, as shown in the table below, a dose of 20 mg in the morning and a dose of 20 mg in the evening, approximately every 12 hours, with or without food. This makes a total daily dose of 40 mg.

Apremilast Zentiva is not available in the necessary pack sizes for the initial and maintenance treatment of patients who weigh between 20 kg and less than 50 kg. Your doctor will prescribe another suitable medicine.

For patients weighing 50 kg or more: the recommended dose of apremilast is 30 mg twice a day after completing the titration phase (the same as the adult dose), as shown in the table below, a dose of 30 mg in the morning and a dose of 30 mg in the evening, approximately every 12 hours, with or without food. This makes a total daily dose of 60 mg.

Patient with severe kidney problems

If you are an adult with severe kidney problems, the recommended dose of apremilast is 30 mg once a day (morning dose).

In children and adolescents from 6 years of age with severe kidney impairment, the recommended dose of apremilast is 30 mg once a day (morning dose)for patients weighing 50 kg or more, and 20 mg once a day (morning dose)for children weighing 20 kg to less than 50 kg.

Your doctor will tell you how to increase the dose when you first start taking apremilast. Your doctor may advise you to take only the morning dose that applies to your case as shown in the table above (for adults or for children/adolescents) and skip the evening dose.

How and when to take Apremilast Zentiva

• Apremilast is taken orally.
• Swallow the tablets whole, preferably with water.
• You can take the tablets with or without food.
• Take apremilast approximately at the same time every day, one tablet in the morning and one tablet in the evening.

If your disease does not improve after six months of treatment, consult your doctor.

If you take moreApremilast Zentivathan you should

If you take more apremilast than you should, consult a doctor or go to a hospital immediately. Take the medicine pack and this package leaflet with you.

If you forget to takeApremilast Zentiva

• If you miss a dose of apremilast, take it as soon as possible. If it is close to the time of your next dose, skip the missed dose. Take your next dose at the usual time.
• Do not take a double dose to make up for missed doses.

If you stop taking Apremilast Zentiva

• You should continue taking apremilast until your doctor tells you to stop.
• Do not stop taking apremilast without consulting your doctor first.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects - depression and suicidal thoughts

Tell your doctor immediately if you experience any change in behavior or mood, feelings of depression, or suicidal thoughts or behaviors (this is uncommon).

Very common side effects(may affect more than 1 in 10 people)

• diarrhea
• nausea
• headache
• upper respiratory tract infections such as cold, runny nose, sinus infection (sinusitis)

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

• cough
• back pain
• vomiting
• fatigue
• stomach pain
• loss of appetite
• frequent bowel movements
• difficulty sleeping (insomnia)
• indigestion or stomach upset
• inflammation and swelling of the airways leading to 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 intestine or stomach
• suicidal ideation or behavior

Rare side effects(frequency cannot be estimated from the available data)

• severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may cause difficulty breathing or swallowing)

If you are 65 years of age or older, you may have a higher risk of experiencing severe diarrhea, nausea, and vomiting. If your gastrointestinal problems become severe, you should talk to your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Apremilast Zentiva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister or on the carton after CAD. The expiry date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging to protect from moisture.

Do not use this medicine if you notice any deterioration or signs of tampering with the medicine packaging.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

The active substance is apremilast.

• Apremilast Zentiva 10 mg film-coated tablets EFG: each film-coated tablet contains 10 mg of apremilast.
• Apremilast Zentiva 20 mg film-coated tablets EFG: each film-coated tablet contains 20 mg of apremilast.
• Apremilast Zentiva 30 mg film-coated tablets EFG: each film-coated tablet contains 30 mg of apremilast.

The other ingredients in the tablet core are lactose monohydrate, microcrystalline cellulose (E460), sodium croscarmellose (E468), and magnesium stearate (E572). The tablet coating contains hypromellose (E464), macrogol, titanium dioxide (E171), talc (E553b), and red iron oxide (E172) in Apremilast Zentiva 10 mg; yellow iron oxide (E172) in Apremilast Zentiva 20 mg; and red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172) in Apremilast Zentiva 30 mg.

Appearance of the Product and Package Contents

Apremilast Zentiva 10 mg film-coated tablets are round, pink tablets with a diameter of approximately 6 mm.

Apremilast Zentiva 20 mg film-coated tablets are elongated, yellow tablets with approximate dimensions of 11 x 6 mm.

Apremilast Zentiva 30 mg film-coated tablets are round, brown to dark brown tablets with a diameter of approximately 9 mm.

Package Sizes

• The starter pack is a foldable wallet containing 27 film-coated tablets: 4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg.
• The standard monthly pack contains 56 film-coated tablets of 30 mg.
• The standard three-month pack contains 168 film-coated tablets of 30 mg.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Zentiva, k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

LABORMED-PHARMA S.A.

Bd. Theodor Pallady nr. 44B, sector 3

032 266, Bucharest

Romania

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

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

Germany: Apremilast Zentiva

Austria: Apremilast Zentiva

Spain: Apremilast Zentiva 30 mg film-coated tablets EFG

Apremilast Zentiva 10 mg + 20 mg + 30 mg film-coated tablets EFG

France: Apremilast Zentiva

Italy: Apremilast Zentiva

Czech Republic: Apremilast Zentiva

Sweden: Apremilast Zentiva

Date of the last revision of this leaflet: November 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/