Apremilast Stada 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

(starter pack)

Apremilast Stada 30 mg film-coated tablets EFG

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as yours, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Apremilast Stada is and what it is used for
2. What you need to know before taking Apremilast Stada
3. How to take Apremilast Stada
4. Possible adverse effects
5. How to store Apremilast Stada
6. Contents of the pack and other information

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

Apremilast Stada is a medicine that contains the active substance apremilast. It belongs to a group of medicines called immunomodulators. Apremilast works by reducing inflammation in the body.

Apremilast Stada is used for the treatment of:

• Moderate to severe plaque psoriasis in adults who may benefit from systemic therapy.
• Active psoriatic arthritis in adults.

Apremilast Stada helps reduce the symptoms of these diseases, such as skin lesions and joint pain, swelling, and stiffness.

What apremilast is

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

What apremilast is used for

Apremilast is used to treat adults with the following conditions:

• Active psoriatic arthritis: if you cannot use another type of medicine called “Disease-Modifying Antirheumatic Drugs” (DMARDs) or when you have already tried one of these medicines and it did not work.

• Moderate to severe chronic 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 in which certain areas of the skin are exposed to ultraviolet light
  • systemic therapy: a treatment that acts throughout the body rather than in 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 aged 6 years or older and weighing at least 20 kg with the following condition:

• Moderate to severe plaque psoriasis: when your doctor considers it appropriate for you to receive a systemic treatment such as apremilast.

What psoriatic arthritis is

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

What plaque psoriasis is

Psoriasis is an inflammatory skin disease, which can cause red, scaly, thickened patches on the skin that may be itchy or painful. It can also affect the scalp and nails.

What Behçet’s disease is

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 works

Psoriatic arthritis, psoriasis, and Behçet’s disease are generally 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, thereby reducing the signs and symptoms of these diseases.

In adults with psoriatic arthritis, treatment with apremilast improves inflamed and painful joints and may improve overall physical function.

In adults and in children and adolescents aged 6 years or older and weighing at least 20 kg with psoriasis, treatment with apremilast reduces psoriatic 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 cause them to disappear completely. It may also reduce associated pain.

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

2. What you need to know before you start taking Apremilast Stada

DO NOT take Apremilast Stada

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take apremilast.

Depression and suicidal thoughts

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

You or your caregiver should also immediately report to your doctor any changes in behavior or mood, feelings of depression, or any suicidal thoughts that may occur after taking apremilast.

Severe kidney problems

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

If you have a lower than normal body weight

Talk to your doctor while taking apremilast if you experience unintended weight loss.

Intestinal problems

If you experience diarrhoea, nausea or severe vomiting, you should inform your doctor.

Children and adolescents

The use of apremilast is not recommended 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.

The use of apremilast is not recommended 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 Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because apremilast may affect how other medicines work. In addition, some medicines may affect how apremilast works.

Specifically, inform your doctor or pharmacist before starting 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 if you are pregnant or think you might be pregnant.

If you are pregnant or breastfeeding, think you might 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 must not become pregnant while taking this medicine, and you should use effective contraceptive methods during treatment with apremilast.

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

Driving and use of machines

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

Apremilast Stada contains lactose and sodium

This medicine contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per recommended dose (30 mg twice daily), i.e., essentially “sodium-free”.

3. How to take Apremilast Stada

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

How much to take

• When you first start taking apremilast, you will receive a "starter pack" containing 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 begin at a lower dose and gradually increase during the first week of treatment (titration phase).
• The "starter pack" will also contain enough tablets for an additional week at the recommended dose.
• Once the recommended dose is reached, prescribed packages will contain only single-dose tablets.
• You will only need to go through the process of gradually increasing the dose once, even if you have to restart treatment.

Adults

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

Day	Morning dose	Evening dose	Total daily dose
Day 1	10 mg (pink)	Do not take the dose	10 mg
Day 2	10 mg (pink)	10 mg (pink)	20 mg
Day 3	10 mg (pink)	20 mg (brown)	30 mg
Day 4	20 mg (brown)	20 mg (brown)	40 mg
Day 5	20 mg (brown)	30 mg (beige)	50 mg
Day 6 onwards	30 mg (beige)	30 mg (beige)	60 mg

Children and adolescents 6 years of age and older

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

For patients with a body weight from 20 kg to less than 50 kg*: The recommended dose of apremilast is 20 mg twice daily after completion of the titration phase, as shown in the following table: one 20 mg dose in the morning and one 20 mg dose in the evening, approximately every 12 hours, with or without food. This results in a total daily dose of 40 mg.

	Weight from 20 kg to less than 50 kg*
Day	Morning dose	Evening dose	Total daily dose
Day 1	10 mg (pink)	Do not take dose	10 mg
Day 2	10 mg (pink)	10 mg (pink)	20 mg
Day 3	10 mg (pink)	20 mg (brown)	30 mg
Day 4	20 mg (brown)	20 mg (brown)	40 mg
Day 5	20 mg (brown)	20 mg (brown)	40 mg
Day 6 onwards	20 mg (brown)	20 mg (brown)	40 mg

• There are no dosage packs for Apremilast Stada that allow for titration and maintenance of treatment in pediatric patients weighing between 20 kg and less than 50 kg. Therefore, it is not possible to treat pediatric patients weighing between 20 kg and less than 50 kg with apremilast; instead, other apremilast products that offer these dosage packs should be used.

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

	Weight of 50 kg or more
Day	Morning dose	Evening dose	Total daily dose
Day 1	10 mg (pink)	Do not take dose	10 mg
Day 2	10 mg (pink)	10 mg (pink)	20 mg
Day 3	10 mg (pink)	20 mg (brown)	30 mg
Day 4	20 mg (brown)	20 mg (brown)	40 mg
Day 5	20 mg (brown)	30 mg (beige)	50 mg
Day 6 onwards	30 mg (beige)	30 mg (beige)	60 mg

Patients with severe kidney problems

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

In children and adolescents aged 6 years or older with severe renal impairment, the recommended dose of apremilast is 30 mg once daily (morning dose) for patients weighing at least 50 kg, and for children weighing between 20 kg and less than 50 kg, the recommended dose of apremilast is 20 mg once daily (morning dose).

Your doctor will advise you on how to increase the dose when starting apremilast for the first time. Your doctor may recommend that you take only the morning dose applicable 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

• Apremilast is taken orally.
• Swallow the tablets whole, preferably with water, to avoid damaging the film coating.
• You may take the tablets with or without food.
• Take apremilast approximately at the same time each day, one tablet in the morning and one tablet in the evening.

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

If you take more Apremilast Stada than you should

If you take more apremilast than you should, contact a doctor or go to a hospital immediately. Take the medicine packaging and leaflet with you.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Apremilast Stada

• If you miss a dose of apremilast, take it as soon as possible. If it is almost time for 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 Stada

• 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects, depression and suicidal thoughts

Inform your doctor immediately if you experience any changes in behaviour or mood, feelings of depression, or suicidal thoughts or behaviour (this is uncommon).

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

• diarrhoea
• nausea
• headache
• upper respiratory tract infections such as cold, runny nose, infection of the sinuses (sinusitis)

Common adverse 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 heartburn
• inflammation and swelling of the airways leading to the lungs (bronchitis)
• common cold (nasopharyngitis)
• depression
• migraine
• tension headache

Uncommon adverse effects (may affect up to 1 in 100 people)

• rash
• hives
• weight loss
• allergic reaction
• bleeding in the stomach or intestines
• suicidal ideation or behaviour

Frequency not known (cannot be estimated from available data)

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Apremilast Stada

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

Do not use this medicine after the expiry date stated on the blister pack or container, following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Apremilast Stada

The active substance is apremilast.

Each film-coated tablet contains 10 mg, 20 mg, or 30 mg of apremilast.

The other components are:

Tablet core: microcrystalline cellulose, lactose monohydrate, calcium carbonate, pregelatinized maize starch, crospovidone, and stearic acid fumarate and sodium.

Film coating:

• 10 mg tablets: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), and red iron oxide (E172).
• 20 mg tablets: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).
• 30 mg tablets: hypromellose (E464), titanium dioxide (E171), macrogol (E1521), red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172).

Appearance of the product and contents of the container

Apremilast Stada 10 mg are film-coated tablets, pink, biconvex, oval-shaped (8 mm in length and 4 mm in width).

Apremilast Stada 20 mg are film-coated tablets, brown, biconvex, oval-shaped (10 mm in length and 5 mm in width).

Apremilast Stada 30 mg are film-coated tablets, beige, biconvex, oval-shaped (13 mm in length and 6 mm in width).

Pack sizes

Apremilast Stada 30 mg is available in PVC/aluminum blisters in packs of 56 or 168 film-coated tablets or in unit-dose PVC/aluminum blisters in packs of 56 or 168 film-coated tablets.

Apremilast Stada 10 mg, 20 mg, and 30 mg are available in PVC/aluminum blisters in packs of 27 film-coated tablets (4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg) or in unit-dose PVC/aluminum blisters in packs of 27 film-coated tablets (4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Local Representative

Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
[email protected]

Manufacturer

Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

o

Stada Arzneimittel GmbH

Muthgasse 36

Vienna 1190

Austria

o

Clonmel Healthcare Ltd.

Waterford Road, Clonmel

E91 D768 Co. Tipperary

Ireland

o

Centrafarm Services B.V.

Van de Reijstraat 31-E

4814 NE Breda

Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Sweden Apremilast STADA 30 mg film-coated tablets

Apremilast STADA 10 mg + 20 mg + 30 mg film-coated tablets

Austria Apremilast STADA 30 mg film-coated tablets

Apremilast STADA Starter pack 10 mg + 20 mg + 30 mg film-coated tablets

Belgium Apremilast EG 30 mg film-coated tablets

Apremilast EG 10 mg + 20 mg + 30 mg film-coated tablets

Cyprus APREMILAST/STADA 30 mg coated tablets (with film)

APREMILAST/STADA 10 mg/20 mg/30 mg coated tablets (with film)

Germany Apremilast STADA 30 mg film-coated tablets

Apremilast STADA 10 mg + 20 mg + 30 mg film-coated tablets

Denmark Apremilast STADA

Spain Apremilast STADA 30 mg film-coated tablets EFG

Apremilast STADA 10 mg 20 mg 30 mg film-coated tablets EFG

Finland Apremilast STADA 30 mg film-coated tablets

Apremilast STADA 10 mg + 20 mg + 30 mg film-coated tablets

France APREMILAST STADA 30 mg, film-coated tablet

APREMILAST STADA 10 mg, film-coated tablet
APREMILAST STADA 20 mg, film-coated tablet
APREMILAST STADA 30 mg, film-coated tablet

Greece APREMILAST/STADA

Hungary Apremilast STADA 30 mg film-coated tablet

Apremilast STADA 10 mg film-coated tablet
Apremilast STADA 20 mg film-coated tablet
Apremilast STADA 30 mg film-coated tablet

Ireland Apremilast Clonmel 30 mg film-coated tablets
Apremilast Clonmel 10 mg film-coated tablets
Apremilast Clonmel 20 mg film-coated tablets
Apremilast Clonmel 30 mg film-coated tablets

Iceland Apremilast STADA 30 mg film-coated tablets
Apremilast STADA 10 mg + 20 mg + 30 mg film-coated tablets

Italy Apremilast EG

Luxembourg Apremilast EG 30 mg film-coated tablets
Apremilast EG 10 mg/20 mg/30 mg film-coated tablets

Netherlands Apremilast STADA 30 mg, film-coated tablets
Apremilast STADA 10 mg + 20 mg + 30 mg, film-coated tablets

Norway Apremilast STADA

Slovakia Apremilast STADA 30 mg film-coated tablets
Apremilast STADA 10 mg film-coated tablets
Apremilast STADA 20 mg film-coated tablets
Apremilast STADA 30 mg film-coated tablets

Malta Apremilast Clonmel 30 mg film-coated tablets
Apremilast Clonmel 10 mg film-coated tablets
Apremilast Clonmel 20 mg film-coated tablets
Apremilast Clonmel 30 mg film-coated tablets

Romania Apremilast Stada 30 mg film-coated tablets
Apremilast Stada 10 mg film-coated tablets
Apremilast Stada 20 mg film-coated tablets
Apremilast Stada 30 mg film-coated tablets

Slovenia Apremilast STADA 30 mg film-coated tablets
Apremilast STADA 10 mg film-coated tablets
Apremilast STADA 20 mg film-coated tablets
Apremilast STADA 30 mg film-coated tablets

Date of latest review of this leaflet: June 2025

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