APREMILAST STADA 30 mg FILM-COATED TABLETS

Q

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

What apremilast 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 has not worked.

• 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 has not worked:
• • phototherapy: a treatment in which 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 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 can 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 can make them disappear completely. It can also reduce associated pain.

Apremilast has also shown that it improves 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 Stada

DO NOT take Apremilast Stada

• 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 to take apremilast.

Depression and suicidal thoughts

Tell your doctor before starting treatment with apremilast if you have depression that could 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

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

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 can affect the way other medicines work. Also, some medicines can affect the way apremilast works.

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

• rifampicin: an antibiotic used for tuberculosis;
• phenytoin, phenobarbital, and carbamazepine: medicines used to treat 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 may be pregnant.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking 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 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 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 recommended dose (30 mg twice a day), i.e., it is essentially “sodium-free”.

3. How to take Apremilast Stada

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How much to take

• When you start taking apremilast for the first time, you will receive a “treatment initiation pack” that contains enough tablets for a total of two weeks of treatment.
• The “treatment initiation 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 during the first week of treatment (titration phase).
• The “treatment initiation pack” will also contain enough tablets for another week at the recommended dose.
• Once the recommended dose is reached, the prescribed packs will contain only tablets of a single dose.
• You will only need to go through the dose escalation process once, even if you have 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, one dose of 30 mg in the morning and one 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 and older

• 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, one dose of 20 mg in the morning and one dose of 20 mg in the evening, approximately every 12 hours, with or without food. This makes a total daily dose of 40 mg.

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

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, one dose of 30 mg in the morning and one dose of 30 mg in the evening, approximately every 12 hours, with or without food. This makes a total daily dose of 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 a day (morning dose).

In children and adolescents from 6 years of age and older 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 for children weighing 20 kg to less than 50 kg, the recommended dose of apremilast is 20 mg once a day (morning dose).

Your doctor will tell you how to increase the dose when you start taking apremilast for the first time. 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

• Apremilast is taken orally.
• Swallow the tablets whole, preferably with water, in order to avoid damaging the film coating.
• 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 more Apremilast Stada than 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 leaflet with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 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 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 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 on 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 all people suffer from them.

Severe Adverse Effects, Depression, and Suicidal Thoughts

Inform your doctor immediately of any change in behavior and mood, feelings of depression, thoughts, or suicidal behavior (this is rare).

Very Common Adverse 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 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 stomach burning
• 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 intestine or stomach
• suicidal ideation or behavior

Frequency Not Known(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 or older, you may have a higher risk of suffering from severe diarrhea, nausea, and vomiting. If your intestinal problems become severe, you should talk to your doctor.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this prospectus. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the blister or packaging after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

C

The active ingredient is apremilast.

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

The other components are:

Core of the tablet: powdered cellulose, lactose monohydrate, calcium carbonate, pregelatinized corn starch, crospovidone, and sodium stearyl fumarate.

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 Package Contents

Apremilast Stada 10 mg are film-coated tablets, pink, biconvex, oval (8 mm long and 4 mm wide).

Apremilast Stada 20 mg are film-coated tablets, brown, biconvex, oval (10 mm long and 5 mm wide).

Apremilast Stada 30 mg are film-coated tablets, beige, biconvex, oval (13 mm long and 6 mm wide).

Package sizes

Apremilast Stada 30 mg is available in PVC/Aluminum blisters in packages of 56 or 168 film-coated tablets or in single-dose PVC/Aluminum blisters in packages of 56 or 168 film-coated tablets.

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

Not all package 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 medicine is authorized 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 Filmtabletten

Apremilast STADA Starter pack 10 mg + 20 mg + 30 mg Filmtabletten

Belgium Apremilast EG 30 mg film-coated tablets

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

Cyprus APREMILAST/STADA 30 mg film-coated tablets

APREMILAST/STADA 10 mg/20 mg/30 mg film-coated tablets

Germany Apremilast STADA 30 mg Filmtabletten

Apremilast STADA 10 mg + 20 mg + 30 mg Filmtabletten

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 30mg film tablet

Apremilast STADA 10mg film tablet

Apremilast STADA 20mg film tablet

Apremilast STADA 30mg film 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 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 10mg film-coated tablets

Apremilast STADA 20mg film-coated tablets

Apremilast STADA 30mg 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 the Last Revision of this Prospectus:June 2025

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