APREMILAST NOUCOR 30 mg FILM-COATED TABLETS

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

This medicine contains the active substance «apremilast». It belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help reduce inflammation.

What Apremilast Noucor is used for

Apremilast is used to treat adults with the following diseases:

• Active psoriatic arthritis:if you cannot use another type of medicine called «disease-modifying antirheumatic drugs» (DMARDs) or if 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 if 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 just a local area, such as «ciclosporin», «methotrexate» or «psoralen».

• Behçet's disease (BD):to treat mouth ulcers, a common problem in people with this disease.

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 that can cause 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 mouth ulcers.

How Apremilast Noucor 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 psoriatic arthritis, treatment with apremilast improves inflamed and painful joints and can improve overall physical function.

In psoriasis, treatment with apremilast reduces psoriasis plaques on the skin and other signs and symptoms of the disease.

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

Apremilast Noucor has also been shown to improve the quality of life of patients with psoriasis, psoriatic arthritis, or 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 Noucor

Do not take Apremilast Noucor:

• 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

Before starting to take apremilast, tell your doctor if you have depression that could get worse with suicidal thoughts.

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

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.

Intestinal problems

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

Children and adolescents

This medicine has not been studied in children and adolescents, so it is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Apremilast Noucor

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 for mild anxiety and depression.

Pregnancy and breastfeeding

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 an effective contraceptive method during treatment with apremilast.

It is not known whether this medicine passes into breast milk. You should not use apremilast during breastfeeding.

Driving and using machines

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

Apremilast Noucor contains sodium

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

3. How to take Apremilast Noucor

Follow exactly the administration instructions of this medicine given 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 all the doses indicated in the table below.
• The «treatment initiation pack» is clearly labeled to ensure that you take the correct dose at the right time.
• Your treatment will start at a lower dose and will gradually increase over the first 6 days of treatment.
• The «treatment initiation pack» will also contain enough tablets for another 8 days at the recommended dose (days 7 to 14).
• The recommended dose of apremilast is 30 mg twice a day after completing the dose adjustment phase: one 30 mg dose in the morning and one 30 mg dose in the evening, approximately every 12 hours, with or without food.
• This is a total daily dose of 60 mg. By the end of day 6, you will have reached this recommended dose.
• Once you have reached the recommended dose, you will only be prescribed packs with 30 mg tablets. You will only need to go through this gradual dose increase phase once, even if you have to restart treatment.

It is not possible to establish a dose adjustment program with this medicine. There are other presentations available to start treatment before using Apremilast Noucor 30 mg.

Patients with severe kidney problems

If you have severe kidney problems, the recommended dose of apremilast is 30 mg once a day (morning dose). Your doctor will explain how to increase the dose when you start taking this medicine for the first time.

How and when to take Apremilast Noucor

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

If your disease has not improved after six months of treatment, consult your doctor.

If you take more Apremilast Noucor than you should

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

If you forget to take Apremilast Noucor

• If you miss a dose of this medicine, take it as soon as possible. If the time for the next dose is near, skip the missed dose. Take the next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Apremilast Noucor

• You should keep taking apremilast until your doctor tells you to stop.
• Do not stop taking this medicine without talking to 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 about any change in behavior or mood, feelings of depression, or suicidal thoughts or behaviors (this is rare).

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

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 acid
• 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 can cause difficulty breathing or swallowing)

If you are 65 years of age or older, you may have a higher risk of complications such as diarrhea, nausea, and vomiting. If your intestinal problems worsen, 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 leaflet. You can also report side effects directly via 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. Storing Apremilast Noucor

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 EXP. The expiry date is the last day of the month shown.

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. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and further information

Composition of Apremilast Noucor

• The active substance is apremilast, each film-coated tablet contains 30 mg of apremilast.

• The other ingredients of the tablet core are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate. The coating contains poly(vinyl alcohol), titanium dioxide (E171), macrogol, talc, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172).

Appearance of the product and package contents

The film-coated tablet is beige, biconvex, round, and 9.5 mm in diameter.

Package sizes

• The standard pack for one month contains PVC/PCTFE (polychlorotrifluoroethylene)/PVC aluminum foil blisters in pack sizes of 56 film-coated tablets of 30 mg.
• The standard pack for three months contains PVC/PCTFE (polychlorotrifluoroethylene)/PVC aluminum foil blisters in pack sizes of 168 film-coated tablets of 30 mg.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Noucor Health S.A.

Avinguda Camí Reial, 51-57

08184 Palau-Solità i Plegamans (Barcelona)

Spain

Date of last revision of this leaflet: October 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/)