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

Introduction

Package Leaflet: Information for the User

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

(treatment initiation pack)

Apremilast Tarbis 30 mg film-coated tablets EFG

Read all of this 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 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 get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What is Apremilast Tarbis

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

What is Apremilast Tarbis 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 plaque psoriasis of moderate to severe: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.

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 Tarbis 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 produces an improvement in 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 oral ulcers and can make them completely disappear. It can also reduce associated pain.

Apremilast has also shown that it improves the quality of life of patients with psoriasis, psoriatic arthritis, or Behçet's disease. This means that the impact of their disease on daily activities, relationships, and other factors should be less than before.

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

Do not take Apremilast Tarbis

• 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 could worsen with suicidal thoughts.

You or your caregiver should also inform your doctor immediately 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 unintentionally.

Gastrointestinal problems

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

Children and adolescents

Apremilast has not been studied in children and adolescents; therefore, it is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Apremilast Tarbis

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 treatment with 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

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 Tarbis contains lactose and sodium

This medicine contains lactose. 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 film-coated tablet; this is essentially “sodium-free”.

3. How to take Apremilast Tarbis

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 all the doses as described in the table below.
• 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 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 titration 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 makes a total daily dose of 60 mg. By the end of day 6, you will have already reached this recommended dose.
• Once the recommended dose is reached, the prescribed packs will contain only 30 mg tablets. You will only need to go through this dose escalation process once, even if you need to restart treatment.

People 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 tell you how to increase the dose when you start taking apremilast for the first time.

How and when to take Apremilast Tarbis

• 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 more Apremilast Tarbis 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, telephone 91 562 04 20, indicating the medicine and the amount ingested/used.

If you forget to take Apremilast Tarbis

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

If you stop taking Apremilast Tarbis

• 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 other questions about 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.

Severe 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 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 (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 (can include swelling of the face, lips, mouth, tongue, or throat that can 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 gastrointestinal problems become severe, you should talk to your doctor.

Reporting of side effects

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

5. Storage of Apremilast Tarbis

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, on the wallet pack, and on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Apremilast Tarbis

The active substance is apremilast.

Apremilast Tarbis 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.

Apremilast Tarbis 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.

Apremilast Tarbis 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.

Other ingredients are:

Core of the tablet: Microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, and magnesium stearate.

Coating: Hypromellose 2910 (E464), titanium dioxide (E171), macrogol 4000 (E1521), talc (E553b).

Only in Apremilast Tarbis 10 mg: Yellow iron oxide (E172).

Only in Apremilast Tarbis 20 mg: Indigo carmine aluminum lake (E132).

Appearance of the product and pack contents

Apremilast Tarbis 10 mg film-coated tablets

Film-coated tablets, biconvex, oval, yellow, approximately 7.8 mm x 4.2 mm, engraved with an “H” on one side and “10” on the other.

Apremilast Tarbis 20 mg film-coated tablets

Film-coated tablet, biconvex, blue, oval, approximately 9.8 mm x 5.3 mm, with an “H” engraved on one side and “20” on the other.

Apremilast Tarbis 30 mg film-coated tablets

Film-coated tablet, biconvex, white to off-white, oval, approximately 11.6 mm x 5.7 mm, engraved with an “H” on one side and “30” on the other.

Pack sizes

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

The treatment initiation pack contains blisters in a foldable wallet with 27 film-coated tablets or unit-dose blisters in a foldable wallet with 27 film-coated tablets: 4 tablets of 10 mg, 4 tablets of 20 mg, and 19 tablets of 30 mg.

Apremilast Tarbis 30 mg film-coated tablets EFG

The maintenance pack contains blisters in cartons with 56 and 168 film-coated tablets or unit-dose blisters in cartons with 56 and 168 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

Netherlands

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

Germany: Apremilast Amarox 10 mg+20 mg+30 mg Filmtabletten

Apremilast Amarox 30 mg Filmtabletten

Netherlands: Apremilast Amarox 10 mg/ 20 mg/ 30 mg filmomhulde tabletten

Apremilast Amarox 30 mg filmomhulde tabletten

Spain: Apremilast Tarbis 10 mg + 20 mg + 30 mg comprimidos recubiertos con película EFG

Apremilast Tarbis 30 mg comprimidos recubiertos con película EFG

Date of last revision of this leaflet: August 2024

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