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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

(starter 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, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Apremilast Tarbis is

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

What Apremilast Tarbis 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 Anti-Rheumatic 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.

What is psoriatic arthritis

Psoriatic arthritis is an inflammatory joint disease, usually accompanied by psoriasis, a skin inflammatory condition.

What is plaque psoriasis

Psoriasis is an inflammatory skin disease that can cause red, scaly, thickened, itchy, or painful skin lesions, and may 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 generally chronic conditions 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 conditions.

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

In psoriasis, treatment with apremilast reduces psoriatic 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 may cause them to disappear completely. It may also reduce associated pain.

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

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

Do not take Apremilast Tarbis

• 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

Talk to your doctor or pharmacist before starting treatment with 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 inform your doctor of any changes in behavior or mood, feelings of depression, or any suicidal thoughts you may experience 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 lose weight unintentionally.

Gastrointestinal problems

If you experience severe diarrhea, nausea, or vomiting, you must inform your doctor.

Children and adolescents

Apremilast has not been studied in children and adolescents; therefore, its use is not recommended in children and adolescents aged 17 years or younger.

Other medicines and Apremilast Tarbis

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

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 should use effective contraception during treatment with apremilast.

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

Driving and using machines

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

Apremilast Tarbis contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with 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 instructions for using this medicine as given 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 all the doses as described in the table below.
• 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 over the first 6 days of treatment.
• The "starter pack" will also contain enough tablets for an additional 8 days at the recommended dose (days 7 to 14).
• The recommended dose of apremilast is 30 mg twice daily after completing the titration phase, one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food.
• This results in a total daily dose of 60 mg. By the end of day 6, you will have reached this recommended dose.
• Once the recommended dose is reached, prescribed packs will contain only 30 mg tablets. You will only need to go through this gradual dose escalation process once, even if you have to restart treatment.

Patients with severe kidney problems

If you have severe kidney problems, the recommended dose of apremilast is 30 mg once daily (morning dose). Your doctor will advise you on how to increase the dose when you first start taking apremilast.

How and when to take Apremilast Tarbis

• Apremilast is taken orally.
• Swallow the tablets whole, preferably with water.
• 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 Tarbis than you should

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 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 almost time for your next dose, skip the missed dose. Take your next dose at the regular 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 first consulting your doctor.

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 may cause adverse effects, although not everyone will experience 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, 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 heartburn
• inflammation and swelling of the airways 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 behaviour

Adverse effects not known (frequency cannot be estimated from available data)

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

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Apremilast Tarbis

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, the carton pack, and the outer box after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater drains or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 components are:

Tablet core: Microcrystalline cellulose, sodium croscarmellose, lactose monohydrate and magnesium stearate.

Film 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 aluminium lake (E132).

Appearance of the product and pack contents

Apremilast Tarbis 10 mg film-coated tablets

Film-coated, biconvex, oval-shaped, yellow tablets, 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, biconvex, oval-shaped, blue tablets, approximately 9.8 mm x 5.3 mm, engraved with an "H" on one side and "20" on the other.

Apremilast Tarbis 30 mg film-coated tablets

Film-coated, biconvex, oval-shaped, white to off-white tablets, 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 starter pack contains blisters in a folding carton with 27 film-coated tablets or unit-dose blisters in a folding carton 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 cardboard boxes with 56 and 168 film-coated tablets or unit-dose blisters in cardboard boxes with 56 and 168 film-coated tablets.

Only certain 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

The Netherlands

This medicinal product is authorized in the European Economic Area member states 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 film-coated tablets EFG
Apremilast Tarbis 30 mg film-coated tablets EFG

Date of the most recent review of this leaflet: August 2024

Detailed and up-to-date 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/