Apremilast Glenmark 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

(Starter pack for treatment initiation)

Apremilast Glenmark 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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.

  • If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if these adverse reactions are not listed in this leaflet. See section 4.

Contents of the leaflet

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

2. What you need to know before taking Apremilast Glenmark

3. How to take Apremilast Glenmark

4. Possible side effects

5. How to store Apremilast Glenmark

6. Contents of the pack and other information

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

What Apremilast Glenmark is

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

What Apremilast Glenmark 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 treatment - a treatment that works 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 psoriatic arthritis is

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

What plaque psoriasis is

Psoriasis is an inflammatory skin disease that can cause red, scaly, thickened, itchy, or painful lesions on the skin, and may 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 Glenmark 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 diseases.

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

In adults with psoriasis, treatment with apremilast reduces psoriatic skin plaques 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 patients with psoriasis, psoriatic arthritis, and 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 Glenmark

Do not take Apremilast Glenmark

• 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 may be pregnant.

Warnings and precautions

Talk to 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 may worsen with suicidal thoughts.

You or your caregiver must also inform your doctor immediately 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, your dose will be different; see section 3.

If you have a low 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

The use of apremilast is not recommended in children and adolescents aged 17 years or younger, as apremilast has not been studied in these age groups.

Other medicines and Apremilast Glenmark

Tell 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 to take 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 anxiety and mild 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 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 should not become pregnant while taking this medicine and must use effective contraceptive methods during treatment with apremilast.

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

Driving and using machines

The influence of apremilast on the ability to drive and use machines is negligible.

Apremilast Glenmark contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

Apremilast Glenmark contains sodium

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

3. How to take Apremilast Glenmark

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, 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 listed 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 will 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 completion of 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 is a total daily dose of 60 mg. By the end of day 6, you will have reached the recommended dose.
• Once the recommended dose is reached, prescribed packs will contain only 30 mg tablets. You will only need to go through the gradual dose escalation process once, even if you have to restart treatment later.

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 instruct you on how to increase the dose when you first start taking apremilast.

How and when to take Apremilast Glenmark

• 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 Glenmark than you should

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

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

If you forget to take Apremilast Glenmark

• 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 regular time.
• Do not take a double dose to make up for missed doses.

If you stop treatment with Apremilast Glenmark

• 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, 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 of unknown frequency (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 an increased risk of developing 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Glenmark

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

Do not use this medicine after the expiry date stated on the blister, wallet-type carton, or 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.

Do not use this medicine if you notice any signs of deterioration or evidence of tampering with the packaging.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the container and other information

Composition of Apremilast Glenmark

• The active substance is apremilast.

Apremilast Glenmark 10 mg + 20 mg + 30 mg film-coated tablets EFG (Starter pack)

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

Apremilast Glenmark 30 mg film-coated tablets EFG

Each film-coated tablet contains 30 mg of apremilast.

• The other components are:

Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171), macrogol, red iron oxide (E172), yellow iron oxide (E172), and black iron oxide (E172) (only in the 30 mg tablets).

Appearance of the product and contents of the container

The 10 mg tablets are pink, film-coated, oval, biconvex tablets, marked with "10" on one side.

The 20 mg tablets are brown, film-coated, oval, biconvex tablets, marked with "20" on one side.

The 30 mg tablets are beige, film-coated, oval, biconvex tablets, marked with "30" on one side.

Pack sizes

Apremilast Glenmark 10 mg + 20 mg + 30 mg film-coated tablets EFG (Starter pack)

The starter pack is a wallet-style pack containing 27 film-coated tablets: 4 film-coated tablets of 10 mg, 4 film-coated tablets of 20 mg, and 19 film-coated tablets of 30 mg.

Apremilast Glenmark 30 mg film-coated tablets EFG

The standard one-month pack contains blisters with 56 film-coated tablets.

The standard one-month pack contains single-dose pre-cut blister packs of 56 x 1 film-coated tablets.

The standard three-month pack contains blisters with 168 film-coated tablets.

The standard three-month pack contains single-dose pre-cut blister packs of 168 x 1 film-coated tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer

Delorbis Pharmaceuticals Ltd.
17 Athinon str., Ergates Industrial Area
2643 Ergates, Lefkosia
Cyprus

Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

Glenmark Pharmaceuticals s.r.o.
Hvezdova 1716/2b
140 78 Praha 4
Czech Republic

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany Apremilast Glenmark Starterpackung 10 mg + 20 mg + 30 mg Filmtabletten
Apremilast Glenmark 30 mg Filmtabletten

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

Ireland Apremilast Glenmark 10 mg + 20 mg + 30 mg film-coated tablets
Apremilast Glenmark 30 mg film-coated tablets

Italy Apremilast Glenmark

Date of the most recent review of this leaflet: September 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/).