Apremilast Teva 30 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the patient
Apremilast Teva 10 mg + 20 mg + 30 mg film-coated tablets EFG
Starter pack
Apremilast Teva 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, 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet:
- What Apremilast Teva is and what it is used for
- What you need to know before taking Apremilast Teva
- How to take Apremilast Teva
- Possible side effects
- How to store Apremilast Teva
- Contents of the pack and other information
1. What Apremilast Teva is and what it is used for
Apremilast Teva contains the active substance “apremilast”. It belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help reduce inflammation.
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.
Apremilast is used to treat children and adolescents aged 6 years or older and weighing at least 20 kg with the following condition:
- Moderate to severe plaque psoriasis – if your doctor considers it appropriate for you to receive a systemic treatment such as apremilast.
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, and painful lesions on the skin. It may also affect the scalp and nails.
What is Behçet’s disease (BD)
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 Teva 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 leads to improvement in inflamed and painful joints and may improve overall physical function.
In adults, and in children and adolescents aged 6 years or older and weighing at least 20 kg with psoriasis, treatment with apremilast reduces psoriatic 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 may cause them to disappear completely. It may also reduce associated pain.
Apremilast has also been shown to improve quality of life in adult and pediatric patients with psoriasis, adult patients with psoriatic arthritis, and adult patients with Behçet’s disease. This means that 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 Apremilast Teva
Do not take Apremilast Teva
- if you are allergic to apremilast or to any of the other components 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 Teva.
Depression and suicidal thoughts
Inform your doctor before starting treatment with apremilast if you have depression that is worsening with suicidal thoughts.
You or your caregiver should 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, the dose will be different – see section 3.
If you have below-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
The use of apremilast is not recommended in children under 6 years of age or weighing less than 20 kg with moderate to severe plaque psoriasis, 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 Teva
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.
In particular, inform your doctor or pharmacist before starting apremilast if you are taking any of the following medicines:
- rifampicin – an antibiotic used to treat tuberculosis;
- phenytoin, phenobarbital, and carbamazepine – medicines used in the treatment of epileptic seizures;
- St. John’s wort – a herbal medicine used for mild anxiety and depression.
Pregnancy and breastfeeding
Do not take Apremilast Teva if you are pregnant or think you might be pregnant.
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 should not become pregnant while taking this medicine and must use effective contraception during treatment with apremilast.
It is unknown whether this medicine passes into breast milk. Apremilast Teva should not be used while breastfeeding.
Driving and using machines
The effect of apremilast on the ability to drive and use machines is none or negligible.
Apremilast Teva contains lactose
If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
Apremilast Teva 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 Teva
Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.
How much to take
- When you first start taking Apremilast Teva, you will receive a “starter pack” containing enough tablets for a total of two weeks of treatment.
- 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 during the first week of treatment (titration phase).
- The “starter pack” will also contain the sufficient number of tablets for another week at the recommended dose.
- Once the recommended dose is reached, prescribed packs will contain only single-dose tablets.
- You will only need to go through the process of gradually increasing the dose once, even if you have to restart treatment.
Adults
- The recommended dose of apremilast for adult patients is 30 mg twice daily after completing the titration phase, as shown in the table below – one 30 mg dose in the morning and one 30 mg dose in the evening, approximately every 12 hours, with or without food. This results in a total daily dose of 60 mg.
- 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.
Day | Morning dose | Evening dose | Total daily dose |
Day 1 | 10 mg (light pink) | Do not take the dose | 10 mg |
Day 2 | 10 mg (light pink) | 10 mg (light pink) | 20 mg |
Day 3 | 10 mg (light pink) | 20 mg (beige) | 30 mg |
Day 4 | 20 mg (beige) | 20 mg (beige) | 40 mg |
Day 5 | 20 mg (beige) | 30 mg (pink) | 50 mg |
Day 6 onwards | 30 mg (pink) | 30 mg (pink) | 60 mg |
Children and adolescents 6 years of age and older
- The dose of apremilast will be based on body weight.
For patients with a body weight from 20 kg to less than 50 kg*: the recommended dose of apremilast is 20 mg twice daily after completion of the titration phase, as shown in the following table – one 20 mg dose in the morning and one 20 mg dose at night, approximately every 12 hours, with or without food. This results in a total daily dose of 40 mg.
Weight from 20 kg to less than 50 kg * | |||
Day | Morning dose | Evening dose | Total daily dose |
Day 1 | 10 mg (light pink) | Do not take the dose | 10 mg |
Day 2 | 10 mg (light pink) | 10 mg (light pink) | 20 mg |
Day 3 | 10 mg (light pink) | 20 mg (beige) | 30 mg |
Day 4 | 20 mg (beige) | 20 mg (beige) | 40 mg |
Day 5 | 20 mg (beige) | 20 mg (beige) | 40 mg |
Day 6 onwards | 20 mg (beige) | 20 mg (beige) | 40 mg |
*There are no Apremilast Teva pack sizes available that allow dose titration and maintenance treatment in pediatric patients weighing between 20 kg and less than 50 kg. Therefore, it is not possible to treat pediatric patients weighing between 20 kg and less than 50 kg with Apremilast Teva; instead, other apremilast products providing these pack sizes should be used.
For patients weighing at least 50 kg: the recommended dose of apremilast is 30 mg twice daily after completing the titration phase (the same as the adult dose), as shown in the table below: one 30 mg dose in the morning and one 30 mg dose in the evening, approximately every 12 hours, with or without food. This results in a total daily dose of 60 mg.
Weight of 50 kg or more | |||
Day | Morning dose | Evening dose | Total daily dose |
Day 1 | 10 mg (light pink) | Do not take dose | 10 mg |
Day 2 | 10 mg (light pink) | 10 mg (light pink) | 20 mg |
Day 3 | 10 mg (light pink) | 20 mg (beige) | 30 mg |
Day 4 | 20 mg (beige) | 20 mg (beige) | 40 mg |
Day 5 | 20 mg (beige) | 30 mg (pink) | 50 mg |
Day 6 onwards | 30 mg (pink) | 30 mg (pink) | 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 daily (morning dose).
In children and adolescents aged 6 years or older with severe renal impairment, the recommended dose of apremilast is 30 mg once daily (morning dose) for patients weighing at least 50 kg, and 20 mg once daily (morning dose) for children weighing between 20 kg and less than 50 kg.
Your doctor will advise you on how to escalate the dose when starting apremilast for the first time. Your doctor may recommend that you take only the morning dose applicable 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 Teva
- Apremilast Teva is taken orally.
- Swallow the tablets whole, preferably with water.
- You may take the tablets with or without food.
- Take Apremilast Teva 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 Teva than you should
If you take more apremilast than you should, contact a doctor or go to a hospital immediately. Take the medicine package and leaflet with you.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken. You are advised to bring the medicine’s packaging and leaflet to the healthcare professional.
If you forget to take Apremilast Teva
- If you miss a dose of apremilast, take it as soon as possible. If it is close to the time for 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 Teva
- 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 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
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 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 stomach or intestines
- suicidal ideation or behaviour
- anxiety
- mood changes
Adverse effects with unknown frequency (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 a higher risk of experiencing 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 adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Apremilast Teva
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container after CAD or 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 deterioration or signs of tampering with the medicine packaging.
Medicines must not be disposed of via wastewater drains or household waste. Unused containers and medicines should be returned to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Apremilast Teva
The active substance is apremilast.
- Apremilast Teva 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
- Apremilast Teva 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
- Apremilast Teva 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast.
The other components of the tablet core are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.
The coating contains: hypromellose (E464), titanium dioxide (E171), macrogol, iron oxide red (E172).
Apremilast Teva 20 mg film-coated tablets also contain iron oxide yellow (E172).
Appearance of the product and contents of the pack
Apremilast Teva 10 mg film-coated tablets are light pink, oval-shaped, film-coated tablets, marked with "TV" on one side and "Y2" on the other. The tablet dimensions are approximately 9 mm x 5 mm.
Apremilast Teva 20 mg film-coated tablets are beige, oval-shaped, film-coated tablets, marked with "TV" on one side and "Y3" on the other. The tablet dimensions are approximately 11 mm x 6 mm.
Apremilast Teva 30 mg film-coated tablets are pink, oval-shaped, film-coated tablets, marked with "TV" on one side and "Y4" on the other. The tablet dimensions are approximately 12 mm x 7 mm.
Apremilast Teva 10 mg + 20 mg + 30 mg film-coated tablets EFG (starter pack)
The starter pack contains 27 film-coated tablets (4 x 10 mg, 4 x 20 mg, 19 x 30 mg) in a wallet pack (cardboard-type format).
Apremilast Teva 30 mg film-coated tablets EFG
Pack sizes: 30x1 (in single-dose blisters), 56, 56x1 (in single-dose blisters), 60, 168x1 (in single-dose blisters).
Only some pack sizes may be commercially available.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva B.V.
Swensweg 5,
2031GA Haarlem,
The Netherlands
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.),
Prilaz baruna Filipovica 25,
10000 Zagreb,
Croatia
or
Teva Operations Poland Sp. z o.o,
ul. Mogilska 80, 31-546,
Kraków
Poland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor
28108, Alcobendas, Madrid (Spain)
Date of the most recent review of this leaflet: March 2026
"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/"
You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following web address: https://cima.aemps.es/cima/dochtml/p/89790/P_89790.html