Patient leaflet - Apremilast Zentiva 30 mg film-coated tablets
1 What Apremilast is and what it is used for
This medicine contains the active substance ‘apremilast’. This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.
Ampremilast is used to treat adults with the following conditions:
- Active psoriatic arthritis - if you cannot use another type of medicine called ‘Disease-Modifying Antirheumatic Drugs’ (DMARDs) or when you have 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 tried one of these treatments and it did not work:
o phototherapy - a treatment where certain areas of skin are exposed to ultraviolet light
o systemic therapy - a treatment that affects the entire body rather than just one local area, such as ‘ciclosporin’, ‘methotrexate’ or ‘psoralen ’.
- Behçet’s disease (BD) - to treat the mouth ulcers which is a common problem for people with this illness.
What psoriatic arthritis is
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
What plaque psoriasis is
Psoriasis is an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails.
What Behçet’s disease is
Behçet’s disease is a rare type of inflammatory disease which affects many parts of the body. The most common problem is mouth ulcers. How Apremilast works
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong conditions and there is currently no cure. Apremilast works by reducing the activity of an enzyme in the body called ‘phosphodiesterase 4’,
which is involved in the process of inflammation. By reducing the activity of this enzyme, Apremilast can help to control the inflammation associated with psoriatic arthritis, psoriasis and Behçet’s disease, and thereby reduce the signs and symptoms of these conditions.
In psoriatic arthritis, treatment with Apremilast results in an improvement in swollen and painful joints, and can improve your general physical function. In psoriasis, treatment with Apremilast results in a reduction in psoriatic skin plaques and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Apremilast reduces the number of mouth ulcers and can stop them completely. It can also reduce the associated pain. Apremilast has also been shown to improve the quality of life in patients with psoriasis, psoriatic arthritis or Behçet’s disease. This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.
2 What you need to know before you take Apremilast
Do not take Apremilast if you;
- are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6).
- are pregnant or think you may be pregnant. Warnings and precautions
Talk to your doctor or pharmacist before taking Apremilast.
Depression and suicidal thoughts
Tell your doctor before starting Apremilast if you have depression which is getting worse with thoughts of suicide. You or your caregiver should also tell your doctor straight away of any changes in behaviour
or mood, feelings of depression and of any suicidal thoughts you may have after taking Apremilast. Severe kidney problems: If you have severe kidney problems, your dose will be different – see section 3. If you are underweight: Talk to your doctor while taking Apremilast if you lose weight without meaning to.
Gut problems: If you experience severe diarrhoea, nausea, or vomiting, you should talk to 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 aged 17 years and under. Other medicines and Apremilast
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 some other medicines work. Also some other medicines can affect the way Apremilast works.
In particular, tell your doctor or pharmacist before taking 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 for mild anxiety and depression.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 little information about the effects of Apremilast in pregnancy. You should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast.
It is not known if this medicine passes into human milk. You should not use Apremilast while breast-feeding. Driving and using machines
Apremilast has no known effects on the ability to drive or use machines.
Apremilast contains lactose and sodium. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3 How to take Apremilast
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
- When you first start taking Apremilast, you will receive a ‘treatment initiation pack’ which contains all the doses as listed below.
- The ‘treatment initiation pack’ is clearly labelled to make sure you take the correct tablet at the correct time.
- Your treatment will start at a lower dose and will gradually be increased 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 the titration phase is complete
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 this recommended dose.
- Once the recommended dose has been reached, you will only get the 30 mg tablet strength in your prescribed packs. You will only ever need to go through this stage of gradually increasing your dose once even if you re-start treatment.
| Morning Dose: | Evening Dose: | Total Daily Dose: | |
| Day 1 | 10 mg (pink) | Do not take a dose | 10 mg |
| Day 2 | 10 mg (pink) | 10 mg (pink) | 20 mg |
| Day 3 | 10 mg (pink) | 20 mg (yellow) | 30 mg |
| Day 4 | 20 mg (yellow) | 20 mg (yellow) | 40 mg |
| Day 5 | 20 mg (yellow) | 30 mg (dark pink/ brown) | 50 mg |
| Day 6 onwards | 30 mg (dark pink/brown) | 30 mg (dark pink/ brown) | 60 mg |
People with severe kidney problems
If you have severe kidney problems then the recommended dose of Apremilast is 30 mg once a day (morning dose). Your doctor will talk to you about how to increase your dose when you first start taking Apremilast.
How and when to take Apremilast
- Apremilast is for oral use.
- Swallow the tablets whole, preferably with water.
- You can take the tablets either with or without food.
- Take Apremilast at about the same time each day, one tablet in the morning and one tablet in the evening. If your condition has not improved after six months of treatment, you should talk to your doctor. If you take more Apremilast than you should
- If you take more Apremilast than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you. If you forget to take Apremilast
- If you miss a dose of Apremilast, take it as soon as you remember. If it is close to the time for your next dose, just skip the missed dose. Take the next dose at your regular time.
- Do not take a double dose to make up for a forgotten dose.
If you stop taking Apremilast
- You should continue taking Apremilast until your doctor tells you to stop.
- Do not stop taking Apremilast 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 straight away about any changes in behaviour or mood, feelings of depression, thoughts of suicide or suicidal behaviour (this is uncommon).
Very common side effects (may affect more than 1 in 10 people)
- diarrhoea
- nausea
- headaches
- upper respiratory tract infections such as cold, runny nose, sinus infection
Common (may affect up to 1 in 10 people):
- cough
- back pain
- vomiting
- feeling tired
- stomach pain
- loss of appetite
- frequent bowel movements
- difficulty sleeping (insomnia)
- indigestion or heartburn
- inflammation and swelling of the tubes in your lungs (bronchitis)
- common cold (nasopharyngitis)
- depression
- migraine
- tension headache
Uncommon (may affect up to 1 in 100 people):
- rash
- hives (urticaria)
- weight loss
- allergic reaction
- bleeding in the bowel or in the stomach
suicidal ideation or behaviour
- anxiety
- mood changes
Not known (frequency cannot be estimated from the available data):
- severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing) If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting. If your gut problems become severe, you should talk to your doctor.
Reporting of side effects
If you get 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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5 How to store Apremilast
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 wallet or carton after “EXP”. The expiry date refers to the last day of that month. Store below 30oC
Store in the original package in order to protect from moisture.
Do not use this medicine if you notice any damage or signs of tampering to the medicine packaging. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What Apremilast contains
The active substance is apremilast.
- Apremilast Zentiva 10 mg film-coated tablets: each film-coated tablet contains 10 mg of apremilast.
- Apremilast Zentiva 20 mg film-coated tablets: each film-coated tablet contains 20 mg of apremilast.
- Apremilast Zentiva 30 mg film-coated tablets: each film-coated tablet contains 30 mg of apremilast. The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate, croscarmellose sodium and magnesium stearate. The tablet coating contains hypromellose, macrogol, titanium dioxide (E171), talc and:
10 mg; iron oxide red (E172).
20 mg; iron oxide yellow (E172).
30 mg; iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172).
What Apremilast looks like and contents of the pack
Apremilast Zentiva 10 mg film-coated tablets are pink, round film-coated tablets with the diameter 6.0 mm.
Apremilast Zentiva 20 mg film-coated tablets are yellow, oblong film-coated tablets with the dimensions 11 × 5.5 mm.
Apremilast Zentiva 30 mg film-coated tablets are brown to dark brown, round film-coated tablets with the diameter 9.0 mm.
Pack sizes
- The treatment initiation pack is a folding wallet containing 27 film-coated tablets: 4 x 10 mg tablets, 4 x 20 mg tablets and 19 x 30 mg tablets.
- The standard pack contains 56 x 30 mg film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Zentiva Pharma UK Limited, 12 New Fetter Lane,
London, EC4A 1JP,
United Kingdom
Manufacturers:
LABORMED-PHARMA S.A.
Bd. Theodor Pallady nr. 44B, sector 3, 032 266 Bucuresti
Romania
This leaflet was last revised in February 2026
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