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The product code(s) for this leaflet are: PLGB 13832/0047 , PLGB 13832/0048.
Otezla 10mg, 20mg, 30mg
Otezla 10 mg film-coated tablets
Otezla 20 mg film-coated tablets
Otezla 30 mg film-coated tablets
apremilast
1. What Otezla is and what it is used for
2. What you need to know before you take Otezla
3. How to take Otezla
4. Possible side effects
5. How to store Otezla
6. Contents of the pack and other information
Otezla contains the active substance ‘apremilast’. This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.
Otezla is used to treat adults with the following conditions:
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin.
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.
Behçet’s disease is a rare type of inflammatory disease which affects many parts of the body. The most common problem is mouth ulcers.
Psoriatic arthritis, psoriasis and Behçet’s disease are usually lifelong conditions and there is currently no cure. Otezla 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, Otezla 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 Otezla results in an improvement in swollen and painful joints, and can improve your general physical function.
In psoriasis, treatment with Otezla results in a reduction in psoriatic skin plaques and other signs and symptoms of the disease.
In Behçet’s disease, treatment with Otezla reduces the number of mouth ulcers and can stop them completely. It can also reduce the associated pain.
Otezla 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.
Talk to your doctor or pharmacist before taking Otezla.
Tell your doctor before starting Otezla 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 Otezla.
If you have severe kidney problems, your dose will be different – see section 3.
Talk to your doctor while taking Otezla if you lose weight without meaning to.
If you experience severe diarrhoea, nausea, or vomiting, you should talk to your doctor.
Otezla has not been studied in children and adolescents, therefore it is not recommended for use in children and adolescents aged 17 years and under.
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 Otezla can affect the way some other medicines work. Also some other medicines can affect the way Otezla works.
In particular, tell your doctor or pharmacist before taking Otezla if you are taking any of the following medicines:
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 Otezla in pregnancy. You should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Otezla.
It is not known if this medicine passes into human milk. You should not use Otezla while breast-feeding.
Otezla has no effect on the ability to drive and use machines.
Otezla contains lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Day 1
Morning Dose: 10 mg (pink)
Evening Dose: Do not take a dose
Total Daily Dose: 10 mg
Day 2
Morning Dose: 10 mg (pink)
Evening Dose: 10 mg (pink)
Total Daily Dose: 20 mg
Day 3
Morning Dose: 10 mg (pink)
Evening Dose: 20 mg (brown)
Total Daily Dose: 30 mg
Day 4
Morning Dose: 20 mg (brown)
Evening Dose: 20 mg (brown)
Total Daily Dose: 40 mg
Day 5
Morning Dose: 20 mg (brown)
Evening Dose: 30 mg (beige)
Total Daily Dose: 50 mg
Day 6 onwards
Morning Dose: 30 mg (beige)
Evening Dose: 30 mg (beige)
Total Daily Dose: 60 mg
If you have severe kidney problems then the recommended dose of Otezla 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 Otezla.
If your condition has not improved after six months of treatment, you should talk to your doctor.
If you take more Otezla 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Not known side effects (frequency cannot be estimated from the available data):
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.
If you get 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 (see details below ). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is apremilast.
The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate, croscarmellose sodium and magnesium stearate.
The Otezla 10 mg film-coated tablet is a pink, diamond shaped film-coated tablet with “APR” engraved on one side and “10” on the opposite side.
The Otezla 20 mg film-coated tablet is a brown, diamond shaped film-coated tablet with “APR” engraved on one side and “20” on the opposite side.
The Otezla 30 mg film-coated tablet is a beige, diamond shaped film-coated tablet with “APR” engraved on one side and “30” on the opposite side.
Pack sizes
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in May 2021.
Other sources of information
Detailed and updated information on this medicine is available by scanning the QR code on the outer packaging with a smartphone. The same information is also available on the following URL: www.medicines.org.uk.