Active ingredient
- apremilast
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: EU/1/14/981/001, EU/1/14/981/002, EU/1/14/981/003.
Otezla 10mg, 20mg, 30mg
Package leaflet: Information for the patient
Otezla 10 mg film-coated tablets
Otezla 20 mg film-coated tablets
Otezla 30 mg film-coated tablets
apremilast
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
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
1. What Otezla is and what it is used for
What Otezla is
Otezla contains the active substance ‘apremilast’. This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.
What Otezla is used for
Otezla is used to treat adults with the following conditions:
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 Otezla works
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.
2. What you need to know before you take Otezla
Do not take Otezla:
Warnings and precautions
Talk to your doctor or pharmacist before taking Otezla.
Depression and suicidal thoughts
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.
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 Otezla 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
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.
Other medicines and Otezla
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:
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 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.
Driving and using machines
Otezla has no effect on the ability to drive and use machines.
Otezla contains lactose
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.
3. How to take Otezla
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
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
People with severe kidney problems
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.
How and when to take 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
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 forget to take Otezla
If you stop taking Otezla
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)
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.
Reporting of side effects
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.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
Ireland
Malta
5. How to store Otezla
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.
6. Contents of the pack and other information
What Otezla contains
The active substance is apremilast.
The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate, croscarmellose sodium and magnesium stearate.
What Otezla looks like and contents of the pack
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
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Manufacturer
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last revised in June 2020.
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.otezla-eu-pil.com.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
240 Cambridge Science Park, Milton Road, Cambridge, CB4 0WD
+44 (0)1223 426 314
+44 (0)1223 426 314
+44 (0)1223 420 305
+44 (0)1223 436 441
+44 (0)808 0100 321