Aprizla belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation.

Aprizla 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:

-    phototherapy - a treatment where certain areas of skin are exposed to ultraviolet light
-     systemic therapy - a treatment that affects the entire body rather than just one local area, such as ‘ciclosporin’, ‘methotrexate’ or ‘psoralen ’.

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. 
How Aprizla works 
Psoriatic arthritis, psoriasis are usually lifelong conditions and there is currently no cure. Aprizla 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, Aprizla can help to control the inflammation associated with psoriatic arthritis, psoriasis thereby reduce the signs and symptoms of these conditions. 
In psoriatic arthritis, treatment with Aprizla results in an improvement in swollen and painful joints, and can improve your general physical function. In psoriasis, treatment with Aprizla results in a reduction in psoriatic skin plaques and other signs and symptoms of the disease. 
Aprizla has also been shown to improve the quality of life in patients with psoriasis, psoriatic arthritis. 
This means that the impact of your condition on daily activities, relationships and other factors should be less than it was  before.

•     if you are allergic to Apremilast or 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 taking Aprizla. Depression and suicidal thoughts Tell your doctor before starting Aprizla 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 Aprizla.
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 Aprizla 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 

Aprizla 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 Aprizla 
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 Aprizla can affect the way some other medicines work. Also some other medicines can affect the way Aprizla works. In particular, tell your doctor or pharmacist before taking Aprizla 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 Aprizla in pregnancy. You should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Aprizla. It is not known if this medicine passes into human milk. You should not use Aprizla while breastfeeding.
Driving and using machines 
Aprizla has no effect on the ability to drive and use machines. 
Aprizla 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. 
How much to take

When you first start taking Aprizla, you will receive a ‘treatment initiation pack’ which contains all the doses as listed in the table 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 Aprizla 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.

People with severe kidney problems 
If you have severe kidney problems then the recommended dose of Aprizla 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 Aprizla. 
How and when to take Aprizla   

 •    Aprizla is for oral use.
 •    Swallow the tablets whole, preferably with water.
 •    You can take the tablets either with or without food.
 •    Take Aprizla 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 Aprizla 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 Aprizla

 •    If you miss a dose of Aprizla, 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 Aprizla
 •    You should continue taking Aprizla until your doctor tells you to stop.
 •    Do not stop taking Aprizla without talking to your doctor first.
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.
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, migraines or tension headaches
•    upper respiratory tract infections such as cold, runny nose, sinus infection

Common side effects (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

Uncommon side effects (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

Not known side effects (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.

•    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 blister or on the wallet or on the carton after EXP. The expiry date refers to the last day of that month.
•    Store below 30°C.
•    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 or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures  will help protect the environment.