Milorizast tablet contains the active substance Apremilast. This
belongs to a group of medicines called phosphodiesterase 4 inhibitors,
which help to reduce inflammation.

Milorizast Tablet is used to treat adults with the following conditions:
• Psoriatic arthritis if you cannot use another type of medicine
called Disease-Modifying Antirheumatic Drugs (DMARDs) or when
you have tried one of these drugs and it did not work.
• Moderate to severe 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 ultraviolet light
• Systemic therapy - a treatment that affects the entire body
than just one local area, such as Ciclosporin or Methotrexate
 

What psoriatic arthritis is
Psoriatic arthritis is an inflammatory disease of the joints, usually
accompanied by psoriasis, an inflammatory disease of the skin.
What plague 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 Milorizast works
Psoriatic arthritis and psoriasis are usually lifelong conditions and
there is currently no cure. Milorizast works by reducing the activity of
an enzyme in the body called phosphodiesterase 4; which is involved
in the process of inflammation. By decreasing the activity of this
enzyme, Milorizast can help to control the inflammation associated
with psoriatic arthritis and psoriasis, and then by reduce the signs and
symptoms of these conditions.
In psoriatic arthritis, treatment with Milorizast results in an
improvement in swollen and painful joints, and can improve your
general physical function.
In psoriasis, treatment with Milorizast results in a reduction in psoriatic
skin plaques and other signs and symptoms of the disease.
Milorizast has also been shown to improve the quality of life in patients
with psoriasis or psoriatic arthritis. This means that the impact of your
condition on daily activities, relationships and other factors should be
less than it was before.

Do not take Milorizast Tablet:
• If you are allergic to apremilast or any of the other ingredients of
this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Milorizast Tablet.
Symptoms you should be aware of
If your doctor considers you to be underweight, and you observe an
unintentional loss of body weight while being treated with Milorizast,
you should talk to your doctor.
If you have severe kidney problems, then the recommended dose of
Milorizast 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
Milorizast.
Before starting treatment with Milorizast, inform your doctor if you are
suffering from symptoms of worsening depression with suicidal thinking
or behavior especially if you take any additional medicines since some
of those could increase the probability of these side effects. You or your
caregiver should also immediately inform your doctor of any changes in
behavior or mood and of any suicidal thoughts you may have. You may
also experience sleeplessness, or depressive mood.
If you experience severe diarrhoea, nausea, or vomiting, you should
talk to your doctor.
Children and adolescents
The safety and effectiveness of Milorizast in pediatric patients less
than 18 years of age have not been established. Therefore, it is not
recommended for use in pediatric patients aged less than 18 years.
Other medicines and Milorizast Tablet
Tell your doctor or pharmacist if you are taking might take any other
medicines. This includes medicines obtained without prescription and
herbal medicines. This is because Milorizast can affect the way some
other medicines work. Also, some other medicines can affect the way
Milorizast works. Tell your doctor or pharmacist if you are taking, have
recently taken or may take any other medicines.
In particular, tell your doctor or pharmacist before taking Milorizast if
you are taking any of the following medications:
• Rifampicin an antibiotic used for tuberculosis
• Phenytoin, phenobarbital and carbamazepine - medications
used in the treatment of seizures or epilepsy
Pregnancy and breastfeeding
There is little information about the effects of Milorizast in pregnancy.
You should not become pregnant while taking this medicine and
should use an effective method of contravention during treatment
with Milorizast. It is not known if this medicine passes into human
milk. Caution should be exercised when Milorizast is administered
to a nursing woman. Because it is not known whether Milorizast
or its metabolites are present in human milk. Tell your doctor if you
think you may be pregnant or are planning to have a baby, or if you are
breastfeeding or intend to breast-feed.
Driving and using machines
Milorizast has no effect on the ability to drive and use machines.
Milorizast contains lactose
Milorizast contains lactose (a type of sugar). If you have been told by
your doctor that you cannot tolerate or digest some sugars, talk to 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
The recommended initial dosage titration of Milorizast from Day 1 to
Day 5 is shown in table below.

Your treatment will start at a lower dose and will gradually be increased
over the first 6 days of treatment.
The recommended dose of Milorizast 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.

People with kidney problems
If you have severe kidney problems, then the recommended dose of
Milorizast 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
Milorizast.
 

How and when to take Milorizast
• Swallow the tablets whole, preferably with water.
• You can take the Tablets either with or without food.
• Take at Milorizast 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 Milorizast than you should
If you take more Milorizast than you should, talk to a doctor or go to a
hospital straightaway. Take the medicine pack and this leaflet with you.
 

If you forget to take Milorizast
• If you miss a dose of Milorizast take it as soon 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 Milorizast
• You should continue taking Milorizast until your doctor tells you to
stop.
• Do not stop taking Milorizast 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.
Psoriatic Arthritis:
Most common adverse reactions:
• Diarrhea (1.8%),
• Nausea (1.8%)
• Headache (1.2%)
• Upper respiratory tract infection
• Vomiting
• Nasopharyngitis
• Upper abdominal pain
Other adverse reactions:
• Immune system disorders: Hypersensitivity
• Investigations: Weight decrease
• Gastrointestina Disorders: Frequent bowel movement,
• gastroesophageal reflux disease, dyspepsia
• Metabolism and Nutrition Disorders: Deceased appetite
• Nervous System Disorders: Migraine
• Respiratory, Thoracic, and Mediastina Disorder : Cough
• Skin and Subcutaneous Tissue Disorders: Rash
Psoriasis:
Most common adverse reactions:
• Diarrhea (1.0%),
• Nausea (1.6%),
• Upper respiratory tract infection, and
• Headache (0.8%), including tension headache.
Other adverse reactions:
• Abdominal pain
• Vomiting
• Fatigue
• Dyspepsia
• Decreased appetite
• Insomnia
• Backpain
• Migraine
• Frequent bowel movements
• Depression
• Bronchitis
• Tooth abscess
• Folliculitis
• Sinus headache
Severe worsening of psoriasis (rebound) occurred in 0.3% subjects
following discontinuation of treatment with Milorizast.
If you are 65 years of age or older, you might have higher risk of
complications of severe diarrhea, nausea and vomiting.
If you get any side effects, talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.

• 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
carton and blister after EXP. The expiry date refers to the last day of
that month.
• This medicinal product needs to be stored below 30°C
• 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.