Aplex 30mg Tablet 10'S

Introduction About APLEX 30MG TABLET

APLEX 30MG TABLET contains Apremilast which belongs to a group of medicines
called Phosphodiesterase 4 inhibitors. APLEX 30MG TABLET is used to manage
active psoriatic arthritis (chronic inflammatory disease of joints) in adults
when disease-modifying antirheumatic drugs (medications used to manage
arthritis) are insufficient to manage the disease.

APLEX 30MG TABLET is also used to manage moderate to severe chronic plaque
psoriasis (chronic inflammatory skin disease) when phototherapy (management with
a special type of light), and/or systemic therapy (with ciclosporin,
methotrexate, psoralen) are insufficient to manage the disease. The medicine is
also indicated for use to manage Behçet’s disease (rare inflammatory disorder
that affects blood vessels and tissues) in adults.

APLEX 30MG TABLET is not recommended for use in patients allergic to Apremilast.
Before taking APLEX 30MG TABLET, inform your doctor if you are underweight,
and/or have gut problems, intolerance to certain sugars (such as lactose),
kidney problems (such as severe kidney disease), and/or liver problems (such as
hepatic impairment).

APLEX 30MG TABLET is generally not recommended for use during pregnancy and in
women planning for pregnancy. It is also not recommended for use in
breastfeeding women as it is not known whether the medicine passes through
breastmilk.

APLEX 30MG TABLET is generally not recommended for use in children and
adolescents (aged below 18 years) and is advised to be used with caution in
elderly patients (aged 65 years/above) after consulting the doctor.

The most common side effects of taking APLEX 30MG TABLET are stomach pain, loss
of appetite, indigestion/heartburn, diarrhoea, nausea, vomiting, and/or
headache. Consult your doctor if any of these side effects worsens.

Uses Of APLEX 30MG TABLET

In adults:

• Manage active psoriatic arthritis when disease-modifying antirheumatic drugs are insufficient to manage the disease
• Manage moderate to severe chronic plaque psoriasis (chronic inflammatory skin disease) when phototherapy (management with a special type of light), and/or systemic therapy (with ciclosporin, methotrexate, psoralen) are insufficient to manage the disease
• Manage Behçet’s disease (rare inflammatory disorder that affects blood vessels and tissues)

How APLEX 30MG TABLET Works

APLEX 30MG TABLET works by reducing the activity of phosphodiesterase 4 (enzyme
involved in the process of inflammation) which leads to reduced occurrence of
inflammatory process and providing relief from signs & symptoms associated with
conditions such as psoriatic arthritis, chronic plaque psoriasis and Behcet’s
disease in affected individuals.

How to use APLEX 30MG TABLET

Take APLEX 30MG TABLET as advised by your physician. Swallow the medicines with
a glass of water. Do not crush or chew the medicine. Your doctor will decide the
correct dose and duration for you depending upon your age, body weight and
disease condition.

Side Effects Of APLEX 30MG TABLET

Common

• stomach pain, loss of appetite, frequent bowel movements, indigestion/heartburn
• diarrhoea, nausea, vomiting
• headache, back pain, tiredness
• upper respiratory tract infections such as common cold, cough, runny nose, sinus infection
• difficulty in sleeping (insomnia)
• bronchitis (inflammation and swelling of tubes in lungs)
• depression
• migraine

Uncommon

• rash, red itchy welts
• weight loss
• allergic reaction
• bleeding in the bowel/stomach
• suicidal ideation/behaviour

Stop taking APLEX 30MG TABLET and contact your doctor immediately if you
experience any of the following side effects:

• changes in behaviour/mood, feeling depressed, suicidal thoughts/behaviour

How To Manage Side Effects

!### Diarrhea

Drink lots of fluids, such as water or fruit juices to keep you hydrated. Do not
take any medicine on your own for managing diarrhea. Contact your doctor if the
symptom did not improve.

Headache

Rest and relax. Drink plenty of fluids such as water or electrolytes and apply a
pain-relieving balm on the head if necessary. Do not consume alcohol. Contact
your doctor if the symptom did not improve.

!### Indigestion

Try to have smaller and more frequent meals and drink slowly. Reduce consum
of coffee, cola, tea, or alcohol and lose weight if you are obese.  Try to avoid
smoking and don’t have rich, fatty or spicy foods. Consult your doctor and
inform if the symptom does not improve.

!### Nausea And Vomiting

Take APLEX 30MG TABLET with or just after a meal. Stick to simple meals. Avoid
eating oil rich or spicy foods, sugary snacks and drinks. Avoid drinking too
much liquid along with your meals, drink slowly in between meals. Inform your
doctor if the condition worsens.

Warning & Precautions

!### Pregnancy

ContraindicatedAPLEX 30MG TABLET is generally not recommended for use during pregnancy and in
women planning for pregnancy. Consult your doctor before taking the medicine.

!### Breastfeeding

ContraindicatedAPLEX 30MG TABLET is generally not recommended for use in breastfeeding women
since it is not known whether the medicine passes through breast milk. Consult
your doctor before taking the medicine.

!### Driving and Using Machines

Use with CautionAPLEX 30MG TABLET is unlikely to affect your ability to drive or operate
machines.

!### Kidney

Use with CautionAPLEX 30MG TABLET should be taken with caution in patients with severe kidney
problems. Consult your doctor before taking APLEX 30MG TABLET.

!### Liver

Use with CautionAPLEX 30MG TABLET should be used with caution in patients with liver problems
such as hepatic impairment. Consult your doctor before taking APLEX 30MG TABLET.

!### Allergy

ContraindicatedDo not take APLEX 30MG TABLET if you are allergic to Apremilast, and/or any of
the other ingredients of this medicine.

!### Use In Pediatrics

ContraindicatedAPLEX 30MG TABLET is generally not recommended for use in children and
adolescents (aged below 17 years). Consult your doctor before taking APLEX 30MG
TABLET.

!### Use In Geriatrics

Use with CautionAPLEX 30MG TABLET should be used with caution in elderly patients (aged above 65
years). Consult your doctor before taking APLEX 30MG TABLET.

Others

Before taking APLEX 30MG TABLET, inform your doctor if you:

• are underweight
• suffer from any gut problems
• have intolerance to certain sugars (such as lactose)

Interactions

A. Drug-Drug interactions:

Before taking APLEX 30MG TABLET, inform your doctor if you are taking any of the
following medicine:

• rifampicin (medicines used to manage tuberculosis)
• phenytoin, phenobarbital, carbamazepine (medicines used to manage seizures/epilepsy)
• St John’s Wort (herbal medicine used for mild anxiety and depression)

Overdosage:

If you or anyone else accidentally take too much of APLEX 30MG TABLET, consult
your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Apremilast
Pharmacological Category	:	Phosphodiesterase-4 inhibitors
Therapeutic Indication	:	Psoriatic arthritis, Plaque psoriasis, Behcet’s disease
Dosage Forms	:	Tablet

More Information

Storage

• Keep APLEX 30MG TABLET out of the sight and reach of children
• Do not store APLEX 30MG TABLET above 30°C

FAQs About APLEX 30MG TABLET

Q: What is APLEX 30MG TABLET used for?

A: APLEX 30MG TABLET is used to manage active psoriatic arthritis (chronic
inflammatory disease of joints) in adults when disease-modifying antirheumatic
drugs (medications used to manage arthritis) are insufficient to manage the
disease. It is also used to manage moderate to severe chronic plaque psoriasis
(chronic inflammatory skin disease) when phototherapy (management with a special
type of light), and/or systemic therapy (with ciclosporin, methotrexate,
psoralen) are insufficient to manage the disease. The medicine is also indicated
for use to manage Behçet’s disease (rare inflammatory disorder that affects
blood vessels and tissues) in adults.

Q: What are the side effects of APLEX 30MG TABLET?

A: The most common side effects of taking APLEX 30MG TABLET are stomach pain,
loss of appetite, indigestion/heartburn, diarrhoea, nausea, vomiting, and/or
headache. Consult your doctor if any of these side effects worsens.

Q: How APLEX 30MG TABLET works?

A: APLEX 30MG TABLET works by reducing the activity of phosphodiesterase 4
(enzyme involved in the process of inflammation) which leads to reduced
occurrence of inflammatory process and providing relief from signs & symptoms
associated with conditions such as psoriatic arthritis, chronic plaque psoriasis
and Behcet’s disease in affected individuals.

Q: How APLEX 30MG TABLET should be taken?

A: Take APLEX 30MG TABLET as advised by your physician. Swallow the medicines
with a glass of water. Do not crush or chew the medicine. Your doctor will
decide the correct dose and duration for you depending upon your age, body
weight and disease condition.

Q: Can APLEX 30MG TABLET be used in children and adolescents?

A: No, APLEX 30MG TABLET is not recommended for use in children and adolescents
(aged below 18 years). Consult your doctor before administering the medicine to
the child.

Useful Diagnostic Tests

• X-ray
• MRI scan
• C-Reactive protein blood test