Ilosure 4mg Tablet 10'S

Introduction About ILOSURE 4MG TABLET

ILOSURE 4MG TABLET contains Iloperidone which belongs to a group of medicines
called Antipsychotic agents. ILOSURE 4MG TABLET is used in adults to manage
schizophrenia, which occurs as a serious mental disorder that affects a person’s
ability to think, feel or behave clearly.

ILOSURE 4MG TABLET is not recommended for use in patients allergic
(hypersensitive) to Iloperidone. It is also not recommended for use in patients
with a history of heart diseases (such as QT prolongation, recent acute
myocardial infarction, uncompensated heart failure, cardiac arrhythmia). The
medicine is also not indicated for use in patients suffering from severe hepatic
impairment.

Before taking ILOSURE 4MG TABLET, inform your doctor if you have a history of
seizures, low white blood cell count (such as leukopenia, neutropenia), suicidal
thoughts, and/or suffer from kidney problems (such as renal impairment), and
liver problems (such as mild to moderate hepatic impairment).

ILOSURE 4MG TABLET should be used with caution during pregnancy only if it is
clearly necessary since it may cause extrapyramidal and/or withdrawal symptoms
in neonates (especially when taken in 3rd trimester period). It is generally not
recommended for use in breastfeeding women.

ILOSURE 4MG TABLET is not recommended for use in children and adolescents (aged
below 18 years) as safety and effectiveness of the medicine is not established
and is advised to be used with caution in elderly patients (aged 65 years/above)
after consulting the doctor.  The medicine is generally not recommended for use
in elderly patients suffering from dementia related psychosis and is advised to
consult the doctor before taking the medicine.

The most common side effects of taking ILOSURE 4MG TABLET are dizziness,
fatigue, nasal congestion, low blood pressure,tachycardia (fast heart
rate), weight gain, arthralgia (joint pain), and/or rash. Consult your
doctor if any of these symptoms worsens.

Uses Of ILOSURE 4MG TABLET

• Manage schizophrenia in adults

How ILOSURE 4MG TABLET Works

ILOSURE 4MG TABLET works by blocking dopamine D2 receptors (proteins responsible
for synthesis & release of dopamine) and serotonin type 2 (5-HT2) receptors
(proteins needed for mediating complex cognitive behaviours) in brain which
results in improved thoughts, feelings and behaviour and thereby managing
symptoms of schizophrenia in affected individuals.

How to use ILOSURE 4MG TABLET

Take ILOSURE 4MG TABLET as advised by your physician. Swallow the medicines with
a glass of water. Do not crush or chew the medicine. Your physician will decide
the correct dose and duration for you depending upon your age, body weight and
disease condition.

Side Effects Of ILOSURE 4MG TABLET

Common

• dizziness, fatigue, somnolence (excess sleepiness)
• nasal congestion
• low blood pressure, orthostatic hypotension (low blood pressure while standing up from sitting/lying position)
• tachycardia (fast heart rate)
• weight gain
• arthralgia (joint pain)
• musculoskeletal stiffness, myalgia (muscle ache and pain), muscle spams
• blurred vision, conjunctivitis (pink eye)
• nausea, dry mouth, diarrhea, abdominal discomfort
• common cold, nasal congestion, signs of upper respiratory tract infection (sore throat, inflamed sinuses), dyspnea (shortness of breath)
• ejaculation failure
• rash
• urinary incontinence
• restlessness, aggression, delusion

Uncommon

• anaemia
• vertigo (internal spinning sensation), tinnitus (ringing in ears)
• hypothyroidism (underactive thyroid)
• dry eye, blepharitis (eyelid inflammation), eyelid edema/swelling, cataract, hyperaemia (increased blood flow to the part of the body)
• gastritis, salivary hypersecretion, faecal incontinence, mouth ulceration
• edema, difficulty in walking, thirst
• gallstones
• increased appetite, dehydration, hypokalemia (low potassium level in blood), fluid retention
• epistaxis (bleeding nose), asthma, runny nose, sinus congestion, nasal dryness

Rare

• arrhythmia, heart block, cardiac failure
• aphthous stomatitis (canker sore), duodenal ulcer, hiatus hernia, hyperchlorhydria (acid stomach), lip ulceration, reflux esophagitis, stomatitis (inflamed and sore mouth)
• hyperthermia (abnormally high temperature)
• torticollis (twisting of neck)
• dry throat, sleep apnoea syndrome (serious sleep disorder), dyspnoea exertional (breathlessness)
• irregular menstruation, gynecomastia (enlarged breasts in man), menorrhagia (heavy menstruation), metrorrhagia (abnormal bleeding), postmenopausal bleeding, prostatitis (prostate inflammation)

Stop taking ILOSURE 4MG TABLET and contact your doctor immediately if you
experience any of the following side effects:

• signs of neurole
• signs of tardive dyskinesia (neurological disorder that cause involuntary movements) such as jaw swinging, repetitive chewing, rapid eye blinking, and/or tongue thrusting
• signs of low white blood cell count such as fever, chills, mouth sores, swelling, and/or diarrhea

How To Manage Side Effects

Nausea/Vomiting:

Take this medicine with, or just after meals. Stick to simple meals. Avoid
eating oil rich or spicy foods, sugary snacks, and drinks. Try to avoid drinking
too much liquid along with your meals, drink slowly in between meals. Consult
your doctor for advice.

Dizziness:

Lie, or sit down immediately when you feel dizzy. If you're feeling a severe
episode of dizziness, lie in a dark and quite place with eyes closed. Discuss
with your doctor.

Rashes:

Try to avoid hot showers because it may cause skin irritation. Avoid frequent
contact and rubbing over the affected area. Use sunscreen and protective
clothing when outdoors. If this symptom does not get better, speak to a doctor.

Dry mouth:

Dry mouth can be managed by chewing sugar-free gum or sucking on sugar-free hard
candies to stimulate the flow of saliva. Sip water at regular intervals of time.
Do not use mouthwashes that contain alcohol because they can be drying.

Warning & Precautions

!### Pregnancy

ILOSURE 4MG TABLET should be used with caution during pregnancy only if it is
clearly necessary since it may cause extrapyramidal and/or withdrawal symptoms
in neonates (when used in 3rd trimester period). Consult your doctor before
taking the medicine.

!### Breastfeeding

ILOSURE 4MG TABLET is not recommended for use in breastfeeding women. Consult
your doctor for before taking the medicine.

!### Driving and Using Machines

Do not drive or operate any machines after taking ILOSURE 4MG TABLET since it
may impair your judgement, thinking, and/or motor skills affecting your ability
to drive/operate machines.

!### Alcohol

Avoid consum
enhance the effect of the medicine.

!### Kidney

ILOSURE 4MG TABLET should be used with caution in patients with kidney problems
such as renal impairment. Consult your doctor before taking ILOSURE 4MG TABLET.

!### Liver

ILOSURE 4MG TABLET is not recommended for use in patients with severe hepatic
impairment. It should be used with caution in other liver diseases such as mild
to moderate hepatic impairment. Consult your doctor before taking ILOSURE 4MG
TABLET.

!### Allergy

Do not take ILOSURE 4MG TABLET if you are allergic (hypersensitive) to
Iloperidone, and/or other ingredients of this medicine.

!### Heart Disease

ILOSURE 4MG TABLET is not recommended for use in patients with a history of
significant cardiovascular disease (such as QT prolongation, recent acute
myocardial infarction, uncompensated heart failure, and/or cardiac arrhythmia).
Consult your doctor before taking the medicine.

Others

Before taking ILOSURE 4MG TABLET, inform your doctor if you:

• have a history of seizures or suffer from a condition that lower seizure threshold
• have a history of low white blood cell count such as leukopenia, neutropenia
• have a history of suicidal thoughts
• suffer from a condition that cause poor metabolism of CYP2D6 enzyme (responsible for drug metabolism in the body)
• are prone for risk of developing aspiration pneumonia (condition that occurs when something other than air is inhaled in respiratory tract)

Use in Pediatrics:

ILOSURE 4MG TABLET is not recommended for use in children and adolescents (aged
below 18 years) as safety and effectiveness of the medicine is not established.
Consult your doctor before administering the medicine to the child.

Use in Geriatrics:

ILOSURE 4MG TABLET is not recommended for use in elderly patients suffering from
dementia (loss of memory, language, and problem-solving abilities) related
psychosis and is advised to be used with caution in elderly patients (aged
65-years and above) after consulting the doctor.

Interactions

A. Drug-Drug interactions:

• fluoxetine, paroxetine (medicines used to manage depression)
• ketoconazole (medicine used to manage fungal infections)
• dextromethorphan (medicine used to relieve cold and cough)
• midazolam (medicine used to induce sleep)
• medicines that prolong the QT interval (Ex. quinidine, amiodarone)

Overdosage:

If you or anyone else accidentally takes too much of ILOSURE 4MG TABLET, consult
your doctor immediately or visit the nearby hospital. Symptoms of overdose are
drowsiness, sedation, tachycardia (fast heartbeat), hypotension (low blood
pressure), and/or extrapyramidal symptoms (such as restlessness, involuntary
muscle contraction, and/or involuntary facial movements).

Synopsis

Drug	:	Iloperidone
Pharmacological Category	:	Antipsychotic agents
Therapeutic Indication	:	Schizophrenia
Dosage Forms	:	Tablet

More Information

• Keep ILOSURE 4MG TABLET out of reach of children
• Store ILOSURE 4MG TABLET at room temperature

FAQs About ILOSURE 4MG TABLET

Q. What is ILOSURE 4MG TABLET used for?

A. ILOSURE 4MG TABLET is used in adults to manage schizophrenia, which occurs as
a serious mental disorder that affects a person’s ability to think, feel or
behave clearly.

Q. How does ILOSURE 4MG TABLET works?

A. ILOSURE 4MG TABLET works by blocking dopamine D2 receptors (proteins
responsible for synthesis & release of dopamine) and serotonin type 2
(5-HT2) receptors (proteins needed for mediating complex cognitive behaviours)
in brain which results in improved thoughts, feelings and behaviour and thereby
managing symptoms of schizophrenia in affected individuals.

Q. What are the common side effects of taking ILOSURE 4MG TABLET?

A. The most common side effects of taking ILOSURE 4MG TABLET are dizziness,
fatigue, nasal congestion, low blood pressure,tachycardia (fast heart
rate), weight gain, arthralgia (joint pain), and/or rash. Consult your
doctor if any of these symptoms worsens.

Q. How ILOSURE 4MG TABLET should be taken?

A. Take ILOSURE 4MG TABLET as advised by your physician. Swallow the medicines
with a glass of water. Do not crush or chew the medicine. Your physician will
decide the correct dose and duration for you depending upon your age, body
weight and disease condition.

Q. Can ILOSURE 4MG TABLET be used in pregnant women?

A.  Yes, ILOSURE 4MG TABLET can be used but with caution during pregnancy only
if necessary since the medicine may cause extrapyramidal and/or withdrawal
symptoms in neonates (when taken in 3rd trimester period). Consult your doctor
before taking the medicine.

Useful Diagnostic Tests

• MRI (Magnetic resonance imaging)
• CT (Computerized Tomography) scan