Tablura 40mg Tablet 10'S

Introduction About TABLURA 40MG TABLET

TABLURA 40MG TABLET contains Lurasidone which belongs to the group of medicines
called Atypical antipsychotic agents. It is used to manage schizophrenia
(disorder that affects a person's ability to think, feel and behave clearly) in
adults and adolescents (aged 13 to 17 years). It is also used as a monotherapy
to manage depressive episode associated with bipolar depression in adults and
children (aged 10 to 17 years).

It is also used as an adjunctive therapy with lithium/valproate to manage
depressive episode associated with bipolar depression in adults. TABLURA 40MG
TABLET is not recommended for use in patients who are allergic to lurasidone.
Before taking TABLURA 40MG TABLET, inform your doctor if you have/had stroke,
low or high blood pressure, diabetes, seizures, suicidal thoughts/behaviour,
kidney or liver problems.

TABLURA 40MG TABLET should be used with caution in pregnant and breastfeeding
women only if advised by the doctor. It is also used with caution in children
and adolescents (aged below 18 years). Consult your doctor before taking this
medicine.

The most common side effects of taking TABLURA 40MG TABLET are excess
sleepiness, akathisia (movement disorder), nausea, vomiting and indigestion.
Consult your doctor if any of the side effects worsen.

Uses Of TABLURA 40MG TABLET

• Manage schizophrenia in adults and adolescents (aged 13 to 17 years)
• Manage major depressive episode associated with bipolar depression in adults and children (aged 10 to 17 years, as monotherapy management)
• Manage major depressive episode associated with bipolar depression in adults (as an adjunctive therapy with lithium/valproate)

How TABLURA 40MG TABLET Works

TABLURA 40MG TABLET works by blocking the receptors of dopamine, serotonin,
noradrenaline (neurotransmitters that play a role in schizophrenia) which leads
to reduced activity of brain in relation to these receptors, thus improving the
symptoms of schizophrenia and depression in affected individuals.

How to use TABLURA 40MG TABLET

Take TABLURA 40MG TABLET as advised by your physician. Swallow the medicine 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 TABLURA 40MG TABLET

Common

• excess sleepiness
• akathisia (movement disorder)
• extrapyramidal symptoms such as inability to sit, involuntary muscle contraction, tremors
• nausea, vomiting
• stuffy nose
• weight gain (in bipolar paediatric patients)
• indigestion
• salivary hypersecretion
• back pain
• dizziness
• agitation, anxiety, restlessness
• common cold, flu
• urinary tract infection
• dry mouth, oropharyngeal pain
• fast heart rate
• upper abdominal pain, loss of appetite
• tiredness
• orthostatic hypotension (blood pressure that occurs while standing up from sitting/lying position)
• blurred vision
• rash, itching
• high blood pressure

Uncommon

• galactorrhoea (nipple discharge unrelated to breastfeeding milk)
• decreased libido
• chest pain, slow heat rate
• vertigo (sudden internal/external spinning sensation)
• inflammation of stomach
• stroke
• slurred speech
• abnormal dreams, p
• sleep disorder
• painful/difficult urination
• amenorrhea (absence of menstruation)
• dysmenorrhea (menstrual cramps)

Rare

• signs of rhabdomyolysis (breakdown of muscle tissue) such as muscle cramps, dark urine, feeling tired
• breast enlargement or pain
• erectile dysfunction
• priapism (prolonged erection of penis)
• angioedema (swelling of arms/legs)

Stop taking TABLURA 40MG TABLET and consult your doctor immediately if you
experience any of the following side effects:

• signs of neurole
• signs of tardive dyskinesia (movement disorder) such as blinking rapidly, chewing motions, frowning
• signs of low white blood cell count (due to leukopenia, neutropenia, agranulocytosis) such as body aches, chills, fever and/or headaches
• stroke (in elderly patients with dementia related psychosis)
• signs of hyperglycemia (high blood sugar) such as feeling very thirsty, feeling very hungry, feeling weak/tired
• signs of increased fat levels (cholesterol and triglycerides) in blood such as obesity, high blood pressure

How To Manage Side Effects

!### Dizziness Or Drowsiness

Try to rest and get enough sleep. Try to avoid driving or operating any tools or
machines while you feel dizzy. Limit consum
dizziness. Consult your doctor if the symptom worsens.

!### Dry Mouth

Sip water regularly and other sugar free liquids. Do not use mouthwashes that
contain alcohol because they can make your mouth dry, use mouthwash that is used
only for dry mouth. Limit your caffeine intake. Avoid smoking or using tobacco
products. Consult your doctor if the symptom does 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 if the
symptom does not improve.

!### Nausea And Vomiting

Try to take TABLURA 40MG TABLET with or just after a meal or a snack. Stick to
simple meals. Avoid eating oil rich or spicy food. Consult your doctor if
symptom gets worse.

!### Skin rash Or Itching

Try to pat or tap your skin instead of scratching it. Hold a damp towel to cool
your skin. Wear loose clothing and avoid tight clothes or clothes made from wool
or synthetic fabrics. Avoid using perfumed soaps, deodorants or moisturizers and
use a skin softener regularly. Consult your doctor if the symptom does not
improve.

Warning & Precautions

!### Pregnancy

Monitoring requiredTABLURA 40MG TABLET should be used with caution during pregnancy and in women
planning for pregnancy only if it is considered clearly necessary. Consult your
doctor before taking TABLURA 40MG TABLET.

!### Breastfeeding

Monitoring requiredTABLURA 40MG TABLET should be used with caution in breastfeeding women only if
it is considered clearly necessary. Consult your doctor before taking TABLURA
40MG TABLET.

!### Driving and Using Machines

Use with CautionDo not drive or operate any machines after taking TABLURA 40MG TABLET since it
may cause drowsiness.

!### Kidney

Use with CautionTABLURA 40MG TABLET should be used with caution in patients with kidney problems
such as moderate to severe renal impairment. Consult your doctor before taking
TABLURA 40MG TABLET.

!### Liver

Use with CautionTABLURA 40MG TABLET should be used with caution in patients with liver problems
such as moderate to severe hepatic impairment. Consult your doctor before taking
TABLURA 40MG TABLET.

!### Allergy

ContraindicatedDo not take TABLURA 40MG TABLET if you are allergic to lurasidone or any other
ingredients of this medicine.

!### Heart Disease

Use with CautionTABLURA 40MG TABLET should be used with caution in patients with heart problems,
heart failure, myocardial infarction, ischemia, and/or conduction abnormalities.
Consult your doctor before taking TABLURA 40MG TABLET.

Others

Before taking TABLURA 40MG TABLET, inform your doctor if you:

• have or had stroke
• have or had low or high blood pressure
• have or had diabetes or high blood sugar
• have or had high levels of total cholesterol/triglycerides
• have or had high prolactin levels
• have or had low white blood cell count
• have bipolar illness
• have or had seizures
• suffer from alzheimer’s dementia
• have suicidal thoughts or behavior
• suffer from parkinson’s disease/ dementia

Use in Pediatrics:

TABLURA 40MG TABLET should be used with caution in children and adolescents
(aged below 18 years). Consult your child’s doctor for advice.

Use in Geriatrics:

TABLURA 40MG TABLET should be used with caution in elderly patients (aged above
65 years). It is not recommended for use in elderly patients affected with
dementia-related psychosis. Consult your doctor before taking TABLURA 40MG
TABLET.

Interactions

A. Drug - Drug interactions:

Before taking TABLURA 40MG TABLET, inform your doctor if you are taking any of
the following medicines:

• nafcillin, rifampin, clarithromycin, erythromycin (used to manage bacterial infections)
• fluconazole, ketoconazole, voriconazole (used to manage fungal infections)
• etravirine, efavirenz, ritonavir, atazanavir (used to manage viral infections)
• diltiazem, mibefradil, verapamil (used to manage high blood pressure)
• avasimibe (used to manage peripheral vascular disease)
• st. john's wort (herbal remedy) (used to manage depression)
• phenytoin, carbamazepine (used to control seizures)
• bosentan (used to manage pulmonary hypertension)
• modafinil (used to manage sleepiness caused by narcolepsy)

B. Drug - Food interaction:

Avoid eating grapefruit or drinking grapefruit juice while taking TABLURA 40MG
TABLET as it may alter the effect of this medicine.

Overdosage:

If you or anyone else accidentally take too much of TABLURA 40MG TABLET, consult
your doctor immediately or visit the nearby hospital.

Synopsis

Drug	:	Lurasidone
Pharmacological Category	:	Adrenergic alpha-2 Receptor Antagonists
Therapeutic Indication	:	Schizophrenia, Depressive episode associated with bipolar depression
Dosage Forms	:	Tablet

More Information

• Keep TABLURA 40MG TABLET out of reach of children
• Store at room temperature

FAQs About TABLURA 40MG TABLET

Q: What are the uses of TABLURA 40MG TABLET?

A: TABLURA 40MG TABLET is used to manage schizophrenia in adults and adolescents
(aged 13 to 17 years). It is also used as a monotherapy to manage depressive
episode associated with bipolar depression in adults and children (aged 10 to 17
years), which is also used as an adjunctive therapy with lithium/valproate to
manage depressive episode associated with bipolar depression in adults.

Q: What are the side effects of TABLURA 40MG TABLET?

A: The most common side effects of taking TABLURA 40MG TABLET are excess
sleepiness, akathisia (movement disorder), extrapyramidal symptoms (such as
inability to sit, tremors), nausea, vomiting, and indigestion. Consult your
doctor if any of the side effects worsen.

Q: Is TABLURA 40MG TABLET safe to use in pregnant and breastfeeding women?

A: Yes, TABLURA 40MG TABLET can be used but with caution during pregnancy and in
breastfeeding women only if it is clearly necessary. Consult your doctor before
taking TABLURA 40MG TABLET.

Q:How does TABLURA 40MG TABLET work?

A: TABLURA 40MG TABLET works by blocking the receptors of dopamine, serotonin,
noradrenaline (neurotransmitters that play a role in schizophrenia) which leads
to reduced activity of brain in relation to these receptors thus improving the
symptoms of schizophrenia and depression in affected individuals.

Q: Is TABLURA 40MG TABLET safe to use in patients with liver problems?

A: TABLURA 40MG TABLET should be used with caution in patients with liver
problems such as moderate to severe hepatic impairment. Consult your doctor for
advice before taking TABLURA 40MG TABLET.

Useful Diagnostic Tests

• Liver function test
• Kidney function test