Zaporil 25mg Tablet 10'S

Introduction About ZAPORIL 25MG TABLET

ZAPORIL 25MG TABLET contains Clozapine which belongs to the group of medicines
called Atypical antipsychotics. ZAPORIL 25MG TABLET is used to manage
schizophrenia when atleast two antipsychotic medicines have been ineffective or
caused severe side effects in affected individuals.

ZAPORIL 25MG TABLET is also used to manage psychotic disorders in patients with
Parkinson’s disease (brain disorder), when standard management becomes
ineffective to manage the disorders.

ZAPORIL 25MG TABLET is not recommended for use in patients allergic to
clozapine. It is also not recommended for use in patients with uncontrolled
fits/epilepsy, reduced consciousness, severe drowsiness, brain disorders, heart
diseases (such as myocarditis, pericarditis, cardiomyopathy), severe kidney
disease, severe liver disease, and/or jaundice (associated with signs such as
yellow colouration of the skin and eyes).

Before taking ZAPORIL 25MG TABLET, inform your doctor if you have orthostatic
hypotension (condition marked by low blood pressure while standing up), prostate
enlargement/difficulty while urinating, glaucoma (rise in eye pressure),
diabetes, and/or heart diseases (such as pericardial effusion, prolonged QT
interval).

ZAPORIL 25MG TABLET should be used with caution during pregnancy and in women
planning for pregnancy only if it is clearly necessary. It is not recommended
for use in breastfeeding women since it may pass through breastmilk.

ZAPORIL 25MG TABLET is not recommended for use in children and adolescents (aged
below 16 years) which is advised to be used with caution in elderly patients
(aged above 60 years) after consulting the doctor.

The most common side effects of taking ZAPORIL 25MG TABLET are dry mouth,
nausea, vomiting, loss of appetite, constipation, drowsiness, and/or dizziness.
Consult your doctor if any of these symptoms worsens.

Uses Of ZAPORIL 25MG TABLET

• Manage Schizophrenia (when atleast two antipsychotic medicines have become ineffective or caused severe side effects) in affected individuals.
• Manage psychotic disorders associated with Parkinson’s disease (when standard management becomes ineffective to manage the disorders) in affected individuals

How ZAPORIL 25MG TABLET Works

ZAPORIL 25MG TABLET works by blocking dopamine receptors (proteins responsible
for synthesis and release of dopamine) in brain which results in reduced
synthesis of dopamine thus improving thoughts, feelings and behaviour and
thereby managing symptoms of schizophrenia and other psychotic disorders
associated with Parkinson’s disease in affected individuals.

How to use ZAPORIL 25MG TABLET

Tablet:

Take ZAPORIL 25MG 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.

Dispersible Tablet:

Take ZAPORIL 25MG TABLET as advised by your physician. Disperse ZAPORIL 25MG
TABLET in the specified quantity of water as mentioned in the label. Consume the
mixture immediately after reconstitution. Your doctor will decide the correct
dose and duration for you depending upon your age, body weight and disease
condition.

Mouth Dissolving Tablet, Orally Disintegrating Tablet:

Take ZAPORIL 25MG TABLET as advised by your physician. Place ZAPORIL 25MG
TABLET inside your mouth and allow it to dissolve completely. Your doctor will
decide the correct dose and duration for you depending upon your age, body
weight and disease condition.

Side Effects Of ZAPORIL 25MG TABLET

Common

• dry mouth, nausea, vomiting, loss of appetite, constipation,
• drowsiness, dizziness, increased production of saliva, tiredness, headache, fever, alterations of sweating, trembling, tremor, stiffness of the limbs, restlessness, problems in coordination, slurring of words, abnormal movements, inability to initiate movement, inability to remain motionless, sudden loss of consciousness.
• high blood pressure, urinary incontinence, urinary retention,
• weight gain, blurred vision
• faintness/light headedness after changing position

Uncommon

• stammering

Rare

• agitation, confusion, delirium (reduced awareness of surroundings)
• inhaling of food into the lungs (aspiration), difficulty swallowing,
• anaemia, serious chest infection.

Stop taking ZAPORIL 25MG TABLET and contact your physician immediately if you
experience any of the following side effects:

• severe constipation
• fast heartbeat
• signs of a cold, fever, flu-like symptoms, sore throat or any other infection
• seizures
• sudden fainting/ loss of consciousness with muscle weakness
• signs of neurole
• light-headedness, dizziness/fainting while getting up from a sitting/lying position
• signs of a respiratory tract infection or pneumonia such as fever, coughing, difficulty breathing, wheezing.
• signs of inflammation of the pancreas such as severe, burning, upper abdominal pain extending to the back accomp
• signs of circulatory collapse (due to significant drop in blood pressure) such as fainting and muscle weakness
• difficulty in swallowing, interru
• signs of heart problems such as fast/irregular heartbeat, racing heartbeat, breathing problems, chest pain, and/or unexplained tiredness
• persistent painful erection of the penis
• signs of decrease in numbers of blood platelets such as spontaneous bleeding/bruising
• signs of uncontrolled blood sugar such as nausea/vomiting, abdominal pain, excessive thirst, excessive urination, disorientation/confusion
• signs of bowel obstruction such as abdominal pain, cramping, swollen abdomen, vomiting, constipation and/or failure to pass gas
• signs of liver disorder such as loss of appetite, swollen abdomen, abdominal pain, yellowing of the skin, severe weakness and/or general discomfort
• signs of inflammation of kidney such as nausea, vomiting, fatigue, weight loss
• signs of heart attack such as crushing chest pain, sensation of chest tightness, pressure/ squeezing chest pain, shortness of breath, sweating, weakness, light headedness, nausea, vomiting and/pr palpitations (symptoms of heart attack)
• signs of insufficient blood flow and oxygen to the heart muscle such as chest pressure, heaviness, tightness, squeezing, burning, and/or choking sensation
• intermittent thumping/pounding/fluttering sensation in the chest
• atrial fibrillation (rapid and irregular heartbeats) associated with racing heartbeat, fainting, shortness of breath, and/or chest discomfort.
• Signs of low blood pressure such as light-headedness, nausea, dizziness, fainting, blurred vision, unusual tiredness, cold and/or clammy skin
• signs of blood clots in the veins especially in the legs such as swelling, pain and/or redness in the leg)
• signs of sepsis such as infection along with fever/low body temperature, abnormally rapid breathing, rapid heart rate, change in responsiveness and awareness, low blood pressure
• signs of cholinergic syndrome such as profuse sweating, headache, nausea, vomiting and diarrhoea
• severely decreased urine output due to kidney failure
• signs of allergic reaction such as swelling of face/mouth/tongue/throat which may be itchy or painful
• intestinal ulceration of stomach/gut associated with signs such as burning upper abdominal pain, tarry/black/bloody stools, bloating, heartburn, nausea/vomiting
• severe abdominal pain intensified by movement, nausea, vomiting including vomiting blood
• enlargement of intestines/intestinal infarction/ischaemia/necrosis associated with signs such as constipation, abdominal pain, abdominal tenderness, fever, bloating, and/or bloody diarrhoea
• sharp chest pain/abdominal pain with shortness of breath with/without cough/fever
• signs of rhabdomyolysis (muscle disorder) such as muscle weakness, muscle spasms, and/or muscle pain
• signs of DRESS syndrome (drug rash with eosinophilia and systemic symptoms) such as extremely intense & serious skin reactions, rashes with/without blisters, skin irritation, oedema and fever and flulike symptoms

How To Manage Side Effects

Dry mouth:

Try to drink plenty of cold water and sip on cold unsweetened drinks and use lip
balm if your lips are dry. Brush your teeth twice a day and use mouthwash.
Consult and inform your doctor if the symptom gets worse.

Nausea and vomiting:

Try to take ZAPORIL 25MG TABLET with or just after a meal or a snack. Stick to
simple meals. Avoid eating rich or spicy food. Consult your doctor if symptom
gets worse.

Constipation:

Try to eat high-fiber foods such as vegetables, cereals, fresh fruit, and drink
plenty of water. Involve in regular exercise (going for a daily walk or run) and
if this does not help, consult and inform your doctor for receiving alternate
managements for constipation.

Dizziness:

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 and inform your doctor if the symptom worsens.

Tiredness:

Make sure you take rest and drink plenty of fluids. Avoid or limit the
consum
sit down (or lie down) when the symptoms are at their worst. Avoid driving or
using tools or machinery until you feel well.

Headache:

If ZAPORIL 25MG TABLET causes headache, then take rest and drink plenty of
fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a
painkiller. Headaches should usually go away after the first week of taking
ZAPORIL 25MG TABLET. If it lasts more than a week or severe, inform your doctor.

Warning & Precautions

!### Pregnancy

ZAPORIL 25MG TABLET should be used with caution during pregnancy and in women
planning for pregnancy only if it is clearly necessary. Consult your doctor
before taking the medicine.

!### Breastfeeding

ZAPORIL 25MG TABLET is not recommended for use in breastfeeding women since it
may pass through breastmilk. Contact your doctor before taking the medicine.

!### Driving and Using Machines

Do not drive or operate any machines if you feel dizzy, tired, drowsy, and/or
faintness after taking ZAPORIL 25MG TABLET.

!### Alcohol

Avoid consum
to unwanted effects.

!### Kidney

ZAPORIL 25MG TABLET is not recommended for use in patients with severe kidney
disease. Contact your doctor before taking the medicine.

!### Liver

ZAPORIL 25MG TABLET is not recommended for use in patients with serious liver
disease and jaundice (associated with signs such as yellow colouration of the
skin and eyes). It should be used with caution in patient with other liver
diseases who should take regular liver function tests while on management with
ZAPORIL 25MG TABLET. Contact your doctor before taking ZAPORIL 25MG TABLET.

!### Allergy

Do not take ZAPORIL 25MG TABLET if you are allergic to clozapine, and/or any
other ingredients of this medicine.

!### Heart Disease

ZAPORIL 25MG TABLET is not recommended for use in patients with heart diseases
such as myocarditis, pericarditis, and/or cardiomyopathy. It should be used
with caution in patients with other heart problems such as pericardial effusion,
prolonged QT interval. Consult your doctor before taking the medicine.

Others

ZAPORIL 25MG TABLET is not recommended for use if you have:

• signs of allergic reactions such as swelling of face and mouth, itchy skin rashes/ red itchy welts, difficulty breathing, and/or faintness.
• suffer from galactose intolerance, total lactase deficiency, glucose-galactose malabsor
• are unable to undergo regular blood tests
• decreased white blood cell count (due to use of this medicine, other medicines, and/or other management)
• bone marrow disease
• uncontrolled fits/epilepsy
• acute mental illness caused by alcohol/medicines/ other substances
• reduced consciousness, severe drowsiness.
• circulatory collapse (due to severe fall in blood pressure)
• brain disorders
• paralytic ileus (reduced bowel movements)
• medicines that affect function of bone marrow

Before taking ZAPORIL 25MG TABLET, inform your doctor if you:

• have high eosinophil granulocytes (white blood cell) count
• suffer from thrombocytopenia (low platelet count in blood) or have a history of blood clots
• have orthostatic hypotension (condition marked by low blood pressure while standing up)
• suffer from well controlled epilepsy/fits
• have prostate enlargement or difficulty while urinating
• have glaucoma (rise in eye pressure)
• have severe/chronic constipation
• have diabetes
• suffer from stroke

Use in Paediatrics:

ZAPORIL 25MG TABLET is not recommended for use in children and adolescents (aged
below 16 years). Consult your doctor before taking ZAPORIL 25MG TABLET

Use in Geriatrics:

ZAPORIL 25MG TABLET should be used with caution in elderly patients (aged above
60 years). Consult your doctor before taking the medicine.

Interactions

A. Drug-Drug interactions:

Before taking ZAPORIL 25MG TABLET, inform your doctor if you are taking any of
the following medicine:

• antibiotics (medicines used to manage bacterial infections) Ex. co-trimoxazole, chloramphenicol, sulphonamides (Ex. sulfadiazine, sulfamethizole), erythromycin, rifampicin, ciprofloxacin
• painkillers (medicines used to manage pain) Ex. phenylbutazone, oxybutazone, antipyrine, dipyrone, morphine
• penicillamine (used to manage rheumatic arthritis)
• carbamazepine, phenytoin, valproic acid (medicines used to manage epilepsy and neuralgic pain)
• cytotoxic agents (medicines used in cancer) Ex. doxorubicin, valrubicin
• neurole
• benzodiazepines (used for anxiety) Ex. alprazolam, diazepam
• antihistamines (for allergies) Ex. loratadine, chlorpheniramine
• anticholinergic medicines (medicine used to relieve stomach cramps, spasms and travel sickness) Ex. hyoscyamine
• medicines used for high blood pressure (Ex. captopril, enalapril, atenolol, metoprolol), diuretics like furosemide
• medicines used to manage a fast/irregular heartbeat such as antiarrhythmics (Ex. flecainide, pilsicainide)
• medicines used for Parkinson’s disease (Ex. apomorphine, selegiline)
• medicines used to manage depression such as tricyclic antidepressants (Ex. amitriptyline, phenelzine), MAO inhibitors (Ex. moclobemide), citalopram, paroxetine, fluoxetine, sertraline, chlorpromazine, mesoridazine, fluphenazine, fluvoxamine
• atropine (used to relieve pain caused by swelling and inflammation of eye)
• diuretics (used to manage hypertension) Ex. chlorothiazide, chlorthalidone
• adrenaline, noradrenaline (medicines used in emergency conditions)
• warfarin (used to manage or manage blood clots)
• digoxin (used to manage heart failure)
• omeprazole, cimetidine (used to manage stomach ulcers)
• medicines used to manage fungal infections (Ex. miconazole, ketoconazole, itraconazole)
• lithium (medicine used for mental illness)
• hormonal contrace
• medicines used to manage HIV infections (Ex. ritonavir, indinavir, saquinavir).

Overdosage:

If you or anyone else accidentally take too much of ZAPORIL 25MG TABLET, consult
your doctor immediately or visit the nearby hospital. Symptoms of overdosage are
drowsiness, confusion and delirium, agitation, lack of energy, light-headedness,
hallucinations, tiredness, unconsciousness, confusion, agitation, incoherent
speech, stiff limbs, trembling hands, increased production of saliva, a fall in
the blood pressure, collapse, widening of the black part of the eye, blurred
vision, shallow/slow breathing/ shortness of breath, fast/irregular heartbeat,
dribbling, fits, and/or coma.

Synopsis

Drug	:	Clozapine
Pharmacological Category	:	Atypical antipsychotics
Therapeutic Indication	:	Schizophrenia, Psychotic disorders (due to Parkinson’s disease)
Dosage Forms	:	Tablet, Dispersible Tablet, Mouth Dissolving Tablet, Orally Disintegrating Tablet

More Information

• Keep ZAPORIL 25MG TABLET out of the sight and reach of children.
• Store ZAPORIL 25MG TABLET below 30°C

FAQs About ZAPORIL 25MG TABLET

What is ZAPORIL 25MG TABLET used for?

ZAPORIL 25MG TABLET is used to manage schizophrenia when atleast two
antipsychotic medicines have been ineffective or caused severe side effects in
affected individuals. It is also used to manage psychotic disorders in patients
with Parkinson’s disease (brain disorder), when standard management becomes
ineffective to manage the disorders.

How ZAPORIL 25MG TABLET works?

ZAPORIL 25MG TABLET works by blocking dopamine receptors (proteins responsible
for synthesis and release of dopamine) in brain which results in reduced
synthesis of dopamine thus improving thoughts, feelings and behaviour and
thereby managing symptoms of schizophrenia and other psychotic disorders
associated with Parkinson’s disease in affected individuals.

What are the most common side effects of taking ZAPORIL 25MG TABLET?

The most common side effects of taking ZAPORIL 25MG TABLET are dry mouth,
nausea, vomiting, loss of appetite, constipation, drowsiness, and/or dizziness.
Consult your doctor if any of these symptoms worsens.

Can ZAPORIL 25MG TABLET be used in pregnant and breastfeeding women?

Yes, ZAPORIL 25MG TABLET can be used but with caution during pregnancy and in
women planning for pregnancy only if it is clearly necessary. It is not
recommended for use in breastfeeding women since it may pass through breastmilk.
Consult your doctor before taking the medicine.

Can ZAPORIL 25MG TABLET cause drowsiness?

Yes, ZAPORIL 25MG TABLET causes drowsiness as it is the most common side effect
associated with the use of medicine. If such side effects experienced, then try
to rest and get enough sleep. Avoid driving/operating any tools/machines while
you feel dizzy. Limit consum
Consult and inform your doctor if the symptom worsens.

Useful Diagnostic Tests

• Imagine tests
• Dopamine transporter scan