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INTRODUCTION

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

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

CLOMACH 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 CLOMACH 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).

CLOMACH 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.

CLOMACH 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 CLOMACH 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 CLOMACH 25MG TABLET

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

HOW CLOMACH 25MG TABLET WORKS

CLOMACH 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 treating symptoms of schizophrenia and other psychotic disorders associated with Parkinson’s disease in affected individuals.

DIRECTIONS FOR USE

Tablet:

Take CLOMACH 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 CLOMACH 25MG TABLET as advised by your physician. Disperse CLOMACH 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 CLOMACH 25MG TABLET as advised by your physician. Place CLOMACH 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 CLOMACH 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 CLOMACH 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 neuroleptic malignant syndrome (life threatening neurologic emergency) such as sudden rapid increase in body temperature, rigid muscles which may lead to unconsciousness
  • 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 accompanied by nausea and vomiting
  • signs of circulatory collapse (due to significant drop in blood pressure) such as fainting and muscle weakness
  • difficulty in swallowing, interruption in breathing with/without snoring during sleep
  • 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 CLOMACH 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 treatments 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 consumption of alcohol, as it can aggravate 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 consumption of alcohol. Try to take CLOMACH 25MG TABLET at a time when you can 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 CLOMACH 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 CLOMACH 25MG TABLET. If it lasts more than a week or severe, inform your doctor.

WARNING & PRECAUTIONS

PREGNANCY

CLOMACH 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

CLOMACH 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 CLOMACH 25MG TABLET.

ALCOHOL

Avoid consumption of alcohol while taking CLOMACH 25MG TABLET since it may lead to unwanted effects.

KIDNEY

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

LIVER

CLOMACH 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 treatment with CLOMACH 25MG TABLET. Contact your doctor before taking CLOMACH 25MG TABLET.

ALLERGY

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

HEART DISEASE

CLOMACH 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

CLOMACH 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 malabsorption leading inability of body to digest lactose sugar
  • are unable to undergo regular blood tests
  • decreased white blood cell count (due to use of this medicine, other medicines, and/or other treatment)
  • 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 CLOMACH 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:

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

Use in Geriatrics:

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

  • antibiotics (medicines used to treat bacterial infections) Ex. co-trimoxazole, chloramphenicol, sulphonamides (Ex. sulfadiazine, sulfamethizole), erythromycin, rifampicin, ciprofloxacin
  • painkillers (medicines used to treat pain) Ex. phenylbutazone, oxybutazone, antipyrine, dipyrone, morphine
  • penicillamine (used to treat rheumatic arthritis)
  • carbamazepine, phenytoin, valproic acid (medicines used to treat epilepsy and neuralgic pain)
  • cytotoxic agents (medicines used in cancer) Ex. doxorubicin, valrubicin
  • neuroleptics (medicines used to treat and manage symptoms of many psychiatric disorders) Ex. butaperazine, risperidone, perazine
  • 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 treat a fast/irregular heartbeat such as antiarrhythmics (Ex. flecainide, pilsicainide)
  • medicines used for Parkinson’s disease (Ex. apomorphine, selegiline)
  • medicines used to treat 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 treat hypertension) Ex. chlorothiazide, chlorthalidone
  • adrenaline, noradrenaline (medicines used in emergency conditions)
  • warfarin (used to treat or prevent blood clots)
  • digoxin (used to treat heart failure)
  • omeprazole, cimetidine (used to treat stomach ulcers)
  • medicines used to treat fungal infections (Ex. miconazole, ketoconazole, itraconazole)
  • lithium (medicine used for mental illness)
  • hormonal contraceptives (medicines used to prevent pregnancy) Ex. ethinyl estradiol
  • medicines used to treat HIV infections (Ex. ritonavir, indinavir, saquinavir).

Overdosage:

If you or anyone else accidentally take too much of CLOMACH 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 CLOMACH 25MG TABLET out of the sight and reach of children.
  • Store CLOMACH 25MG TABLET below 30°C

FAQs ABOUT CLOMACH 25MG TABLET

What is CLOMACH 25MG TABLET used for?

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

How CLOMACH 25MG TABLET works?

CLOMACH 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 treating symptoms of schizophrenia and other psychotic disorders associated with Parkinson’s disease in affected individuals.

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

The most common side effects of taking CLOMACH 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 CLOMACH 25MG TABLET be used in pregnant and breastfeeding women?

Yes, CLOMACH 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 CLOMACH 25MG TABLET cause drowsiness?

Yes, CLOMACH 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 consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom worsens.

REFERENCES

1. K.D. Tripathi. Drugs Used in Mental Illness: Antipsychotic and Antimanic Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 441.

2. Habib A. Haidary, Ranjit K. Padhy. Clozapine.  NIH National Library of Medicine. National Center for Biotechnology Information. Stat Pearls [Internet]. December 2021. [Accessed on 11th August 2022] https://www.ncbi.nlm.nih.gov/books/NBK535399/

3. Britannia Pharmaceuticals Ltd. Electronic Medicines Compendium (EMC). [Revised in February 2019] [Accessed on 11th August 2022 https://www.medicines.org.uk/emc/files/pil.6078.pdf

4. Leyden Delta B.V. Electronic Medicines Compendium (EMC). [Revised in July 2020] [Accessed on 11th August 2022] https://www.medicines.org.uk/emc/files/pil.10121.pdf

USEFUL DIAGNOSTIC TESTS

  • Imagine tests
  • Dopamine transporter scan

AUTHOR DETAILS

Written By Dr. K .AZEEM HUSSAIN, B.D.S
Last updated on 31 Oct 2022 | 04:12 PM(IST)

PRODUCT DETAILS
    Net Qty
    1 N
    Shelf Life
    720
    Item Weight
    17.5 g
    Ingredient
    Clozapine 25 mg
    Hsn Code
    30049099
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