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Intas Pharmaceuticals Ltd

Spenzo 0.5mg Tablet 10'S

Schizophrenia
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    Introduction About SPENZO 0.5MG TABLET

    SPENZO 0.5MG TABLET contains Flupenthixol which belongs to the group of medicines called Antipsychotics. SPENZO 0.5MG TABLET is used to manage schizophrenia (serious mental disorder) and other psychoses in affected individuals.

    SPENZO 0.5MG TABLET is not recommended for use in patients allergic to Flupentixol, antipsychotic drugs, and/or other thioxanthene drugs. It is also not recommended for use in patients with serious blood circulation problems.

    Before taking SPENZO 0.5MG TABLET inform your doctor if you suffer from ankle swelling/shortness of breath, thyroid problems, epilepsy, diabetes, lung problems (such as asthma/bronchitis), heart problems (such as irregular/slow heartbeat, recent heart attack), kidney problems (such as phaeochromocytoma), and/or liver disease.

    SPENZO 0.5MG TABLET is generally not recommended for use during pregnancy unless it is clearly necessary. It is also not recommended for use in breastfeeding women.

    SPENZO 0.5MG TABLET is also 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 your doctor.

    The most common side effects of taking SPENZO 0.5MG TABLET are drowsiness, dry mouth, muscle spasm, vomiting, indigestion, diarrhea, and/or drowsiness. Consult your doctor if any of these symptoms worsen.

    Uses Of SPENZO 0.5MG TABLET

    • Manage schizophrenia and other psychoses in affected individuals

    How SPENZO 0.5MG TABLET Works

    SPENZO 0.5MG TABLET works by acting on specific nerve pathways in brain which leads to balance of certain chemicals in the brain thus managing the occurrence of schizophrenia and other psychotic symptoms in affected individuals.  

    How to use SPENZO 0.5MG TABLET

    Take SPENZO 0.5MG 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 right dose and duration depending upon your age, body weight and disease condition.

    Side Effects Of SPENZO 0.5MG TABLET

    Common

    • drowsiness
    • dry mouth
    • muscle spasm
    • rigidity of the whole body
    • changes in appetite/weight
    • sleeplessness
    • depression
    • nervousness/agitation
    • dizziness
    • headache
    • reduction in sex drive
    • speech problems
    • fits
    • poor concentration
    • blurred/abnormal vision
    • throbbing/fast heartbeats
    • shortness of breath
    • increase of saliva
    • vomiting
    • indigestion
    • diarrhea
    • increased sweating
    • itching
    • muscle pain
    • tremor
    • abnormal urination
    • general weakness/pain
    • tiredness/feeling unwell

    Uncommon

    • confusion
    • loss of co-ordination/altered muscle movements (including unusual movements of mouth, tongue and eyeballs)
    • low blood pressure
    • hot flushes
    • stomach pain
    • nausea
    • flatulence and constipation
    • rashes/skin reactions (including sensitivity to sunlight)
    • stiff and floppy muscle
    • trouble with ejaculation/erections in men

    Rare

    • difficulty in breathing
    • swelling of the face, lips, tongue, and/or throat which leads to difficulty in swallowing/breathing
    • severe itching of skin (with raised lumps)
    • signs of reduced blood platelet count such as risk of bleeding/bruising
    • breast enlargement in male
    • unexpected excretion of breast milk
    • absence of menstrual periods (in women)

    Stop taking SPENZO 0.5MG TABLET and contact your doctor immediately if you experience any of the following side effects:

    • signs of blood clots in the veins especially in the legs such as redness, swelling, and pain associated with chest pain and difficulty in breathing
    • signs of neuroleptic malignant syndrome (life threatening antipsychotic drug reaction) such as high fever, unusual stiffness of the muscles and/or changes in consciousness (associated with sweating and fast heart rate)
    • signs of tardive dyskinesia (movement disorder that causes involuntary, repetitive body movements) such as unusual movements of the mouth and tongue
    • signs of extra pyramidal reaction (drug induced disorders) such as unusual muscle movements (circular movements of the eyes), stiffness, tremor and restlessness 
    • irregular heartbeats
    • signs of jaundice such as yellowing of skin and whites of eyes
    • difficulty in breathing
    • swelling of the face, lips, tongue, or throat which leads to difficulty in swallowing/breathing
    • severe itching of the skin (with raised lumps)
    • if you have suicidal thoughts

    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.

    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.

    Headache:

    If SPENZO 0.5MG 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 SPENZO 0.5MG TABLET. If it lasts more than a week or severe, inform your doctor.

    Nausea and vomiting:

    Try to take SPENZO 0.5MG 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.

    Diarrhoea:

    Drink plenty of water and stay hydrated. Try to avoid taking any medicine on your own to manage diarrhea. Consult your doctor and inform them if the symptom gets worse.

    Itchy Skin:

    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.

    Tiredness:

    Make sure you take rest and drink plenty of fluids. Avoid or limit the consumption of alcohol. Try to take SPENZO 0.5MG 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.

    Warning & Precautions

    Pregnancy

    SPENZO 0.5MG TABLET is generally not recommended for use during pregnancy unless it is clearly necessary. Consult your doctor before taking it.

    Breastfeeding

    SPENZO 0.5MG TABLETis not recommended for use in breastfeeding women as it can pass into the breast milk. Consult your doctor before taking it.

    Driving and Using Machines

    Do not drive or use machines while taking SPENZO 0.5MG TABLET since it may cause drowsiness, dizziness, and/or blurred vision.

    Alcohol

    Do not drink alcohol while taking SPENZO 0.5MG TABLET as it may increase the sedative effects of alcohol making you drowsier.

    Kidney

    SPENZO 0.5MG TABLET should be used with caution in patients with kidney disease such as phaeochromocytoma (rare type of cancer of a gland near the kidney). Consult your doctor before taking the medicine.

    Liver

    SPENZO 0.5MG TABLETshould be used with caution in patients with liver disease. Consult your doctor before taking the medicine.

    Allergy

    Do not take SPENZO 0.5MG TABLET if you are allergic to Flupentixol, antipsychotic drugs, other thioxanthene drugs, and/or any of the other ingredients of this medicine.

    Lungs

    SPENZO 0.5MG TABLET should be used with caution in patients with severe breathing problems (such as asthma/bronchitis). Consult your doctor before taking the medicine.

    Heart Disease

    SPENZO 0.5MG TABLET should be used with caution in patients with heart problems such as irregular/slow heartbeat, recent heart attack. Consult your doctor before taking the medicine.

    Others

    SPENZO 0.5MG TABLET is not recommended for use if you:

    • are feeling less alert than usual/drowsy/sleepy
    • suffer from serious blood circulation problems
    • feel excited/agitated

    Before taking SPENZO 0.5MG TABLET, inform your doctor if you:

    • have problems that cause ankle swelling/shortness of breath
    • have thyroid problems
    • suffer from epilepsy, and/or are at a risk of having fits (due to brain injury or alcohol withdrawal)
    • suffer from Parkinson’s disease (age related degenerative condition) or myasthenia gravis (condition marked by severe muscular weakness)
    • have an enlarged prostate gland
    • suffer from glaucoma (increased pressure within the eye)
    • are at a risk of developing stroke (due to factors such as smoking and hypertension)
    • have too low potassium/magnesium levels in blood
    • have a family history of irregular heartbeats
    • suffer from diabetes
    • have a history of blood clots
    • are intolerant to certain sugars such as lactose
    • are schedule for any surgery (including dental)

    Use in Pediatrics:

    SPENZO 0.5MG TABLET is not recommended for use in children and adolescents (below 18 years of age). Consult your doctor before taking the medicine.

    Use in Geriatrics:

    SPENZO 0.5MG TABLET should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking the medicine.

    Interactions

    A. Drug-Drug interactions:

    Before taking SPENZO 0.5MG TABLET, inform your doctor if you are taking any of the following medicine:

    • medicines that change the heartbeat (Ex. quinidine, amiodarone, sotalol, dofetilide, erythromycin, moxifloxacin, cisapride, lithium)
    • other antipsychotic medicines (used to manage psychosis) Ex. risperidone, quetiapine, olanzapine
    • tricyclic anti-depressants (medicines used in the management of major depressive disorder) Ex. amitriptyline, amoxapine, desipramine
    • barbiturates (medicines that make you feel sleepy) Ex. amobarbitol, butalbital
    • anticoagulant drugs (medicines used to manage blood clots) Ex. warfarin
    • anticholinergic drugs (medicines used to manage cold, allergy, travel sickness) Ex. diphenhydramine, scopolamine
    • metoclopramide (used to manage nausea and other stomach conditions)
    • piperazine (used to manage worm infections)
    • levodopa (used to manage Parkinson’s disease)
    • sibutramine (used to reduce appetite)
    • digoxin (used to control heart rhythm)
    • corticosteroids (used to reduce inflammation and suppress immune system) Ex. prednisolone
    • medicines used to lower the blood pressure such as alpha blockers (Ex. doxazosin) betablockers (Ex. atenolol, acebutolol), hydralazine, methyldopa, clonidine, guanethidine
    • medicines that reduce potassium/magnesium level in blood (Ex. amphotericin B, chloroquine)
    • medicines to manage epilepsy (Ex. carbamazepine)
    • medicines used to manage diabetes (Ex. glimepiride)
    • epinephrine (medicine used for emergency management of severe allergic reactions)
    • general anesthetics (medicines used to render patient unconscious during surgery) Ex. propofol, etomidate, isoflurane
    • muscle relaxing drugs (medicines used to manage acute, painful musculoskeletal conditions) Ex. carisoprodol, cyclobenzaprine

    Overdosage:

    If you or anyone else accidentally take too much of SPENZO 0.5MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose includes drowsiness, unconsciousness, muscle movements/stiffness, fits, low blood pressure, weak pulse, fast heart rate, pale skin, restlessness, high/low body temperature, and/or changes in heartbeat (including irregular/slow heart rate).

    Synopsis

    Drug :   Flupenthixol
    Pharmacological Category :   Antipsychotic agents
    Therapeutic Indication :   Schizophrenia and other psychoses          
    Dosage Forms :   Tablet, Injection

    More Information

    • Keep SPENZO 0.5MG TABLET out of reach of children
    • Store it at room temperature

    FAQs About SPENZO 0.5MG TABLET

    How SPENZO 0.5MG TABLET works?

    SPENZO 0.5MG TABLET works by acting on specific nerve pathways in brain which leads to balance of certain chemicals in the brain thus managing the occurrence of schizophrenia and other psychotic symptoms in affected individuals.

    What SPENZO 0.5MG TABLET is used for?

    SPENZO 0.5MG TABLET is used in the management of schizophrenia and other psychoses in affected individuals. Schizophrenia is a serious mental disorder in which people interpret reality in an abnormal way which is generally characterized by symptoms such as hallucinations, delusions, disordered thinking and/or behavior that impairs daily functioning.

    Can SPENZO 0.5MG TABLET be used in children and elderly patients?

    No, SPENZO 0.5MG TABLET is not recommended for use in children and adolescents (aged below 18 years of age). The medicine is used but with caution in elderly patients (aged above 65 years). Consult your doctor before taking the medicine.

    How to take SPENZO 0.5MG TABLET?

    Take SPENZO 0.5MG 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.

    What happens if you take more SPENZO 0.5MG TABLET than your required dose?

    If you or anyone else accidentally take too much of SPENZO 0.5MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose includes drowsiness, unconsciousness, muscle movements/stiffness, fits, low blood pressure, weak pulse, fast heart rate, pale skin, restlessness, high/low body temperature, and/or changes in heartbeat (including irregular/slow heart rate).

    References

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

    2. Jataveda Mahapatra, Seema N Quraishi, Anthony David, Stephanie Sampson, Clive E Adams. Flupenthixol decanoate (depot) for schizophrenia or other similar psychotic disorders. NIH National Library of Medicine. National center for biotechnology information. PMC PubMed Central. June 2014. [Accessed on 14th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7057031/

    3. H. Lundbeck A/S. Electronic Medicines Compendium (EMC). [Revised in January 2021] [Accessed on 14th June 2022] https://www.medicines.org.uk/emc/files/pil.997.pdf

    4. Intas Pharmaceuticals Ltd. SPENZO-0.5 TAB, SPENZO-1. [Accessed on 14th June 2022] https://www.intaspharma.com/products/

    Useful Diagnostic Tests

    • Magnetic resonance imaging
    • Computed tomography

    Author Details

    Written By Dr. K .AZEEM HUSSAIN - B.D.S
    Reviewed For Accuracy By Dr. Aravindan Balachandran - MBBS, MD (Psychiatry)
    Last updated on 03 Dec 2022 | 09:30 AM(IST)
    Lab updated