INTRODUCTION

NULET 2.5MG contains Aripiprazole which belongs to the group of medicine called antipsychotics. It is indicated in the treatment of bipolar I disorder and schizophrenia in adolescents (13-17 years). Bipolar I disorder is a serious mental illness in which the person will experience a full manic episode with or without a major depressive episode. Manic episodes are usually characterized by emotional highs, hyperactivity, needing much less sleep than usual, pressure of speech, talking very quickly with racing ideas, aggressiveness and sometimes severe irritability. Schizophrenia is a serious mental disorder characterized by extremely disordered thinking, hallucinations, delusions, suspiciousness, incoherent speech, anxiety, depression and abnormal behavior which affects your daily functioning.

Aripiprazole acts by altering the levels of certain chemical messengers which are responsible for your stabilizing mood and thoughts. While taking this medicine, inform your doctor immediately if you experience any unusual mental problems such as thoughts of killing or harming yourself (suicidal thoughts) or are developing uncontrollable unusual urges or cravings (such as addictive gambling, excessive eating or spending, increase in sexual thoughts or feelings or an abnormally high sex drive). Your doctor might reduce the dose or suggest an alternative therapy. 

Before taking this medicine inform your doctor if you have any blood problems or heart disease. If you are pregnant or think you may be pregnant or breastfeeding, contact your doctor before taking this medicine. Your doctor would suggest whether you can take NULET 2.5MG or not. This medicine is strictly not recommended for use in children and adolescents under 13 years of age. Consult your doctor before taking. The most common side effects of taking this medicine are nausea, vomiting, headache, abnormal body movements, tiredness, anxiety and blurred vision. Contact your doctor if any of the symptoms bother you. Also inform your doctor if you experience any sudden weight gain, muscle stiffness with fever, unusual movements, somnolence or allergic reaction.

USES OF NULET 2.5MG

• Bipolar I disorder and Schizophrenia in adolescents (13-17 years)

HOW NULET 2.5MG WORKS

Aripiprazole is a partial agonist of dopamine (D2) and serotonin (5HT1A) receptors. It works by affecting the neurotransmission of certain chemical messengers (e.g. dopamine) in the brain that affects your mood and thoughts. It diminishes subcortical dopamine hyperfunction but enhances the transmission of dopamine in the prefrontal cortex which helps to treat both positive and negative symptoms of schizophrenia and bipolar disorder.

DIRECTIONS FOR USE

Take this medicine as directed by your physician. It can be taken with or without meals. Swallow the medicine as whole with a sip of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and health condition.

SIDE EFFECTS OF NULET 2.5MG

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after meals. Stick to simple meals. Do not eat rich or spicy food.

Indigestion:

Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. If the symptoms get worse, contact your doctor immediately.

Headache:  

Rest and drink plenty of fluids. Do not drink too much alcohol. Ask your doctor to recommend a painkiller.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• medicines used to treat hypertension (e.g. captopril, enalapril, atenolol)
• medicines used to treat abnormal heart rhythm (e.g. quinidine, amiodarone, flecainide)
• medicines used to treat depression, anxiety or OCD (e.g. fluoxetine, paroxetine, venlafaxine, tryptophan, clomipramine, amitriptyline St. John's Wort)
• medicines used to treat fungal infections (e.g. ketoconazole or itraconazole)
• medicines used to treat HIV infection (e.g. ritonavir, indinavir, efavirenz, nevirapine)
• medicines used to treat epilepsy (e.g. phenytoin, carbamazepine phenobarbital)
• medicines used to treat tuberculosis (e.g. rifabutin, rifampicin)
• medicines used to provide pain relief (e.g. tramadol and pethidine)
• medicines used to treat migraine (e.g. sumatriptan and zolmitripitan)

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT NULET 2.5MG

Is NULET 2.5MG addictive?

This medicine is not addictive in nature. However, inform your doctor if you feel like getting addicted to this medicine.

Is NULET 2.5MG safe during pregnancy?

If you are pregnant or think you may be pregnant, contact your doctor before taking this medicine. Your doctor would suggest whether you can take this medicine or not.

Can I consume alcohol while taking NULET 2.5MG?

No. Avoid consumption of alcohol while taking this medicine, as it may increase the severity of side effects like tiredness and fatigue.

Can NULET 2.5MG cause weight gain?

Yes. This medicine may rarely cause increase in weight in some individuals. Contact your doctor immediately if you experience this.

REFERENCES

1. KD. Tripathi. Drugs Used in Mental Illness: Antipsychotic and Antimanic Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page - 442.

2. Jonathan M. Meyer. Pharmacotherapy of Psychosis and Mania. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 429-430.

3. Gerald G. Briggs and Roger K. Freeman. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 266-269.

4. Otsuka Pharmaceutical Development & Commercialization, Inc. Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia (ATTAIN 266). NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on April 2015] [Accessed 12th January 2021]. https://clinicaltrials.gov/ct2/show/NCT01149655

5. Leslie Citrome. A review of aripiprazole in the treatment of patients with schizophrenia or bipolar I disorder. NCBI; PMC US National Library of Medicine, National Institute of Health. December 2006. [Accessed 12th January 2021]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2671949/

6. Torrent Pharmaceuticals Ltd. ARIP MT 2. [Accessed 12th January 2021]. https://www.torrentian.com/pisheet/Upload/PI_Sheet/2892.pdf

7. Elaiapharm. Electronic Medicines Compendium (EMC). [Revised on September 2020] [Accessed 12th January 2021]. https://www.medicines.org.uk/emc/files/pil.7148.pdf

8. Otsuka Pharmaceutical Co., Ltd. U.S. Food & Drug Administration. [Revised on August 2016] [Accessed 12th January 2021]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf