INTRODUCTION

ETIWELL 0.5 TABLET contains Etizolam which belongs to the group of medicines called Antidepressants. It is used in the treatment of short-term anxiety. Anxiety is a mental health disease characterized by fear, worry, and excessive nervousness.

ETIWELL 0.5 TABLET is also used to treat insomnia. Insomnia is a sleep disease that causes trouble in falling asleep or staying asleep.

ETIWELL 0.5 TABLET can have a serious side effect like suicidal thoughts, consult your doctor immediately if you have suicidal or aggressive thoughts.

ETIWELL 0.5 TABLET is not recommended for use in patients having severe liver disease, lung diseases, myasthenia gravis, acute narrow-angle glaucoma (increased pressure in the eye), chronic psychosis, or porphyria.

Before taking ETIWELL 0.5 TABLET, inform your doctor if you have kidney disease, alcohol addiction, or personality disorders. ETIWELL 0.5 TABLET is not recommended for use in pregnant or breastfeeding women. ETIWELL 0.5 TABLET can be used in children and adolescents. However, consult with your child’s doctor before giving it to your child.

In elderly patients, ETIWELL 0.5 TABLET should be used with caution. The most common side effects of taking ETIWELL 0.5 TABLET are decreased heart rate, impaired coordination, sleepiness, yawning, decreased appetite, nausea, vomiting, dry mouth and headache. Ask for your doctor’s advice if any of these worsen or doesn’t improve.

USES OF ETIWELL 0.5 TABLET

Treats:

• short-term anxiety
• insomnia

HOW ETIWELL 0.5 TABLET WORKS

ETIWELL 0.5 TABLET work by increasing the activity of GABA (a chemical messenger in the brain that acts as a natural nerve-calming agent) and inducing sleep. Thereby, relaxes muscles, reduces anxiety, and helps to fall asleep.

DIRECTIONS FOR USE

Take ETIWELL 0.5 TABLET as advised by your physician. Take this medicine with or without meals.

For Tablet, Capsule: Swallow ETIWELL 0.5 TABLET with a glass of water. Do not crush or chew the medicine.

For Mouth Dissolving Tablet, Orally Disintegrating Tablet: Place ETIWELL 0.5 TABLET inside your mouth and allow it to dissolve completely. Do not swallow or chew the medicine.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition. Continue to take ETIWELL 0.5 TABLET for the stipulated duration prescribed by your doctor to achieve better results.

SIDE EFFECTS OF ETIWELL 0.5 TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea:

Take this medicine with or after meals. Stick to simple meals while taking this medicine. Avoid eating rich or spicy food. Do not take any medication on your own. Ask for your doctor’s advice if nausea doesn’t improve.

Headache:

Try to take rest and don’t involve yourself in exertive activities. Rest in a quiet and dark room. Apply a pain-relieving balm on your forehead. Ask for your doctor’s advice if headache doesn’t improve

Vomiting:

Drink clear or ice-cold drinks. Eat light, bland foods and avoid fried, oily, or sweet foods. Avoid carbonated drinks. Ask for your doctor’s advice if vomiting doesn’t improve.

Dry mouth:

Dry mouth can be managed by chewing sugar-free gum or sucking on sugar-free hard candies to stimulate the flow of saliva. Sip water at regular intervals of time. Do not use mouthwashes that contain alcohol because they can be drying. Consult your physician for advice.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

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

• medicines used to treat depression (Ex. fluoxetine, paroxetine), psychosis (Ex. risperidone, olanzapine), schizophrenia (Ex. clozapine)
• medicines used to treat allergy (Ex. levocetirizine)
• medicines used as general anesthetics (Ex. propofol, isoflurane)
• medicines used to treat sleep problems (Ex. zolpidem)
• medicines used to treat severe pain (Ex. tramadol, methadone)
• medicines used to treat stomach problems (Ex. cisapride, cimetidine, esomeprazole, omeprazole)
• medicines used to treat heart diseases (Ex. amlodipine, diltiazem, clonidine, moxonidine, propranolol, bisoprolol, nitroglycerine, isosorbide, hydralazine, minoxidil, losartan. nitroprusside)
• medicines used to treat low blood sugar (Ex. diazoxide)
• medicines used to treat chronic alcoholism (Ex. disulfiram)
• medicines used to treat fluid build-up in the body (Ex. spironolactone, furosemide)
• medicines used as muscle relaxants Ex. thiocolchicine)
• medicines used to treat Parkinson’s disease (Ex. levodopa)
• medicine used to treat withdrawal symptoms of opioid withdrawal (Ex. lofexidine)
• medicines used to treat fungal infections (Ex. ketoconazole, fluconazole)
• medicines used to treat epilepsy (Ex. clonazepam, phenytoin)
• medicines used to treat certain infections (Ex. erythromycin)

Overdosage:

If you or anyone else accidentally take too much of ETIWELL 0.5 TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep ETIWELL 0.5 TABLET out of reach of children
• Store ETIWELL 0.5 TABLET below 30°C

FAQs ABOUT ETIWELL 0.5 TABLET

What is ETIWELL 0.5 TABLETused for?

ETIWELL 0.5 TABLET contains Etizolam which belongs to the group of medicines called Antidepressants. It is used in the treatment of short-term anxiety and insomnia.

Can ETIWELL 0.5 TABLETbe used in children?

ETIWELL 0.5 TABLET can be used in children and adolescents. However, consult with your child’s doctor before giving ETIWELL 0.5 TABLET to your child.

Can I stop taking ETIWELL 0.5 TABLET?

Take ETIWELL 0.5 TABLET for the time it has been prescribed to you. Do not stop taking ETIWELL 0.5 TABLET until and unless your doctor advice you to. Stopping early or taking for prolonged periods of time may cause some unwanted side effects. Ask for your doctor’s advice if you wish to discontinue taking ETIWELL 0.5 TABLET.

Can I drink alcohol while taking ETIWELL 0.5 TABLET?

Avoid consumption of alcohol while taking ETIWELL 0.5 TABLET as it can worsen your side effects or can make you feel dizzier. Consult your doctor before taking it.

Does ETIWELL 0.5 TABLET affects my ability to drive?

Do not drive or use machines if you feel sleepy and dizzy after taking ETIWELL 0.5 TABLET or until you know how it affects you. You can resume doing your activities once you feel normal again.

Is it safe to use ETIWELL 0.5 TABLET in pregnant and breastfeeding women?

ETIWELL 0.5 TABLET is not recommended to use among pregnant and breastfeeding women. Consult your doctor before taking it.

REFERENCES

1. Sean C Sweetman. Anxiolytic Sedatives Hypnotics and Antipsychotics. Martindale-The Complete Drug Reference. Thirty Sixth Edition. 2009. Page – 996.

2. Yuki Omori, Takashi Kanbayashi, Yohei Sagawa, Aya Imanishi, Ko Tsutsui, Yuya Takahashi, Masahiro Takeshima, Manabu Takaki, Seiji Nishino, Tetsuo Shimizu. Low dose of aripiprazole advanced sleep rhythm and reduced nocturnal sleep time in the patients with delayed sleep phase syndrome: an open-labeled clinical observation. NIH National Library of Medicine, National center for biotechnology information. Pubmed Central. May 2018. [Accessed on 9th September 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5965391/

3. Lohit Somashekar Reddy, Raghavendra Nayak, Sameeran S Chate, Nanasaheb M Patil. Etizolam: Use and safety profile in children and adolescent. Research Gate. December 2016 https://www.researchgate.net/publication/328529331_Etizolam_Use_and_safety_profile_in_children_and_adolescent#:~:text=Conclusions%3A%20Etizolam%20is%20effective%20in,tolerated%20with%20minimal%20adverse%20effects.

4. Scottish Drugs Forum. Etizolam [Revised in June 2014] [Accessed on 9th September 2022] https://www.nhsaaa.net/media/4654/etizolam_infosheet_sdf_drugwatch1_1-2.pdf

5. Vibcare Pharma Pvt. Ltd. Etizovib (Etizolam). [Accessed on 9th September 2022] https://vibcare.co.in/etizolam/

6. MIMS. Etizolam. [Accessed on 9th September 2022] https://www.mims.com/philippines/drug/info/etizolam?mtype=generic

7. Neuracle Lifesciences Private Limited. Ripstress (Etizolam). [Accessed on 9th September 2022] https://www.neuraclelife.com/product/etizolam-0-5-mg/

8. Leeford Healthcare. Nitocal 0.25 (Etizolam). [Accessed on 9th September 2022] https://www.leeford.in/product/757/nitocalm-025

9. Leeford Healthcare. Nitocal 0.5 (Etizolam). [Accessed on 9th September 2022] https://www.leeford.in/product/758/nitocalm-05

10. JABS Biotech Pvt Ltd. Etijab-1 (Etizolam). [Accessed on 9th September 2022] https://www.jabsbiotech.com/product/etijab-1

11. Drug Bank. Etizolam. [Accessed on 9th September 2022] https://go.drugbank.com/drugs/DB09166