INTRODUCTION

TOFICALM contains Tofisopam which belongs to the group of medicines called as Benzodiazepine derivatives. It is used in the treatment of anxiety and depression. Anxiety is an intense, excessive, persistent worry and fear about everyday situations which is characterized by symptoms such as fast heart rate, rapid breathing, sweating and tiredness. Depression is a mood disorder that causes a persistent feeling of sadness and loss of interest that affects the way you feel, think, and behave which can lead to variety of emotional and physical problems such as back pain or headache.

Tofisopam works by increasing the action of a chemical messenger in the brain known as GABA (gamma-amino-butyric-acid), which suppresses the excessive and abnormal activity of nerve cells in the brain that results in reducing depression and anxiety.

TOFICALM is not recommended for use in patients having decompensated respiratory insufficiency (shortness of breath and wheezing), history of coma and sleep apnoea, increased pressure in the eye, chronic psychosis, and obsessive-compulsive phobic disorders. Before taking TOFICALM, inform your doctor if you have mental illness, personality disorders, atherosclerosis, epilepsy, liver, and kidney disease.

TOFICALM is not recommended for use in first trimester during pregnancy and in breast-feeding women. It should be used with caution in children and adolescents (below 18 years). The most common side effects of taking TOFICALM are loss of appetite, vomiting, nausea, constipation, flatulence, dry mouth, and rash. Consult your doctor if any of the symptoms worsen.

USES OF TOFICALM

• To treat anxiety and depression

HOW TOFICALM WORKS

TOFICALM works by increasing the action of a chemical messenger in the brain known as GABA (gamma-amino-butyric-acid), which suppresses the excessive and abnormal activity of nerve cells in the brain that results in reducing depression and anxiety.

DIRECTIONS FOR USE

Take TOFICALM 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 of TOFICALM for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF TOFICALM

HOW TO MANAGE SIDE EFFECTS

Constipation:

Try to eat high-fiber foods such as vegetables, cereals, fresh fruits, 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.

Nausea and vomiting:

Try to take TOFICALM 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.

Flatulence:

Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. If it does not improve, contact your doctor.

Loss of appetite:

Eat when you feel hungry. Eat smaller meals frequently than usual. Snack only when you're hungry. Eat a nutritious snack which is rich in calories and protein, such as dried fruit and nuts. Consult your doctor if the symptom does not improve.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug – Drug Interactions:

Before taking TOFICALM inform your doctor if you are taking any of the following medicines:

• medicines used to suppress graft rejection (Ex. tacrolimus, sirolimus, ciclosporin)
• analgesics (medicines used to reduce fever and relive pain) Ex. paracetamol
• total anaesthetics (medicines used to prevent pain during surgery and other procedures) Ex. propofol
• antidepressants (medicines used to help relieve symptoms of depression) Ex. citalopram
• sedative and hypnotics (medicines used to induce sleep and or maintain sleep) Ex. zolpidem
• neuroleptics (medicines used to treat psychosis) Ex. haloperidol
• H1-antihistaminics (medicine used to treat allergic rhinitis) Ex. levocetirizine
• antifungals (medicines used to treat fungal infections) Ex. ketoconazole, itraconazole
• antihypertensives (medicines used to treat high blood pressure) Ex. clonidine, verapamil
• medicines used to treat heart problems (Ex. digoxin)
• anticoagulants (medicines used to prevent blood clot) (Ex. warfarin)
• medicines used to treat chronic alcoholism (Ex. disulfiram)
• antacids (medicines used to relieve indigestion and heartburn) (Ex. calcium carbonate)
• oral contraceptives (medicines used to prevent pregnancy) (Ex. estradiol)

Overdosage:

If you or anyone else accidentally take too much of TOFICALM, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of TOFICALM include vomiting, confusion, coma, respiratory depression, and seizures.

SYNOPSIS

MORE INFORMATION

• Keep TOFICALM out of reach of children
• Store below 30°C

FAQs ABOUT TOFICALM

What is TOFICALM and why is it prescribed?

TOFICALM contains Tofisopam which belongs to the group of medicines called as Benzodiazepine derivatives which is used in the treatment of anxiety and depression. Consult your doctor for advice before taking TOFICALM.

Is TOFICALM safe in pregnant and breast-feeding women?

TOFICALM is not recommended for use in pregnant women in the first trimester. It should be used with caution after first three months of pregnancy. TOFICALM is not recommended for use in breastfeeding women as it is passed in the breast milk. Consult your doctor before taking TOFICALM.

Can TOFICALM affect the ability to drive?

TOFICALM might cause hyperactivity and aggressiveness at high doses which might affect your ability to drive and using machines. Consult your doctor before taking TOFICALM.

What if someone takes more TOFICALM than recommended dose?

If you or anyone else accidentally take too much of TOFICALM, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage are vomiting, confusion, coma, respiratory depression, and seizures.

Can TOFICALM be given to children?

 TOFICALM should be used with caution in children and adolescents (below 18 years of age) since safety and efficacy not established. Consult child’s doctor for advice before giving TOFICALM to your children.

REFERENCES

1. Ashton Acton. Therapies and Treatments. Nephropathy: New Insights for the Healthcare Professional. Edition 2013. Page – 111-114.

2. Tofisopam. NIH National Library of Medicine, National center for biotechnology information. Pubchem. [Accessed on 13th June 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Tofisopam

3. Mai Yamamoto, Ken Inada, Minori Enomoto, Mitsunari Habukawa, Takahisa Hirose, Yuichi Inoue, Jun Ishigooka, Yuichi Kamei, Tsuyoshi Kitajima, Masayuki Miyamoto, Hideto Shinno, Katsuji Nishimura, Motohiro Ozone, Masahiro Takeshima, Mayumi Suzuki, Hidehisa Yamashita, and Kazuo Mishima. Current state of hypnotic use disorders: Results of a survey using the Japanese version of Benzodiazepine Dependence Self-Report Questionnaire. NIH National Library of Medicine, National Center for Biotechnology Information. PMC PubMed Central. March 2021 [Accessed on 13th June 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8182966/

4. Torrent Pharmaceuticals. Nextril 50 (Tofisopam Tablets 50mg). [Revised in June 2015] [Accessed on 13th June 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2735.pdf

5. Torrent Pharmaceuticals. Nextril 100. (Tofisopam Tablets 100mg). [Revised in June 2015] [Accessed on 13th June 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2736.pdf

USEFUL DIAGNOSTIC TESTS

• Dexamethasone suppression test (DST)