INTRODUCTION ABOUT FRISIUM 10MG TABLET

FRISIUM 10MG TABLET contains Clobazam which belongs to the group of medicines called Benzodiazepines. FRISIUM 10MG TABLET is used to manage epilepsy over a long time (a neurologic disorder characterized by multiple episodes of seizures), severe anxiety (for a short period) and mental illnesses such as schizophrenia (a disorder that affects one’s thoughts, emotions and behaviour).

FRISIUM 10MG TABLET is also used to relieve the short-term symptoms of alcohol withdrawal syndrome (effects experienced when a person stops consuming alcohol).

Avoid alcohol consumption while taking FRISIUM 10MG TABLET as it may increase the side effects and cause drowsiness.

Use of FRISIUM 10MG TABLET is not recommended in patients with breathing disorders, liver disorders, myasthenia gravis, sleep apnoea. Contact your doctor before taking this medicine. FRISIUM 10MG TABLET should be used with caution in patients with existing kidney disease. Contact your doctor before taking FRISIUM 10MG TABLET.

Use of FRISIUM 10MG TABLET is not recommended in pregnancy and in breastfeeding mothers (as it may pass through the breast milk). Contact your doctor before taking FRISIUM 10MG TABLET.

It is not recommended for use in children under 6 years of age. Contact your doctor before taking. FRISIUM 10MG TABLET should be used with caution in elderly patients over 65 years of age. Contact your doctor before taking FRISIUM 10MG TABLET.

This medicine may cause patients to have suicidal ideations or thoughts and therefore proper attention should be given to any sudden change in behaviour while taking FRISIUM 10MG TABLET and must be reported to the managing physician immediately.

The most common side effects of FRISIUM 10MG TABLET are drowsiness, fatigue difficulty in staying awake or alert, sleepiness or dizziness, upper respiratory infections, fatigue, agitation or being aggressive, depression, headache, dry mouth, constipation, loss of appetite, nausea. Contact your doctor if you get any of the above side effects.

USES OF FRISIUM 10MG TABLET

It is used to manage:

• epilepsy
• severe anxiety for short period
• mental illnesses such as schizophrenia

HOW FRISIUM 10MG TABLET WORKS

FRISIUM 10MG TABLET works by calming the brain. It binds itself to the various binding sites present in the receptor (GABA receptor) and thereby causes membrane stabilization and helps to manage anxiety and fits.

DIRECTIONS FOR USE

Take FRISIUM 10MG TABLET with a glass of water and do not crush or chew the medicine.

For Tablet, Capsule: Swallow FRISIUM 10MG TABLET with a glass of water. Do not crush or chew the medicine.

For Dispersible Tablet: Disperse FRISIUM 10MG TABLET in the specified quantity of water as mentioned in the label. Consume the mixture immediately after reconstitution.

For Mouth Dissolving Tablet, Orally Disintegrating Tablet: Place FRISIUM 10MG 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 FRISIUM 10MG TABLET for the stipulated duration prescribed by your doctor to achieve better results.

SIDE EFFECTS OF FRISIUM 10MG TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea:

Take this medicine with or just after meals. Stick to simple meals. Avoid eating rich or spicy food. Contact your doctor if nausea persists.

Constipation:

Eat fibre rich food such as fresh fruits, vegetables and cereals and drink plenty of water. Exercise more regularly. Contact your doctor if constipation persists.

Dry mouth:

Drink lots of fluids (water or fruit juices) to keep yourself hydrated. Chew sugar free gummies and candies. Contact your doctor if dry mouth persists.

Headache:

Try to rest and relax. Apply a balm on your head. If the headache does not improve, contact your doctor.

Loss of appetite:

Eat when you are hungry. Have smaller meals more often. Snack only when you're hungry. Eat a nutritious snack rich in calories and protein, such as dry fruits and nuts. Contact your doctor if your appetite did not improve.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operate machinery if you feel dizziness. Avoid alcohol consumption as it aggravates dizziness. Contact your doctor if dizziness worsens.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug Interactions:

Before taking FRISIUM 10MG TABLET, inform your doctor if you are taking any of the following medicine:

• Other medicines for epilepsy (such as phenytoin, carbamazepine, stiripentol or valproic acid)
• anti-depressants (medicines used to manage depression such as Monoamine Oxidase Inhibitors (MAOIs such as moclobemide, isocarboxazid), tricyclic anti-depressants such as trazodone or Selective Serotonin Re-uptake Inhibitors (SSRIs) such as fluvoxamine or paroxetine)
• antipsychotics (medicines used to manage severe mental illness such as chlorpromazine, haloperidol, clozapine, olanzapine and pimozide)
• sleeping medicines (zolpidem)
• tranquilisers, medicines used to manage anxiety or produce sleep (like diazepam, temazepam or lorazepam)
• muscle relaxants (baclofen)
• antihistamines (medicines that cause sleep such as chlorphenamine, promethazine or diphenhydramine)
• lithium (medicine used to manage a mental illness called manic-depressive illness)
• cimetidine (medicine used to manage ulcers and heartburn)
• omeprazole (medicine used to manage the symptoms of acid reflux)
• ticlopidine (used to manage blood clots)
• fluconazole (medicine used to manage fungal infections)
• dextromethorphan (medicine used to relieve dry, irritating coughs)
• nebivolol (medicine used for high blood pressure)
• cannabidiol-containing products (medicines used for fits)
• opioids Ex. codeine, dihydrocodeine, hydrocodone, morphine, (medicines used for severe pain, cough)
• hormonal contraceptives (medicines used for managing pregnancy)
• prednisone (medicine used to manage inflammatory conditions)
• rifampin (medicine used for tuberculosis)
• herbs with sedative properties (Ex. chamomile, kava kava, valerian)
• St. John’s wort (medicine used for depression)

Overdosage:

If you or anyone else takes extra dose of FRISIUM 10MG TABLET accidentally, report to the nearest hospital immediately or call for your doctor. The effects of overdose may cause symptoms like drowsiness, CNS depression, confusion and lethargy, possibly progressing to ataxia, respiratory depression, hypotension.

SYNOPSIS

MORE INFORMATION

• Keep FRISIUM 10MG TABLET out of sight and reach of children
• Store FRISIUM 10MG TABLET below 25°C