Tranquil 10

• Acute and chronic anxiety states
• Seizures associated with Lennox-Gastaut syndrome (adjunctive therapy)
• Epilepsy (when not adequately stabilized with anticonvulsant monotherapy)

Clobazam binds at distinct binding sites associated with the chloride ionopore at the post-synaptic GABA receptor. These GABA receptors are in various locations in the CNS (limbic, reticular formation) and clobazam increases the duration of time for which the chloride ionopore is open. As a result, hyperpolarization and stabilization of the membrane occur as the post-synaptic inhibitory effect of GABA is enhanced.

Anxiety (Adults & >15 years): Initial: 20 mg/day (max 30 mg/day); Elderly: 10-15 mg/day; Children (3-15 years): 5-10 mg/day.

Epilepsy (Adults & >15 years): Initial: 5-15 mg/day, gradually increase to max 80 mg/day.

Children (3-15 years): Initial: 5 mg/day; Maintenance: 0.3-1.0 mg/kg/day.

Lennox-Gastaut syndrome: >30 kg: 5 mg q12h (max 40 mg/day); ≤30 kg: 5 mg/day (max 20 mg/day).

Hepatic Dose: Mild-moderate (Child-Pugh 5-9): Half the typical adult dose; Severe: Not recommended.

Very Common (≥1/10): Somnolence (especially at start and with higher doses), fatigue

Common (≥1/100 and <1/10): Sedation, dizziness, disturbance in attention, slow speech/dysarthria, headache, tremor, ataxia, irritability, aggression, restlessness, depression, decreased appetite, dry mouth, nausea, constipation

Uncommon (≥1/1,000 and <1/100): Diplopia, weight increased, rash

Not Known: Respiratory depression, photosensitivity reaction, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, muscle weakness, muscle spasms, hypothermia

[CONSULT YOUR DOCTOR] Clobazam may be unsafe to use during pregnancy. Not recommended during the first trimester. Pregnancy Category D. Administration during late pregnancy may cause neonatal respiratory depression, "floppy infant syndrome," and withdrawal syndrome.

• [UNSAFE] Clobazam may cause side effects which could affect your ability to drive. You may feel sleepy or have concentration or memory problems.
• The addiction/habit-forming potential is very high; take only as per the dose and duration advised by your doctor.
• Avoid consuming alcohol as it may increase dizziness and drowsiness.
• Inform your doctor if you notice sores or blisters on your skin, lips, or inside your mouth.
• Do not stop taking medication suddenly without talking to your doctor as that may lead to nausea, anxiety, agitation, flu-like symptoms, sweating, tremor, and confusion.
• Contraindicated during the first trimester of pregnancy and lactation.

Clobazam overdose symptoms include somnolence, confusion, coma, and respiratory depression. Treatment is symptomatic and supportive. Flumazenil may be used as an antidote.

Store below 30°C, protect from light. Keep out of reach of children. Do not use after the expiry date.