Restol3 mg

Established Use

Restol is indicated for the short-term symptomatic treatment of anxiety, including severe, disabling anxiety, tension, and agitation associated with acute emotional or situational stress. Restol is intended for short-term use only; current psychiatric guidance does not support routine long-term or continuous use of Restol because of the risk of tolerance and dependence.

Adjunctive Use

Restol may be used as an adjunct for the short-term symptomatic relief of anxiety-related functional and psychosomatic complaints, such as anxiety-associated irritable bowel syndrome, functional cardiovascular or respiratory symptoms, anxiety-related insomnia, and anxiety accompanying certain organic disorders, when anxiety is a significant contributing component. This adjunctive use of Restol should also be limited to the shortest duration necessary.

Each tablet contains Bromazepam INN 3 mg.

Restol is a medicine belonging to the benzodiazepine group, used for the short-term relief of anxiety, tension, and related symptoms. Restol works by calming overactive signaling in the brain, helping reduce feelings of nervousness and restlessness so that anxiety symptoms become more manageable. Restol is intended for short courses of treatment under a doctor's supervision and is not meant for long-term or everyday use. Because Restol can cause drowsiness and dependence and interacts with alcohol and other sedating medicines, it should be taken only exactly as prescribed. In Bangladesh, Restol is available as a 3 mg oral tablet.

Anxiolytic (Benzodiazepine)

Bromazepam is a benzodiazepine that acts on the central nervous system by binding to a specific site on the GABA-A receptor complex. This binding produces a conformational change that enhances the inhibitory effect of gamma-aminobutyric acid (GABA), the principal inhibitory neurotransmitter in the brain, without directly affecting other neurotransmitter systems. The enhanced GABA-ergic inhibition produced by Bromazepam underlies its anxiolytic, sedative, muscle-relaxant, and anticonvulsant properties. At lower doses, Bromazepam predominantly reduces tension and anxiety, while at higher doses sedative and muscle-relaxant effects of Bromazepam become more prominent.

• Take Restol tablets by mouth, exactly as prescribed by your doctor.
• Swallow the Restol tablet whole with a glass of water; Restol may be taken with or without food.
• Take Restol at the same times each day to maintain a steady effect.
• Do not increase the dose of Restol or take it more often than prescribed.
• Do not stop taking Restol suddenly after regular use; your doctor will advise how to reduce the dose of Restol gradually.
• Avoid drinking alcohol while taking Restol.
• Do not share your Restol prescription with anyone else, even if their symptoms seem similar.

• Opioids (e.g., codeine, tramadol, morphine, other opioid pain relievers or cough medicines): Combining Restol with opioids can cause profound sedation, respiratory depression, coma, and death. This combination should be avoided whenever possible; if a physician judges it necessary, the lowest effective doses of Restol and the opioid should be used for the shortest possible time, with close monitoring for breathing difficulty or excessive drowsiness. See Precautions and Warnings for full guidance.
• Alcohol: Alcohol enhances the sedative effects of Restol and should be avoided during treatment with Restol.
• Other central nervous system depressants (antidepressants, antipsychotics, other hypnotics/sedatives, antiepileptics, sedating antihistamines, general anesthetics, muscle relaxants): Concurrent use with Restol may enhance central nervous system depression, increasing the risk of excessive sedation and impaired coordination.
• CYP3A4 inhibitors (e.g., azole antifungals such as ketoconazole, macrolide antibiotics, protease inhibitors, certain calcium channel blockers, cimetidine): These drugs can reduce the metabolism of Restol and increase its blood levels, potentially requiring a dose reduction of Restol.
• Disulfiram: May prolong the elimination of Restol and increase its sedative effects.

Common Side Effects

Drowsiness, fatigue, muscle weakness, reduced alertness, confusion, headache, and unsteadiness (ataxia) are common with Restol, particularly at the start of treatment or with higher doses, and often lessen with continued use. Short-term memory problems (anterograde amnesia) can also occur with Restol.

Serious Side Effects – Seek Medical Attention

Contact a doctor or emergency services if Restol causes: severe drowsiness, confusion, or difficulty waking up; slow, shallow, or labored breathing (especially if Restol is combined with opioids, alcohol, or other sedatives); paradoxical reactions such as increased agitation, aggression, hallucinations, or unusual excitability; signs of a severe allergic reaction (swelling of the face, lips, or throat, difficulty breathing, rash); or, on stopping Restol after prolonged use, withdrawal symptoms such as seizures, severe anxiety, tremor, or confusion.

Pregnancy

The safety of Restol during pregnancy has not been established, and Restol should generally be avoided during pregnancy unless considered clearly necessary by a physician. Benzodiazepines cross the placenta; use of Restol in late pregnancy or during labor has been associated with neonatal hypotonia, reduced respiratory function, and hypothermia in the newborn ("floppy infant syndrome"), and infants born to mothers who used Restol or other benzodiazepines regularly in late pregnancy may develop neonatal withdrawal symptoms. If Restol has been used during pregnancy, the newborn should be monitored accordingly.

Breastfeeding

Restol is excreted into breast milk, and breastfeeding should be avoided during treatment with Restol.

• Risk of dependence, tolerance, and withdrawal: Restol can cause physical and psychological dependence, which increases with higher doses and longer duration of use, and withdrawal symptoms can appear after as little as one week of regular use of Restol. Restol should be used for the shortest duration necessary, and treatment should never be stopped abruptly after regular use; abrupt discontinuation of Restol can cause withdrawal effects including rebound anxiety, tremor, sweating, confusion, hallucinations, and seizures, particularly after prolonged use. Any reduction or discontinuation of Restol should be done gradually and under medical supervision.
• Danger of combining with opioids: Taking Restol together with opioid medicines (including opioid pain relievers and cough suppressants) can cause profound sedation, respiratory depression, coma, and death, reflecting a well-documented, serious safety concern with combined benzodiazepine and opioid use. This combination should be reserved for situations with no alternative treatment, using the lowest effective doses of Restol and the opioid for the shortest possible time, with close monitoring.
• Sedation and impaired ability to drive or operate machinery: Restol can cause drowsiness, impaired coordination, amnesia, and slowed reaction time, which may persist into the next day; patients taking Restol should not drive or operate hazardous machinery until they know how Restol affects them, and this risk increases substantially if alcohol is also consumed.
• Use only for short-term treatment: Restol is intended for short courses of treatment; continuous long-term use of Restol is not recommended by current guidance, and the need for continued treatment with Restol should be reassessed regularly by a doctor.
• Caution in elderly patients: Elderly patients are more sensitive to the sedative effects of Restol and have reduced clearance, increasing the risk of excessive sedation, confusion, unsteadiness, and falls; lower doses of Restol are recommended.
• Caution in hepatic and respiratory disease: Restol should be used with caution in patients with mild-to-moderate hepatic impairment or compromised respiratory function, as Restol is contraindicated in severe hepatic insufficiency, severe respiratory insufficiency, and sleep apnea syndrome.
• Risk of paradoxical reactions: Rarely, Restol can cause paradoxical reactions such as increased anxiety, agitation, aggression, or hallucinations, particularly in children, elderly patients, or those with underlying psychiatric conditions; if this occurs, Restol should be discontinued under medical guidance.

Overdose with Restol commonly causes drowsiness, confusion, slurred speech, and unsteadiness (ataxia), which can progress to impaired reflexes, low blood pressure, respiratory depression, and coma in more severe cases, particularly when Restol is taken together with alcohol or other central nervous system depressants. Do not induce vomiting unless specifically directed to do so by a doctor or poison control. If an overdose of Restol is suspected, contact emergency medical services or a poison control center immediately, or go to the nearest hospital, taking the medicine packaging if possible. Management of Restol overdose is generally supportive; in a hospital setting, flumazenil, a specific benzodiazepine-reversal agent, may be used by medical staff for severe central nervous system depression under close monitoring, but it is not for self-administration.

Store Restol according to the instructions on the product label, out of reach of children, and away from moisture and direct light. Do not use Restol after the expiry date printed on the pack.

Children

The use of Restol in children is not recommended; the safety and efficacy of Restol have not been established in the pediatric population.

Elderly

Elderly patients should receive lower doses of Restol, as clearance is reduced and the risk of excessive sedation, confusion, unsteadiness, and falls is increased.

Renal Impairment

Restol should be used with caution in patients with renal impairment, starting at the lowest effective dose, since specific dose-adjustment data for Restol are limited.

Hepatic Impairment

Restol should be used with caution and at reduced doses in mild-to-moderate hepatic impairment; Restol is contraindicated in severe hepatic insufficiency due to the risk of encephalopathy.

Other Populations

Restol should be used with caution in patients with a history of alcohol or drug dependence, and in those with respiratory disease, due to increased sensitivity to the sedative and respiratory-depressant effects of Restol.

Treatment with Restol should be as short as possible; current guidance generally limits regular use of Restol to about 2 to 4 weeks, including a gradual tapering period, with an overall course of Restol (including tapering) typically not exceeding 8 to 12 weeks. Continuous long-term use of Restol is not recommended, and the need for continued treatment with Restol should be reviewed regularly by a doctor.

Benzodiazepine; Anxiolytic/Sedative

Bromazepam binds to a specific benzodiazepine binding site on the GABA-A receptor complex in the central nervous system, producing a conformational change that enhances the effect of gamma-aminobutyric acid (GABA) on chloride channel opening. This action of Bromazepam increases inhibitory neurotransmission, producing anxiolytic, sedative, muscle-relaxant, and anticonvulsant effects.

Restol is not recommended for use in children. The safety and efficacy of Restol have not been established in the pediatric population, so Restol should not be given to children.