Full Prescribing Info
Frisium also contains the following excipients: Lactose, talc and magnesium stearate.
Anxiolytic agent.
Anxiety states. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjuvant or different treatment.
Dosage/Direction for Use
Pharmaceutical presentation, dosage and duration of treatment must be adjusted to the individual clinical response, the indication, and the severity of the condition. Due regard must be paid to the possibility of interference with alertness and reaction time. The fundamental principle is to keep the dose as low as possible.
In patients with impairment of hepatic or renal function, Frisium must be administered in reduced doses; in long-term treatment, hepatic and renal functions should be checked regularly, as a precaution.
When treatment with Frisium is to be discontinued after prolonged administration, the dosage should normally be tapered off over a period of time.
Treatment of Anxiety States: The initial dose is usually 20 mg Frisium daily. If necessary, the daily dose may be increased to 30 mg.
For elderly patients, a total daily dose of 10-15 mg is often enough.
For children, as directed by a physician.
Discontinuation of Treatment of Anxiety States: After improvement of the symptoms, the dose may be reduced. After prolonged treatment, Frisium should not be withdrawn suddenly. The dose should be reduced gradually under medical supervision, otherwise symptoms eg, restlessness, anxiety and insomnia may occur.
Treatment of Epilepsy: As with other benzodiazepines, the possibility of a decrease in anticonvulsant efficacy in the course of treatment must be borne in mind.
Dosage in Adults and Adolescents >15 years: Small doses (5-15 mg/day as the initial dose), gradually increasing to a maximum daily dose of about 80 mg. Furthermore, constant doses (eg, 20 mg/day) and intermittent therapy (discontinuing Frisium and subsequently prescribing it again) have proved effective.
Discontinuation of Treatment or Combined Treatment of Epilepsy: At the end of treatment, also in cases where there has been a poor response to therapy, the dose should be gradually reduced because otherwise an increased proneness to seizures cannot be excluded.
Administration: The tablets should be swallowed whole with some liquid.
If the dose is to be distributed over the day, the larger portion should be taken in the evening. Doses of up to 30 mg Frisium can also be administered as a single evening dose.
The duration of treatment is determined by the doctor. After a period not exceeding 4 weeks, the doctor should decide whether continuation of treatment is necessary. Prolonged spells of uninterrupted treatment should be avoided, since they may lead to dependence.
Patients with hypersensitivity to clobazam or to any of the excipients, or with any history of drug dependence.
Special Precautions
Special caution is necessary if Frisium is to be administered to patients with serious pathological muscle weakness (myasthenia gravis), unsteadiness of movement and gait due to diseases of the spinal cord and cerebellum (spinal and cerebellar ataxia), and in case of acute poisoning by alcohol, hypnotics, analgesics, neuroleptic agents, antidepressives or lithium, in patients with serious liver damage (eg, cholestatic jaundice), and in patients with transient cessation of respiration in sleep (sleep-apnoea syndrome).
Monitoring of respiratory function is necessary in patients with severe acute respiratory impairment (respiratory failure).
Frisium contains a benzodiazepine. Benzodiazepines are drugs for the treatment of certain disorders which are associated with restlessness and anxiety states, inner tension or insomnia. When using benzodiazepines, there is a risk of developing or promoting dependence. To minimize this risk, the patient is advised to observe the following instructions exactly:
1. Benzodiazepines have been developed solely for the treatment of a specific group of illnesses and may only be taken on doctor's instructions.
2. When these drugs have been taken for a maximum of 4 weeks, the doctor should decide whether the treatment is to be continued. An uninterrupted, prolonged period of administration should be avoided, as it may lead to dependence. If these drugs are taken without consulting the doctor, the chance of seeking their help is reduced.
3. On no account should the dose, prescribed by the doctor, be increased even if the effect has lessened. Treatment will not have the desired effect if the patient increases the dose on his own initiative.
4. When benzodiazepines are discontinued after prolonged use, restlessness, anxiety states and insomnia may occur, often after a delay of several days. These withdrawal symptoms usually disappear after 2-3 weeks.
5. The patient should inform the doctor if he has suffered or is still suffering from alcohol or drug dependence or hard drug addiction. If this is the case, benzodiazepines must not be taken, except in rare situations, determined only by the doctor.
6. Benzodiazepine-containing drugs should not be taken upon the recommendation of other patients or passed on to others even if proven effective.
Effects on the Ability to Drive or Operate Machinery: Frisium may alter reactivity to impair driving performance or the ability to operate machinery, especially when it is taken in conjunction with alcohol.
Notes: Under experimental conditions, impairment of alertness has been observed to be less pronounced after therapeutic doses of clobazam (20-30 mg) than after other benzodiazepines.
Use in pregnancy: Frisium should not be used in the 1st trimester of pregnancy, and in the later stages only if there are compelling indication for its use.
Use in lactation: Frisium should not be taken by nursing mothers, since it passes into the breast milk. If there are compelling indications for its use, breastfeeding should be stopped.
Use in children: Children between the ages of 6 months and 3 years should not normally be given Frisium; however, in exceptional cases, where there are compelling indications, it can be used for anticonvulsant treatment.
Adverse Reactions
Symptoms of tiredness may sometimes appear, especially at the beginning of treatment and when higher doses are used. Also in rare instances, and usually only temporarily, the patient may experience dryness of the mouth, constipation, loss of appetite, nausea, dizziness or a fine tremor of the fingers. Another possibility is the emergence of paradoxical reactions (eg, restlessness, irritability, acute agitational states, anxiety, suicidal tendencies, frequent muscle spasms, difficulty in falling asleep and to sleep through).
In the event of such reactions, treatment with Frisium should be discontinued.
Slowing of reaction time, ataxia, drowsiness, confusion and headaches may occasionally occur.
Cutaneous reactions eg, eruptions or urticaria have been observed in isolated cases.
Impairment of respiratory function may become manifest in certain diseases of the respiratory passages (airways obstruction eg, in bronchial asthma) and in patients with brain damage.
After prolonged use of benzodiazepines, impairment of consciousness sometimes combined with respiratory disorders, has been reported in very rare cases, particularly in elderly patients; it sometimes persists for some length of time.
Especially in patients receiving high doses or long-term treatment, there may be reversible abnormalities eg, slowing or indistinctness of speech (disorders of articulation), lack of confidence in walking and other motor functions, visual disorders (double vision, nystagmus), weight gain or loss of libido.
When used as an adjuvant in the treatment of epilepsy, Frisium occasionally causes restlessness and muscle weakness.
As with other drugs of this type (benzodiazepines), the therapeutic benefit must be balanced against the risk of habituation and dependence during prolonged use (see under Precautions). Should any adverse reactions occur, consult a physician.
Drug Interactions
A mutually potentiating effect is to be expected if other central nervous system depressant drugs (eg, analgesics, sedatives and hypnotics) or alcohol are consumed at the same time.
If Frisium is administered simultaneously with anticonvulsants in the treatment of epilepsy, the dosage must be adjusted under regular medical supervision (EEG monitoring), as there may be interactions with the patient's basic anticonvulsant medication.
Especially in patients receiving concurrent treatment with valproic acid and Frisium, there may be a slight to moderate rise in plasma valproic acid concentration. If possible, the blood levels of the active ingredients should be determined in such cases. Carbamazepine and phenytoin may cause an increase in the metabolic conversion of clobazam to N-desmethyl clobazam.
The effects of muscle relaxants, analgesics and nitrous oxide may be enhanced. Concurrent treatment with drugs that inhibit the monooxygenase system, eg cimetidine, may enhance and prolong the action of clobazam.
MIMS Class
ATC Classification
N05BA09 - clobazam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
Tab 5 mg x 100 x 10's.
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