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Frisium 10Frisium
Active ingredient: Clobazam


Composition
Each tablet contains 10mg clobazam as active ingredient.
Excipients: Lactose, maize starch, colloidal anhydrous silica, talc, magnesium stearate.


Properties
Clobazam, the active ingredient of Frisium 10, relieves anxiety and prevents or arrests convulsions. It is a substance belonging to a group of medicines called "benzodiazepines".


Indications
- Acute and chronic anxiety states, which may produce the following symptoms in particular: Anxiety, tension, restlessness, excitement, irritability, sleep disturbances from emotional causes, psychovegetative and psychosomatic disorders (for example, in the cardiovascular or gastrointestinal area), and emotional instability.


In cases of psychovegetative and psychosomatic disorders, the possibility of an organic cause must be investigated. In patients with depression or anxiety associated with depression, Frisium 10 must only be used in conjunction with adequate concomitant treatment, since the use of benzodiazepines (e.g. Frisium 10) alone can precipitate suicide. Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment. In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary, treatment. As adjunctive therapy in patients with epilepsy not adequately stabilised with their basic medication.


Contraindications
Frisium 10 must not be taken by patients with
  - hypersensitivity to clobazam or any of the excipients (see "Composition")

  - any history of drug or alcohol dependence (increased risk of developing dependence)
  - chronic progressive muscle disease (myasthenia gravis) (risk of aggravation of muscle weakness)
severe respiratory insufficiency (risk of deterioration)
  - temporary cessation of breathing during sleep (sleep apnoea syndrome) (risk of deterioration)
  - severe impairment of liver function (risk of precipitating a certain disease of the brain [encephalopathy]).


Benzodiazepines must only be used in children after carefully evaluating the need for their use. In children between the ages of 6 months and 3 years, Frisium 10 must not be used, except - in the presence of compelling indications - as adjunctive therapy for treatment of epilepsy.


Patients should not drink alcohol during treatment with Frisium 10, because there is an increased risk of sedation and other adverse effects.

 

Pregnancy and lactation
Frisium 10 must not be used in the first three months of pregnancy, and in the later stages must only be used if there are compelling indications. If Frisium 10 is used in high doses immediately before or during childbirth, undercooling (hypothermia), diminished muscle tension or loss of tension (hypotonia), a restriction in the breathing function (respiratory depression), and difficulty in drinking (signs and symptoms of the so-called "floppy infant syndrome") may occur. In addition, physical dependence to benzodiazepines may develop in infants born to mothers who have taken such medicines for longer periods during the later stages of pregnancy. In the period following birth, these infants may be at risk of developing a withdrawal syndrome.


Since clobazam passes into breast milk, Frisium 10 must not be taken by breastfeeding women.


Special warnings and precautions
Frisium 10, especially if taken in high doses, may cause respiratory depression. Therefore, in patients with chronic or acute respiratory insufficiency (insofar as they tolerate Frisium 10 at all; see "Contraindications"), respiratory function must be monitored and a dose reduction may be necessary. Frisium 10 can cause muscle weakness. Therefore, in patients with preexisting muscle weakness (insofar as they tolerate Frisium 10 at all; see "Contraindications"), or with unsteadiness of movement and gait due to diseases of the spinal cord and cerebellum (spinal or cerebellar ataxia), special observation is required and a dose reduction may be necessary. Memory lapses for events occurring after lapse-causing event (anterograde amnesia) may occur even if benzodiazepines are used in the normal dose range, but especially at higher dose levels.


Patients with impairment of renal or hepatic function have an increased response to Frisium 10 and a higher susceptibility to its adverse effects; in such patients, a dose reduction may be necessary. In long-term treatment, renal and hepatic function must be checked regularly.


Benzodiazepines- including Frisium 10 - may lead to physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment. However, this risk is present even with daily intake of Frisium 10 over periods of only a few weeks, and applies not only to possible abuse with particularly high doses but also to the therapeutic dose range. The risk of dependence is increased in patients with a history of alcohol or drug abuse. The therapeutic benefit must be balanced against the risk of dependence during prolonged use (see also the information for the patient at the end of this text). On withdrawal of benzodiazepines, especially if abrupt, a rebound phenomenon or a withdrawal syndrome may occur.


Rebound phenomenon: A rebound phenomenon is characterised by a recurrence in enhanced form of the symptoms which originally led to treatment with Frisium 10 (e.g. anxiety, seizures). This may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness.

 

Withdrawn, syndrome: Once physical dependence has developed, abrupt termination of treatment with Frisium 10 will lead to withdrawal symptoms. These may include headaches, sleep disturbances, increased dreaming, extreme anxiety, tension, restlessness, confusion, and excitability, an alteration in environmental perception (derealization), loss of feeling of identity in relation to others or of one's own sense of reality (depersonalisation), hallucinations and symptomatic psychoses (e.g. withdrawal delirium), numbness and tingling sensations in the extremities, muscle pain, tremor, sweating, nausea, vomiting, abnormal acuteness of hearing (hyperacusis), hypersensitivity to light, noise and physical contact, as well as epileptic seizures. A withdrawal syndrome may also occur when abruptly changing over from a benzodiazepine with a long duration of action (for example, Frisium 10) to one with a short duration of action.

 

In the treatment of epilepsy with benzodiazepines. including Frisium 10, consideration must be given to the possibility of a decrease in effectiveness (development of tolerance) in the course of treatment.


Frisium 10 may cause sedation and similar adverse effects as well as muscle weakness (see "Adverse effects"). These effects may impair the ability to concentrate and react and therefore constitute a risk in situations where these abilities are of particular importance (e.g. operating a car or machinery).


Adverse effects
Sedation, leading to tiredness and sleepiness, may occur, especially at the start of treatment with Frisium 10 and when higher doses are used. Slowing of reaction time, drowsiness, numbed emotions, confusion, headaches, dryness of the mouth, constipation, loss of appetite, nausea dizziness, muscle weakness, ataxia, or a fine tremor of the fingers may also occur.

 

Particularly when high doses are taken or in long-term treatment, slowed or indistinct speech (disorders of articulation), unsteadiness of gait and of other motor functions, visual disorders (double vision, rhythmical oscillations of the eyeballs [nystagmus]), weight gain, or loss of libido may occur. Such reactions are reversible. After prolonged use of benzodiazepines, impairment of consciousness, sometimes combined with respiratory disorders, may occur in very rare cases, particularly in elderly patients; these effects sometimes persist over longer periods. Skin reactions, such as eruptions (also in the form of itching wheals [urticaria]), may develop in very rare cases.


Especially in the elderly and in children paradoxical reactions such as restlessness, difficulty in falling asleep and in sleeping through, irritability, acute agitational states, anxiety, aggressiveness, delusions, fits of rage, nightmares, hallucinations, psychotic reactions, suicidal tendencies, or frequent muscle spasms may occur. In the event of such reactions, treatment with Frisium 10 must be discontinued.


Tolerance and dependence may develop, especially during prolonged use. Anterograde amnesia may occur even if benzodiazepines are used in the normal dose range, but especially at higher dose levels. Amnestic effects may be associated with inappropriate behaviour.
 

Respiratory depression may occur, especially if high doses of Frisium 10 are taken. Therefore, particularly in patients with a preexisting impairment of respiratory function (e.g. patients with bronchial asthma) or in those with brain damage, respiratory insufficiency may occur or deteriorate.

 

Pre-existing depression may be unmasked during benzodiazepine treatment.

 

Please speak with your doctor if you notice any of the adverse effects listed in this package insert or any other undesired effects or unexpected changes.

 

Since some adverse effects, e.g. respiratory depression, may under certain circumstances become life-threatening, it is essential that, if sudden or severe reactions do occur, you inform a doctor at once.

 

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