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 Frisium
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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