CLONAZEPAM TILLOMED

Posology Mode of administration Treatment should be started with low doses. The dose may be increased progressively until the maintenance dose suited to the individual patient has been found. The scored tablets facilitate the administration of lower daily doses in the initial stages of treatment.

The dosage of clonazepam must be adjusted to the needs of each individual and depends on the individual response to therapy. The maintenance dosage must be determined according to clinical response and tolerance. The daily dose should be divided into 3 or 4 equal doses.

If doses are not equally divided, the largest dose should be given before retiring. Once the maintenance dose level has been reached, the daily amount may be given in a single dose in the evening. Simultaneous administration of more than one antiepileptic drug is a common practice in the treatment of epilepsy and may be undertaken with clonazepam.

The dosage of each drug may be required to be adjusted to obtain the optimum effect. If status epilepticus occurs in a patient receiving oral clonazepam, intravenous clonazepam may still control the status. Before adding clonazepam to an existing anticonvulsant regimen, it should be considered that the use of multiple anticonvulsants may result in an increase of undesired effects.

If necessary, larger doses may be given at the discretion of the physician, up to a maximum of 20 mg daily. The maintenance dose should be attained after 2 to 4 weeks of treatment. Adults Initial dosage should not exceed 1 mg/day. The maintenance dosage for adults normally falls within the range 4 to 8 mg.

5 mg/day. The elderly are particularly sensitive to the effects of centrally depressant drugs and may experience confusion. 5 mg tablets. 5 mg/day for older children. 5 to 1 mg/day Small children (1 to 5 years) 1 to 3 mg/day School children (5 to 12 years) 3 to 6 mg/day In some forms of childhood epilepsy, certain patients may cease to be adequately controlled by clonazepam.

Control may be re-established by increasing the dose or interrupting treatment with clonazepam for 2 or 3 weeks. During the interruption in therapy, careful observation and other drugs may be needed. 3). Patients with mild to moderate hepatic impairment the dose should be adjusted to individual requirements and will probably be lower.

Method of administration For oral administration

The following have been observed. Frequencies are defined according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Immune system disorders Allergic reactions and very rare cases of anaphylaxis have been reported to occur with benzodiazepines. Angioedema may occur in rare cases. Endocrine disorders Isolated cases of reversible development of premature secondary sex characteristics in children (incomplete precocious puberty) have been reported.

Psychiatric disorders Impaired concentration, restlessness, confusional state and disorientation have been observed. Depression may occur in patients treated with clonazepam, but it may be also associated with the underlying disease.

The following paradoxical reactions have been observed: excitability, irritability, aggression, agitation, nervousness, hostility, anxiety, sleep disturbances, nightmares, vivid dreams and psychotic disorders and activation of new types of seizures may be precipitated.

If these occur, the benefit of continuing the drug should be weighed against the adverse effect. The addition to the regimen of another suitable drug may be necessary or, in some cases, it may be advisable to discontinue clonazepam therapy.

4) In rare cases loss of libido may occur. Nervous system disorders Somnolence, slowed reaction, muscular hypotonia, dizziness and ataxia. These undesirable effects occur relatively frequently and are usually transient and generally disappear spontaneously in the course of the treatment or on reduction of the dosage.

They can be partially prevented by increasing the dose slowly at the start of treatment. Headache was observed in rare cases. Causing of generalised fits was observed very rarely. Particularly in long-term or high-dose treatment, reversible disorders such as a slowing or slurring of speech (dysarthria), reduced coordination of movements and gait disorder (ataxia) and nystagmus may occur.

Anterograde amnesia may occur using benzodiazepines at therapeutic dosages, the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behaviour. With certain forms of epilepsy, an increase in the frequency of seizures during long- term treatment is possible.

Although clonazepam has been given uneventfully to patients with porphyria, rarely it may induce convulsions in these patients. Eye disorders Particularly in long-term or high-dose treatment, reversible disorders of vision (diplopia) may occur.

Common: nystagmus Cardiac Disorders Cardiac failure including cardiac arrest has been reported. Respiratory, thoracic and mediastinal disorders Rarely respiratory depression may occur, particularly on intravenous administration of clonazepam.

This effect may be aggravated by pre-existing airways obstruction or brain damage or if other medications which depress respiration have been given. As a rule, this effect can be avoided by careful adjustment of the dose to individual requirements.

In infants and small children, and particularly those with a degree of mental impairment, clonazepam may give rise to salivary or bronchial hypersecretion with drooling. Supervision of the airway may be required. Gastrointestinal disorders The following effects have been reported in rare cases: nausea, gastrointestinal and epigastric symptoms Skin and subcutaneous tissue disorders The following effects may occur in rare cases: urticaria, pruritus, rash, transient hair loss and pigmentation changes.

Musculoskeletal and connective tissue disorders Muscle weakness, this undesirable effect occurs relatively frequently and is usually transient and generally disappears spontaneously in the course of the treatment or on reduction of the dosage.

It can be partially prevented by increasing the dose slowly at the start of the treatment. Renal and urinary disorders In rare cases urinary incontinence may occur. Reproductive System and breast disorders In rare cases erectile dysfunction or loss of libido may occur.

General disorders and administration site conditions Fatigue (tiredness, lassitude), this undesirable effect occurs relatively frequently and is usually transient and generally disappears spontaneously in the course of the treatment or on reduction of the dosage.

It can be partially prevented by increasing the dose slowly at the start of treatment. 4) Investigations In rare cases decreased platelet count may occur. As with other benzodiazepines, isolated cases of blood dyscrasias and abnormal liver function tests have been reported.

Injury, poisoning and procedural complications There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly. 8.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Clonazepam should be used with caution in patients with chronic pulmonary insufficiency, or with impairment of renal or hepatic function, and in the elderly or debilitated. In these cases dosage should generally be reduced. g. 5). Effects on the respiratory system may be aggravated by pre-existing airways obstruction or brain damage or if other medications which depress respiration have been given.

As a rule, this effect can be avoided by careful adjustment of the dose to individual requirements. g. cirrhosis of the liver). Do not interrupt treatment abruptly. As with all other antiepileptic drugs, treatment with clonazepam even if of short duration, must be withdrawn by gradually reducing the dose in view of the risk of precipitating status epilepticus.

This precaution must also be taken when withdrawing another drug while the patient is still receiving clonazepam therapy. Prolonged use of benzodiazepines may result in dependence with withdrawal symptoms on cessation of use. (See 'Dependence').

In cases of loss or bereavement, psychological adjustment may be inhibited by benzodiazepines.

Suicidal behaviour:

Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo-controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour.

The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for clonazepam. Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.

Patients (and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviour emerge. Patients with a history of depression and/or suicide attempts should be kept under close supervision.

Concomitant use with alcohol / CNS depressants The concomitant use of clonazepam with alcohol or/and CNS depressants should be avoided. 5). Clonazepam should be used with extreme caution in patients with a history of alcohol or drug abuse.

Risk from concomitant use of opioids Concomitant use of clonazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs with opioids should be reserved for patients for whom alternative treatment options are not possible.

If a decision is made to prescribe clonazepam concomitantly with opioids, the lowest effective dose should be used, and the duration of treatment should be as short as possible. The patients should be followed closely for signs and symptoms of respiratory depression and sedation.

5). g. 7). As a general rule, epileptic patients are not allowed to drive. Even when adequately controlled on clonazepam, it should be remembered that any increase in dosage or alteration in timings of dosage may modify patients' reactions, depending on individual susceptibility.

8). In particular long-term or high-dose treatment, may lead to reversible disorders such as dysarthria, reduced coordination of movements and gait disorder (ataxia), nystagmus and double vision (diplopia). Furthermore, the risk of anterograde amnesia, which may occur using benzodiazepines at therapeutic dosages, increases at higher dosages.

Amnestic effects may be associated with inappropriate behaviour. 8) during long-term treatment is possible. The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a medical history of alcohol and/or drug abuse.

Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. During long-term treatment, withdrawal symptoms may develop after a lengthy period of use, especially with high doses or if the daily dose is reduced rapidly or abruptly discontinued.

The symptoms include tremor, sweating, agitation, sleep disturbances and anxiety, headaches, muscle pain, extreme anxiety, tension, restlessness, confusion, irritability and epileptic seizures which may be associated with the underlying disease.

In severe cases the following symptoms may occur: derealisation, depersonalisation, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact or hallucinations. Since the risk of withdrawal symptoms is greater after abrupt discontinuation of treatment, abrupt withdrawal of the drug should therefore be avoided and treatment - even if only of short duration - should be terminated by gradually reducing the daily dose.

The […]

1 • Acute pulmonary insufficiency • Severe respiratory insufficiency • Sleep apnoea syndrome • Myasthenia gravis • Severe hepatic insufficiency Clonazepam must not be used in patients in a coma, or in patients known to be abusing pharmaceuticals, drugs or alcohol.