Rivotril Special Precautions

General: Rivotril may be used only with particular caution in patients with spinal or cerebellar ataxia, in the event of acute intoxication with alcohol or drugs and in patients with severe liver damage (e.g. cirrhosis of the liver).
Concomitant use of alcohol / CNS depressants: The concomitant use of Rivotril with alcohol or/and CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects of Rivotril possibly including severe sedation, clinically relevant respiratory and/or cardiovascular depression (see Interactions).
Medical history of alcohol or drug abuse: Rivotril should be used with extreme caution in patients with a history of alcohol or drug abuse.
For warnings related to the use in infants and small children, see Use in Children as follows.
The dosage of Rivotril must be carefully adjusted to individual requirements in patients with pre-existing disease of the respiratory system (e.g. chronic obstructive pulmonary disease) or liver and in patients undergoing treatment with other centrally-acting medications or anticonvulsant (antiepileptic) agents (see Interactions).
Like all drugs of this type, Rivotril may, depending on dosage, administration and individual susceptibility, modify the patient's reactions (e.g. driving ability, behaviour in traffic) (see Ability to Drive and Use Machines as follows).
Anticonvulsant drugs including Rivotril should not be discontinued abruptly in epileptic patients as this may precipitate status epilepticus. When, in the judgement of the clinician, the need for dosage reduction or discontinuation arises, this should be done gradually.
Patients with a history of depression and/or suicide attempts should be kept under close supervision.
Suicidal Thinking and Behavior: Patients, their caregivers, and families should be counseled that AEDs, including Rivotril, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Lactose intolerance: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Porphyria: In patients with porphyria, clonazepam has to be used with care because it may have a porphyrogenic effect.
Drug Abuse and Dependence: Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products (see Adverse Reactions). 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: derealization, depersonalization, 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.
Renal Impairment: See Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
Hepatic Impairment: See General as previously mentioned.
Ability to Drive and Use Machines: Even if taken as directed, clonazepam can slow reactions to such an extent that the ability to drive a vehicle or operate machinery is impaired. This effect is aggravated by consumption of alcohol.
Driving, operating machinery and other hazardous activities should therefore be avoided altogether or at least during the first few days of treatment. The decision on this question rests with the patient's physician and should be based on the patient's response to treatment and the dosage involved (see Adverse Reactions).
Use in Children: In infants and small children, Rivotril may cause increased production of saliva and bronchial secretion. Therefore, special attention must be paid to maintaining patency of the airways. See General as previously mentioned.