Consumer medicine information

1. Why am I using Rivotril^®?

Rivotril^® contains the active ingredient clonazepam. Rivotril^® is used to treat epilepsy in infants, children and adults and it is also used to treat status epilepticus (prolonged or repeated fits or seizures without any recovery between attacks).
For more information, see Section 1. Why am I using Rivotril^®? in the full CMI.

2. What should I know before I use Rivotril^®?

Do not use if you have ever had an allergic reaction to clonazepam, other benzodiazepine medicines or any of the ingredients listed at the end of the CMI.
Do not use if you have severe and chronic lung disease or severe liver disease.
Do not use if you have an addiction to drugs or alcohol. This medicine may be addictive.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Rivotril^®? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Rivotril^® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Rivotril^®?

• Take Rivotril^® exactly as your doctor has prescribed.

• Measure the prescribed dose of Rivotril^® oral liquid as DROPS ONLY.

5. What should I know while using Rivotril^®?

6. Are there any side effects?

Mild side effects: drowsiness, tiredness, dizziness, unsteadiness, muscle weakness, tremor, loss of memory, inattentiveness, confusion, lack of concentration, headache, hangover feeling in the morning, slurred speech, unpleasant dreams, palpitations, vomiting. Serious side effects: difficulties in breathing, sudden anxiety or excitation, hallucinations or delusions, severe sleep disturbances, severe withdrawal symptoms following discontinuation of Rivotril^®.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Clonazepam.

2 Qualitative and Quantitative Composition

Rivotril tablets contain 500 micrograms clonazepam.
Rivotril oral liquid contains 2.5 mg/mL clonazepam (one drop contains 0.1 mg clonazepam).
Rivotril concentrated injection solution contains 1 mg clonazepam in 1 mL and is supplied with 1 mL diluent ampoules containing 1 mL of water for injections.
Excipients with known effect. Tablet contains sugars as lactose.
Injection contains alcohol as 20% v/v ethanol.
Oral liquid contains saccharin.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

The tablet is a cylindrical, biplanar, pale orange tablet, marked "0,5" on upper face, and break bar on reverse face.
The oral liquid is a clear blue homogeneous liquid.
The concentrated injection solution is a clear slightly yellowish liquid. The diluent is a clear colourless liquid.

4 Clinical Particulars

4.9 Overdose

Symptoms. Overdosage of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases, symptoms may include ataxia, dysarthria, nystagmus, hypotonia, hypotension, respiratory depression, coma and, very rarely, death. Coma may be more protracted and cyclical, particularly in elderly patients. Increased frequency of seizures may occur in patients at supratherapeutic plasma concentrations (see Section 5.2 Pharmacokinetic Properties). Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease.
Benzodiazepines increase the effects of other central nervous system depressants, including alcohol. When combined with other CNS depressants, the effects of overdosage are likely to be severe and may prove fatal.
Treatment. Treatment of overdose is symptomatic; institute supportive measures as indicated by the patient's clinical state. If the overdosage is known to be small, observation of the patient and monitoring of their vital signs only may be appropriate. In adults or children who have taken an overdose of benzodiazepines within 1-2 hours, consider activated charcoal with airway protection if indicated.
If CNS depression is severe consider the use of flumazenil (Anexate), a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore, patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil may precipitate seizures and is to be used with extreme caution in the presence of medicines that reduce seizure threshold (e.g. tricyclic antidepressants) and epileptic patients who have been treated with benzodiazepines. Refer to the prescribing information for flumazenil (Anexate) for further information on the correct use of this medicine.
Haemoperfusion and haemodialysis are not useful in benzodiazepine intoxication.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Clonazepam and five of its metabolites were negative in bacterial gene mutation assays. Chromosomal damage assays have not been conducted with clonazepam.
Carcinogenicity. No 2-year carcinogenicity studies have been conducted with clonazepam. An 18-month chronic study in rats showed no treatment-related histopathological changes at dietary doses up to 1800 mg/m²/day (greater than 100-fold MRHD).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Clonazepam is a light yellow powder which is practically insoluble in water.
Chemical structure. Clonazepam has the following chemical structure, (5-(2-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4 benzodiazepin-2-one) and a molecular weight 315.7:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCLONAZ.gif CAS number. 1622-61-3.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/RIVOTRST.gif