Consumer medicine information

1. Why am I using SEREPAX?

SEREPAX contains the active ingredient oxazepam. SEREPAX is used to treat anxiety, tremor, confusion or anxiety associated with alcohol withdrawal.
For more information, see Section 1. Why am I using SEREPAX? in the full CMI.

2. What should I know before I use SEREPAX?

Do not use if you have ever had an allergic reaction to SEREPAX or any of the ingredients listed at the end of the CMI.
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 SEREPAX? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with SEREPAX 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 SEREPAX?

• The dose will vary between patients. Your doctor will tell you how many tablets you need to take each day and when to take them.

• Swallow SEREPAX with a glass of water, with or without food.

• Take SEREPAX only for as long as your doctor recommends. It is usually used for short periods only (such as 2 to 4 weeks).

5. What should I know while using SEREPAX?

6. Are there any side effects?

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking SEREPAX. Some mild side effect include dizziness, drowsiness, feeling tired, lightheadedness or feeling faint and headache. Some serious side effects include confusion, behavioural or mood changes such as sudden outbursts of anger and increased excitement and hallucinations.
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

Oxazepam.

2 Qualitative and Quantitative Composition

Serepax tablets are available in two (2) strengths, 15 mg and 30 mg tablet. The excipients include lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Serepax oxazepam 15 mg tablets. White, round tablet, one face convex embossed "15", opposite face flat with Ezi-split breakline.
Serepax oxazepam 30 mg tablets. Orange, round tablet, one face convex embossed "30", opposite face flat with Ezi-split breakline.

4 Clinical Particulars

4.9 Overdose

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, hypotonia, hypotension, respiratory depression, coma, and very rarely proves fatal.
Treatment. In the management of overdosage with any medication, it should be borne in mind that multiple agents may have been taken.
Following overdosage with oral benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airways protected if the patient is comatose. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Hypotension and respiratory depression should be managed according to general principles.
Haemoperfusion and haemodialysis are not useful in benzodiazepine intoxication. The benzodiazepine antagonist flumazenil may be used in hospitalised patients for the reversal of acute benzodiazepine effects. Please consult the flumazenil product information prior to usage.
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. In vitro mutagenicity reports on oxazepam are inconclusive. One study reported oxazepam to be mutagenic in a modified Ames Salmonella typhimurium test in the presence, but not in the absence, of metabolic activation. Other investigations (employing the Salmonella/microsome test, the Ames test, and tests in Aspergillus nidulans, Saccharomyces cerevisiae, isolated rat hepatocytes and a rat liver cell line) have obtained negative results for the mutagenicity of oxazepam.
Carcinogenicity. In a two year carcinogenicity study in which rats were administered oxazepam in the diet (5, 15, 60 mg/kg/day), no oxazepam related malignant tumours were found. However, there was a significant increase in the incidence of testicular interstitial cell tumours and thyroid cystadenomas (benign tumours) in high dose males. There was also a significant trend for increased incidence of prostatic adenomas. An earlier published study reported that mice fed diets containing 0.05% or 0.15% oxazepam for nine months developed a dose related increase in liver adenomas. In an independent analysis of some of the microscopic slides from this mouse study several of these tumours were classified as liver carcinomas. Although comprehensive studies have not been performed to examine the possibility of an increased incidence of tumours in humans exposed to oxazepam, at the present time there is no evidence that the clinical use of oxazepam is associated with tumours.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Oxazepam (Serepax), an antianxiety agent, is a 1,4 benzodiazepine with the chemical name 7-chloro-1,3- dihydro-3-hydroxy-5- phenyl-2H-1,4- benzodiazepine-2-one. Its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSOXAZEP.gif Oxazepam is a creamy white to pale yellow powder that is practically odourless. It is almost insoluble in water and slightly soluble in alcohol and chloroform. It has a bitter taste. The molecular weight is 286.7.
CAS number. 604-75-1.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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