Consumer medicine information

1. Why am I using ALEPAM?

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

2. What should I know before I use ALEPAM?

Do not use if you have ever had an allergic reaction to ALEPAM 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 ALEPAM? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ALEPAM 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 ALEPAM?

• 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 ALEPAM with a glass of water, with or without food.

• Take ALEPAM 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 ALEPAM?

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 ALEPAM. 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

Each Alepam 15 and Alepam 30 tablet contains 15 mg and 30 mg of oxazepam, respectively.
Excipients with known effect. Sugars as lactose and trace quantities of sulfites.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Alepam 15 (oxazepam) 15 mg: 8 mm pale yellow flat bevelled edged tablet marked OM/15 on one side, G on reverse.
Alepam 30 (oxazepam) 30 mg: 8 mm pale orange flat bevelled edged tablet marked OM/30 on one side, G on reverse.

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, 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

A white or almost white, crystalline powder, practically insoluble in water, slightly soluble in alcohol and in methylene chloride.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSOXZPAM.gif Chemical name: (3RS)-7-chloro-3- hydroxy-5-phenyl-1,3-dihydro-2H- 1,4-benzodiazepin-2-one.
Molecular formula: C₁₅H₁₁ClN₂O₂.
Molecular weight: 286.72.
CAS number. 604-75-1.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

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