SUMMARY CMI

OXAZEPAM-WGR

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using OXAZEPAM-WGR?

OXAZEPAM-WGR contains the active ingredient oxazepam. OXAZEPAM-WGR is used to treat anxiety, tremor, confusion or anxiety associated with alcohol withdrawal.

For more information, see Section 1. Why am I using OXAZEPAM-WGR? in the full CMI.

2. What should I know before I use OXAZEPAM-WGR?

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

3. What if I am taking other medicines?

Some medicines may interfere with OXAZEPAM-WGR 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 OXAZEPAM-WGR?

• 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 OXAZEPAM-WGR with a glass of water, with or without food.
• Take OXAZEPAM-WGR only for as long as your doctor recommends. It is usually used for short periods only (such as 2 to 4 weeks).

More instructions can be found in Section 4. How do I use OXAZEPAM-WGR? in the full CMI.

5. What should I know while using OXAZEPAM-WGR?

For more information, see Section 5. What should I know while using OXAZEPAM-WGR? in the full CMI.

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 OXAZEPAM-WGR. 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

FULL CMI

OXAZEPAM-WGR

Active ingredient(s): oxazepam

Consumer Medicine Information (CMI)

This leaflet provides important information about using OXAZEPAM-WGR. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using OXAZEPAM-WGR.

Where to find information in this leaflet:

1. Why am I using OXAZEPAM-WGR?
2. What should I know before I use OXAZEPAM-WGR?
3. What if I am taking other medicines?
4. How do I use OXAZEPAM-WGR?
5. What should I know while using OXAZEPAM-WGR?
6. Are there any side effects?
7. Product details

1. Why am I using OXAZEPAM-WGR?

OXAZEPAM-WGR contains the active ingredient oxazepam. OXAZEPAM-WGR is a benzodiazepine which is thought to work by acting on the brain chemicals.

OXAZEPAM-WGR is used to treat:

• Anxiety
• Tremor, confusion or anxiety associated with alcohol withdrawal.

Your doctor may have prescribed this medicine for another reason. Ask your doctor if you have any questions about why it has been prescribed for you.

2. What should I know before I use OXAZEPAM-WGR?

In general, benzodiazepines should be taken for short periods only (for example 2 to 4 weeks). Continuous long term use is not recommended unless advised by your doctor. The use of benzodiazepines may lead to dependence on the medicine.

Warnings

Do not use OXAZEPAM-WGR if:

• you are allergic to oxazepam, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• you have severe and chronic lung disease or breathing difficulties.
• you have sleep apnoea.
• the expiry date (EXP) printed on the pack has passed.
• the packaging shows signs of tampering or the tablets do not look quite right.

Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath.

Check with your doctor if you:

• take any medicines for any other condition.
• have any medical conditions, especially the following:
  - liver, kidney or lung problems
  - epilepsy, fits or convulsions
  - severe muscle weakness known as myasthenia gravis
  - low blood pressure
  - glaucoma (increased pressure in the eye)
  - depression, psychosis or schizophrenia
  - drug or alcohol dependence or a history of these problems.
• are allergic to any other medicines, foods, dyes or preservatives.
• are pregnant or plan to become pregnant.
• are breastfeeding or wish to breastfeed.
• drink alcohol regularly. Alcohol may increase the effects of OXAZEPAM-WGR.
• plan to have surgery.

Suddenly stopping OXAZEPAM-WGR in patients with epilepsy can cause a temporary increase in the number and severity of seizures.

Your doctor may have prescribed OXAZEPAM-WGR for depression or psychosis. OXAZEPAM-WGR is not recommended as the first choice of treatment for depression and psychosis. It may increase depression, worsen mental illness, suicidal thoughts and actions. Your doctor may want to take special care if you have any of these conditions. During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

OXAZEPAM-WGR should not be used during pregnancy. It should be avoided during the first trimester of pregnancy as it may increase the risk of defects present at birth.

It may cause unwanted effects in the newborn baby if taken during the late phase of pregnancy or during childbirth, such as low muscle strength, shallow breathing and feeding problems.

Your doctor will discuss the risks and benefits of taking this medicine during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed. This medicine may pass into breast milk and cause drowsiness and feeding difficulties in the baby. Your doctor will discuss the risks and benefits of taking it when breastfeeding.

Children under 16 years of age

OXAZEPAM-WGR is not recommended for use in children under 16 years of age, as its safety and effectiveness have not been established in this age group.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with OXAZEPAM-WGR and affect how it works.

• other sleeping tablets, sedatives or tranquillisers
• medicines for depression, schizophrenia and other mental illnesses
• medicines to treat epilepsy and fits
• medicines for allergies, for example antihistamines or cold tablets
• medicines used to treat Parkinson's disease
• muscle relaxants
• some pain relievers

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect OXAZEPAM-WGR.

4. How do I use OXAZEPAM-WGR?

How much to take

• The dose will vary from patient to patient.
• Your doctor will tell you how many tablets you need to take each day and when to take them.
• This depends on your condition and whether or not you are taking any other medicines.

When to take/use OXAZEPAM-WGR

Take OXAZEPAM-WGR only for as long as your doctor recommends.

It is usually used for short periods only (such as 2 to 4 weeks). Continuous long-term use is not recommended unless advised by your doctor. The use of benzodiazepines may lead to dependence on the medicine.

How to take OXAZEPAM-WGR

• Swallow OXAZEPAM-WGR with a glass of water.
• This medicine can be taken with or without food.

If you forget to use OXAZEPAM-WGR

OXAZEPAM-WGR should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect. If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you use too much OXAZEPAM-WGR

If you think that you have used too much OXAZEPAM-WGR, you may need urgent medical attention. If you take too much OXAZEPAM-WGR you may feel drowsy, confused, tired, dizzy, have low muscle strength, low blood pressure, difficulty breathing, lack of coordination, feel weak or become unconscious. It can be rarely fatal.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using OXAZEPAM-WGR?

Things you should do

• Take OXAZEPAM-WGR exactly as your doctor has prescribed.
• Visit your doctor regularly so they can check on your progress. Your doctor will check your condition to see whether you should continue to take it.
• If you have any blood tests, tell your doctor that you are taking OXAZEPAM-WGR. It may affect the results of some tests.
• Keep enough of your medicine to last weekends and holidays.

Be careful if you are elderly, unwell or taking other medicines.

Some people may experience side effects such as drowsiness, confusion, dizziness and unsteadiness, which may increase the risk of a fall.

Call your doctor straight away if you:

• Become pregnant while you are taking it, tell your doctor immediately.
• Feel this medicine is not helping your condition.

All thoughts of suicide must be taken seriously. Tell your doctor or a mental health professional immediately if you have any suicidal thoughts or other mental/mood changes.

Remind any doctor, dentist or pharmacist you visit that you are using OXAZEPAM-WGR.

Things you should not do

• Do not take it for a longer time than your doctor has prescribed.
• Do not use it to treat any other complaints unless your doctor tells you to.
• Do not give it to anyone else, even if they have the same condition as you.

Do not stop taking it or change the dose, without first checking with your doctor.

Stopping OXAZEPAM-WGR suddenly may cause some unwanted withdrawal effects. It is more common in patients that have received high doses over longer periods of time. Withdrawal symptoms include insomnia, anxiety, unusual mood, panic attacks, dizziness, light sensitivity, confusion, seeing or hearing things that are not real (hallucinations), vomiting, sweating, fits (convulsions), a feeling of loss of identity/feeling detached from yourself (depersonalisation or derealisation) and loss of short-term memory. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This may help reduce the possibility of unwanted side effects.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how OXAZEPAM-WGR affects you.

It may cause drowsiness or dizziness in some people. If any of these occur, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol regularly.

Combining OXAZEPAM-WGR and alcohol can make you more sleepy, dizzy or lightheaded. Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you drink while you are taking this medicine.

Looking after your medicine

• Keep your tablets in their blister pack until it is time to take them. If you take the tablets out of the blister pack they may not keep well.
• Keep your medicine in a cool dry place where the temperature stays below 30°C.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If your doctor tells you to stop taking OXAZEPAM-WGR or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets left over.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What OXAZEPAM-WGR contains

Do not take this medicine if you are allergic to any of these ingredients.

OXAZEPAM-WGR does not contain gluten, sucrose, tartrazine or any other azo dyes.

What OXAZEPAM-WGR looks like

OXAZEPAM-WGR 30 mg are white, round tablets with one side convex and embossed “30”, and the other side flat with an Ezi-split breakline.

OXAZEPAM-WGR comes in a box of blister strips containing 25 tablets.

Australian Registration Number:

OXAZEPAM-WGR 30 mg tablets - AUST R 423290

Who Supplies OXAZEPAM-WGR

Wagner Pharmaceuticals Pty Ltd
6 Albert Street
Preston VIC 3072
Tel: 1800 936 140

This leaflet was prepared in April 2024.

Published by MIMS January 2025

1 Name of Medicine

Oxazepam.

2 Qualitative and Quantitative Composition

Oxazepam-WGR tablets contain oxazepam 30 mg.

Excipients with known effect.

3 Pharmaceutical Form

Oxazepam-WGR 30 mg tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Oxazepam-WGR is indicated for:
Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety associated with depression is also responsive to Oxazepam-WGR therapy. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The physician should periodically reassess the usefulness of the drug for the individual patient.
Alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.

4.2 Dose and Method of Administration

Oxazepam-WGR is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualised according to patient response.
For mild to moderate anxiety, with associated tension, irritability, agitation or related symptoms of functional origin or secondary to organic disease, the usual dose is 7.5-15 mg, 3 or 4 times daily.
For severe anxiety syndromes, agitation or anxiety associated with depression, the usual dose is 15-30 mg, 3 or 4 times daily.
For older patients with anxiety, tension, irritability and agitation, the initial dose is 7.5 mg, 2-3 times daily. If necessary, increase cautiously to 15 mg, 3 or 4 times daily.
For alcoholics with tremulousness or anxiety on withdrawal, the usual dose is 15-30 mg, 3 or 4 times daily. Oxazepam-WGR should not be administered to alcoholics with acute inebriation.

Paediatric use.

4.3 Contraindications

Oxazepam-WGR is contraindicated in:
1. Patients with known hypersensitivity to benzodiazepines.
2. Patients with chronic obstructive airways disease with incipient respiratory failure.
3. Patients with sleep apnoea.

4.4 Special Warnings and Precautions for Use

As with all patients taking CNS-depressant medications, patients receiving Oxazepam-WGR should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Oxazepam-WGR therapy. Abilities may be impaired on the day following use. Patients should be advised that their tolerance for alcohol and other CNS depressants will be diminished and that these medications should either be eliminated or given in reduced dosage in the presence of Oxazepam-WGR.
Following the prolonged use of Oxazepam-WGR at therapeutic dose withdrawal from the medication should be gradual. An individualised withdrawal timetable needs to be planned for each patient in whom dependence is known or suspected. Periods from four weeks to four months have been suggested. As with other benzodiazepines, when treatment is suddenly withdrawn, a temporary increase of sleep disturbance can occur after use of Oxazepam-WGR (see Section 4.4 Special Warnings and Precautions for Use, Dependence).
In general, benzodiazepines should be prescribed for short periods only (e.g. 2-4 weeks). Continuous long-term use of Oxazepam-WGR is not recommended. There is evidence that tolerance develops to the sedative effects of benzodiazepines. After as little as one week of therapy withdrawal symptoms can appear following the cessation of recommended doses (e.g. rebound insomnia following cessation of a hypnotic benzodiazepine).
Although hypotension has occurred only rarely, Oxazepam-WGR should be administered with caution to patients in whom a drop in blood pressure might lead to cardiac or cerebral complications. This is particularly important in elderly patients.
Transient amnesia or memory impairment has been reported in association with the use of benzodiazepines.
Oxazepam-WGR could increase the muscle weakness in myasthenia gravis and should be used with caution in this condition.
Caution should be used in the treatment of patients with acute narrow-angle glaucoma (because of atropine-like side effects).

Blood dyscrasias.

Elevation of liver enzymes.

Depression, psychosis and schizophrenia.

Paradoxical reactions.

Impaired respiratory function.

Epilepsy.

Abuse.

Dependence.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

1. Benzodiazepines, including oxazepam, produce additive CNS depressant effects when co-administered with other medications which themselves produce CNS depression, e.g. barbiturates, alcohol, sedatives, tricyclic antidepressants, non selective MAO inhibitors, phenothiazines and other antipsychotics, skeletal muscle relaxants, antihistamines or narcotic analgesics and anaesthetics.
2. The cytochrome P450 system has not been shown to be involved in the disposition of oxazepam and, unlike many benzodiazepines, pharmacokinetic interactions involving the P450 system have not been observed with oxazepam.
3. The anticholinergic effects of other drugs, including atropine and similar drugs, antihistamines and antidepressants may be potentiated.
4. Interactions have been reported between some benzodiazepines and anticonvulsants, with changes in the serum concentration of the benzodiazepine or anticonvulsant. It is recommended that patients be observed for altered responses when benzodiazepines and anticonvulsants are prescribed together, and that serum level monitoring of the anticonvulsant be performed more frequently.
5. Minor EEG changes, usually low voltage fast activity, of no known clinical significance; have been reported with benzodiazepine administration.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

See Section 4.4 Special Warnings and Precautions for Use.

4.8 Adverse Effects (Undesirable Effects)

More common reactions.

Less common reactions.

Cardiovascular.

Dermatological.

Gastrointestinal.

General.

Haematological.

Musculo-skeletal.

Nervous system.

Psychiatric.

Serious or life threatening reactions.

Reporting suspected adverse effects.

4.9 Overdose

Overdose 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.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Oxazepam-WGR is readily absorbed when given orally. Peak concentrations in plasma occur approximately 2-3 hours following administration of 30 mg. The half-life of oxazepam in human plasma ranges from 4 to 15 hours. At clinically relevant concentrations, oxazepam is 95% to 98% bound to plasma protein. Oxazepam is conjugated at its 3-hydroxy substituent to its glucuronide, which accounts for at least 95% of the urinary excretion products. There are no active metabolites of oxazepam. Multiple-dose therapy leads to no excessive drug accumulation.
There is no indication of induction of drug-metabolising enzymes with oxazepam. Oxazepam is not a substrate for N-dealkylating enzymes of the cytochrome P450 system nor is it hydroxylated to any significant extent.
The pharmacokinetics of oxazepam remain unaltered in older patients, however the elderly generally show increased central nervous system sensitivity to benzodiazepines, and may require a reduced dosage. Hepatic diseases (hepatitis, alcoholic cirrhosis) have a minimal influence on oxazepam kinetics, however these patients have increased cerebral sensitivity to benzodiazepines and dosage reduction may be advisable. As with other benzodiazepines, the pharmacokinetics of oxazepam may change in patients with impaired renal function and the medication should be used with caution.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Oxazepam-WGR tablets contain the following excipients: magnesium stearate, methylcellulose, polacrilin potassium and lactose monohydrate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Oxazepam-WGR 30 mg.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine S4.

Summary Table of Changes