Consumer medicine information

Serepax

Oxazepam

BRAND INFORMATION

Brand name

Serepax

Active ingredient

Oxazepam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Serepax.

SUMMARY CMI

SEREPAX

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 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).

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

5. What should I know while using SEREPAX?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using SEREPAX.
  • Take SEREPAX exactly as your doctor has prescribed.
  • If you become pregnant while you are taking it, tell your doctor immediately.
Things you should not do
  • Do not stop taking this medicine or change the dose, without first checking with your doctor.
  • Do not take it for a longer time than your doctor has prescribed.
Driving or using machines
  • Do not drive or operate machinery until you know how SEREPAX affects you.
Drinking alcohol
  • Be careful when drinking alcohol
  • Combining SEREPAX and alcohol can make you more sleepy, dizzy or lightheaded.
Looking after your medicine
  • Keep your medicine in a cool dry place where the temperature stays below 30°C
  • 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.

For more information, see Section 5. What should I know while using SEREPAX? 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 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



FULL CMI

SEREPAX

Active ingredient(s): oxazepam


Consumer Medicine Information (CMI)

This leaflet provides important information about using SEREPAX. 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 SEREPAX.

Where to find information in this leaflet:

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

1. Why am I using SEREPAX?

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

SEREPAX 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 SEREPAX?

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 SEREPAX 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 SEREPAX.
  • plan to have surgery.

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

Your doctor may have prescribed SEREPAX for depression or psychosis. SEREPAX 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.

SEREPAX 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

SEREPAX 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 SEREPAX 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 SEREPAX.

4. How do I use SEREPAX?

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 SEREPAX

Take SEREPAX 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 SEREPAX

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

If you forget to use SEREPAX

SEREPAX 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 SEREPAX

If you think that you have used too much SEREPAX, you may need urgent medical attention.

If you take too much SEREPAX 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 SEREPAX?

Things you should do

  • Take SEREPAX 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 SEREPAX. 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 SEREPAX.

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 SEREPAX 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 SEREPAX 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 SEREPAX 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 SEREPAX 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

Less serious side effectsWhat to do
  • dizziness, drowsiness, feeling tired
  • lightheadedness or feeling faint
  • headache
  • nausea, stomach pain
  • unpleasant dreams
  • slurred speech
  • blurred vision
  • tingling or numbness of the hands or feet
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • confusion
  • behavioural or mood changes such as sudden outbursts of anger and increased excitement
  • hallucinations
  • signs of frequent infections such as fever, chills, sore throat or mouth ulcers
  • yellowing of the eyes and skin (jaundice)
  • dark coloured urine
The very serious side effects below may require urgent medical attention. Go straight to the Emergency Department at your nearest hospital.
Very Serious Side Effects:
  • fainting
  • any type of skin rashes, itching or hives
  • swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
  • wheezing or shortness of breath
Call your doctor straight away or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 SEREPAX contains

Active ingredient
(main ingredient)
Each SEREPAX 15 mg tablet contains 15mg oxazepam.
Each SEREPAX 30 mg tablet contains 30mg oxazepam.
Other ingredients
(inactive ingredients)
SEREPAX 15 mg contains the following excipients: magnesium stearate, microcrystalline cellulose, polacrilin potassium and lactose monohydrate.
SEREPAX 30 mg contains the following excipients: magnesium stearate, methyl cellulose, polacrilin potassium and lactose monohydrate, Sunset Yellow CI 15985 as a colouring agent.
Potential allergensLactose

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

Serepax does not contain gluten, sucrose, tartrazine or any other azo dyes.

What SEREPAX looks like

Serepax tablets are available in 2 strengths.

Serepax 15 - white, round tablets, one face convex marked “15” and the opposite face flat with Ezi-split breakline.

Serepax 30 - orange, round tablets, one face convex marked “30” and the opposite face flat with Ezi-split breakline.

Each pack contains 25 tablets.

Australian Registration Numbers:

SEREPAX 15 - AUST R 174675

SEREPAX 30 - AUST R 10417

Who Supplies SEREPAX

Aspen Pharma Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australia

This leaflet was prepared in October 2022.

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Serepax

Active ingredient

Oxazepam

Schedule

S4

 

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

4.1 Therapeutic Indications

Serepax is indicated for:
1. Management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety associated with depression is also responsive to Serepax 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.
2. Alcoholics with acute tremulousness, confusional state or anxiety associated with alcohol withdrawal are responsive to therapy.

4.2 Dose and Method of Administration

Serepax 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 to 15 mg, 3 or 4 times daily.
For severe anxiety syndromes, agitation or anxiety associated with depression, the usual dose is 15 to 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 to 30 mg, 3 or 4 times daily. Serepax should not be administered to alcoholics with acute inebriation.

Paediatric use.

Serepax is not indicated in children under 16 years of age.
The need for continued therapy with Serepax in patients who have been taking medication for several weeks should be evaluated periodically.

4.3 Contraindications

Serepax 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 Serepax should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Serepax 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 Serepax.
Following the prolonged use of Serepax at therapeutic doses, 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 Serepax (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 Serepax 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, Serepax 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.
Serepax 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.

In rare instances, some patients taking benzodiazepines have developed blood dyscrasias, and some have had elevations of liver enzymes. As with other benzodiazepines, periodic blood counts and liver function tests are recommended.

Depression, psychosis and schizophrenia.

Serepax is not recommended as primary therapy in patients with depression and psychosis. In such conditions, psychiatric assessment and supervision are necessary if benzodiazepines are indicated. Benzodiazepines may increase depression in some patients, and may contribute to deterioration in severely disturbed schizophrenics with confusion and withdrawal. Suicidal tendencies may be present or uncovered, and protective measures may be required.

Paradoxical reactions.

Paradoxical reactions such as acute rage, stimulation or excitement may occur; should such reactions occur, Serepax should be discontinued.

Impaired respiratory function.

Caution in the use of Serepax is recommended in patients with respiratory depression. In patients with chronic obstructive pulmonary disease, benzodiazepines can cause increased arterial carbon dioxide tension and decreased arterial oxygen tension.

Epilepsy.

Abrupt withdrawal of benzodiazepines in patients with convulsive disorders may be associated with a temporary increase in the frequency and/or severity of seizures.

Abuse.

Caution must be exercised in administering Serepax to individuals known to be addiction prone or those whose history suggests they may increase the dosage on their own initiative. It is desirable to limit repeat prescription without adequate medical supervision.

Dependence.

The use of benzodiazepines may lead to dependence as defined by the presence of a withdrawal syndrome on discontinuation of the drug. Tolerance as defined by a need to increase the dose in order to achieve the same therapeutic effect seldom occurs in patients receiving recommended doses under medical supervision. Tolerance to sedation may occur with benzodiazepines especially in those with drug seeking behaviour. Withdrawal symptoms similar in character to those noted with barbiturates and alcohol have occurred following abrupt discontinuation of benzodiazepines. These symptoms can range from insomnia, anxiety, dysphoria, palpitations, panic attacks, vertigo, myoclonus, akinesia, hypersensitivity to light, sound and touch, abnormal body sensations (e.g. feelings of motion, metallic taste), depersonalisation, derealisation, delusional beliefs, hyperreflexia and loss of short-term memory, to a major syndrome which may include convulsions, tremor, abdominal and muscle cramps, confusional states, delirium, hallucinations, hyperthermia, psychosis, vomiting and sweating. Such manifestations of withdrawal, especially the more serious ones, are more common in those patients who have received excessive doses over a prolonged period. However, withdrawal symptoms have also been reported following abrupt discontinuation of benzodiazepines taken continuously at therapeutic levels. Accordingly, Serepax should be terminated by tapering the dose to minimise occurrence of withdrawal symptoms. Patients should be advised to consult with their physician before either increasing the dose or abruptly discontinuing the medication.
Rebound phenomena have been described in the context of benzodiazepine use. Rebound insomnia and anxiety mean an increase in the severity of these symptoms beyond pretreatment levels following cessation of benzodiazepines. Rebound phenomena in general possibly reflect re-emergence of pre-existing symptoms combined with withdrawal symptoms described earlier. Some patients prescribed benzodiazepines with very short half-lives (in the order of 2 to 4 hours) may experience relatively mild rebound symptoms in between their regular doses. Withdrawal/ rebound symptoms may follow high doses taken for relatively short periods.

Use in hepatic impairment.

Patients with impaired hepatic function should use benzodiazepine medication with caution and dosage reduction may be advisable.

Use in renal impairment.

Patients with impaired renal function should use benzodiazepine medication with caution and dosage reduction may be advisable.

Use in elderly.

Such patients may be particularly susceptible to the sedative effects of benzodiazepines and associated giddiness, ataxia and confusion which may increase the possibility of a fall.

Paediatric use.

The safety and effectiveness of oxazepam has not been established in children less than 16 years of age.

Effect on laboratory tests.

1. Oxazepam may decrease values of leukocytes in testing for leukopoiesis.
2. Oxazepam may give high blood glucose level utilising the Somogyi procedure but not the glucose oxidase procedure.

4.5 Interactions with Other Medicines and Other Forms of Interactions

1. The benzodiazepines, including Serepax, produce additive CNS depressant effects when coadministered with other medications which themselves produce CNS depression, e.g. barbiturates, alcohol, sedatives, tricyclic antidepressants, nonselective 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

Impairment of fertility.

Female mice fed diets containing 0.05% or 0.75% oxazepam were reported to exhibit significant decreases in the frequency of vaginal oestrus.
(Category C)
Benzodiazepines cross the placenta and may cause hypotonia, reduced respiratory function and hypothermia in the newborn infant. Continuous treatment during pregnancy and administration of high doses in connection with delivery should be avoided. Withdrawal symptoms in newborn infants have been reported with this class of drugs.
The use of benzodiazepines during the first trimester of pregnancy should almost always be avoided. If the drug is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuation of the drug if she intends to become or suspects that she is pregnant.

Nonteratogenic effects.

The use of benzodiazepines during the last phase of pregnancy or at delivery may require ventilation of the infant at birth.
Caution should be exercised when Serepax is given to a breastfeeding woman. Serepax is excreted in human breast milk, and may cause drowsiness and feeding difficulties in the infant.

4.7 Effects on Ability to Drive and Use Machines

As with all patients taking CNS depressant medications, patients receiving Serepax should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from Serepax 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 Serepax.

4.8 Adverse Effects (Undesirable Effects)

More common reactions.

Mild drowsiness, if it occurs, is usually observed at the beginning of therapy and generally decreases in severity or disappears on continued medication or upon decreasing the dose.

Less common reactions.

Cardiovascular.

Oedema, hypotension.

Dermatological.

Skin rashes (morbilliform, urticarial and maculopapular).

Gastrointestinal.

Nausea, hepatic dysfunction, abdominal pain.

General.

Hypersensitivity, lethargy, altered libido, slurred speech, blurred vision, disorientation and fever.

Haematological.

Leucopenia.

Musculoskeletal.

Tremor, paraesthesia.

Nervous system.

Dizziness, vertigo, headache, syncope, ataxia, confusion, hallucination, aggression, unpleasant dreams.

Psychiatric.

Paradoxical reactions.
Paradoxical reactions such as stimulation, excitement, or rage rarely occur (see Section 4.4 Special Warnings and Precautions for Use).

Serious or life threatening reactions.

Although rare, leucopenia and hepatic dysfunction including jaundice have been reported during oxazepam therapy.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reportingproblems.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

The exact mechanism of action of benzodiazepines has not yet been elucidated; however, benzodiazepines appear to work through several mechanisms. Benzodiazepines presumably exert their effects by binding to specific receptors at several sites within the central nervous system either by potentiating the effects of synaptic or presynaptic inhibition mediated by gamma-aminobutyric acid or by directly affecting the action potential generating mechanisms.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Serepax 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.

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

6.1 List of Excipients

Serepax 15 mg tablets contain the following excipients: magnesium stearate, microcrystalline cellulose, polacrilin potassium and lactose monohydrate.
Serepax 30 mg tablets contain the following excipients: magnesium stearate, methyl cellulose, polacrilin potassium and lactose monohydrate. Serepax 30 mg also contains Sunset Yellow as a coloring agent.

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

PVC/Aluminium blister packs of 5*, 25 and 50's*.
Note: pack sizes marked with '*' are currently not available on the Australian market.

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

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. 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.

Chemical structure.

It's structural formula is:

CAS number.

604-75-1.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes