Consumer medicine information

Serepax

Oxazepam

BRAND INFORMATION

Brand name

Serepax Tablets

Active ingredient

Oxazepam

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Serepax.

What is in this leaflet

This leaflet answers some common questions about Serepax. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Serepax against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Serepax is used for

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.

Serepax contains the active ingredient oxazepam, a benzodiazepine. It is thought to work by acting on the brain chemicals.

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.

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

Before you take it

When you must not take it

Do not take SEREPAX if you are allergic to:

  • Oxazepam or any other benzodiazepine medicines
  • Any of the ingredients listed at the end of this leaflet.

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.

Do not take this medicine if you have:

  • severe and chronic lung disease or breathing difficulties
  • sleep apnoea

Do not take it if the packaging shows signs of tampering or the tablets do not look quite right.

Do not take it if the expiry date (EXP) printed on the pack has passed.

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.

Before you take it

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant.

Like other benzodiazepine medicines, Serepax may cause unwanted effects in the newborn baby if used during pregnancy. Your doctor will discuss the risks and benefits of taking this medicine during pregnancy.

Tell your doctor you are breastfeeding or wish to breastfeed.

Serepax may pass into breast milk and cause drowsiness and feeding difficulties in the baby. Your doctor will discuss the risks and benefits of taking Serepax when breastfeeding.

Tell your doctor if you 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 past history of these problems.

Your doctor may want to take special care if you have any of these conditions.

Tell your doctor if you drink alcohol regularly.

Alcohol may increase the effects of Serepax.

Tell your doctor if you plan to have surgery.

If you have not told your doctor about any of the above, tell them before you take any medicine.

Taking other medicines

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

Some medicines may interfere with Serepax. These include:

  • 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 parksinson's disease
  • muscle relaxants
  • some pain relievers

Your doctor can tell you what to do if you are taking any of these medicines.

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor or pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take it

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ from the information contained in this leaflet.

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.

How to take it

Swallow Serepax with a glass of water.

This medicine can be taken with or without food.

How long to take it

Take Serepax only for as longer 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.

If you forget to take it

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 that 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 take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Serepax. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you take too much Serepax you may feel drowsy, confused, tired, dizzy, have difficulty breathing, feel weak or become unconscious.

While you are using it

Things you must do

Take Serepax exactly as your doctor has prescribed.

Tell all doctors, dentists and pharmacists who are treating you that you are taking this medicine.

If you become pregnant while you are taking it, tell your doctor immediately.

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.

Tell your doctor if you feel this medicine is not helping your condition.

If you have to 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.

Things you must not do

Do not drive or operate machinery 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.

Do not take it for a longer time than your doctor has prescribed.

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

Stopping Serepax suddenly may cause some unwanted effects. 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.

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.

Things to be careful of

Be careful when drinking alcohol.

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.

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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Serepax.

Like all other medicines, it may have unwanted side effects in some people. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • 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

Tell your doctor immediately if you notice any of the following:

  • 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 above list includes serious side effects which may require medical attention.

Tell your doctor immediately or go to Accident and Emergency at the nearest hospital if you notice any of the following:

  • 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

The side effects listed above are serious and require urgent medical attention or hospitalisation.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything that is making you feel unwell.

After using it

Storage

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.

Do not store Serepax, or any other medicines, in the bathroom or near a sink. Do not leave it in the car or on window sills.

Heat and dampness can destroy some medicines.

Keep it where children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

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.

Product description

What it 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.

Ingredients

The active ingredient in SEREPAX tablets is oxazepam.

Each SEREPAX 15 mg tablet contains 15 mg oxazepam.

Each SEREPAX 30 mg tablet contains 30 mg oxazepam.

SEREPAX 15 mg also contains the following excipients: magnesium stearate, microcrystalline cellulose, polacrilin potassium and lactose.

SEREPAX 30 mg also contains the following excipients: magnesium stearate, methyl cellulose, polacrilin potassium and lactose, Sunset Yellow CI 15985 as a colouring agent.

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

Supplier

SEREPAX is supplied in Australia by:

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

Australian Registration Numbers:
SEREPAX 15 - AUST R 174675
SEREPAX 30 - AUST R 10417

This leaflet was prepared in June 2012.

® Registered Trade Mark

BRAND INFORMATION

Brand name

Serepax Tablets

Active ingredient

Oxazepam

Schedule

S4

 

1 Name of Medicine

Oxazepam.

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.

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.

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.

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.

4.3 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.

4.8 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.

4.2 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.

4.7 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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

S4.

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.

Summary Table of Changes