SUMMARY CMI

LORAZEPAM LUPIN

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 taking LORAZEPAM LUPIN?

LORAZEPAM LUPIN contains the active ingredient lorazepam. LORAZEPAM LUPIN is used to relieve anxiety or before surgery to help relax you.

For more information, see Section 1. Why am I taking LORAZEPAM LUPIN? in the full CMI.

2. What should I know before I take LORAZEPAM LUPIN?

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

3. What if I am taking other medicines?

Some medicines may interfere with LORAZEPAM LUPIN 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 take LORAZEPAM LUPIN?

• Swallow the tablets with a glass of water with or without food.
• Your doctor will tell you how many times during the day you need to take LORAZEPAM LUPIN and at what times.

More instructions can be found in Section 4. How do I take LORAZEPAM LUPIN? in the full CMI.

5. What should I know while taking LORAZEPAM LUPIN?

For more information, see Section 5. What should I know while taking LORAZEPAM LUPIN? in the full CMI.

6. Are there any side effects?

Common side effects include drowsiness, dizziness, sleepiness, clumsiness or unsteadines, weakness and loss of memory.

Rare side effects include skin rashes, feeling sick or vomiting, outbursts of anger and increased excitement, confusion or depression, headache, sleep disturbances, blurred vision, low blood pressure, dry mouth, excessive salivation, changes in appetite and nausea. These side effects may be serious.

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

LORAZEPAM LUPIN

Active ingredient(s): lorazepam

Consumer Medicine Information (CMI)

This leaflet provides important information about using LORAZEPAM LUPIN. 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 LORAZEPAM LUPIN.

Where to find information in this leaflet:

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

1. Why am I taking LORAZEPAM LUPIN?

LORAZEPAM LUPIN contains the active ingredient lorazepam. LORAZEPAM LUPIN belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals.

LORAZEPAM LUPIN is used to relieve anxiety. However anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines.

LORAZEPAM LUPIN is also used before surgery to help relax you.

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

2. What should I know before I take LORAZEPAM LUPIN?

Warnings

Do not take LORAZEPAM LUPIN if:

• you are allergic to lorazepam, any of the ingredients listed at the end of this leaflet or any other medicine from the benzodiazepine group of medicines.
  Always check the ingredients to make sure you can use this medicine.
• you have severe and chronic lung disease
• you have sleep apnoea, a condition where you have breathing problems when you sleep
• you are depressed with or without anxiety problems

Lorazepam can increase thoughts of death or suicide.

Check with your doctor if you:

• liver, kidney or lung disease
• blood disorders
• fits or convulsions
• severe muscle weakness known as myasthenia gravis
• low blood pressure
• glaucoma (high pressure in the eye)
• depression, psychosis or schizophrenia.

Tell your doctor if you drink alcohol regularly. Alcohol may increase the effects of LORAZEPAM LUPIN.

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.

Do not take LORAZEPAM LUPIN if you are pregnant or planning to become pregnant unless you and your doctor have discussed the risks and benefits involved.

LORAZEPAM LUPIN may affect the development of newborn babies and cause breathing difficulty, muscle stiffness, a drop in body temperature or yellowing of the skin.

Babies born to mothers who take LORAZEPAM LUPIN throughout their pregnancy may be at risk of withdrawal symptoms. The baby may require ventilation at birth.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Do not take LORAZEPAM LUPIN if you are breast feeding or planning to breast feed unless you and your doctor have discussed the risks and benefits involved.

Do not give this medicine to children unless advised by the child's doctor.

The safety and effectiveness of LORAZEPAM LUPIN in children under 16 years has not been established.

Do not take LORAZEPAM LUPIN if the expiry date (Exp.) printed on the pack has passed.

Do not take LORAZEPAM LUPIN if the packaging is torn or shows signs of tampering.

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 LORAZEPAM LUPIN, or may affect how well it works.

These include:

• other sleeping tablets, sedatives or tranquillisers
• medicines for depression
• medicines for allergies for example antihistamines or cold tablets
• pain relievers
• muscle relaxants
• medicines to control fits

These medicines may increase the effects of LORAZEPAM LUPIN. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.

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

4. How do I take LORAZEPAM LUPIN?

How much to take

• The dose of LORAZEPAM LUPIN may be different for each person. Your doctor will decide the right dose for you.
• For anxiety, the usual daily dose is 2 to 3 mg administered in divided doses. However the daily dose can range from 1 to 10 mg.
• For sleeping problems (insomnia) due to anxiety, a dose of 1 to 2 mg taken at bedtime is usually prescribed.
• If you are taking LORAZEPAM LUPIN before surgery the usual dose is 2 to 4 mg the night before surgery. Another dose of 2 to 4 mg may also be given 1 to 2 hours before surgery.
• Elderly people may need a lower dose.
• Follow all directions given to you by your doctor and pharmacist carefully.

When to take LORAZEPAM LUPIN

• Your doctor will tell you how many times during the day you need to take LORAZEPAM LUPIN.

How long to take LORAZEPAM LUPIN for

• Do not take LORAZEPAM LUPIN for longer than your doctor says.
• LORAZPEAM LUPIN is usually used for short periods only (for example 2-4 weeks). Continuous long term use is not recommended unless advised by your doctor. The use of benzodiazepines may lead to dependence on the medicine.
• Continue taking LORAZEPAM LUPIN as long as your doctor recommends it.

How to take LORAZEPAM LUPIN

• Swallow the tablets with a glass of water.
• It may be taken with or without food.

If you forget to take LORAZEPAM LUPIN

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 forgotten dose.

If you have missed more than two doses in a row, speak to your doctor or pharmacist.

If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.

If you are taking LORAZEPAM LUPIN for insomnia due to anxiety and forget to take LORAZEPAM LUPIN before you go to bed, do not take any LORAZEPAM LUPIN if you wake up late in the night or early morning.

Taking LORAZEPAM LUPIN late at night or early in the morning may make it hard for you to wake in the morning. If you have any questions about this, ask your doctor or pharmacist.

If you take too much LORAZEPAM LUPIN

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

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.

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

5. What should I know while taking LORAZEPAM LUPIN?

Things you should do

Take LORAZEPAM LUPIN exactly as your doctor has prescribed.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

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

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking LORAZEPAM LUPIN.

If you are being treated for anxiety, be sure to discuss with your doctor any problems you may have and how you feel, especially if your anxiety attacks are getting worse or more frequent.

Visit your doctor regularly. Your doctor needs to check your progress and see whether you need to keep taking LORAZEPAM LUPIN. Always discuss with your doctor any problems or difficulties you have during or after taking LORAZEPAM LUPIN.

Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise your doctor may think that it was not effective and change your treatment unnecessarily.

Keep enough LORAZEPAM LUPIN to last weekends and holidays.

Things you should not do

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

LORAZEPAM LUPIN should be taken for short periods only (for example 2 to 4 weeks), unless advised otherwise by your doctor.

Do not change your dose without first checking with your doctor.

Do not stop taking LORAZEPAM LUPIN or lower the dose, without first checking with your doctor.
Stopping this medicine suddenly may cause some unwanted withdrawal effects. This is more common in patients that have taken high doses over longer periods of time.

Withdrawal symptoms may include insomnia, anxiety, unusual mood, fast heartbeat, panic attacks, dizziness, lack of normal movement, light sensitivity, increased sound and touch sensitivity, abnormal body sensations (e.g. feels of motion, metallic taste), confusion, hallucinations, vomiting, sweating and loss of short-term memory.

Your doctor will slowly reduce your dose before you can stop taking it completely. This will minimise these unwanted withdrawal symptoms.

Do not suddenly stop taking LORAZEPAM LUPIN if you suffer from epilepsy.

Stopping this medicine suddenly may make your epilepsy worse.

Do not use this medicine to treat any other complaints unless your doctor says to.

Do not give LORAZEPAM LUPIN to anyone else, even if their symptoms seem similar to yours.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how LORAZEPAM LUPIN affects you.

This medicine may cause drowsiness or dizziness in some people and therefore may affect alertness.

Make sure you know how you react to LORAZEPAM LUPIN before you drive a car, operate machinery, or do anything else that could be dangerous if you are drowsy, dizzy or not alert.

Even if you take LORAZEPAM LUPIN at night, you may still be drowsy or dizzy the next day.

Drinking alcohol

Tell your doctor if you drink alcohol.

If you drink alcohol, symptoms such as dizziness and drowsiness may be worse.

Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you drink while you are taking LORAZEPAM LUPIN.

Use in the Elderly

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.

Looking after your medicine

Keep your tablets in the pack until it is time to take them. If you take the tablets out of the pack they may not keep well.

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 your tablets in a cool dry place where the temperature stays below 25°C.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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.

If side effects do happen, they are more likely to happen when you first start taking LORAZEPAM LUPIN. These side effects may go away during treatment as your body adjusts to the dose.

Less serious /common side effects

Less common/rare side effects

These side effects may be serious.

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 LORAZEPAM LUPIN contains

The tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.

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

What LORAZEPAM LUPIN looks like

LORAZEPAM LUPIN 1 mg:
white, round, flat, beveled, scored tablets, with the inscription “1.0” on one side.
(AUST R 389601)

LORAZEPAM LUPIN 2.5 mg:
white, round, flat, beveled, scored tablets.
(AUST R 389602)

Each blister pack contains 50 tablets

Who distributes LORAZEPAM LUPIN

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia

  [email protected]

  +61 3 9809 7900

  www.generichealth.com.au

This leaflet was prepared in September 2024.

Published by MIMS November 2024

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Lorazepam.

2 Qualitative and Quantitative Composition

Lorazepam Lupin immediate release tablets contain the active ingredient lorazepam.
Each Lorazepam Lupin 1 mg tablet contains 1 mg of lorazepam.
Each Lorazepam Lupin 2.5 mg tablet contains 2.5 mg of lorazepam.
Lorazepam is a white or almost white crystalline powder.
Lorazepam Lupin contains lactose, for the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Lorazepam Lupin 1 mg immediate release tablets are white, round, flat, beveled and scored with the inscription "1.0" on one side.
Lorazepam Lupin 2.5 mg immediate release tablets are white, round, flat, beveled and scored tablets.

4 Clinical Particulars

4.1 Therapeutic Indications

Management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms.
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.
Pre-surgical medication taken the night before surgery and/or 1-2 hours prior to the surgical procedure.

4.2 Dose and Method of Administration

Lorazepam Lupin is administered orally. For optimal results, dose, frequency of administration and duration of therapy should be individualised according to patient response. Dosage should be individualised for maximum beneficial effect. In patients previously treated with anxiolytic agents, higher initial dosages of Lorazepam Lupin may be indicated.
The average daily dosage for treatment of anxiety is 2-3 mg administered in divided doses, however, this may range between 1 and 10 mg.
For insomnia due to anxiety or transient situational stress, a single daily dose of 1-2 mg may be given, usually at bedtime.
For patients with anxiety and/or insomnia, the duration of treatment should not exceed 4 weeks, including tapering off process (see Section 4.4 Special Warnings and Precautions for Use, Duration of treatment).
For elderly or debilitated patients, an initial dosage of 1 or 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
The need for continued therapy with Lorazepam Lupin in patients who have been taking medication for several weeks should be evaluated, periodically.
For pre-surgical medication, a dosage of 2-4 mg of Lorazepam Lupin is recommended the night before surgery and/or 1-2 hours prior to the surgical procedure.
Lorazepam Lupin is not recommended for children.

4.3 Contraindications

Patients with a known hypersensitivity to benzodiazepines.
Patients with chronic obstructive airways disease with incipient respiratory failure.
Patients with sleep apnoea.
Lorazepam should not be used as monotherapy in patients with depression, or symptoms of anxiety associated with depression, due to a risk of suicide (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

As with all patients taking CNS-depressant medications, patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from lorazepam therapy. Abilities may be impaired on the day following use.
Following the prolonged use of lorazepam 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 lorazepam (see Dependence).

Duration of treatment.

Tolerance.

Use in renal or hepatic impairment.

Depression, psychosis and schizophrenia.

CNS and/or paradoxical reactions.

Amnestic symptoms.

Confusional states.

Agitational states.

Geriatric or debilitated patients.

Impaired respiratory function.

Epilepsy.

Use in the elderly.

Abuse.

Dependence.

Concomitant use with alcohol/CNS depressants.

Paediatric use.

Paediatric neurotoxicity.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The benzodiazepines, including lorazepam, 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.
The cytochrome P450 system has not been shown to be involved in the disposition of lorazepam and, unlike many benzodiazepines, pharmacokinetic interactions involving the P450 system have not been observed with lorazepam.
The anticholinergic effects of other drugs including atropine and similar drugs, antihistamines and antidepressants may be potentiated.
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.
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

As with all patients taking CNS-depressant medications, patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from lorazepam therapy. Abilities may be impaired on the day following use.

4.8 Adverse Effects (Undesirable Effects)

More common reactions.

Nervous system.

Musculo-skeletal.

Less common reactions.

Autonomic manifestations.

Dermatological.

Gastrointestinal.

Miscellaneous.

Nervous system.

Ocular.

Psychiatric.

Reporting suspected adverse effects.

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 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Lorazepam 1 mg and 2.5 mg tablets contain the following inactive ingredients: maize starch, microcrystalline cellulose, sodium starch glycollate type A, lactose monohydrate, povidone, crospovidone, magnesium stearate, polacrilin potassium.

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 25°C. Protect from light and store in original container.

6.5 Nature and Contents of Container

Lorazepam tablets are available in PA/Al/PVC/Al blister packs.
1 mg and 2.5 mg in blister packs of 50 tablets.

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)

S4 (Prescription Only Medicine).

Summary Table of Changes