SUMMARY CMI

LORAZEPAM-WGR

Consumer Medicine Information (CMI) summary

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

1. Why am I taking LORAZEPAM-WGR?

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

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

2. What should I know before I taking LORAZEPAM-WGR?

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

3. What if I am taking other medicines?

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

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take LORAZEPAM-WGR?

• The dose of lorazepam may be different for each person. Your doctor will decide the right dose for you and your condition.
• The usual daily dose for: anxiety is 2 to 3 mg administered in divided doses; sleeping problems is 1 to 2 mg taken at bedtime; and before surgery is 2 to 4 mg the night before the procedure.
• Swallow the tablets whole with a glass of water.

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

5. What should I know while taking LORAZEPAM-WGR?

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

6. Are there any side effects?

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

Serious side effects include feeling sick or vomiting, outbursts of anger and increased excitement, dry mouth, excessive salivation, changes in appetite, nausea, headache, skin rashes, confusion or depression, sleep disturbances, tiredness, blurred vision; dizziness, light-headedness and fainting; unsteadiness, heartbeats become more noticeable. Signs of an allergic reaction include cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin.

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-WGR

Active ingredient: lorazepam

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

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

1. Why am I taking LORAZEPAM-WGR?

LORAZEPAM-WGR contains the active ingredient lorazepam. LORAZEPAM-WGR belongs to a group of medicines called benzodiazepines, thought to work by their action on brain chemicals.

LORAZEPAM-WGR is used to relieve anxiety or used before surgery to help you relax. However, anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines.

In general, benzodiazepines such as lorazepam, should be taken for short periods only (e.g. 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.

2. What should I know before I take LORAZEPAM-WGR?

Warnings

Do not take LORAZEPAM-WGR if you:

• are allergic to lorazepam, any other medicine from the benzodiazepine group of medicines, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
  Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, or rash, itching or hives on the skin
• have severe and chronic lung disease
• have sleep apnoea, a condition where you have breathing problems when you sleep
• have depression with or without anxiety problems
• are pregnant or breastfeeding
• you are under 16 years of age. Safety and effectiveness in children younger than 16 years has not been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Check with your doctor if you:

• have liver, kidney or lung disease
• have blood disorders
• have fits or convulsions
• have severe muscle weakness known as myasthenia gravis
• have low blood pressure
• have glaucoma (high pressure in the eye)
• have depression, psychosis or schizophrenia
• drink alcohol regularly. Alcohol may increase the effects of lorazepam.
• have any other medical conditions
• take any medicines for any other condition
• have allergies to any other medicines, foods, preservatives or dyes.

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

Do not take this medicine if you are pregnant or intend to become pregnant. It may affect your developing baby if you take it during pregnancy.

LORAZEPAM-WGR 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-WGR throughout their pregnancy may be at risk of withdrawal symptoms. The baby may require ventilation at birth

Do not take this medicine if you are breastfeeding or intend to breastfeed. Lorazepam passes into breast milk and there is a possibility that your baby may be affected.

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 and lorazepam may interfere with each other. 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

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

4. How do I take LORAZEPAM-WGR?

How much to take

• The dose of lorazepam 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 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.
• Swallow the tablets with a full glass of water.
• Follow the instructions provided by your doctor and take LORAZEPAM-WGR until your doctor tells you to stop.

When to take LORAZEPAM-WGR

• Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
• It does not matter if you take this medicine before or after food.
• Do not take this medicine for longer than your doctor advises. Lorazepam is usually used for short periods only (e.g. 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 LORAZEPAM-WGR

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

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

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

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

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 this medicine for insomnia due to anxiety and forget to take it before you go to bed, do not take it if you wake up late in the night or early morning.

Taking lorazepam late at night or early in the morning may make it hard for you to wake in the morning.

If you are not sure what to do, ask your doctor or pharmacist.

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

If you take too much LORAZEPAM-WGR

If you think that you have taken too much LORAZEPAM-WGR, 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.

Symptoms of an overdose may include feeling drowsy, confused, tired, dizzy, weak, having difficulty breathing, or becoming unconscious.

5. What should I know while taking LORAZEPAM-WGR?

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

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

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.

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

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. This will help your doctor to determine the best treatment for you.

If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all your doctor's appointments so that your progress can be checked.

Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Always discuss with your doctor any problems or difficulties you have during or after taking this medicine.

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.

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:

• If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.
• Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.

Things you should not do

• Do not take this medicine to treat any other complaints unless your doctor tells you to.
• Do not give your medicine to anyone else, even if they have the same condition as you.
• Do not stop taking your medicine or change the dosage without checking with your doctor.
  Stopping this medicine suddenly may cause some unwanted withdrawal effects. 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 this medicine if you suffer from epilepsy
  Stopping this medicine suddenly may make your epilepsy worse.
• Do not take this medicine for a longer time than your doctor has prescribed.
  Lorazepam should be taken for short periods only (e.g. 2 to 4 weeks), unless advised otherwise by your doctor.

Driving or using machines

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

LORAZEPAM-WGR may cause dizziness or drowsiness in some people and therefore may affect alertness.

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

Drinking alcohol

Tell your doctor if you drink alcohol.

Alcohol may cause symptoms of dizziness and drowsiness to be worse.

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

Looking after your medicine

Keep your tablets in the pack until it is time to take them.

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

Follow the instructions on 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 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.

Less serious side effects

Serious side effects

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

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

Reporting side effects

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

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

7. Product details

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

What LORAZEPAM-WGR contains

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

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

What LORAZEPAM-WGR looks like

LORAZEPAM-WGR 1 mg:

White, round, flat, bevelled, scored tablets, with the inscription “1.0” on one side. (AUST R 439654).

Available in blister packs of 50 tablets.

LORAZEPAM-WGR 2.5 mg:

White, round, flat, bevelled, scored tablets. (AUST R 439655).

Available in blister packs of 50 tablets.

Not all strengths may be available.

Who distributes LORAZEPAM-WGR

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

This leaflet was prepared in September 2024.

Published by MIMS March 2025