APO-Lorazepam

Contains the active ingredient lorazepam
Consumer Medicine Information
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about APO-Lorazepam. It does not contain all the information that is known about APO-Lorazepam. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What this medicine is used for

The name of your medicine is APO-Lorazepam. It contains the active ingredient lorazepam.
It is used to manage and relieve anxiety, including anxiety associated with symptoms of depression
Anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines.
It is also used before surgery to help relax you.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.

How it works

Lorazepam belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals.
In general, benzodiazepines such as lorazepam 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.

Use in children

This medicine should not be used in children. The safety and effectiveness of lorazepam in children has not been established.

Before you use this medicine

When you must not use it

Do not use this medicine if:
You are hypersensitive to or have had an allergic reaction to lorazepam, any other medicine from the benzodiazepine group of medicines, or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction may 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; fainting or hayfever-like symptoms.
If you think you are having an allergic reaction do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.
You have severe and chronic lung disease.
You have sleep apnoea, a condition where you have breathing problems when you sleep.
The expiry date (EXP) printed on the pack has passed.
The packaging is torn, shows signs of tampering or it does not look quite right.

Before you start to take it

Before you start taking this medicine, tell your doctor if:

1. You have allergies to:

any other medicines
any other substances, such as foods, preservatives or dyes.

2. You are pregnant or planning to become pregnant.

Do not take this medicine whilst pregnant until you and your doctor have discussed the risks and benefits involved.

3. You are breast-feeding or plan to breast-feed.

Do not take this medicine whilst breastfeeding until you and your doctor have discussed the risks and benefits involved.

4. You have or have had any medical conditions, especially the following:

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

5. Your drink alcohol regularly.

Alcohol may increase the effects of lorazepam.

6. You are planning to have surgery or an anaesthetic.

7. You are currently receiving or are planning to receive dental treatment.

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

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy at the chemist, 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
These medicines may be affected by lorazepam or may affect the way lorazepam works. You may need different amounts of your medicines, or may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow carefully all directions given to you by your doctor carefully.
Their instructions may be different to the information in this leaflet.
If you are not sure how to take this medicine, ask your doctor or pharmacist for help.

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.
Do not stop taking your medicine or change your dosage without first checking with your doctor.

How to take it

Swallow lorazepam with a glass of water.

When to take it

Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.
This medicine may be taken with or without food.

How long to take it

Lorazepam 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 this medicine for as long as your doctor tells you.
Make sure you have enough to last over weekends and holidays.

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 experiencing side effects.
If you are unsure about whether to take your next dose, speak to your doctor or pharmacist.
If you have missed more than two doses in a row, speak to your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your doctor or pharmacist for some hints.
If you are taking lorazepam for insomnia due to anxiety and forget to take this medicine before you go to bed, do not take any 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 have any questions about this, ask your doctor or pharmacist.

If you take too much (overdose)

If you think that you or anyone else may have taken too much of this medicine, immediately telephone your doctor or the Poisons Information Centre (Tel: 13 11 26 in Australia) for advice. Alternatively go to the Accident and Emergency Department at your nearest hospital.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much lorazepam you may feel drowsy, confused, tired, dizzy, have difficulty breathing, feel weak or become unconscious.

While you are using this medicine

Things you must do

Take this medicine exactly as your doctor has prescribed.
If you become pregnant or are planning to become pregnant while you are using this medicine, tell your doctor.
If you are breast-feeding or are planning to breast-feed while you are using this medicine, tell your doctor.
Tell all doctors, dentists and pharmacists who are treating you that you are using this medicine.
If you are about to be started on any new medicine, tell your doctor or pharmacist that you are using this medicine.
If you are going to have surgery or an anaesthetic or are going into hospital, inform your doctor and tell the surgeon or anaesthetist that you are using this medicine.
you are about to have any blood tests
Tell your doctor if you feel this medicine is not helping your condition.
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.
Visit your doctor regularly.
Your doctor needs to check your progress and see whether you need to keep taking lorazepam.
Always discuss with your doctor any problems or difficulties you have during or after taking lorazepam
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.

Things you must not do

Do not:
Give this medicine to anyone else, even if their symptoms seem similar to yours.
Take your medicine to treat any other condition unless your doctor or pharmacist tells you to.
Stop taking your medicine, or change the dosage, without first checking with your doctor.
Stopping this medicine suddenly may cause some unwanted effects. Your doctor will slowly reduce your dose of lorazepam before you can stop taking it completely.
If you suffer from epilepsy, stopping this medicine suddenly may make your epilepsy worse.
Take lorazepam for a longer time than your doctor has prescribed.
This medicine should be taken for short periods only (for example 2 to 4 weeks), unless advised otherwise by your doctor.
Drive or operate machinery until you know how lorazepam 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 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 at night, you may still be drowsy or dizzy the next day.

Things to be careful of

Be careful when drinking alcohol while taking lorazepam.
Combining lorazepam 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.
Please talk to your doctor or pharmacist about any concerns you may have about the above.

Possible side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using this medicine.
Your doctor will decide whether any change in your treatment is needed.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. If you are over 65 years of age, you may have an increased chance of getting side effects.
Lorazepam helps most people, but it may have side effects in a few people.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following:
Drowsiness
Dizziness
Sleepiness
Clumsiness or unsteadiness
Weakness
Loss of memory
These are the more common side effects of lorazepam.
Other less common or rare side effects are listed below, tell your doctor if you notice any of them:
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
Nausea
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Other side effects not listed above may above may occur in some people. Tell your doctor if you notice any other side effects.

Allergic reactions

If you think you are having an allergic reaction to lorazepam, do not take any more of this medicine and tell your doctor immediately or go to the Accident and Emergency department at your nearest hospital.
Symptoms of an allergic reaction may include some or all of the following:
cough, shortness of breath, wheezing or difficulty breathing.
swelling of the face, lips, tongue, or other parts of the body
rash, itching or hives on the skin
fainting
hayfever-like symptoms

Storage and disposal

Storage

Keep your tablets in the blister pack until it is time to take them.
Keep your tablets in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep this medicine 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 or pharmacist tells you to stop taking this medicine or they have passed their expiry date, your pharmacist can dispose of the remaining medicine safely.

Product description

What APO-Lorazepam looks like

APO-Lorazepam 1 mg tablets: white with a score to make them easy to split. They are embossed with the letter "W" on the back and with "1 mg" on the front face.
APO-Lorazepam 2.5 mg tablets: yellow with a deep score to make them easy to split. They are embossed with the letter "W" on the back and "2.5 mg" on the front face.
To break tablet, place on a hard surface with score facing upwards and press gently on the tablet with your thumb.

Ingredients

Each tablet contains 1 mg or 2.5 mg, of the active ingredient lorazepam.
It also contains the following inactive ingredients:
lactose monohydrate
magnesium stearate
microcrystalline cellulose
polacrilin potassium
iron oxide yellow (2.5 mg tablets only)
quinoline yellow (2.5 mg tablets only)
This medicine is gluten-free, sucrose-free, tartrazine-free and free of other azo dyes.
APO-Lorazepam 1 mg and 2.5 mg tablets are available in blister packs of 50 tablets.
Not all strengths, pack types and/or pack sizes may be available

Australian Registration Numbers

APO-Lorazepam 1 mg blister pack: AUST R 173222.
APO-Lorazepam 2.5 mg blister pack: AUST R 173223.

Distributor

Apotex Pty Ltd
66 Waterloo Road
North Ryde, NSW 2113
Australia
Apotex Pty Ltd is the licensee of the registered trademarks APO and APOTEX from the registered proprietor, Apotex Inc.
This leaflet was prepared in April 2011.