General Information
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about NORMISON. 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 NORMISON against the benefits this medicine is expected to 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 NORMISON is used for
NORMISON is used to treat sleeping problems, also called insomnia.
Your doctor, however, may have prescribed NORMISON for another purpose. Ask your doctor if you have any questions about why NORMISON has been prescribed for you.
NORMISON belongs to a group of medicines called benzodiazepines. They are thought to work by their action on brain chemicals.
In general, benzodiazepines such as NORMISON 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.
This medicine is available only with a doctor's prescription.
Before you take NORMISON
When you must not take it
Do not take NORMISON if:
1. you are allergic to:
NORMISON or any of the ingredients listed at the end of this leaflet
any other medicine from the benzodiazepine group of medicines. Some of the symptoms of an allergic reaction may include skin rash, itching, hives or other serious allergic reaction which is rare and its symptoms can include swelling of the face, tongue, throat or voice box and difficulty in breathing. If any of these symptoms occur, you should seek medical attention as soon as possible.
2. you have severe lung disease or breathing difficulties.
3. you have sleep apnoea, a condition where you have breathing problems when you sleep
Do not take NORMISON if the packaging is torn or shows signs of tampering.
Do not take NORMISON after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work as well or have no effect at all.
Do not give this medicine to children unless advised by the child's doctor. The safety and effectiveness of NORMISON in children under 16 years have not been established.
Before you take it
You must tell your doctor if:
1. you have any 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 NORMISON if you are pregnant or planning to become pregnant unless you and your doctor have discussed the risks and benefits involved.
3. you are breastfeeding or planning to breastfeed
Do not take NORMISON if you are breastfeeding or planning to breastfeed unless you and your doctor have discussed the risks and benefits involved.
NORMISON may pass into breast milk and cause drowsiness and/or feeding difficulties in the baby.
4. you have or have had any other medical conditions including:
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. you drink alcohol regularly.
Alcohol may increase the effects of NORMISON.
If you have not told your doctor about any of the above, tell them before you take any NORMISON.
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 NORMISON. 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 NORMISON. You may need to take different amounts of your medicine or you may need to take different medicines. Your doctor will advise you.
Your doctor or pharmacist may have more information on medicines to be careful with or avoid while taking NORMISON.
How to take NORMISON
How much to take
The dose of NORMISON may be different for each person. Your doctor will decide the right dose for you.
The recommended dose is 10 to 30 mg taken 30 minutes before going to bed
If you are elderly or unwell 10 mg is the usual starting dose.
How to take it
Swallow NORMISON tablets whole with a glass of water. Do not chew them. NORMISON may be taken with or without food.
When to take it
Take NORMISON 30 minutes before going to bed in the evening.
How long to take it
Do not take NORMISON for longer than your doctor says. NORMISON 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 NORMISON as long as your doctor recommends it.
If you forget to take it
If you forget to take NORMISON before you go to bed and you wake up late in the night or early morning, do not take any NORMISON as you may have trouble waking in the morning. If you have any questions about this, ask your doctor or pharmacist.
Do not try to make up for missed doses by taking more than one dose at a time. 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 Australia, (03) 474 7000 NZ) for advice, or go to casualty at your nearest hospital, if you think that you or anyone else may have taken too much NORMISON. Do this even if there are no signs of discomfort or poisoning. Also report any other medicine or alcohol which has been taken. You may need urgent medical attention. Keep telephone numbers for these places handy.
If you take too much NORMISON you may feel drowsy, confused, tired, dizzy, have difficulty breathing, feel weak or become unconscious.
While you are taking NORMISON Things you must do
Take NORMISON exactly as your doctor has prescribed.
Tell all doctors, dentists and pharmacists who are treating you that you are taking NORMISON.
If you become pregnant while you are taking NORMISON, tell your doctor immediately:
Visit your doctor regularly. Your doctor needs to check your progress and see whether you need to keep taking NORMISON.
Tell your doctor if you feel NORMISON is not helping your condition.
Always discuss with your doctor any problems or difficulties during or after taking NORMISON.
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 NORMISON to last weekends and holidays.
Things you must not do
Do not drive or operate machinery until you know how NORMISON affects you. NORMISON may cause drowsiness or dizziness in some people and therefore may affect alertness.
Make sure you know how you react to NORMISON 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 NORMISON at night, you may still be drowsy or dizzy the next day. Do not take NORMISON for a longer time than your doctor has prescribed. NORMISON should be taken for short periods only (for example 2 to 4 weeks), unless advised otherwise by your doctor.
Do not stop taking NORMISON or change the dose, without first checking with your doctor. Stopping this medicine suddenly may cause some unwanted effects. Your doctor will slowly reduce your dose of NORMISON before you can stop taking it completely.
Do not suddenly stop taking NORMISON 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 NORMISON to anyone else, even if their symptoms seem similar to yours.
Things to be careful of
Be careful when drinking alcohol while taking NORMISON. Combining NORMISON and alcohol can make you more sleepy, dizzy or lightheaded, or increase the risk of sleep walking and some other related sleep behaviours which may include sleep-driving, making phone calls, or preparing and eating food while asleep.
Your doctor may suggest that you avoid alcohol or reduce the amount of alcohol you drink while you are taking NORMISON.
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 NORMISON. NORMISON helps most people with insomnia, but it may have unwanted side effects in some people.
All medicines may 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.
Ask your doctor or pharmacist to answer any questions you may have.
If side effects do happen, they are more likely to happen when you first start taking NORMISON. These side effects may go away during treatment as your body adjusts to the dose. However, tell your doctor if you notice any of the following and they worry you:
dizziness
headache
mild daytime drowsiness
These are the more common side effects of NORMISON.
Less common or rare side effects of NORMISON include:
unsteadiness
confusion
faintness
shaking or tremors
weakness
leg cramps
skin rashes
feeling sick or vomiting
dry mouth
loss of taste
irritability
outbursts of anger and increased excitement
depression
sleep disturbances
memory loss
blurred vision
low blood pressure
feeling out of breath
fast or irregular heartbeats
Other side effects not listed above may occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell when you are taking, or soon after you have finished taking, NORMISON.
Some people may get other side effects while using NORMISON.
Ask your doctor or pharmacist if you don't understand anything in this list. Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using NORMISON
Storage
Keep your tablets or capsules in their blister pack or bottle until it is time to take them. If you take the tablets out of their container they may not keep well.
Keep NORMISON tablets in a cool, dry place where the temperature stays below 30 deg C.
Do not store NORMISON tablets or any other medicines, in a 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 NORMISON or the tablets have passed their expiry date, ask your pharmacist what to do with any tablets or capsules left over.
Product description
What it looks like
NORMISON comes in one tablet strength.
1. NORMISON 10 mg tablets are orange, round, biconvex tablet, one face plain the other with break bar. The tablets come in blister packs of 25.
Ingredients
The active ingredient in NORMISON is temazepam.
Each NORMISON 10 mg tablet contains 10 mg temazepam
NORMISON 10 mg tablets also contain:
lactose
microcrystalline cellulose
maize starch
magnesium stearate
The coloring agent is sunset yellow lake.
NORMISON tablets do not contain gluten, sucrose, tartrazine or any other azo dyes.
Sponsor
Sigma Pharmaceuticals (Australia) Pty Ltd
(A.C.N. 004 118 594)
Locked Bag 268 (96 Merrindale Drive) Croydon Victoria, 3136 Australia
Phone: (03) 9839 2800
Australian Registration Numbers
NORMISON 10 mg tablets
AUST R 41637
This leaflet was prepared on
12 August 1999 and
updated 1st July 2002, 10th Jan 2007, 2nd April 2007