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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

NORFLEX™

Orphenadrine citrate 100mg tablets

What is in this leaflet

This leaflet answers some common questions about NORFLEX tablets. However it does not contain all the available information. Your doctor and pharmacist have more information about this medicine. If you have any questions about NORFLEX that are not answered by this leaflet, please ask your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of your taking NORFLEX against the benefits before prescribing it for you. If you are worried about taking this medicine please talk to your doctor or pharmacist. Keep this leaflet with your medicine as you may want to read it again.

What NORFLEX is used for

The name of your medicine is NORFLEX. It contains orphenadrine citrate. Orphenadrine citrate is a skeletal muscle relaxant. It acts in the central nervous system to produce its muscle relaxant effects.

NORFLEX is used to help relax certain muscles in your body and to relieve the pain and discomfort caused by sprains, strains or other injury to your muscles.

Your doctor may have prescribed NORFLEX for another purpose. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take NORFLEX

When you must not take it

Do not take NORFLEX if:

Do not give this medicine to a child under the age of 12 years. Safety and effectiveness in children younger than 12 years have not been established.

Before you start to take it

Tell your doctor or pharmacist if:

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

Taking other medicines

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

Some medicines may be affected by NORFLEX. These include:

You may need different amounts of your medicines, or you may need to take different medicines. Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking NORFLEX.

How to take NORFLEX

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle ask you doctor or pharmacist for help.

How much to take

The usual dose of NORFLEX in adults is one tablet twice a day. Your doctor will prescribe the correct dose for you. Take NORFLEX tablets only as directed by your doctor or pharmacist. Do not change the dose unless your doctor tells you to do so.

If you forget to take your medicine

If you miss a dose of this medicine and remember within an hour or so of the missed dose, take it right away. If you do not remember until later, skip the missed dose and go back to taking it as you would normally. Do not double doses.

If you take too much (overdose)

Do not take more than the recommended dose unless your doctor tells you to. If you or someone else has taken too much NORFLEX contact your doctor or pharmacist, or the poisons information centre (in Australia call 131126; in New Zealand call 0800 POISON or 0800 746 766), or go to Accident and Emergency at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention. Symptoms of an overdose include excitement; confusion; severe confusion leading to coma; convulsions; fast heart rate; dilated pupils and difficulty passing urine.

While you are taking NORFLEX

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are taking NORFLEX. If you become pregnant while taking this medicine tell your doctor immediately.

Be careful driving or operating machinery until you know how the medicine affects you. NORFLEX may cause some people to have blurred vision or to become drowsy, dizzy, light-headed, faint, or less alert than they are normally. It may also cause muscle weakness in some people. If you have any of these symptoms do not drive or operate machinery or do anything else that could be dangerous.

NORFLEX may cause dryness of the mouth. For temporary relief use sugarless gum or sweets, melt some ice in your mouth or use a saliva substitute. If dry mouth continues for more than 2 weeks speak to your dentist. Continued dryness of the mouth can increase the chance of dental disease, including tooth decay, gum disease and fungal infections.

Things you must not do

NORFLEX is a prescription medicine and has been prescribed for you only. Do not give it to anyone else even if they have the same condition as you. Do not take NORFLEX to treat any other complaints unless your doctor tells you to.

Side Effects

All medicines can cause unwanted side effects. Sometimes they are serious, most of the time they are not.

Speak to your doctor if any of the following side effects occur:

Less common : decreased urination; eye pain; fainting; fast or pounding heartbeat.

Rare : hallucinations; shortness of breath; troubled breathing; tightness in chest and/or wheezing; skin rash; sores, ulcers or white spots on lips or in mouth; swollen and/or painful glands; unusual bruising or bleeding; unusual tiredness or weakness.

The following side effects usually do not need medical attention and may go away during treatment as your body adjusts to the medicine. Speak to your doctor if any of the following side effects continue or are bothersome:

More common : dry mouth.

Less common or rare : abdominal or stomach cramps or pain; blurred or double vision; confusion; constipation; difficulty in urination; dizziness or light-headedness; drowsiness; excitement, irritability, nervousness or restlessness; headache; muscle weakness; unusually large pupils of the eyes.

Other side effects not listed above may also occur in some patients. If you notice any side effects that are not listed here tell your doctor or pharmacist.

After taking NORFLEX

Storage

Keep this medicine in a cool dry place where the temperature stays below 30°C. Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Keep all medicines where children cannot reach them. A locked cupboard at least 1.5 metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine, or if it has passed its 'Use By' date, ask your pharmacist what to do with any tablets that are left over.

Product Description

What it looks like

NORFLEX are white tablets with 3M marked on one side and N/X on the other side.

Ingredients

Each NORFLEX tablet contains 100mg orphenadrine citrate.

NORFLEX also contains:

This medicine does not contain gluten.

Sponsor

NORFLEX is made in Australia by:

iNova Pharmaceuticals (Australia) Pty Limited
(ABN: 88 000 222 408)
9-15 Chilvers Road
THORNLEIGH NSW 2120.

NORFLEX is distributed in New Zealand by:

iNova Pharmaceuticals (New Zealand) Limited
c/o Simpson Grierson
Level 27
88 Shortland Street
AUCKLAND

This leaflet was prepared in February 2003