Consumer Medicine Information
What is in this leafletThis leaflet answers some common questions about EDRONAX.It does not contain all of theavailable 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 EDRONAX against the benefits they expect it will 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 EDRONAX is used forEDRONAX is used to treat depression.Depression is longer lasting and/or more severe than the 'low moods' everyone has from time to time due to the stress of every day life. It is thought to be caused by a chemical imbalance in parts of the brain.EDRONAX may correct this chemical imbalance and help to relieve the symptoms of depression.This medicine is available only with a doctor's prescription.Your doctor may have prescribed EDRONAX for another reason. Ask your doctor if you have anyquestions about why EDRONAX has been prescribed for you.There is no evidence that EDRONAX is addictive.Before you take EDRONAXWhen you must not take it
Do not take EDRONAX if you have an allergy to any medicine containing reboxetine or any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction to EDRONAX may include:
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.
Do not take EDRONAX if you are taking other medicines used to treat depression such as monoamine oxidase inhibitors (MAOIs).
Do not take EDRONAX if you have glaucoma (high pressure in the eye).
Do not give EDRONAX to children or adolescents less than 18 years of age.
Safety and effectiveness of EDRONAX have not been established in children or adolescents less than 18 years.Do not take EDRONAX after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well.
Do not take EDRONAX if the packaging is torn or shows signs of tampering.
If you are not sure whether you should start taking EDRONAX, talk to your doctor or pharmacist.
Before you start to take it
Tell your doctor or pharmacist if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Your doctor or pharmacist will discuss the possible risks or benefits of using EDRONAX during pregnancy.
Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed. EDRONAX is not recommended in women who are breast-feeding.
Tell your doctor or pharmacist if you have or have had any medical conditions, especially thefollowing:
liver or kidney disease
fits or seizures
severe mood swings
difficulty in passing urine
heart problems, including high blood pressure, particularly ifyou are over 65 years old, heart failure, recent heart attack
overactive thyroid gland.
Taking other medicines
Tell your doctor or pharmacist if you are taking or using any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and EDRONAX may interfere with each other. These include:
medicines used to lower blood pressure
medicines used to treat fungal or bacterial infections
carbamazepine, a medicine used to control fits or seizures
potassium-depleting diuretics, medicines used to remove fluid
fluvoxamine, a medicine used to treat depression
ergot derivatives, medicines used to treat migraine
lithium, a medicine used to treat certain mental conditions.
These medicines may be affected by EDRONAX, or may affect how well it works. You may need different amounts of your medicine, or you may need to take or use different medicines. Your doctor or pharmacist will advise you.Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking EDRONAX.How to take EDRONAXFollow 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 label, ask your doctor or pharmacist for help.
How much to take
The usual dose of EDRONAX in adults is 4 mg taken twice a day.After 3 weeks your doctor may increase the dose up to 10 mg per day, if required.In people over 65 years the usual starting dose is 2 mg taken twice a day. After 3 weeks your doctor may increase the dose up to 6 mg per day, if required.How to take it
Swallow the tablets whole with a glass of water.EDRONAX tablets can be broken in half along the breakline if your doctor has prescribed a half tablet.When to take it
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 it before or after food.How long to take it
Most antidepressants take some time to work, so do not be discouraged if you do not feel better straight away. Some of your symptoms may improve after two weeks but it may take four to six weeks for you to start to feel the full benefit of EDRONAX. You may need to take EDRONAX for several months or longer.Continue taking your medicine for as long as your doctor tells you.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.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 your medicine 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 getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor or pharmacist or the Australian Poisons Information Centre (telephone 13 11 26) or the New Zealand National Poisons Information Centre (telephone 0800 POISON or 0800 764 766), or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much EDRONAX. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much EDRONAX you may feel nervous, dizzy or have a fast heart rate.While you are using EDRONAXThings you must do
If you become pregnant while taking EDRONAX, tell your doctor or pharmacist.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking EDRONAX.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are taking EDRONAX.
Tell your doctor if, for any reason, you have not taken your tablets exactly as prescribed.
Otherwise your doctor may think that it was not effective and may change your treatment unnecessarily.Tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes.
A worsening of depressive symptoms including thoughts of suicide or self-harm may occur in the first one or two months of you taking EDRONAX or when the doctor changes your dose. These symptoms should be controlled when the full effect of EDRONAX takes place.
Children, adolescents or young adults under 24 years of age are more likely to experience these effects during the first few months of treatment.
Patients and caregivers should be alert and monitor for these effects.
Signs and symptoms of suicide include:
Thoughts or talk of death or suicide
Thoughts or talk of self-harm or harm to others
Any recent attempts of self-harm
Increase in aggressive behaviour, irritability or agitation
Mention of suicide or violence must be taken seriously.
If you or someone you know is demonstrating these warning signs of suicide while taking EDRONAX, contact your doctor or a mental health professional right away.
Discuss with your doctor any problems you may have and how you feel, especially any feelings of severe sadness or unusual bursts of energy or anger.
This will help the doctor determine the best treatment for you.Keep all your appointments with your doctor 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.Things you must not do
Do not give EDRONAX to anyone else, even if they have the same condition as you.
Do not take EDRONAX to treat any other complaints unless your doctor or pharmacist tells you to.
Do not take any other medicines, whether they require a prescription or not, without first telling your doctor.
Do not stop taking EDRONAX, or change the dosage, without checking with your doctor or pharmacist.
Do not give EDRONAX to a child or adolescent under the age of 18 years.
Safety and effectiveness in children and adolescents younger than 18 years have not been established.Things to be careful of
Be careful driving or operating machinery until you know how EDRONAX affects you.
As with other medicines for depression, EDRONAX may cause dizziness or drowsiness in some people. Make sure you know how you react to EDRONAX before you drive a car, operate machinery, or do anything else that could be dangerous.Side effectsTell your doctor or pharmacist as soon as possible if you do not feel well while you are taking EDRONAX.
EDRONAX helps most people with depression, but it may have unwanted side effects in a few people. 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.Ask your doctor or pharmacist to answer any questions you may have.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.Tell your doctor or pharmacist if you notice any of the following and they worry you:
fast heart beat
difficulty passing urine
unusual tiredness or weakness
tingling or numbness of thehands or feet.
These are the more common side effects of EDRONAX.Tell your doctor or go to Accident and Emergency at your nearest hospital immediately if you notice any of the following:
fits or seizures
frequent signs of infection suchas fever, sore throat, severe chills, mouth ulcers
bleeding or bruising more easily than normal
tiredness, headache, shortness of breath when exercising, dizziness or pale skin
change in heart beat (fast, slow, irregular), sometimes with fainting
itching skin rash or hives
shortness of breath, wheezing or trouble breathing
swelling of the face, lips, tongue or other part of the body.
These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may occur in some patients. Some of these side effects (for example, high cholesterol, abnormal liver function tests) can only be found when your doctor does tests from time to time to check your progress.After using EDRONAXStorage
Keep your tablets in the pack or bottle until it is time to take them.
If you take the tablets out of the container they will not keep well.Keep your tablets in a cool dry place where the temperature stays below 25 degrees C.
Do not store EDRONAX or any other medicine in the bathroom or near a sink.
Do not leave it in the car on hot days 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.
If your doctor or pharmacist tells you to stop taking EDRONAX or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
Product descriptionWhat it looks like
EDRONAX Tablets 4 mg are white, convex, round tablets with a breakline on one side and engraved 'P' on the left of the breakline and 'U' on the right side of the breakline, and '7671' on the opposite side.Ingredients
Active ingredient: Reboxetine mesilate. Each 4 mg tablet contains 4 mg of reboxetine as mesilate.Other ingredients:
calcium hydrogen phosphate.
EDRONAX does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes.Supplier
EDRONAX is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free number: 1800 675 229
EDRONAX is supplied in New Zealand by:
Pfizer New Zealand Ltd
PO Box 3998
Auckland, New Zealand
Toll Free number: 0800 736 363
Australian Registration Number
4 mg tablets in blisters: AUST R 79745This leaflet was prepared in November 2008© Pfizer Australia Pty Ltd 2004All rights reserved.® Registered trademark.