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dextropropoxyphene napsylate
Consumer Medicine Information
Disclaimer
This document answers some common questions about DOLOXENE. It does not contain all the available information and does not take the place of talking with your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this document with this medicine.
You may need to read it again.
What DOLOXENE is used for
DOLOXENE belongs to a group of medicines called analgesics and is used for the relief of mild to moderate pain.
DOLOXENE may be habit forming so it is important to take it exactly as directed by your doctor.
Ask your doctor if you have any questions about why it has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
Before you take it
Tell your doctor if you have any of the following conditions or if you have ever experienced any of these conditions.
When you must not take it
Do not take DOLOXENE:
• if you have had an allergic reaction to it or to any other products containing
dextropropoxyphene or to any of the ingredients listed at the end of this leaflet (see
'Product Description').
Signs of an allergic reaction include rash, swelling of the face or tongue or difficulty in
breathing.
• if you have a history of alcoholism or substance abuse
• if you have ever been suicidal
• if the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
• if the packaging is torn or shows signs of tampering or the capsules do not look quite
right.
Before you start to take it
You must tell your doctor:
• if you have or have had kidney or liver disease
• if you have had any allergies to any other medicines or any other substances, such as
foods, preservatives or dyes
• if you are pregnant or intend to become pregnant
• if you are breast-feeding or plan to breast-feed.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by DOLOXENE or may affect how well it works. These include:
• tranquillisers, medicines that calm you down
• antidepressants, medicines to treat depression
• sedatives, medicines that help you sleep
• muscle relaxants eg. orphenadrine
• alcohol
• any other central nervous system depressant drugs
• anticonvulsants eg. carbamazepine
• medicines that prevent blood clotting eg. warfarin.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.
Do not give DOLOXENE to children.
The safety of this medicine in children has not been established.
How to take it
How much to take
Take your medicine as directed by your doctor.
The usual adult dose is one capsule every four hours, as needed for pain. The maximum recommended dose is 6 capsules per day. If you are elderly or have a pre-existing kidney or liver condition, you may need to take fewer capsules.
Tell your doctor if you do not get pain relief at the recommended dose.
Do not take more than the recommended dosage even if you are not getting pain relief.
DOLOXENE can produce drug dependence when taken in higher than recommended doses over long periods of time.
How to take it
Swallow the capsules whole with a glass of water.
How long to take it
Your doctor will decide how long you should take this medicine.
If you forget to take it
If you forget to take your medicine, take your dose as soon as you remember.
Do not try to make up for missed doses by taking more than one dose at a time.
Do not take more than the dosage recommended by your doctor even if you are not getting pain relief.
Taking more of this medicine may increase the chance of getting an unwanted side effect.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre on 13 11 26, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much DOLOXENE.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking it
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking DOLOXENE.
Tell your doctor or pharmacist before you start any new medicine.
If you become pregnant while you are taking DOLOXENE, tell your doctor or pharmacist.
You should avoid alcohol while you are taking DOLOXENE.
This medicine and alcohol in combination are dangerous and may lead to symptoms of overdose (difficulty breathing, confusion, anxiety, severe drowsiness and dizziness).
Things you must not do
Do not take more than the dosage recommended by your doctor even if you are not getting pain relief.
Do not drive or operate machinery until you know how DOLOXENE affects you.
It may make you drowsy or dizzy.
Do not give DOLOXENE to anyone else.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DOLOXENE.
Tell your doctor if you notice anything unusual or if you are concerned about any aspect of your health, even if you think the problems are not connected with this medicine and are not referred to in this document.
Like other medicines, DOLOXENE may cause some unwanted side effects. These are likely to vary from patient to patient. Some side effects may be related to the dose of DOLOXENE. Your doctor may then decide to adjust the dose you are taking.
Tell your doctor if you notice any of the following common side effects and they worry you:
• dizziness
• sleepiness
• nausea
• vomiting.
These side effects may be lessened if you lie down.
Tell your doctor or pharmacist if you notice any of the following:
• constipation
• stomach pain
• skin rashes
• allergic reactions
• light headedness
• headache
• muscle weakness
• hallucinations
• sensation of extreme happiness, known as euphoria
• abnormal unhappy mood
• minor visual disturbances
• bleeding or bruising more easily than normal
• frequent infections such as fever, severe chills, sore throat or mouth ulcers.
Some of these may be serious side effects of DOLOXENE. You may need medical attention. Serious side effects are rare.
If any of the following happens, stop taking DOLOXENE and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
• yellowing of your skin or eyes, known as jaundice
• fits
• abnormal thought processes and delusions, known as psychoses.
These are very rare side effects. You may need urgent medical attention or hospitalisation.
After taking it
Storage
Keep your capsules in the blister pack until it is time to take them.
Keep the medicine in a cool, dry place where the temperature stays below 25°C.
Keep it where young 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 DOLOXENE or you find that this medicine has passed its expiry date, ask your pharmacist what to do with any capsules that are left over.
Product Description
What it looks like
DOLOXENE capsules are pink.
It is available in blister packs of 10 capsules.
Ingredients
Active ingredient:
• dextropropoxyphene napsylate (100 mg).
Inactive ingredients:
• starch-pregelatinised maize
• dimethicone 350.
The capsule shell consists of:
• gelatin
• red iron oxide
• titanium dioxide.
Doloxene does not contain lactose, gluten, sucrose or azo dyes.
Supplier
Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australian Registration Number: AUST R 161853
This document was revised in August 2009.
Consumer Medicine Information
Disclaimer
This document answers some common questions about DOLOXENE. It does not contain all the available information and does not take the place of talking with your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, talk to your doctor or pharmacist.
Keep this document with this medicine.
You may need to read it again.
What DOLOXENE is used for
DOLOXENE belongs to a group of medicines called analgesics and is used for the relief of mild to moderate pain.
DOLOXENE may be habit forming so it is important to take it exactly as directed by your doctor.
Ask your doctor if you have any questions about why it has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
Before you take it
Tell your doctor if you have any of the following conditions or if you have ever experienced any of these conditions.
When you must not take it
Do not take DOLOXENE:
• if you have had an allergic reaction to it or to any other products containing
dextropropoxyphene or to any of the ingredients listed at the end of this leaflet (see
'Product Description').
Signs of an allergic reaction include rash, swelling of the face or tongue or difficulty in
breathing.
• if you have a history of alcoholism or substance abuse
• if you have ever been suicidal
• if the expiry date on the pack has passed.
If you take this medicine after the expiry date has passed, it may not work as well.
• if the packaging is torn or shows signs of tampering or the capsules do not look quite
right.
Before you start to take it
You must tell your doctor:
• if you have or have had kidney or liver disease
• if you have had any allergies to any other medicines or any other substances, such as
foods, preservatives or dyes
• if you are pregnant or intend to become pregnant
• if you are breast-feeding or plan to breast-feed.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by DOLOXENE or may affect how well it works. These include:
• tranquillisers, medicines that calm you down
• antidepressants, medicines to treat depression
• sedatives, medicines that help you sleep
• muscle relaxants eg. orphenadrine
• alcohol
• any other central nervous system depressant drugs
• anticonvulsants eg. carbamazepine
• medicines that prevent blood clotting eg. warfarin.
Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking this medicine.
Do not give DOLOXENE to children.
The safety of this medicine in children has not been established.
How to take it
How much to take
Take your medicine as directed by your doctor.
The usual adult dose is one capsule every four hours, as needed for pain. The maximum recommended dose is 6 capsules per day. If you are elderly or have a pre-existing kidney or liver condition, you may need to take fewer capsules.
Tell your doctor if you do not get pain relief at the recommended dose.
Do not take more than the recommended dosage even if you are not getting pain relief.
DOLOXENE can produce drug dependence when taken in higher than recommended doses over long periods of time.
How to take it
Swallow the capsules whole with a glass of water.
How long to take it
Your doctor will decide how long you should take this medicine.
If you forget to take it
If you forget to take your medicine, take your dose as soon as you remember.
Do not try to make up for missed doses by taking more than one dose at a time.
Do not take more than the dosage recommended by your doctor even if you are not getting pain relief.
Taking more of this medicine may increase the chance of getting an unwanted side effect.
If you take too much (overdose)
Immediately telephone your doctor or Poisons Information Centre on 13 11 26, or go to Accident and Emergency at your nearest hospital, if you think you or anyone else has taken too much DOLOXENE.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking it
Things you must do
Tell all doctors, dentists and pharmacists who are treating you that you are taking DOLOXENE.
Tell your doctor or pharmacist before you start any new medicine.
If you become pregnant while you are taking DOLOXENE, tell your doctor or pharmacist.
You should avoid alcohol while you are taking DOLOXENE.
This medicine and alcohol in combination are dangerous and may lead to symptoms of overdose (difficulty breathing, confusion, anxiety, severe drowsiness and dizziness).
Things you must not do
Do not take more than the dosage recommended by your doctor even if you are not getting pain relief.
Do not drive or operate machinery until you know how DOLOXENE affects you.
It may make you drowsy or dizzy.
Do not give DOLOXENE to anyone else.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking DOLOXENE.
Tell your doctor if you notice anything unusual or if you are concerned about any aspect of your health, even if you think the problems are not connected with this medicine and are not referred to in this document.
Like other medicines, DOLOXENE may cause some unwanted side effects. These are likely to vary from patient to patient. Some side effects may be related to the dose of DOLOXENE. Your doctor may then decide to adjust the dose you are taking.
Tell your doctor if you notice any of the following common side effects and they worry you:
• dizziness
• sleepiness
• nausea
• vomiting.
These side effects may be lessened if you lie down.
Tell your doctor or pharmacist if you notice any of the following:
• constipation
• stomach pain
• skin rashes
• allergic reactions
• light headedness
• headache
• muscle weakness
• hallucinations
• sensation of extreme happiness, known as euphoria
• abnormal unhappy mood
• minor visual disturbances
• bleeding or bruising more easily than normal
• frequent infections such as fever, severe chills, sore throat or mouth ulcers.
Some of these may be serious side effects of DOLOXENE. You may need medical attention. Serious side effects are rare.
If any of the following happens, stop taking DOLOXENE and tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
• yellowing of your skin or eyes, known as jaundice
• fits
• abnormal thought processes and delusions, known as psychoses.
These are very rare side effects. You may need urgent medical attention or hospitalisation.
After taking it
Storage
Keep your capsules in the blister pack until it is time to take them.
Keep the medicine in a cool, dry place where the temperature stays below 25°C.
Keep it where young 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 DOLOXENE or you find that this medicine has passed its expiry date, ask your pharmacist what to do with any capsules that are left over.
Product Description
What it looks like
DOLOXENE capsules are pink.
It is available in blister packs of 10 capsules.
Ingredients
Active ingredient:
• dextropropoxyphene napsylate (100 mg).
Inactive ingredients:
• starch-pregelatinised maize
• dimethicone 350.
The capsule shell consists of:
• gelatin
• red iron oxide
• titanium dioxide.
Doloxene does not contain lactose, gluten, sucrose or azo dyes.
Supplier
Aspen Pharmacare Australia Pty Ltd
34-36 Chandos Street
St Leonards NSW 2065
Australian Registration Number: AUST R 161853
This document was revised in August 2009.
