Oxycodone BNM
Capsules 5 mg, 10 mg and 20 mg

Oxycodone hydrochloride


Consumer Medicine Information

What is in this leaflet

Please read this leaflet carefully before you start taking Oxycodone BNM.

This leaflet answers some common questions about Oxycodone BNM.

It does not contain all 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 Oxycodone BNM 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 Oxycodone BNM is used for

Oxycodone BNM contain oxycodone hydrochloride.

Oxycodone belongs to a group of medicines called opioid analgesics.

Oxycodone BNM is used to relieve moderate to severe pain.

Your doctor, however, may prescribe it for another purpose.

Ask your doctor if you have any questions about why it has been prescribed for you.

As with all strong painkillers, your body may become used to you taking Oxycodone BNM. Taking it may result in physical dependence.

Physical dependence means that you may experience withdrawal symptoms if you stop taking oxycodone suddenly, so it is important to take it exactly as directed by your doctor. This medicine is only available with a doctor's prescription.

Your doctor may have prescribed it for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Before you take Oxycodone BNM

Long-term use of Oxycodone BNM may result in a decrease in sex hormone levels which may affect sperm production in men and the menstrual cycle in females. Talk to your doctor if you have any concerns.

Oxycodone BNM is not suitable for everyone.

When you must not take it

Do not take Oxycodone BNM if you:

  • suffer from shallow breathing or have any breathing problems such as acute asthma, chronic bronchitis or impaired lung function
  • are severely drowsy or have a reduced level of consciousness
  • suffer from irregular or fast heartbeats or changes in the way the heart beats
  • have heart problems due to long-term lung disease
  • have just consumed a large amount of alcohol, regularly consume large amounts of alcohol or have confusion and shaking due to alcohol withdrawal
  • suffer from convulsions, fits or seizures
  • have a head injury, brain tumour or have raised pressure within the head, brain or spinal cord
  • have sudden severe abdominal pain
  • have a condition where your stomach empties more slowly than it should, or your small bowel does not work properly
  • are about to have an operation (including surgery on your spine for pain relief in the next 6 hours)
  • have severe kidney or liver disease
  • take a medicine for depression called as 'monoamine oxidase inhibitor' or 'benzodiazepines' or have taken any in the last two weeks.

Do not take Oxycodone BNM if you have an allergy to:

  • any medicine containing oxycodone hydrochloride
  • any of the ingredients listed at the end of this leaflet
  • opioid painkillers.

Do not take this medicine after the expiry date (EXP) printed on the pack. If you take it after the expiry date has passed, it may not work very well.

Do not take this medicine if the packaging is torn or shows signs of tampering.

Do not take this medicine if you are pregnant or intend to become pregnant whilst taking this medicine. Like most medicines of this kind, Oxycodone BNM is not recommended to be taken during pregnancy. Your doctor will discuss the risks of taking them if you are pregnant.

Do not breastfeed if you are taking this medicine. The active ingredient in Oxycodone BNM passes into breast milk and there is a possibility that your baby may be affected.

Do not give this medicine to a child under the age of 18 years of age. Safety and effectiveness in children younger than 18 years of age have not been established.

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

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • low blood pressure
  • increased prostate size or difficulty passing urine
  • chronic lung, liver or kidney disease
  • disease of your gall bladder or bile duct
  • inflammation of the pancreas
  • underactive adrenal glands
  • underactive thyroid gland
  • inflammatory bowel disease or recent abdominal surgery
  • severe mental condition involving losing contact with reality, hearing voices or an inability to think clearly
  • an addiction or history of abuse of alcohol, opioids or other drugs.

This medicine is not recommended to be taken during labour. Oxycodone given to the mother during labour can cause breathing problems and signs of withdrawal in the newborn.

If you have not told your doctor about any of the above, tell them before you start taking Oxycodone BNM.

Taking other medicines

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

Tell any healthcare professional who is prescribing a new medicine for you that you are taking Oxycodone BNM.

Some medicines and Oxycodone BNM may interfere with each other. These include:

  • medicines to treat depression, psychiatric or mental disorders
  • medicines to treat depression belonging to a group called monoamine oxidase inhibitors must be stopped 14 days before Oxycodone BNM is taken
  • medicines to help you sleep or stay calm (for example hypnotics or sedatives, including benzodiazepines)
  • medicines to put you to sleep during an operation or procedure
  • medicines to relax your muscles
  • medicines to lower blood pressure
  • quinidine and other medicines to treat the heart
  • medicines to treat convulsions, e.g. phenytoin and carbamazepine
  • medicines to thin the blood e.g. coumarin derivatives such as warfarin
  • cimetidine, a medicine to treat stomach ulcers and heartburn
  • medicines to relieve stomach cramps or spasms, or to prevent travel sickness and the symptoms of allergies
  • medicines to treat Parkinson's disease
  • medicines to treat urinary incontinence
  • medicines to stop nausea or vomiting e.g. metoclopramide
  • other pain relievers including other opioids
  • medicines to treat fungal infections, e.g. ketoconazole
  • antibiotics, e.g. clarithromycin, rifampin
  • medicines to treat HIV infection and AIDS, e.g. ritonavir
  • alcohol
  • St John's wort (a herbal preparation)
  • grapefruit and grapefruit juice.

These medicines may be affected by Oxycodone BNM or may affect how well it works. You may need different amounts of your medicines, or you 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 Oxycodone BNM

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

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you exactly how much to take.

Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take. This depends on your condition and whether or not you are taking any other medicines.

If you take the wrong dose, Oxycodone BNM may not work as well and your problem may not improve.

Follow the instructions given to you by your doctor or pharmacist exactly.

Swallow the capsules whole with a full glass of water.

Do not open, chew or crush them. Oxycodone BNM is only designed to work properly if swallowed whole.

You must only take Oxycodone BNM by mouth. If you have trouble swallowing your capsules whole, talk to your doctor.

Taking this medicine in a manner other than that prescribed by your doctor can be harmful to your health.

When to take it

Take Oxycodone BNM every 4 to 6 hours or as directed by your doctor. If you begin to experience pain and you are taking Oxycodone BNM as prescribed, contact your doctor as your dosage may have to be reviewed.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

If you stop taking this medicine suddenly, your pain may worsen and you may experience withdrawal symptoms such as:

  • body aches
  • loss of appetite, nausea, stomach cramps or diarrhoea
  • fast heart rate
  • sneezing or runny nose
  • chills, tremors, shivering or fever
  • trouble sleeping
  • increased sweating and yawning
  • weakness
  • nervousness or restlessness.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.

Do not try to make up missed doses by taking more than one dose at a time. This may increase the chance of getting an unwanted side effect.

If there is still a long time to go before your next dose, take it as soon as you remember, and then go back to taking it as you would normally.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

In case of overdose

If you take too much

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Oxycodone BNM. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep telephone numbers for these places handy. You should also follow the above steps if someone other than you has accidently taken the tablets that were prescribed for you.

Symptoms of an overdose may include:

  • difficulty in breathing
  • drowsiness and tiredness
  • lack muscle tone
  • cold or clammy skin
  • constricted pupils
  • low blood pressure
  • slow heart rate
  • unconsciousness
  • death

When seeking medical attention, take this leaflet and any remaining capsules with you to show the doctor.

Also tell them about any other medicines or alcohol which have been taken.

While you are taking Oxycodone BNM

Things you must do

Take Oxycodone BNM exactly as your doctor has prescribed.

Before you start on a new medicine, remind your doctor and pharmacist that you are taking Oxycodone BNM.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

You may experience hormonal changes while taking this medicine. Your doctor may want to monitor these changes.

Keep all of your doctor's appointments so that your progress can be checked. Tell your doctor if your pain is getting worse. Always discuss any problems or difficulties you have while you are taking Oxycodone BNM.

Tolerance to oxycodone may develop which means that the effect of the medicine may decrease. If this happens, your doctor may review your dose so that you get adequate pain relief.

Keep enough Oxycodone BNM with you to last over weekends or holidays.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as you. This medicine is only intended for the person it has been prescribed for.

Do not drink alcohol while you are taking Oxycodone BNM. Drinking alcohol whilst taking Oxycodone BNM may make you feel more sleepy and increase the risk of serious side effects such as shallow breathing with the risk of stopping breathing and loss of consciousness.

Do not take Oxycodone BNM to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine, exceed the dose recommended or change the dosage without checking with your doctor. Over time your body may become used to oxycodone. If you stop taking it suddenly, your pain may worsen, and you may have unwanted side effects such as withdrawal symptoms. This is called physical dependence.

If you need to stop taking this medicine, your doctor will gradually reduce the amount you take each day, if possible, before stopping the medicine completely.

Things to be careful of

Do not drive or operate machinery until you know how Oxycodone BNM affects you. Oxycodone BNM may cause drowsiness, dizziness, hallucinations, disorientation, blurred vision or other vision problems or may affect alertness. If you are affected, you should not drive or operate machinery. Discuss these effects with your doctor.

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.

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Tell your doctor if you suffer from nausea or vomiting when taking Oxycodone BNM. If you vomit after your dose, your pain may come back, as you may not have absorbed your medicine. If this happens, speak to your doctor. Your doctor may prescribe some medicine to help you stop vomiting.

Tell your doctor if taking Oxycodone BNM causes constipation. Your doctor can advise about your diet, the proper use of laxatives and suitable exercise you can do to help manage this.

There is potential for abuse of oxycodone and the development of dependence. It is important that you discuss this issue with your doctor.

If you continue to feel unwell, tell your doctor.

Side effects

All medicines may have some unwanted side effects. Sometimes they are serious but most of the time they are not. As for other medicines of this type, that is opioid analgesics, side effects tend to reduce over time, with the exception of constipation. This means that the longer you take this medicine, the less it may cause problems for you. Your doctor has weighed the risks of this medicine against the benefits they expect it will have for you.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Oxycodone BNM.

This medicine helps people with moderate to severe pain, but it may have unwanted side effects in some people. Other side effects not listed here may also occur.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • mild abdominal symptoms such as diarrhoea, accumulation of gas, feeling sick (nausea), decreased appetite or constipation
  • dry mouth, swelling and redness of mouth, hiccups, burping or belching, sore throat, trouble swallowing or changes in voice
  • excessive sweating
  • feeling anxious or nervous, trouble sleeping or abnormal dreams
  • trouble with your balance, vertigo
  • new problems with your eyesight
  • skin rash, itching, dry skin, chills or fever
  • muscle problems, such as spasms, twitching or tremors
  • swelling of legs or ankles
  • absence of menstrual periods
  • impotence
  • decreased sexual drive
  • ringing in the ears
  • speech disorder
  • distorted taste
  • dental caries
  • low blood pressure
  • neck pain
  • thirst, dehydration
  • aggression.

Tell your doctor as soon as possible if you notice any of the following:

  • stomach discomfort, vomiting, indigestion or abdominal pain
  • abnormal thinking, changes in mood or feeling deep sadness
  • fatigue, feeling of tiredness, drowsiness or lack of energy, fainting or dizziness especially when standing up
  • slow or noticeable heartbeats
  • headache or confusion
  • unusual weakness or loss of strength or trouble walking
  • changes in passing urine such as the volume passed, pain or feeling the need to urinate urgently.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • your breathing slows or weakens
  • you have an allergic reaction: shortness of breath, wheezing, shallow or difficult breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin
  • seizures, fits or convulsions
  • fast or irregular heartbeats
  • chest pain or chest tightness.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

Do not be alarmed by list of possible side effects. Not everybody experiences them.

After taking Oxycodone BNM

Storage

Keep your capsules in the blister pack until it is time to take them. If you take capsules out of the blister pack they may not keep well.

Keep your capsules in a cool dry place where the temperature stays below 30°C.

Do not store Oxycodone BNM 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 it and any other 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.

Do not keep Oxycodone BNM past its expiry date.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist how to dispose of medicines no longer required.

Product description

What it looks like

Oxycodone BNM capsules come in three strengths:

Oxycodone BNM 5 mg capsules are hard gelatin capsules having a dark pink body and brown cap printed '5' on body and 'OXY' on cap.

Oxycodone BNM 10 mg capsules are hard gelatin capsules having a white body and brown cap printed '10' on body and 'OXY' on cap.

Oxycodone BNM 20 mg capsules are hard gelatin capsules having a light pink body and brown cap printed '20' on body and 'OXY' on cap.

Ingredients

Oxycodone BNM contains:

  • 5 mg of oxycodone hydrochloride in Oxycodone BNM 5 mg
  • 10 mg of oxycodone hydrochloride in Oxycodone BNM 10 mg
  • 20 mg of oxycodone hydrochloride in Oxycodone BNM 20 mg

They also contain:

  • microcrystalline cellulose
  • magnesium stearate

The capsule shells contain the following ingredients:

  • gelatin
  • sodium laureth sulfate
  • iron oxide yellow (E172)
  • iron oxide red (E172)
  • indigo carmine (E132)
  • titanium dioxide (E171)
  • TekPrint SW-9008 Black Ink (2328)

This medicine does not contain lactose, sucrose, gluten or tartrazine.

Sponsor

Boucher & Muir Pty Ltd
Level 9, 76 Berry Street
North Sydney NSW 2060

Australian Registration Numbers are:

Oxycodone 5 mg capsules:
AUST R 227847

Oxycodone 10 mg capsules:
AUST R 227833

Oxycodone 20 mg capsules:
AUST R 227841

Date of preparation
26 July 2019

Published by MIMS October 2019


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