Patient Leaflet Updated 23-Feb-2024 | Wockhardt UK Ltd
Oxycodone Hydrochloride 5mg/5ml Oral Solution (Sugar Free) PL 29831/0458
Oxycodone Hydrochloride 5mg/5ml Oral Solution
(referred to as Oxycodone 5mg/5ml Solution in this leaflet)
This medicine contains oxycodone which is an opioid, which can cause addiction. You can get withdrawal symptoms if you stop taking it suddenly.
1. What Oxycodone 5mg/5ml Solution is and what it is used for
2. What you need to know before you take Oxycodone 5mg/5ml Solution
3. How to take Oxycodone 5mg/5ml Solution
4. Possible side effects
5. How to store Oxycodone 5mg/5ml Solution
6. Contents of the pack and other information
This medicine has been prescribed for you for the relief of moderate to severe pain. It contains oxycodone which belongs to a group of medicines called opioids, which are ‘pain relievers’. This medicine has been prescribed for you and should not be given to anyone else. Opioids can cause addiction and you may get withdrawal symptoms if you stop taking it suddenly. Your prescriber should have explained how long you will be taking it for and when it is appropriate to stop, how to do this safely.
Talk to your doctor before using Oxycodone 5mg/5ml Solution if you:
Taking this medicine regularly, particularly for a long time, can lead to addiction and may result in life-threatening overdose. If you have concern that you may become dependent on Oxycodone 5mg/5ml Solution, it is important that you consult your doctor. Your doctor should have explained how long you will be using it for and when it is appropriate to stop, how to do this safely.
Rarely, increasing the dose of this medicine can make you more sensitive to pain. If this happens, you need to speak to your doctor about your treatment.
Addiction can cause withdrawal symptoms when you stop taking this medicine.Withdrawal symptoms can include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, shaking, shivering or sweating. Your doctor will discuss with you how to gradually reduce your dose before stopping the medicine. It is important that you do not stop taking the medicine suddenly as you will be more likely to experience withdrawal symptoms.
Opioids should only be used by those they are prescribed for. Do not give your medicine to anyone else. Taking higher doses or more frequent doses of opioid may increase the risk of addiction. Overuse and misuse can lead to overdose and/or death.
This medicine contains oxycodone which is an opioid medicine.
Repeated use of opioid painkillers can result in the drug being less effective (you become accustomed to it, known as tolerance).
Repeated use of Oxycodone 5mg/5ml Solution may lead to dependence abuse, and addiction which may result in life-threatening overdose.
The risk of these side effects can increase with a higher dose and longer duration of use.
Dependence or addiction can make you feel that you are no longer in control of how much medicine you need to take or how often you need to take it. You might feel that you need to carry on taking your medicine, even when it doesn’t help to relieve your pain.
The risk of becoming dependent or addicted varies from person to person. You may have a greater risk of becoming dependent or addicted on Oxycodone if:
If you notice any of the following signs whilst taking Oxycodone 5mg/5ml Solution, it could be a sign that you have become dependent or addicted.
If you notice any of these signs, speak to your doctor to discuss the best treatment pathway for you, including when it is appropriate to stop and how to stop safely (See section 3, If you stop using Oxycodone).
Oxycodone 5mg/5ml Solution can cause sleep-related breathing disorders such as sleep apnoea (breathing pauses during sleep) and sleep related hypoxemia (low oxygen level in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. A dose reduction may be considered by your doctor.
You may experience hormonal changes while taking this medicine. Your doctor may want to monitor these changes.
Concomitant use of opioids and benzodiazepines increases the risk of drowsiness, difficulties in breathing (respiratory depression), coma and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.
However if your doctor does prescribe benzodiazepines or related drugs with opioids the dosage and duration of concomitant treatment should be limited by your doctor. The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may interact with oxycodone and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms. Please follow your doctor’s dosage recommendation closely. It could be helpful to inform friends or relatives to be aware of sign and symptoms stated above. Contact your doctor when experiencing such symptoms.
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. If you take this medicine with some other medicines, the effect of this medicine or the other medicine may be changed.
Tell your doctor or pharmacist if you are taking:
Contact your doctor if you experience severe upper abdominal pain possibly radiating to the back, nausea, vomiting or fever as this could be symptoms associated with inflammation of the pancreas (pancreatitis) and the biliary tract system.
Also tell your doctor if you have recently been given an anaesthetic.
Drinking alcohol during your treatment with this medicine may make you sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness. It is recommended not to drink alcohol while you’re taking Oxycodone 5mg/5ml Solution liquid.
You should avoid drinking grapefruit juice during your treatment with this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Do not take Oxycodone 5mg/5ml Solution if you are pregnant or think you might be pregnant unless you have discussed this with your doctor and the benefits of treatment are considered to outweigh the potential harm to the baby. If you take Oxycodone 5mg/5ml Solution during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated.
Breast-feeding
Do not take Oxycodone 5mg/5ml Solution while you are breastfeeding as oxycodone passes into breast milk and will affect your baby.
This medicine may cause a number of side effects such as drowsiness which could affect your ability to drive or use machinery (see section 4 for a full list of side effects). These are usually more noticeable when you first start taking this medicine, or when changing to a higher dose. If you are affected you should not drive or use machinery. This medicine can affect your ability to drive as it may make you sleepy or dizzy.
Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: http://www.gov.uk/drug-driving-law
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.
This medicine contains 4.25mg sodium (main component of cooking/table salt) in each 5ml. This is equivalent to 0.21% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 1mg sodium benzoate in each ml, which is equivalent to 5mg/5ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
Always take this medicine exactly as your doctor has told you. The label on your medicine will tell you how much to take and how often. Your doctor should have discussed with you how long the course of Oxycodone 5mg/ml Solution will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine.
Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Oxycodone 5mg/5ml Solution, when and how long you need to take it, when to contact your doctor, and when you need to stop it (see also if you stop using Oxycodone 5mg/5ml Solution).
The usual starting dose is 5ml every four to six hours. However, your doctor will prescribe the dose required to treat your pain. If you find that you are still in pain whilst taking this medicine discuss this with your doctor.
Children and adolescents under 18 years of age should not take the medicine.
Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition.
Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if you are not sure.
You must only take this medicine by mouth. This medicine should never be injected as this may lead to serious side effects, which may be fatal.
Call your doctor or hospital straight away. People who have taken an overdose may feel very sleepy, sick or dizzy. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining medicine with you to show the doctor. An overdose may result in a brain disorder (known as toxic leukoencephalopathy).
If you miss a dose you should take the next dose as soon as you remember then carry on as before. Do not take two doses within four hours. Do not take a double dose to make up for a forgotten dose.
Do not suddenly stop taking this medicine. If you want to stop taking this medicine, discuss this with your doctor first. They will tell you how to do this, usually by reducing the dose gradually so that any unpleasant withdrawal effects are kept to a minimum. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating may occur if you suddenly stop taking this medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.
The most serious side effect is a condition where you breathe more slowly or weakly than expected (respiratory depression). Tell your doctor immediately if this happens to you.
As with all strong painkillers, there is a risk that you may become addicted or reliant on this medicine.
When you stop taking Oxycodone 5mg/5ml Solution you may experience drug withdrawal symptoms, which include restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, shaking, shivering or sweating.
If you notice any of the following signs whilst taking Oxycodone 5mg/5ml Solution it could be a sign that you have become addicted.
If you notice any of these signs it is important you talk to your doctor.
Very common side effects
(May affect more than 1 in 10 people)Common side effects (May affect up to 1 in 10 people)
Uncommon side effects (May affect up to 1 in 100 people)
Rare side effects (May affect up to 1 in 1,000 people)
Frequency not known (Frequency cannot be estimated from the available data)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. Accidental overdose by a child is dangerous and may be fatal. Store this medicine in a locked safe and secure storage space, where other people cannot access it. It can cause serious harm and be fatal to people when it has not been prescribed for them.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active ingredient is oxycodone hydrochloride. Each 5ml contains oxycodone hydrochloride 5mg (equivalent to 4.5mg oxycodone base).
The other ingredients are: citric acid monohydrate, sodium citrate, sodium benzoate (E211), sodium saccharin, hypromellose (methocel-E15 premium LV) and purified water.
This medicine is a clear colourless solution. Each bottle contains 250ml of solution.
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Product name Reference number
Oxycodone Hydrochloride 5mg/5ml Oral Solution 29831/0458
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in 01/2024
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