What it is and what it is used for

for

• You are a smoker This injection has been prescribed for you by your doctor to relieve
• You have ever had problems with your mood (depression, anxiety moderate to severe pain. It contains the active ingredient oxycodone or a personality disorder) or have been treated by a psychiatrist which belongs to a group of medicines called strong analgesics or for other mental illnesses. 'painkillers'. This medicine has been prescribed for you and should If you notice any of the following signs whilst taking Oxycodone not be given to anyone else. Opioids can cause addiction and you Injection, it could be a sign that you have become dependent or may get withdrawal symptoms if you stop taking it suddenly. Your addicted. prescriber should have explained how long you will be using it for
• You need to take the medicine for longer than advised by your and when it is appropriate to stop, how to do this safely. doctor

What you need to know before you take it

e Oxycodone

• You need to take more than the recommended dose Injection
• You are using the medicine for reasons other than prescribed, for instance, 'to stay calm' or 'help you sleep' Do not use Oxycodone Injection if you:
• You have made repeated, unsuccessful attempts to quit or control
• are allergic (hypersensitive) to oxycodone, or any of the other the use of the medicine ingredients of the injection (listed in section 6)
• have breathing problems, such as severe chronic obstructive lung – When you stop taking the medicine you feel unwell, and you feel better once taking the medicine again ('withdrawal effects'). disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. If you notice any of these signs, it is important to talk to your doctor. Sleep-related breathing disorders Symptoms may include breathlessness, coughing or breathing Oxycodone injection can cause sleep-related breathing disorders more slowly or weakly than expected such as sleep apnoea (breathing pauses during sleep) and sleep
• have a condition where the small bowel does not work properly related hypoxemia (low oxygen level in the blood). The symptoms (paralytic ileus) or you have severe pain in your abdomen can include breathing pauses during sleep, night awakening due to
• have a heart problem after long-term lung disease shortness of breath, difficulties to maintain sleep or excessive (cor pulmonale) drowsiness during the day. If you or another person observe these
• have ongoing problems with constipation
• have increased carbon dioxide levels in the blood. Symptoms may symptoms, contact your doctor. A dose reduction may be considered by your doctor. include dizziness, drowsiness, fatigue, shortness of breath and Withdrawal headache Addiction can cause withdrawal symptoms when you stop taking
• have moderate to severe liver problems. If you have other longthis medicine. Withdrawal symptoms can include restlessness, term liver problems you should only use this injection if difficulty sleeping, irritability, agitation, anxiety, feeling your recommended by your doctor heartbeat (palpitations), increased blood pressure, feeling or being
• are under 18 years of age. sick, diarrhoea, loss of appetite, shaking, shivering or sweating. If you Warnings and precautions notice any of these signs, speak to your doctor to discuss the best Talk to your doctor, pharmacist or nurse before treatment with treatment pathway for you, including when it is appropriate to stop Oxycodone injection if you: and how to stop safely (See section 3, If you stop taking Oxycodone
• or anyone in your family are or have ever been addicted to Injection). opioids, alcohol, prescription medicines or illegal drugs It is important that you do not stop taking the medicine suddenly as
• have previously suffered from withdrawal symptoms such as you will be more likely to experience withdrawal symptoms. agitation, anxiety, shaking or sweating, when you have stopped Opioids should only be used by those they are prescribed for. Do taking alcohol or drugs not give your medicine to anyone else. Taking higher doses or more
• feel you need to use more of this medicine to get the same level frequent doses of opioid may increase the risk of addiction. Overuse of pain relief, this may mean you are becoming tolerant to the and misuse can lead to overdose and/or death. effects of this medicine or are becoming addicted to it. Speak to Other medicines and Oxycodone Injection your prescriber who will discuss your treatment and may change Using Oxycodone Injection at the same time as other medicines that your dose or switch you to an alternative pain reliever slow down the central nervous system can cause slow or difficulty
• are elderly or weakened;
• have an under-active thyroid gland (hypothyroidism), as you may breathing (respiratory depression), severe sleepiness, loss of consciousness and death. These medicines include: need a lower dose of injection
• other medicines used to treat pain known as opioids (such as
• have myxoedema (a thyroid disorder associated with dryness, codeine or morphine) coldness and swelling or puffiness of the skin affecting the face
• medicines used to treat epilepsy (gabapentinoids) such as and limbs) pregabalin
• know you are suffering from a brain injury or tumour, or you have
• medicines used to treat anxiety a head injury, severe headache or feel sick, as this may indicate
• medicines used to make you feel sleepy (such as that the pressure in your skull is increased benzodiazepines)
• have low blood pressure (hypotension)
• medicines used to treat psychiatric or mental disorders (such as
• have low blood volume (hypovolaemia). This can occur due to phenothiazines) severe external or internal bleeding, severe burns, excessive
• anaesthetics sweating, severe diarrhoea or vomiting
• muscle relaxants
• feel very lightheaded or faint
• medicines used to treat high blood pressure
• have a mental disorder following use of certain medicines
• a type of medicine used to treat depression known as (toxic psychosis) monoamine oxidase inhibitors (MAOIs), such as tranylcypromine,
• have inflammation of the pancreas (which causes severe pain in phenelzine and isocarboxazid. You should not use Oxycodone the abdomen and back) Injection if you are currently taking this type of medicine, or have
• have problems with your gall bladder or bile duct taken this medicine in the last two weeks.
• have inflammatory bowel disease
• have an enlarged prostate gland, which causes difficulty in Because of this, your doctor will only prescribe Oxycodone Injection passing urine (in men) where there are no other treatment options, and only in small doses
• have poor adrenal gland function (your adrenal gland is not for short periods of time. If you or your friends, family or caregivers working properly which may cause symptoms including notice that you are having difficulty breathing or that you have weakness, weight loss, dizziness, feeling or being sick), become very sleepy or lost consciousness you (or they) should for example due to Addison's disease inform your doctor immediately.
• have severely impaired lung function. Symptoms may include Using Oxycodone Injection with medicines used to treat depression breathlessness and coughing; known as Selective Serotonin Re-uptake Inhibitors (SSRIs) or
• have long term pain unrelated to cancer Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs) can cause a
• have a condition where your breathing stops for short periods condition known as serotonin toxicity. The symptoms of this include whilst you are asleep, known as sleep apnoea agitation, seeing or hearing things that aren't real (hallucinations),
• have kidney or liver problems. loss of consciousness, a fast heartbeat, blood pressure changes, If you are going to have an operation, or have just had an operation, increased body temperature, muscle twitching, lack of coordination, please tell the doctor at the hospital that you are using this medicine. stiffness, feeling or being sick, or diarrhoea. If you are taking SSRI Your doctor may adjust your dose. or SNRI medicines such as citalopram, duloxetine, escitalopram, You may experience hormonal changes while taking this medicine. fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine your Your doctor may want to monitor these changes. doctor may reduce your dose of Oxycodone Injection. Tolerance, dependence and addiction Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines This medicine contains oxycodone, which is an opioid. It can obtained without a prescription. Tell your doctor or pharmacist if you cause dependence and/or addiction. are taking any of the following medicines, as they may need to adjust This medicine contains oxycodone which is an opioid medicine. your dose: Repeated use of opioid painkillers can result in the drug being less
• a type of medicine used to treat depression known as tricyclic effective (you become accustomed to it, known as tolerance). antidepressants, such as amitriptyline, clomipramine, imipramine, Repeated use of Oxycodone Injection can also lead to dependence, lofepramine or nortriptyline abuse, and addiction, which may result in life-threatening overdose.
• medicines used to treat allergies, such as cetirizine, fexofenadine The risk of these side effects can increase with a higher dose and or chlorphenamine longer duration of use.
• quinidine, a medicine to treat an irregular heartbeat If you have concerns that you may become dependent on
• cimetidine, a medicine used to treat stomach ulcers Oxycodone Injection, it is important that you consult your doctor.
• antifungal medicines such as ketoconazole, voriconazole, Your doctor should have explained how long you will be using it for itraconazole and posaconazole and when it is appropriate to stop, how to do this safely.
• antibiotics such as clarithromycin, erythromycin or telithromycin
• medicines used to treat HIV known as protease inhibitors such as Dependence or addiction can make you feel that you are no longer boceprevir, ritonavir, indinavir, nelfinavir or saquinavir in control of how much medicine you need to take or how often you
• rifampicin, a medicine to treat tuberculosis need to take it. You might feel that you need to carry on taking your
• medicines used to treat seizures, fits or convulsions such as medicine, even when it doesn't help to relieve your pain. carbamazepine and phenytoin Rarely, increasing the dose of this medicine can make you more
• a herbal remedy used to treat depression known as St. John's Wort sensitive to pain. If this happens, you need to speak to your doctor (also known as Hypericum perforatum); about your treatment.
• medicines to treat Parkinson's disease. The risk of becoming dependent or addicted varies from person Using Oxycodone Injection with food, drink and alcohol to person. You may have a greater risk of becoming dependent or Drinking alcohol during your treatment with Oxycodone Injection addicted on Oxycodone Injection if: may make you sleepy or increase the risk of serious side effects such
• You or anyone in your family have ever abused or been as shallow breathing with a risk of stopping breathing, and loss of Information for Healthcare Professionals Oxycodone Hydrochloride 50mg/ml Solution for Injection or Infusion Please refer to the Summary of Product Characteristics (SmPC) for further details on this product. Qualitative and Quantitative Composition Each ml contains oxycodone hydrochloride 50mg (equivalent to 45mg of oxycodone base). Pharmaceutical Form Solution for injection or infusion (injection or infusion). A clear, colourless solution practically free of particles. Therapeutic indications For the treatment of moderate to severe pain in patients with cancer and postoperative pain. For the treatment of severe pain requiring the use of a strong opioid. Posology and method of administration Route of administration: Subcutaneous injection or infusion. Intravenous injection or infusion. Posology: The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication. Adults over 18 years: The following starting doses are recommended. A gradual increase in dose may be required if analgesia is inadequate or if pain severity increases. i.v. (Bolus): Dilute to 1mg/ml in 0.9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10mg slowly over one to two minutes in opioid naive patients. Doses should not be administered more frequently than every four hours. i.v. (Infusion): Dilute to 1mg/ml in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2mg/hour is recommended for opioid naive patients. i.v. (PCA): Dilute to 1mg/ml in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03mg/kg should be administered with a minimum lock-out time of five

minutes for opioid naive patients. s.c. (Bolus): Use as 10mg/ml concentration. Dilute in 0.9% saline, 5% dextrose or water for injections. A starting dose of 5 mg is recommended, repeated at four-hourly intervals as required for opioid naive patients. s.c. (Infusion): Dilute to 1mg/ml in 0.9% saline, 5% dextrose or water for injections if required. A starting dose of 7.5 mg/day is recommended in opioid naïve patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below). Transferring patients between oral and parenteral oxycodone: The dose should be based on the following ratio: 2mg of oral oxycodone is equivalent to 1mg of parenteral oxycodone. It must be emphasised that this is a guide to the dose required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Conversion from morphine Patients switching from parenteral morphine to parenteral oxycodone therapy should do so on the basis of a one to one dose ratio. It must be emphasised that this is a guide to the dose of Oxycodone injection required. Inter-patient variability requires that each patient is carefully titrated to the appropriate dose. Elderly: Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control. Patients with renal and hepatic impairment: The dose initiation should follow a conservative approach in these patients. The recommended adult starting dose should be reduced by 50% (for example a total daily dose of 10mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation. Children under 18 years: There are no data on the use of Oxycodone injection in patients under 18 years of age. Use in non-malignant pain: Opioids are not first-line therapy for chronic non-malignant pain, nor are they

Customer

Wockhardt UK Limited

Description

OXYCODONE INJ 50MG AMP COMMON LEAFLET

Item Code

105940/14

Profile

As per the uploaded annotated pdf

Size

460 x 150mm

Min.Point Size

Other

Market

UK

Language

English

Standard

Pharma Height

7mm Minimum

PRINTING COLOURS

DATE

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Barcode Proof By

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Proof No.

1

Date

05.02.2026

Body Text Fonts: Myriad Pro

TECHNICAL COLOURS Keyline (Non-Printing) Text Free Area (Non-Printing)

16 East Park Road | Leicester | LE5 4QA | UK

APPROVAL SIGNATURE

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Actual Min Point Size 5.5pt

185

consciousness. It is recommended not to drink alcohol while you're taking Oxycodone injection. You should avoid drinking grapefruit juice during your treatment with this medicine. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Pregnancy Do not use Oxycodone injection 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 use Oxycodone injection during pregnancy your baby may become dependent and experience withdrawal symptoms after the birth which may need to be treated. Breast-feeding Do not use Oxycodone injection while you are breastfeeding as oxycodone passes into breast milk and will affect your baby. Driving and using machines This injection may cause a number of side effects such as drowsiness or dizziness which could affect your ability to drive or use machinery (see section 4 'Possible side effects' for a full list of side effects). These are usually most noticeable when you first start using the injection, or when increasing to a higher dose. • Do not drive whilst taking this medicine until you know how this medicine affects you

• It is an offence to drive if this medicine affects your ability to drive
• However you would not be committing an offence if: -The medicine has been prescribed to treat a medical or dental problem and -You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and -It was not affecting your ability to drive safely. Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine. Oxycodone Injection contains sodium This injection contains less than 1mmol sodium (23mg) per 1ml, i.e. it is essentially "sodium-free".

How to take it

Oxycodone Injection A doctor or nurse will usually prepare and administer the injection for you. The injection should be used immediately after opening. The dose and how often the injection is given may be adjusted according to the severity of your pain. Check with your doctor or pharmacist if you are not sure. Before starting treatment and regularly during treatment, your doctor will discuss with you what you may expect from using Oxycodone Injection, 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 Injection). Your doctor should have discussed with you how long the course of Oxycodone injection will last. They will arrange a plan for stopping treatment. This will outline how to gradually reduce the dose and stop taking the medicine. Adults (over 18 years of age) The usual starting dose is dependent upon how the injection is administered. The usual starting doses are as follows:

• As a single injection into a vein, the usual dose is 1 to 10mg given slowly over 1 to 2 minutes. This can be repeated every 4 hours
• As an infusion into a vein, the usual starting dose is 2mg/hour
• As a single injection through a fine needle into the tissue under the skin, the usual starting dose is 5mg repeated at 4-hourly intervals if needed
• As an infusion through a fine needle into the tissue under the skin, the usual starting dose is 7.5mg/day.
• If given by patient controlled analgesia (PCA), the dose is worked out according to your weight (0.03mg per kg of body weight). Your doctor or nurse will set a suitable frequency Children Children and adolescents under 18 years of age should not be given this injection. Patients with kidney or liver problems Please tell your doctor if you suffer from kidney or liver problems as they may prescribe a lower dose depending on your condition. The dose recommended by the doctor should not be exceeded. Check with the doctor, pharmacist or nurse if you are unsure. If you find that you are still in pain whilst being given Oxycodone Injection discuss this with your doctor. If you use more Oxycodone Injection than you should, or if someone else uses your injection Call your doctor or hospital immediately. People who have been given an overdose may feel very sleepy, sick or dizzy, or have hallucinations. They may also have breathing difficulties leading to unconsciousness or even death and may need emergency treatment in hospital. An overdose may result in a brain disorder (known as toxic leukoencephalopathy). When seeking medical attention make sure that you take this leaflet and any remaining injection with you to show to the doctor. If you stop using Oxycodone Injection Do not suddenly stop using this injection. If you want to stop using your injection, 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 Oxycodone Injection, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Oxycodone Injection 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. These may be signs of a serious allergic reaction. The most serious side effect is a condition where you breathe more slowly or weakly than usual (respiratory depression) and can lead to severe sleepiness and loss of consciousness. This side effect may affect up to 1 in 100 people and is more likely to occur when taking certain other medicines (see section 2 'Other medicines and Oxycodone Injection'). Tell your doctor immediately if this happens to you. You may wish to ask your friends, family or caregivers to monitor you for these signs and symptoms. Drug withdrawal When you stop using Oxycodone injection 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. Other possible side effects Very common: may affect more than 1 in 10 people

• Constipation (your doctor can prescribe a laxative to overcome this problem) recommended as the only treatment. Types of chronic pain which have been shown to be alleviated by strong opioids include chronic osteoarthritic pain and intervertebral disc disease. Treatment goals and discontinuation Before initiating treatment with Oxycodone Injection, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal. In absence of adequate pain control, the possibility of hyperalgesia, tolerance and progression of underlying disease should be considered (see section 4.4). Duration of treatment Oxycodone should not be used for longer than necessary. Incompatibilities This medicinal product must not be mixed with other medicinal products except those mentioned below (special precautions for disposal/handling). Cyclizine at concentrations of 3mg/ml or less, when mixed with oxycodone injection, either undiluted or diluted with water for injections, shows no sign of precipitation over a period of 24 hours storage at room temperature. Precipitation has been shown to occur in mixtures with oxycodone injection at cyclizine concentrations greater than 3mg/ml or when diluted with 0.9% saline. It is recommended that Water for Injections be used as a diluent when cyclizine and oxycodone hydrochloride are co-administered, as cyclizine will precipitate in the presence of 0.9% saline. Prochlorperazine is chemically incompatible with Oxycodone injection. Shelf life and special precautions for storage/handling Unopened: 3 years. The injection should be given immediately after opening the ampoule. Once opened, any unused portion should be discarded. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature.

• Feeling or being sick (this should normally wear off after a few days, however your doctor can prescribe an anti-sickness medicine if it continues to be a problem)
• Drowsiness (this is most likely when you start taking your medicine or when your dose is increased, but it should wear off after a few days)
• Dizziness
• Headache
• Itchy skin. Common: may affect up to 1 in 10 people
• Dry mouth, loss of appetite, indigestion, abdominal pain or discomfort, diarrhoea
• Confusion, depression, a feeling of unusual weakness, shaking, lack of energy, tiredness, anxiety, nervousness, difficulty in sleeping, abnormal thoughts or dreams
• Difficulty in breathing or wheezing, shortness of breath, decreased cough reflex
• Rash
• Sweating. Uncommon: may affect up to 1 in 100 people
• Difficulty in swallowing, belching, hiccups, wind, a condition where the bowel does not work properly (ileus), inflammation of the stomach, changes in taste or unpleasant taste
• A feeling of dizziness or spinning (vertigo), hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, disorientation, restlessness, agitation, generally feeling unwell, loss of memory, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness in the hands or feet, seizures, fits or convulsions, blurred or impaired vision, unusual muscle stiffness or slackness, involuntary muscle contractions or spasms
• Difficulty or pain passing urine, impotence, decreased sexual drive, low levels of sex hormones in the blood ('hypogonadism', seen in a blood test)
• Fast, irregular heartbeat, palpitations, a feeling of lightheadedness, dizziness or fainting, flushing of the skin
• Dehydration, thirst, chills, swelling of the hands, ankles or feet
• Dry skin, severe flaking or peeling of the skin
• Redness of the face, reduction in size of the pupils in the eye, high temperature
• Colicky abdominal pain or discomfort
• A worsening of liver function tests (seen in a blood test). Rare: may affect up to 1 in 1,000 people
• Low blood pressure or feeling faint, especially on standing up
• A raised, itchy rash (hives). Not known: frequency cannot be estimated from the available data
• Dependence and addiction (see in section 2 of the leaflet)
• Withdrawal symptoms (see 'Drug withdrawal' in section 2 of the leaflet)
• A need to take increasingly higher doses of this medicine to obtain the same level of pain relief (tolerance)
• An increased sensitivity to pain
• Aggression
• Tooth decay
• Absence of menstrual periods
• A blockage in the flow of bile from the liver (cholestasis). This can cause itchy skin, yellow skin, very dark urine and very pale stools.
• Sleep apnoea (breathing pauses during sleep). Long term use of Oxycodone injection during pregnancy may cause life-threatening withdrawal symptoms in the newborn. Symptoms to look for in the baby include irritability, hyperactivity and abnormal sleep pattern, high pitched cry, shaking, being sick, diarrhoea and not putting on weight. Reporting of side effects If you get any side effects, talk to your doctor, or 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.

How to store it

Oxycodone Injection Keep this medicine out of the sight and reach of children. 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 use Oxycodone Injection after the expiry date which is stated on the ampoule label and carton after EXP. The expiry date refers to the last day of that month. Do not store above 25°C. Keep the ampoule in the outer carton in order to protect from light. The injection should be given immediately after opening the ampoule. Once opened, any unused portion should be discarded. Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature. 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 to protect the environment.

Contents of the pack and other information

What Oxycodone Injection contains The active ingredient is oxycodone hydrochloride. The other ingredients are: Citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid (dilute), sodium hydroxide (dilute) and water for injections. What Oxycodone Injection looks like and contents of the pack Oxycodone Injection is a clear, colourless solution practically free of particles supplied in clear glass ampoules. The 50mg/ml strength is available as 1ml of solution, containing 50mg of oxycodone hydrochloride (equivalent to 45mg of oxycodone base). It is available in packs of 5 ampoules. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK Manufacturer CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF, UK Other formats: To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK only). Please be ready to give the following information: Product name Reference number 29831/0367 Oxycodone Hydrochloride 50mg/ml Solution for Injection or Infusion This is a service provided by the Royal National Institute of Blind People. This leaflet was last revised in 02/2026.

105940/14 From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution, dilution, etc has taken place in controlled and validated aseptic conditions. Do not store above 25°C. Keep the ampoule in the outer carton in order to protect from light. Nature and contents of container Type I neutral glass ampoules: 1ml. Pack size: 5 ampoules. Special precautions for disposal Oxycodone injection has been shown to be compatible with the following drugs:

• Hyoscine butylbromide • Hyoscine hydrobromide • Dexamethasone sodium phosphate • Haloperidol • Midazolam hydrochloride • Metoclopramide hydrochloride
• Levomepromazine hydrochloride Oxycodone injection, undiluted or diluted to 1mg/ml with 0.9% w/v saline, 5% w/v dextrose or water for injections, is physically and chemically stable when in contact with representative brands of polypropylene or polycarbonate syringes, polyethylene or PVC tubing, and PVC or EVA infusion bags, over a 24 hour period at room temperature. Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Date of Revision of the Text: 02/2026

105940/14

Customer

Wockhardt UK Limited

Description

OXYCODONE INJ 50MG AMP COMMON LEAFLET

PRINTING COLOURS

DATE

105940/14

Profile

As per the uploaded annotated pdf

Warning! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our client's brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Size

460 x 150mm

Min.Point Size

Other

Market

UK

Actual Min Point Size 5.5pt

Language

English

Standard

Pharma Height

7mm Minimum

Barcode Proof By

EBR

Proof No.

1

Date

05.02.2026

Body Text Fonts: Myriad Pro

TECHNICAL COLOURS Keyline (Non-Printing) Text Free Area (Non-Printing)

Item Code 16 East Park Road | Leicester | LE5 4QA | UK

APPROVAL SIGNATURE

Black

185