Patient leaflet - Oxycodone Hydrochloride 50 mg / ml solution for injection/infusion

1. What Oxycodone hydrochloride is and what it is used for

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.

This injection has been prescribed for you

by your doctor to relieve moderate to severe

pain. It contains the active ingredient

oxycodone which belongs to a group of

medicines called strong analgesics or

‘painkillers’.

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 use this injection with some other medicines, the effect of this injection or the other medicines may be changed.

2. What you need to know before you use Oxycodone hydrochloride

Do not use Oxycodone hydrochloride if you:

Tell your doctor or pharmacist if you are taking:

are allergic to oxycodone or any of the
- a type of medicine known as a

other ingredients of this medicine (listed

monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks

in section 6)

have breathing problems, such as
severe chronic obstructive lung disease,
- medicines to help you sleep or stay

severe bronchial asthma or severe

calm (for example hypnotics or sedatives, including benzodiazepines)

respiratory depression. Your doctor will

have told you if you have any of these

medicines to treat depression (such as

conditions. Symptoms may include

paroxetine)

breathlessness, coughing or breathing

medicines to treat psychiatric or mental

more slowly or weakly than expected

disorders (such as phenothiazines or neuroleptics)

have a condition where the bowel does
not work properly (paralytic ileus) or you have severe pain in your abdomen
- other strong analgesics (‘painkillers’)
- muscle relaxants
have a heart problem after long-term
- medicines to treat high blood pressure

lung disease (cor pulmonale)

quinidine (a medicine to treat a fast
have moderate to severe liver
heart beat)
problems. If you have other long term
cimetidine (a medicine for stomach

liver problems you should only use this

ulcers, indigestion or heartburn)

injection if recommended by your doctor

antifungal medicines (such as
have ongoing problems with
constipation
or posaconazole)
are under 18 years of age.
antibiotics (such as clarithromycin,
erythromycin or telithromycin)

Warnings and precautions

medicines known as ‘protease

Talk to your doctor, pharmacist or nurse before treatment with Oxycodone hydrochloride if you:

inhibitors’ to treat HIV (e.g. boceprevir, ritonavir, indinavir, nelfinavir or saquinavir)

are elderly or weakened
- rifampicin (to treat tuberculosis)
have an under-active thyroid gland
- carbamazepine (a medicine to treat

(hypothyroidism), as you may need a lower dose

seizures, fits or convulsions and certain pain conditions)

have myxoedema (a thyroid disorder,
- phenytoin (a medicine to treat seizures,

with dryness, coldness, and swelling [‘puffiness’] of the skin, affecting the face and limbs)

fits or convulsions)

a herbal remedy called St. John’s Wort
(also known as Hypericum perforatum)
have a head injury, severe headache or
antihistamines

feel sick as this may indicate that the pressure in your skull is increased

medicines to treat Parkinson’s disease. Also tell your doctor if you have recently been given an anaesthetic.
have low blood pressure (hypotension)
have low blood volume (hypovolaemia);
this can happen with severe external or internal bleeding
Oxycodone hydrochloride with food, drink and alcohol
severe burns, excessive sweating,
severe diarrhoea or vomiting
Drinking alcohol during your treatment with this injection may make you feel more 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 hydrochloride.
have a mental disorder as a result of an
infection (toxic psychosis)
have inflammation of the pancreas
(which may cause severe pain in the abdomen and back)
have problems with your gall bladder or
bile duct
have inflammatory bowel disease
You should avoid drinking grapefruit juice during your treatment with this medicine.
have an enlarged prostate gland which
causes difficulty in passing urine (in men)
Pregnancy and breastfeeding
have poor adrenal gland function (your
Do not use this injection if you are pregnant or breastfeeding.
adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling or being sick), e.g. Addison’s disease
Ask your doctor or pharmacist for advice before taking any medicine.
have breathing problems such as
Driving and using machines
severe pulmonary disease, your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing
You may feel sleepy when you first start using Oxycodone hydrochloride, or when increasing to a higher dose. If you are affected you should not drive or use machinery.
have kidney or liver problems
have previously suffered from withdrawal
This medicine can affect your ability to drive as it may make you sleepy or dizzy.
symptoms such as agitation, anxiety, palpitations, shaking or sweating upon stopping taking alcohol or drugs
Do not drive while taking this medicine
until you know how it affects you.
are or have ever been addicted to
It is an offence to drive while you have

alcohol or drugs, or have a known opioid dependence

this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).

have an increase in sensitivity to pain
need to take increasingly higher doses of
- This defence applies when:

Oxycodone hydrochloride to gain the same level of pain relief (tolerance). If you are going to have an operation, please tell the doctor at the hospital that you have been given this injection. You may experience hormonal changes while taking this medicine. Your doctor may want to monitor these changes.

o the medicine has been prescribed to

treat a medical or dental problem; and

o you have taken it according to the

instructions given by the prescriber and in the information provided with the medicine.

Please note that it is still an offence to
drive if you are unfit because of the medicine (i.e. your ability to drive is being affected).

Other medicines and Oxycodone hydrochloride

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking this medicine.

Concomitant use of opioids and

benzodiazepines increases the risk of drowsiness, difficulties in breathing

Oxycodone hydrochloride Injection contains less than 1 mmol sodium (23 mg) per 1 ml, i.e. it is essentially “sodium-free”.

(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.

Information for Health Professionals

Oxycodone hydrochloride 50 mg/ml Solution for Injection/Infusion

Oxycodone hydrochloride

Please refer to the Summary of Product Characteristics for further information.

Posology and method of administration

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 in 0.9% saline, 5% dextrose or water for injections. Administer a bolus dose of 1 to 10 mg slowly over 1-2 minutes in opioid naïve patients. Doses should not be administered more frequently than every 4 hours.

i.v. (Infusion): Dilute in 0.9% saline, 5% dextrose or water for injections. A starting dose of 2 mg/hour is recommended for opioid naïve patients.

i.v. (PCA): Dilute in 0.9% saline, 5% dextrose or water for injections. Bolus doses of 0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes for opioid naïve patients.

S.C. (Bolus): Use the 10 mg/ml or the 50 mg/ml and dilute in 0.9 % saline, 5% dextrose or water for injections if required. A starting dose of 5 mg is recommended, repeated at 4-hourly intervals as required for opioid naive patients.

S.C. (infusion): Dilute 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: 2 mg of oral oxycodone is equivalent to 1 mg 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.

Elderly patients:

Elderly patients should be treated with caution.

The lowest dose should be administered with careful titration to pain control.

DRxxxxxx SAP No

Brand: Dr Reddy’s

Product Name:

Oxycodone

Strength:

50 mg/1 ml

Form:

Solution for Injection or Infusion

Leaflet

Pack Size:

5 Ampoules

Country:

Date Created:

12/06/2018

Date Modified:

03 MAR 2020

BEC 160/2019 9 pt

HBM

150mm x 650 mm Dimensions:

Project:

Process Black

Dr. Reddy’s Laboratories (UK) Ltd 6 Riverview Road, Beverley, HU17 0LD, UK

FMD Requirements

PC:

00000000000000

SN:

BN:

EXP:

$(EMPTY)

150 mm

3. How to use Oxycodone hydrochloride

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 (see Information for Health Professionals).

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 10 mg 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 2 mg/hour.
as a single injection through a fine needle
into the tissue under the skin, the usual starting dose is 5 mg 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 7.5 mg/day.
if given by patient controlled analgesia
(PCA), the dose is worked out according to your weight (0.03 mg 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 or pharmacist if you are unsure. If you find that you are still in pain whilst being given this injection, discuss this with your doctor.

If you use more Oxycodone hydrochloride than you should, or if someone else uses your injection

Call your doctor or hospital straight away. People who have been given 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 injection with you to show to the doctor.

If you stop using Oxycodone hydrochloride

You should not suddenly stop using this injection unless your doctor tells you to. 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 you do not experience unpleasant effects. Withdrawal symptoms such as agitation, anxiety, palpitations, shaking or sweating may occur if you suddenly stop using this injection. If you have any further questions on the use of this injection, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this 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.

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 injection.

Very common side effects (may affect more than 1 in 10 people)

constipation (your doctor can prescribe a
laxative to overcome this problem)
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 side effects (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 side effects (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
a feeling of dizziness or ‘spinning’
(vertigo), hallucinations, mood changes,
unpleasant or uncomfortable mood, a
feeling of extreme happiness,
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 vision, fainting, unusual muscle
stiffness or slackness, involuntary muscle
contractions
- difficulty passing urine, impotence,
  decreased sexual drive, low levels of sex hormones in the blood (‘hypogonadism’, seen in a blood test)
- fast, irregular heart beat, 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, muscle spasm, high temperature
- a need to take increasingly higher doses
  of this medicine to obtain the same level of pain relief (tolerance)
- colicky abdominal pain or discomfort
- a worsening in liver function tests (seen in
  a blood test)

Rare side effects (May affect up to 1 in 1,000 people)

low blood pressure
a feeling of ‘faintness’ especially on
standing up
hives (nettle rash)

Frequency not known (Frequency cannot be estimated from the available data)

an increase in sensitivity to pain
aggression
tooth decay
absence of menstrual periods
a blockage in the flow of bile from the
liver. This can cause itchy skin, yellow skin, very dark urine and very pale stools.
Long term use of Oxycodone
hydrochloride 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, 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.

5. How to store Oxycodone hydrochloride

Keep this medicine out of the sight and reach of children. Accidental overdose by a child is dangerous and may be fatal. Do not use this injection after the expiry date which is stated on the ampoule label and carton. EXP 08 2020 means that you should

not use the injection after the last day of that month i.e. August 2020.

Keep the ampoules in the outer carton in order to protect from light. Once the ampoule is opened the injection should be used immediately. Any unused portion should be discarded immediately. The medicine should be examined visually and should not be used if particulate matter or discolouration are present.

If the solutions becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

Oxycodone hydrochloride, undiluted or diluted to 1 mg/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.

The injection, whether undiluted or diluted to 1 mg/ml in the infusion fluids used in these studies and contained in the various assemblies, does not need to be protected from light.

Inappropriate handling of the undiluted solution after opening of the original ampoule, or of the diluted solutions may compromise the sterility of the product. 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.

6. Contents of the pack and other information

What Oxycodone hydrochloride Injection contains

The active ingredient is oxycodone hydrochloride. Each 1 ml of the solution for injection or infusion contains 50 mg oxycodone hydrochloride, equivalent to 45 mg oxycodone.

The other ingredients are citric acid monohydrate, sodium citrate, sodium chloride, hydrochloric acid, dilute (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections. For excipients with known effect, see section 2.

What Oxycodone hydrochloride Injection looks like and contents of the pack

This injection is a clear, colourless solution supplied in clear glass ampoules. The 50 mg/ml strength is available as 1 ml of solution (containing 50 mg of oxycodone hydrochloride).

Marketing Authorisation Holder

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom

Manufacturer

HBM Pharma s.r.o.

Sklabinská 30

036 80 Martin

Slovak Republic

This leaflet was last revised in December 2019

Patients with renal or 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 10 mg orally in opioid naïve patients), and each patient should be titrated to adequate pain control according to their clinical situation.

Paediatric population:

There are no data on the use of Oxycodone hydrochloride 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 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. The need for continued treatment in non-malignant pain should be assessed at regular intervals.

Endocrine system

Opioids such as oxycodone hydrochloride may influence the hypothalamic-pituitary-adrenal or – gonadal axes. Some changes that can be seen include an increase in serum prolactin, and decreases in plasma cortisol and testosterone. Clinical symptoms may be manifest from these hormonal changes.

Concomitant therapy

There can be an enhanced CNS depressant effect which can result in profound sedation, respiratory depression, coma and death during concomitant therapy with benzodiazepines or other drugs which affect the CNS such as tranquillisers, anaesthetics, hypnotics, anti-depressants, non-benzodiazepine sedatives, phenothiazines, neuroleptic drugs, alcohol, other opioids, muscle relaxants and antihypertensives.

Route of administration:

Subcutaneous injection or infusion.

Intravenous injection or infusion.

Duration of treatment

Oxycodone should not be used for longer than necessary.

Discontinuation of treatment:

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

Instructions for use/handling

Each ampoule is for single use in a single patient.

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.

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.