Shortec 50mg/Ml Solution For Injection Or Infusion

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Package leaflet: Information for the user

Shortec® 50 mg/ml, solution for injection or infusion

Oxycodone hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4.

In this leaflet:

1. What Shortec injection is and what it is used for

2. What you need to know before you use Shortec injection

3. How to use Shortec injection

4. Possible side effects

5. How to store Shortec injection

6. Contents of the pack and other information

1. What Shortec injection is and what it is used for

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’. The other ingredients are listed in section 6 of this leaflet.

2. What you need to know before you use Shortec injection

Do not use Shortec injection if

• are allergic to oxycodone, or any of the other ingredients of Shortec injection (listed in section 6);

• have breathing problems, such as severe obstructive lung disease, severe bronchial asthma or severe respiratory depression. Your doctor will have told you if you have any of these conditions. Symptoms may include breathlessness, coughing or breathing more slowly or weakly than expected;

• have a condition where the small bowel does not work properly (paralytic ileus) or you have severe pain in your abdomen;

• have a heart problem after long-term lung disease (cor pulmonale);

• have moderate to severe liver problems. If you have other long term liver problems you should only use Shortec injection if recommended by your doctor;

• have ongoing problems with constipation;

• are under 18 years of age.

Warnings and precautions

Talk to your doctor, pharmacist or

nurse before treatment with Shortec

injection if you:

• are elderly or weakened;

• have an under-active thyroid gland (hypothyroidism), as you may need a lower dose of Shortec injection;

• have myxoedema (a thyroid disorder with dryness, coldness and swelling [‘puffiness’] of the skin affecting the face and limbs);

• have a head injury, severe headache or feel sick as this may indicate that the pressure in your skull is increased;

• have low blood pressure (hypotension);

• have low blood volume (hypovolaemia); this can happen with severe external or internal bleeding, severe burns, excessive sweating, severe diarrhoea or vomiting;

• have a mental disorder as a result of an infection (toxic psychosis);

• have inflammation of the pancreas (which causes severe pain in the abdomen and back);

• have problems with your gall bladder or bile duct;

• have inflammatory bowel disease;

• have an enlarged prostate gland, which causes difficulty in passing urine (in men);

• have poor adrenal gland function (your adrenal gland is not working properly which may cause symptoms including weakness, weight loss, dizziness, feeling

or being sick), e.g. Addison’s disease;

• have breathing problems such as severe pulmonary disease. Your doctor will have told you if you have this condition. Symptoms may include breathlessness and coughing;

• have kidney or liver problems;

• have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol or drugs;

• are or have ever been addicted to alcohol or drugs or have a known opioid dependence;

• have an increased sensitivity to

• need to take increasingly higher doses of Shortec 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 are taking this medicine.

Other medicines and Shortec injection

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

Tell your doctor or pharmacist if you are taking:

• a type of medicine known as a monoamine oxidase inhibitor or you have taken this type of medicine in the last two weeks;

• medicines to help you sleep or stay calm (for example tranquillisers, hypnotics or sedatives);

• medicines to treat depression (such as paroxetine);

• medicines to treat psychiatric or mental disorders;

• other strong analgesics (‘painkillers’);

• muscle relaxants;

• medicines to treat high blood pressure;

• quinidine (a medicine to treat a fast heart beat);

• cimetidine (a medicine for stomach ulcers, indigestion or heartburn);

• antifungal medicines (such as ketoconazole, voriconazole, itraconazole and posaconazole);

• antibiotics (such as clarithromycin, erythromycin or telithromycin);

• medicines known as ‘protease

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

• rifampicin (to treat tuberculosis);

• carbamazepine (a medicine to treat seizures, fits or convulsions and certain pain conditions);

• phenytoin (a medicine to treat seizures, fits or convulsions);

• a herbal remedy called St. John’s Wort (also known as Hypericum perforatum);

• antihistamines;

• medicines to treat Parkinson’s

Using Shortec injection with food, drink and alcohol

Drinking alcohol during your treatment with Shortec injection 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 are taking Shortec injection.

You should avoid drinking grapefruit juice during your treatment with this medicine.

Pregnancy and breastfeeding

Do not use Shortec injection if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines You may feel sleepy when you first start using Shortec injection, or when increasing 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.

• Do not drive while taking this medicine until you know how it affects you.

• It is an offence to drive while you have this medicine in your body over a specified limit unless you have a defence (called the ‘statutory defence’).

• This defence applies when:

• 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 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).

Details regarding a new driving offence concerning driving after drugs have been taken in the UK may be found here: https://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

Shortec injection contains less than 1 mmol sodium (23 mg) per

1 ml, i.e. it is essentially “sodium-free”.

| 3. How to use Shortec 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.

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 the injection.

Information for Healthcare Professionals

This leaflet provides technical information for the healthcare professional about Shortec 50 mg/ml, solution for injection or infusion. 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. Adult over 18years:

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 naive 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 naive 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 naive patients. s.c. (Bolus): Use the 10 mg/ml or the 50 mg/ml strength 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 naive patients, titrating gradually according to symptom control. Cancer patients transferring from oral oxycodone may require much higher doses (see below).

Transferring patient 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 patient:

Elderly patients should be treated with caution. The lowest dose should be administered with careful titration to pain control.

Patient 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 10 mg orally in opioid naive patients), and each patient should be titrated to adequate pain control according to their clinical situation.

Shortec® 50 mg/ml, solution for injection or infusion

Oxycodone hydrochloride

05/07/2016 15:-

SHORTEC INJ 50MG-ML PIL 1M UK 196028 I

Children under 18 years:

There are no data on the use of Shortec injection in patients under 18 years of age.

Use in non-malignantpain: 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. 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

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 ofview, 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.

Shortec injection, 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.

This leaflet was last revised in January 2016.

® QDEM and SHORTEC are registered trade marks.

™ The ‘Qdem pharmaceuticals’ logo is a trade mark.

QdemfJ

Patients with kidney or liver ■ I

problems | ⁴~ ^{Possll)le Sldf elTects}_[

Please tell your doctor if you suffer

from kidney or liver problems as they Like all medicines, Shortec injection may prescribe a lower dose depending can cause side effects, although not on your condition. everybody gets them.

The dose recommended by the doctor All medicines can cause allergic should not be exceeded. Check with the reactions, although serious allergic doctor or pharmacist if you are unsure, reactions are rare. Tell your doctor If you find that you are still in pain immediately if you get any sudden

whilst being given Shortec injection wheeziness, difficulties in breathing, discuss this with your doctor. swelling of the eyelids, face or lips.

If you use more Shortec injection than^{rash or itchin}8 especially those you should, or if someone else uses covering your whole body, your injection ^{The m0St Serl0US sl<le effect IS a}

Call your doctor or hospital straight condition where you breathe more away. People who have been given slowly or weakly than expected an overdose may feel very sleepy and (respiratory depression). Tell your sick. They may also have breathing ^doctor “''"'cdiately if this happens difficulties leading to unconsciousness ^to y°y-

or even death and may need emergency ^{As wlth}M stron8 painkillers, there

treatment in hospital. When seeking ‘s a risk that you may become

medical attention make sure that you addicted or reliant on Shortec

take this leaflet and any remaining injection.

injection with you to show to the doctor. Very common side effects

If you stop using Shortec injection ^ ^{affect more} *an 1 in 10

You should not suddenly stop using this P^e°ple)

injection unless your doctor tells you to.* Constipation (your doctor can If you want to stop using your injection. Prescribe a laxative to overcome discuss this with your doctor first. They ^tlus Problem), will tell you how to do this, usually by * fc^cling^or b^eing sick (tlus

reducing the dose gradually so you do ‘ "" ” ...... **“

not experience unpleasant effects.

If you have any further questions on the use of Shortec injection, ask your doctor or pharmacist.

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 medieine 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’, hallucinations, mood changes, unpleasant or uncomfortable mood, a feeling of extreme happiness, restlessness, agitation, generally feeling

SHORTEC INJ 50MG-ML PlL 1M UK 196028 028002-1 V3.indd 3

6. Content of the pack and other information

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, irregul ar 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 ofthe face, reduction in size ofthe 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 of 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‘faintness⁵ especially on standing up.

• Hives (nettle rash).

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

• 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

• Long term use ofShortee 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, 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 at: www.mhra.gov.uk/yellowcard.

By reporting side e fleets you can help provide more information on the safety of this medicine.

I S. How to store Shortee injection [

Keep this medicine out of the sight and reach o f children. Accidental overdose by a child is dangerous and may be fatal.

Do not use Shortee 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.

There are no special precautions for storage prior to use however once the ampoule is opened the injection should be used immediately. Any unusedportion should be discarded immediately.

Do not throw away any medicines via wastewater or household waste.

A sk your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

What Shortee injection contains

The active ingredient is oxycodone hydrochloride.

The other ingredients are:

• Citric acid monohydrate

• Sodium citrate

• Sodium chloride

• Hydrochloric acid, dilute

• Sodium hydroxide

• Water for injections

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What Shortee inj eeflon looks like and the contents of the pack Shortee 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 and Manufacturer

Shortee injection is manufactured by Bard Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 OGW, UK. The marketing authorisation holder is Qdem Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge CB4 OAB, UK.

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on :

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Shortee solution for inj ection or infusion Reference number: 40431/0016

This leaflet was last rerased in April 2016.

® QDEM, SHORTEC and the ‘Qdem pharmaceuticals⁵logo are registered trade marks.

Qdem

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05:07/2016 15: