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_j

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’.

2. What you need to know before

| you use Skortee injection_

Do not use Shortec injection if you:

•    are allergic to oxycodone, or any of the other ingredients of the 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 problems you should only use this injection if recommended by your doctor;

•    have ongoing problems with constipation;

•    are under IS 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;

•    have myx oedema (a thyroid disorder with dryness, coldness and swelling [‘puffiness’] of the skin affecting the face and

•    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 bums, 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

•    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 pain;

•    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 i f 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.

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);

•    me dicine s to treat psychiatri c or mental disorders (such as phenothiazines or neuroleptics):

•    other strong analgesics (‘painkillers’);

•    muscle relaxants;

•    medicines to treat high blood

•    quinidine (a medicine to treat a fast heartbeat);

•    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, nelflnavir or saquinavir);

•    rifampicin (to treat tuberculosis);

•    carb amaze pine (a medicine 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 disease.

Also tell your doctor if you have recently been given an anaesthetic. Using Shortec injection with food, drink and alcohol Drinking alcohol during your treatment with this 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 this injection if you are pregnant or breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

SHORTEC INJ 10MGML PIL1ML UK 196027 027002-I V2.indd 2

This leaflet provides technical information for the healthcare professional about Shortec 10 mg/ ml, solution for injection or

Posology and method of administration

Route of administration: Subcutaneous injection or infusion. Intravenous injection or infusion.

Posolog}’:

The dose should be adjusted according to the severity of pain, the total condition of the patient and previous or concurrent medication.

Adults over 18years:

The following starting doses are recommended. A gradual increase in dose maybe 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 of2 mg/houris recommended for opioid naive patients. i.v. (PCAl: Dilute in 0.9% saline, 5% dextrose or water for injections. Bolus doses of0.03 mg/kg should be administered with a minimum lock-out time of 5 minutes for opioid naive patients. s-c. /Bolus^-): 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 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. Interpatient 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.

Patients with renal and hepatic impairm ent:

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.

Children under 18 years:

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

Use in non-malignant pain: Opioids are not fust-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 nse/handUng Each ampoule is for single use in a single patient. The injection should be given immediately after opening the ampoule and 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. 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 orPVC 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.

Children

Children and adolescents under 18 years of age should not be given the 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 Shortec injection 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 Shortec injection 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 ofthe 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 inunediately 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 eneigy, 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 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 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 ofmenstrual 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 j

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. EXPOS 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 unused portion 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.

6. Contents of the pack and other information

What Shortee inj eeflon 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

Illllllll

What Shortee injection looks like and the contents of the pack This injection is a clear, colourless solution supplied in clear glass ampoules. The 10 mg/ml strength is available as either 1 ml or 2 ml of solution (containing 10 mg or 20 mg of oxycodone hydrochloride respectively).

Marketing Authorisation Holder and Manufacturer

This 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.

QdemC

05:07/2016