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PALLADONE 2MG/ML SOLUTION FOR INJECTION OR INFUSION

Active substance(s): HYDROMORPHONE HYDROCHLORIDE

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670x200mm (LSN-CON-44) (L) V2

Palladone® 2 mg/ml, 10 mg/ml, 20 mg/ml and
50 mg/ml solution for injection or infusion
Hydromorphone 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,
pharmacist or nurse.
• 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 possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Palladone injection is and what it is used for
2. What you need to know before you use Palladone
injection
3. How to use Palladone injection
4. Possible side effects
5. How to store Palladone injection
6. Contents of the pack and other information

1. What Palladone injection is and what it is used
for
You have been prescribed Palladone injection to relieve
severe pain.
It contains the active substance hydromorphone
hydrochloride, which is a potent analgesic (strong
“painkiller”) of the opioid group.

2. What you need to know before you use
Palladone injection
Do not use Palladone injection if you:
• are allergic to hydromorphone or to any of the other
ingredients of this medicine (listed in section 6);
• have breathing problems (respiratory depression);

• suffer from a severe lung disease associated with
obstruction of the airways (severe chronic obstructive
pulmonary disease or severe COPD);
• have a heart problem after long-term lung disease
(cor pulmonale);
• have severe pain in your abdomen;
• have a condition where the small bowel does not work
properly (paralytic ileus);
• are taking a type of medicine known as a monoamine
oxidase inhibitor (examples include tranylcypromine,
phenelzine, isocarboxazid, moclobemide and
linezolid), or you have taken this type of medicine in
the last two weeks.
Palladone injection must not be used if the patient is in a
coma.
Warnings and precautions
Talk to your doctor or pharmacist before using Palladone
injection if you:
• have a dependence on strong painkillers;
• have a head injury (due to the risk of increased brain
pressure);
• suffer from seizures, fits or convulsions;
• have an addiction to alcohol;
• have previously suffered from withdrawal symptoms
such as agitation, anxiety, nervousness, difficulty in
sleeping, being unusually overactive, shaking and
gastrointestinal problems upon stopping taking alcohol
or drugs;
• suffer from a mental disorder as a result of an
intoxication (toxic psychosis);
• have low blood pressure associated with low
circulating blood volume (hypotension with
hypovolaemia);
• are feeling light-headed or faint;
• have problems with your gall bladder;
• have inflammation of the pancreas (pancreatitis);
• have any bowel problems (such as obstructive or
inflammatory bowel disease);

• have prostate problems (such as difficulties in passing
urine);
• have poor adrenal gland function (e.g. Addison’s
disease).
• have an under-active thyroid gland (hypothyroidism);
• have a chronic obstructive airway disease (such as
COPD) or reduced pulmonary function;
• suffer from a debilitated general condition or are
elderly;
• suffer from severe kidney problems (including ureteric
colic);
• suffer from severe liver problems.
If this information applies to you or formerly applied to
you, please speak to your doctor.
Palladone injection is not recommended for children
under 12 years of age.
The major risk of opioid excess is difficulty in breathing
(respiratory depression).
Patients may develop tolerance with long-term use of this
medicine. This means you may require higher doses to
achieve the desired pain control.
Long-term use of this medicine may lead to physical
dependence. If treatment is stopped abruptly, withdrawal
symptoms such as agitation, anxiety, nervousness,
difficulty in sleeping, involuntary muscle contractions,
shaking, and gastro-intestinal problems may occur. If
you no longer require therapy with hydromorphone, your
doctor will taper the daily dose gradually to prevent these
symptoms.
The active substance hydromorphone hydrochloride has
an abuse profile similar to other strong opioids. There is
potential for development of psychological dependence.
Therefore, this medicine should be used with particular
care in patients with a history of alcohol and drug abuse.
An increase in sensitivity to pain (hyperalgesia) that will
not respond to a further dose increase of this medicine
may occur in particular in high doses. Your doctor will
decide whether a dose reduction or change in analgesic
(opioid) is required in such a situation.
Please tell your doctor if you experience small bowel
problems (paralytic ileus) during treatment with this
medicine. He or she will take appropriate measures.
If you are going to have an operation, please tell the
doctor at the hospital that you are using this medicine as
they may need to adjust the amount of injection you are
given.

The use of this medicine may produce positive results in
doping controls.
Other medicines and Palladone injection
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
When taken with some other medicines or alcohol, the
side effects of Palladone injection (such as drowsiness,
breathing problems, constipation, dry mouth, difficulty in
passing urine) or the other medicine may be altered.
Tell your doctor if you:
• are taking medicines to treat anxiety (for example
tranquillisers);
• have been given an anaesthetic (for example a
barbiturate);
• are taking medicines to help you sleep (hypnotics or
sedatives);
• are taking medicines to treat psychiatric or mental
disorders (neuroleptics or psychotropics);
• are taking medicines to treat depression
(antidepressants);
• are taking medicines used to stop you feeling sick or
being sick (antiemetics);
• are taking medicines used to prevent or relieve the
symptoms of an allergy (antihistamines);
• are taking medicines to treat Parkinson’s disease;
• are taking other strong analgesics or ‘painkillers’, or
have recently taken another painkiller from the opioid
class.
Do not take this medicine if you are taking a specific type
of medicine known as a monoamine oxidase inhibitor,
or you have taken this type of medicine in the last two
weeks.
Palladone injection with food, drink and alcohol
Drinking alcohol during your treatment with this
medicine may make you drowsy. If you are affected you
should avoid drinking alcohol.
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
You should not use this medicine during pregnancy and
labour unless you have been specifically told by your
doctor. If you use this medicine during labour, uterine
contractility may be impaired. In addition slow and

shallow breathing (respiratory depression) may occur in
3. How to use Palladone injection
the newborn infant.
If you use this medicine for a long time during pregnancy, Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
withdrawal symptoms may be observed in the newborn
pharmacist if you are not sure.
infant.
A doctor or nurse will usually prepare and administer
Breast-feeding
the injection for you.
This medicine should not be used while breast-feeding
Your doctor will decide how much Palladone injection
because the active substance can get into breast milk.
you require based on:
Driving and using machines
• the severity of your pain;
This medicine may make you drowsy and thus impair
• the dose of painkiller you have previously been
your ability to drive and use machines. This applies
given;
particularly:
• your age and weight.
• at the beginning of treatment;
Your doctor will increase the amount of this medicine
• if your dose is increased;
you are given until your pain is relieved. If you find
• if you have switched to this medicine from a different
that you are still in pain whilst undergoing treatment
opioid.
with this medicine discuss this with your doctor.
• if you drink alcohol or use medicines which influence
You should not use Palladone 10 mg, [20 mg, 50 mg]
your brain function.
injection as initial opioid therapy. This higher strength
You should consult your doctor before driving or using
may only be used as individual doses if you have
machinery.
no longer sufficiently responded to lower doses of
This medicine can affect your ability to drive as it may
hydromorphone preparations (Palladone 2 mg) or
make you sleepy or dizzy.
comparably strong analgesics as part of long term pain
• Do not drive while taking this medicine until you know therapy.
how it affects you.
The usual starting doses of Palladone injection are as
• It is an offence to drive while you have this medicine
follows:
in your body over a specified limit unless you have a
Use in adults and adolescents (older than 12 years of
defence (called the ‘statutory defence’).
age)
• This defence applies when:
• As a single injection into a vein, the usual dose is
• The medicine has been prescribed to treat a medical
1 to 1.5 mg given slowly over 2 to 3 minutes. This
or dental problem; and
can be repeated every 3 to 4 hours.
• You have taken it according to the instructions given
• As a single injection through a fine needle into the
by the prescriber and in the information provided
tissue under the skin, the usual dose is 1 to 2 mg.
with the medicine.
This can be repeated every 3 to 4 hours.
• Please note that it is still an offence to drive if you are
unfit because of the medicine (i.e. your ability to drive • As an infusion into a vein or through a fine needle
into the tissue under the skin, the usual starting
is being affected).
dose is 0.15 to 0.45 mg/hour (or 0.004 mg/kg
Details regarding a new driving offence concerning
bodyweight/hour).
driving after drugs have been taken in the UK may be
• If given by patient controlled analgesia (PCA), the
found here: https://www.gov.uk/drug-driving-law
usual recommended bolus dose is 0.2 mg with a stop
Talk to your doctor or pharmacist if you are not sure
interval of 5 to 10 minutes.
whether it is safe for you to drive while taking this
Use
in children (under 12 years of age)
medicine.
Palladone injection is not recommended for children
Palladone injection contains sodium
under 12 years of age.
This medicine contains less than 1 mmol sodium (23 mg)
per ml, i.e. essentially “sodium-free”.

Information for Health Professionals
Palladone® 2 mg/ml, 10 mg/ml, 20 mg/ml and 50 mg/ml,
solutions for injection or infusion
Hydromorphone hydrochloride
This leaflet provides technical information for the healthcare
professional about Palladone 2 mg/ml, 10 mg/ml, 20 mg/ml
and 50 mg/ml, solutions for injection or infusion.
Posology and method of administration
Method of administration
Intravenous injection or infusion
Subcutaneous injection or infusion
Posology
The dosing of Palladone injection has to be adjusted to the
patients’ severity of pain and to their individual response.
The dose should be titrated until optimum analgesic effect is
achieved.
While a sufficiently high dose should generally be
administered, the smallest dose to achieve analgesia should be
aimed at in the individual case.
Palladone injection should not be administered for longer
than absolutely necessary. If long-term treatment is required
careful and regular monitoring should control whether and
to what degree further treatment is necessary. When a patient
no longer requires therapy with hydromorphone, it may
be advisable to taper the daily dose gradually to prevent
withdrawal symptoms.
Age

Bolus

Infants (Children < 12 years)
Palladone injection is not recommended for use in
children under 12 years, since there is not enough
evidence documented for this age group.
Elderly patients
Elderly patients (as a rule over 75 years) may require
a lower dosage than other adults to achieve adequate
analgesia.
Patients with hepatic and/or renal impairment
These patients may require lower doses than other
patient groups to achieve adequate analgesia. They
should be carefully titrated to clinical effect.

Palladone®
2 mg/ml, 10 mg/ml,
20 mg/ml and 50 mg/ml
solution for injection or infusion

Infusion

Adults and adolescents (> 12 years) ≥ 50 kg BW
subcutaneous
(s.c.) use

1-2 mg s.c. every
3-4 hours

0.15-0.45 mg/h

intravenous
(i.v.) use

1-1.5 mg i.v. every
3-4 hours to be
injected slowly
over at least
2-3 minutes

0.15-0.45 mg/h

PCA (s.c. and i.v.)

0.2 mg bolus, stop interval 5-10 min.

Children (<12 years)
Not recommended

12619479 0814

Package leaflet: Information for the user

670x200mm (LSN-CON-44) (L) V2

Use in patients with liver and kidney problems
If you suffer from liver or kidney problems, you may
require less of this medicine in order to relieve your pain.
Route of administration
A doctor or nurse will usually administer Palladone
injection for you.
This medicine is intended for injection or infusion into
a vein (intravenous = IV) or through a fine needle under
the skin (subcutaneous = SC).
Duration of treatment
This medicine should only be used as long as necessary.
Your doctor will decide when and how the treatment
will be stopped. If you get long term treatment, your
doctor should verify regularly whether you still need this
medicine. Do not stop the treatment without talking to
your doctor (see “If you stop using Palladone injection”).

If you use more Palladone injection than you should
Call your doctor, hospital or an ambulance straight away
as the patient may need emergency treatment in hospital.
In severe cases an overdose may lead to unconsciousness
or even death. The following symptoms may occur after
an overdose:
• pin point pupils;
• slowing of heartbeat;
• respiratory problems;
• low blood pressure;
• unconsciousness leading to coma.
If you have used too much Palladone injection under no
circumstances should you put yourself in a situation that
requires you to be alert e.g. driving a car.
When seeking medical attention make sure that you take
this leaflet and any remaining ampoules with you to show
to the doctor.
If you forget to use Palladone injection
Please use Palladone injection as soon as you notice that
you forgot a dose. Never double the dose.
If you forget to use Palladone injection or use a smaller
dose than prescribed, this will lead to unsatisfactory and/
or insufficient pain relief.
If you stop using Palladone injection
You should not suddenly stop using this medicine unless
your doctor tells you to. If you want to stop using this
medicine discuss this with your doctor first. If you
do stop using this medicine suddenly after extended
treatment, you may experience withdrawal symptoms
such as agitation, anxiety, nervousness, difficulty in
sleeping, involuntary muscle contractions, shaking, and
gastro-intestinal problems. Your doctor will tell you
how to stop your treatment, usually by reducing the dose
gradually so you do not experience unpleasant effects.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
This medicine can cause allergic reactions
(hypersensitivity reactions). The incidence of serious
allergic reactions (anaphylactic reactions) is not known.
Tell your doctor immediately if you get any sudden
wheeziness, difficulties in breathing, swelling of the

eyelids, face, lips, mouth or throat, or any rash or itching
especially those covering your whole body.
Difficulty in breathing (respiratory depression) is the
chief hazard of an opioid overdose.
Most people will have constipation when using
this medicine. Increasing the amount of fibre (fruit,
vegetables, wholemeal bread, pasta, brown rice) and
fluids you eat and drink may help reduce the problem, but
if necessary your doctor may prescribe a laxative.
You may feel sick or vomit (be sick) when you use this
medicine, this should normally wear off after a few days
however your doctor can prescribe an anti-vomiting
medicine if it continues to be a problem.
Very common side effects (may affect more than 1 in
10 people)
• dizziness, feel more sleepy than normal
• constipation, feel sick
Common side effects (may affect up to 1 in 10 people)
• confusion, anxiety, sleeplessness
• headache
• dry mouth, vomiting (be sick)
• itchy skin, sweating
• urgency in passing urine
• a feeling of unusual weakness
• loss of appetite
• abdominal pain or discomfort
• skin reactions at the injection site
Uncommon side effects (may affect up to 1 in 100
people)
• feeling of extreme happiness, hallucinations
• shaking, muscle spasms, tingling in the hands or feet
• blurred vision
• low blood pressure
• indigestion
• rash
• decreased sexual drive, impotence
• withdrawal symptoms such as agitation, anxiety,
nervousness, difficulty in sleeping, being unusually
overactive, shaking and gastrointestinal problems
• tiredness, generally feeling unwell
• swelling of hands, ankles or feet
• agitation, depression, nightmares
• shortness of breath
• diarrhoea, changes in taste
• difficulty in passing urine
• a worsening in liver function tests (seen in a blood test)

Rare side effects (may affect up to 1 in 1,000 people)
• sedation, lack of energy
• slow, fast or irregular heartbeat
• difficulty in breathing or wheezing
• a worsening in pancreas function tests (seen in a blood
test)
Very rare side effects (may affect up to 1 in 10,000
people)
• irritation and hardening of the skin at the injection
site (particularly after repeated subcutaneous
administration)
Side effects with unknown frequency (frequency
cannot be estimated from the available data)
• drug dependence, drug tolerance
• unpleasant or uncomfortable mood
• reduction in size of the pupils in the eye
• an increase in sensitivity to pain (hyperalgesia; see
“Warnings and precautions” in section 2)
• seizures, fits or convulsions
• uncontrolled muscle movements
• facial flushing (redness of the face)
• a condition where the small bowel (part of your gut)
does not work properly (paralytic ileus)
• itching rash (hives)
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 effects you can help provide more
information on the safety of this medicine.

5. How to store Palladone injection
Keep this medicine out of the sight and reach of children.
Keep the ampoules in the outer carton in order to protect
from light.
Do not use this medicine after the expiry date which is
stated on the carton and the ampoule label after “EXP”.
The expiry date refers to the last day of that month.
Instructions for stability of the medicinal product
after preparation
After opening, this medicine should be used immediately.
The physical and chemical in-use stability has been
demonstrated for a dilution of Palladone injection with

solutions for infusion/injection of sodium chloride
9 mg/ml (0.9%), glucose 50 mg/ml (5%) or water for
injections for 24 hours at 25°C.
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 2-8°C, unless opening/ dilution
has taken place in controlled and validated aseptic
conditions.
The medicine is to be visually inspected prior to use.
Only clear solutions free from particles should be used.
Do not use opened ampoules and previously diluted
solutions.
Instructions for stability after use or dilution:
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. Ask you 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 Palladone injection contains:
Palladone 2 mg/ml injection:
• The active substance is hydromorphone hydrochloride.
Each ampoule contains 2 mg hydromorphone
hydrochloride (corresponding to 1.77 mg
hydromorphone) in 1 ml solution.
Palladone 10 mg/ml injection:
• The active substance is hydromorphone hydrochloride.
Each ampoule contains 10 mg hydromorphone
hydrochloride (corresponding to 8.87 mg
hydromorphone) in 1 ml solution.
Palladone 20 mg/ml injection:
• The active substance is hydromorphone hydrochloride.
Each ampoule contains 20 mg hydromorphone
hydrochloride (corresponding to 17.7 mg
hydromorphone) in 1 ml solution.
Palladone 50 mg/ml injection:
• The active substance is hydromorphone hydrochloride.
Each ampoule contains 50 mg hydromorphone
hydrochloride (corresponding to 44.33 mg
hydromorphone) in 1 ml solution.

The other ingredients are:
• Citric acid anhydrous
• Sodium citrate
• Sodium chloride
• Sodium hydroxide
• Hydrochloric acid
• Water for injections
What Palladone injection looks like and contents
of the pack
Palladone injection is a clear, colourless to pale
yellow, pH 4.0 solution for injection or infusion
supplied in clear glass ampoules, available in packs
of 5 x 1 ml ampoules.
Marketing Authorisation Holder
Napp Pharmaceuticals Limited, Cambridge Science
Park, Milton Road, Cambridge CB4 0GW, UK.
Manufacturer
Bard Pharmaceuticals Limited, Cambridge Science
Park, Milton Road, Cambridge CB4 0GW, 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: Palladone solution for
injection or infusion
Reference number: 16950/0163
This leaflet was last revised in October 2015
® Palladone and the NAPP logo are registered trade
marks.
© 2012-2015 Napp Pharmaceuticals Limited

This leaflet was last revised in April 201
Cessation of therapy
When a patient no longer requires therapy with
® Palladone and the NAPP device (logo) are Registered
hydromorphone, it may be advisable to taper the daily
Trade Marks.
dose gradually to prevent withdrawal symptoms.
© 2012 Napp Pharmaceuticals Limited
Special precautions for disposal and other 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 ambient temperature
(25°C).
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 2-8 °C, unless opening/dilution,
etc has taken place in controlled and validated aseptic
conditions.
No evidence of incompatibility was observed between
Palladone injection and representative brands of
injectable forms of the following drugs, when stored
in high and low dose combinations in polypropylene
syringes over a 24 hour period at ambient temperature.
Hyoscine butylbromide
Hyoscine hydrobromide
Dexamethasone sodium phosphate
Haloperidol
Midazolam hydrochloride
Metoclopramide hydrochloride
Levomepromazine hydrochloride
Glycopyrronium bromide
Ketamine hydrochloride
Palladone injection, undiluted or diluted with 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 ambient temperature
(25°C).
The injection, whether undiluted or diluted 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.

12619479 0814

Use in elderly patients (over 75 years of age)
A lower dosage might be enough for adequate pain relief
in elderly patients.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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