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PALLADONE 2.6MG CAPSULES

Active substance(s): HYDROMORPHONE HYDROCHLORIDE

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7360-8

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Package Leaflet: Information for the user

Palladone® 1.3 mg and 2.6 mg capsules
Hydromorphone hydrochloride

Read all of this leaflet carefully before
you start taking 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.
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 or pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.

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In this leaflet:
1. What Palladone capsules are and what they
are used for
2. What you need to know before you take
Palladone capsules
3. How to take Palladone capsules
4. Possible side effects
5. How to store Palladone capsules
6. Contents of the pack and other information
1. What Palladone capsules are and what
they are used for
These capsules have been prescribed for you
to relieve severe pain. They contain the active
ingredient hydromorphone which belongs to a
group of medicines called strong analgesics or
‘painkillers’.

2. What you need to know before you
take Palladone capsules
Do not take Palladone capsules if you:
• are allergic to hydromorphone or to any of
the other ingredients of the capsules (listed
in section 6);
• have a condition where you breathe more
slowly or weakly than expected (respiratory
depression);
• have a severe pain in your abdomen;
• have liver problems;
• 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;
• are under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before
taking this medicine if you:
• have breathing problems, such as severely
impaired pulmonary function, chronic
obstructive airways disease or reduced
respiratory reserve. Your doctor will have
told you if you have any of these conditions.
Symptoms may include breathlessness and
coughing;

• have a severe headache or feel sick due to
a head injury or increased pressure in your
skull (for instance due to brain disease). This
is because the capsules may make symptoms
worse or hide the extent of a head injury;
• suffer from seizures, fits or convulsions;
• 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 an under-active thyroid gland
(hypothyroidism);
• have low blood pressure (hypotension);
• have kidney problems;
• 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);
• have prostate problems;
• are suffering from shock (this may make you
suddenly feel very light-headed, faint, cold or
clammy and look pale);
• are or have ever been addicted to either alcohol
or drugs;
• have withdrawal symptoms such as agitation,
anxiety, shaking or sweating upon stopping
alcohol or drugs;
• have an increase in sensitivity to pain. Your
doctor will decide whether you need a change
in dose or a change in strong analgesic
(‘painkiller’).
If you are going to have an operation, please tell
the doctor at the hospital that you are taking these
capsules.

Other medicines Palladone capsules
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. If you take these capsules
with some other medicines, the effect of
the capsules or the other medicine may be
changed.
These capsules must not be used together with
a monoamine oxidase inhibitor, or if you have
taken this type of medicine in the last two
weeks (see section 2 ‘Do not take…’).
Tell your doctor or pharmacist if you are
taking:
• medicines to help you sleep (for example
tranquillisers, hypnotics or sedatives);
• medicines known as barbiturates to either
treat fits or to help you sleep;
• medicines to stop you feeling or being sick;
• medicines to treat depression;
• medicines to treat psychiatric or mental
disorders (such as neuroleptics);
• other strong analgesics or ‘painkillers’.
Also tell your doctor if you have recently been
given an anaesthetic.
Palladone capsules with alcohol
Drinking alcohol during your treatment
with these capsules 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 whilst you
are taking Palladone capsules.

Pregnancy and breastfeeding
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.
Driving and using machines
These capsules may cause a number of side
effects such as drowsiness, which could
affect your ability to drive or use machinery
(see section 4 for a full list of side effects).
These are usually most noticeable when
you first start taking the capsules, or
when changing 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 medicine.
Palladone capsules contain lactose
These capsules contain lactose which is a
form of sugar. If you have been told by your
doctor that you have an intolerance to some
sugars, contact your doctor before taking these
capsules.
3. How to take Palladone capsules
Always take the capsules exactly as your
doctor has told you. The label on your
medicine will tell you how many capsules to
take and how often.
Adults and children over 12 years of age
The usual starting dose is one capsule every
4 hours. However, your doctor will prescribe
the dose required to treat your pain. If you find
that you are still in pain whilst taking these
capsules, discuss this with your doctor.

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Children under 12 years of age
Children under 12 years of age should not take
the capsules.
Do not exceed the dose recommended by your
doctor. You should check with your doctor or
pharmacist if you are not sure.
Swallow your capsules whole with a glass of
water. If you prefer, you can open the capsules
and sprinkle the contents on to cold soft food,
such as yoghurt. You must only take the capsules
by mouth.
The capsule contents should never be injected as
this may lead to serious side effects, which may
be fatal.
If you take more Palladone capsules than you
should or if someone accidentally swallows
your capsules
Call your doctor or hospital straight away.
People who have taken 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 capsules with you to show the doctor.
If you forget to take Palladone capsules
If you miss a dose you should take it as soon as
you remember and then carry on as before. Do
not take two doses within 4 hours. Do not take a
double dose to make up for a forgotten capsule.

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If you stop taking Palladone capsules
You should not stop taking these capsules
unless your doctor tells you to. If you want to
stop taking your capsules, 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 side effects.
Withdrawal symptoms such as agitation,
anxiety, shaking or sweating may occur if you
suddenly stop taking these capsules.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, these capsules can cause
side effects, although not everybody gets
them.
This medicine can cause allergic reactions.
The incidence of serious allergic reactions is
not known. 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).
As with all strong painkillers, there is a risk
you may become addicted or reliant on these
capsules.

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, constipation, feel sick.
• Drowsiness (this is most likely when you
first start taking your capsules or when your
dose is increased, but it should wear off
after a few days).
Common side effects (may affect up to 1 in
10 people)
• Loss of appetite.
• Confusion, anxiety, difficulty sleeping.
• Headache.
• Being sick, abdominal pain, dry mouth.
• A feeling of unusual weakness.
• Itchy skin, sweating.
Uncommon side effects (may affect up to 1 in
100 people)
• Agitation, depression, hallucinations,
nightmares.
• A feeling of extreme happiness.
• Muscle spasms, shaking, tingling in the
hands or feet.







Blurred vision.
Low blood pressure.
Shortness of breath.
Diarrhoea, changes in taste.
A worsening in liver function tests (seen in
a blood test)
• Rash.
• Difficulty in passing urine.
• Impotence.
• Withdrawal symptoms (see section 3, If you
stop taking Palladone capsules).
• Tiredness, generally feeling unwell.
• Swelling of the hands, ankles or feet.
Rare side effects (may affect up to 1 in 1,000
people)
• Sedation, lack of energy.
• Fast heartbeat.
• A condition where you breathe more slowly
and weakly than expected
Side effects with unknown frequency
(frequency cannot be estimated from the
available data)
• Allergic reactions.
• 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 capsules
Keep this medicine out of the sight and reach
of children.
Do not use any capsules after the expiry date
which is stated on the blister and carton after
“EXP”.
Do not store your capsules above 25°C. Store
in the original package.
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.

6. Contents of the pack and other
information
What Palladone capsules contain
The active ingredient is hydromorphone
hydrochloride. Each capsule contains 1.3 mg
or 2.6 mg of hydromorphone hydrochloride.
The other ingredients are:
• Microcrystalline cellulose
• Lactose
• Gelatin
• Sodium laurilsulfate
• Erythrosine (E127)
• Shellac
• Propylene glycol
• Titanium dioxide (E171)
• Iron oxide (E172)

What Palladone capsules look like and
the contents of the pack
The capsules have a hard gelatin shell
containing spherical pellets. The capsules
are marked HNR followed by the strength
(e.g. 1.3) and are coloured as follows:
1.3 mg - orange/clear, 2.6 mg - red/clear.
In each box there are 56 capsules.
Marketing Authorisation Holder and
Manufacturer
The capsules are made by Bard
Pharmaceuticals Limited for the marketing
authorisation holder Napp Pharmaceuticals
Limited, both at 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 capsules
Reference number: 16950/0049
This leaflet was last revised in June 2015.
Palladone® capsules are protected by UK Patent No 2264640.
® Palladone, NAPP and the NAPP logo are registered trade marks.
© 2009-2014 Napp Pharmaceuticals Limited

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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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