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460x148mm (LSN-NAPP-02) (L) V1


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460x148mm (LSN-NAPP-02)(L) V1

PALLADONE SR CAPS PIL UK 7354-11 V1.indd 1

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11/01/2017 13:06


460x148mm (LSN-NAPP-02) (L) V1

Package leaflet: Information for the user
Palladone® SR 2 mg, 4 mg, 8 mg, 16 mg and
24 mg prolonged-release 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.
In this leaflet:
1. What Palladone SR capsules are and
what they are used for
2. What you need to know before you
take Palladone SR capsules
3. How to take Palladone SR capsules
4. Possible side effects
5. How to store Palladone SR capsules
6. Contents of the pack and other

PALLADONE SR CAPS PIL UK 7354-11 V1.indd 2

1. What Palladone SR capsules are
and what they are used for
These capsules have been prescribed
for you to relieve severe pain over a
period of 12 hours. 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 SR capsules
Do not take Palladone SR capsules if
• 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.
If you are going to have an operation,
please tell the doctor at the hospital that
you are taking these capsules.
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
• suffer from seizures, fits or
• 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
• have low blood pressure
• 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 lightheaded, 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
• 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’).
Other medicines and Palladone SR
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 type of medicine known as a
monoamine oxidase inhibitor, or if you
have taken this type of medicine in the
last two weeks (see section 2 ‘Do not
Tell your doctor or pharmacist if you are
• medicines to help you sleep or stay
calm (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
• other strong analgesics or
Also tell your doctor if you have recently
been given an anaesthetic.
Palladone SR capsules with alcohol
Drinking alcohol whilst taking
Palladone SR capsules 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 whilst
you are taking Palladone SR 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.
Newborn babies may suffer withdrawal
effects (such as high-pitched cry,
jitteriness, fits, poor feeding and
diarrhoea) if their mothers have taken
hydromorphone for a long time during
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

• 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:
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
drive while taking this medicine.
3. How to take Palladone SR
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 4 mg
capsule every 12 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.

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
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. Do not crush
or chew the capsule or the capsule
Palladone SR capsules are designed
to work properly over 12 hours. If
the capsule contents are crushed,
dissolved or chewed, the entire 12hour dose may be absorbed rapidly
into your body. The capsule contents
should never be injected. This can be
dangerous, causing serious problems
such as an overdose, which may be
You should take your capsules every
12 hours. For instance, if you take a
capsule at 8 o’clock in the morning,
you should take your next capsule at
8 o’clock in the evening.

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460x148mm (LSN-NAPP-02) (L) V1

If you take more Palladone SR
capsules than you should or if
someone accidentally swallows your
Call your doctor or hospital straight
away as you may need emergency
treatment in hospital. People who
have taken an overdose may feel very
sleepy, sick, dizzy or get pneumonia
from inhaling vomit or foreign matter
(symptoms may include breathlessness,
cough and fever). They may also
have breathing difficulties leading
to unconsciousness, or even death.
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 SR
If you remember within 4 hours of the
time your capsule was due, take your
capsule straight away. Take your next
capsule at your normal time. If you are
more than 4 hours late, please call your
doctor or pharmacist for advice. Do
not take a double dose to make up for a
forgotten capsule.
If you stop taking Palladone SR
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,

PALLADONE SR CAPS PIL UK 7354-11 V1.indd 3

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
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, mouth or throat, or any 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
• Headache.
• Being sick, abdominal pain, dry
• A feeling of unusual weakness.
• Itchy skin, sweating.
Uncommon side effects (may affect up
to 1 in 100 people)
• Agitation, depression, hallucinations,
• 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-SR
• 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
• 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).

• Withdrawal symptoms in babies
born to mothers who have used
hydromorphone (see “Pregnancy and
breastfeeding” in section 2).

away medicines you no longer use.
These measures will help to protect the

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

6. Contents of the pack and other

5. How to store Palladone SR
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”. The expiry date
refers to the last day of that month.
Do not store your capsules above 25oC.
Store in the original package.
Do not take your capsules if they
are broken or crushed as this can
be dangerous and can cause serious
problems such as overdose.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to throw

What Palladone SR capsules contain
The active ingredient is hydromorphone
hydrochloride. Each capsule contains
2 mg, 4 mg, 8 mg, 16 mg or 24 mg of
hydromorphone hydrochloride.
The other ingredients are:
• Microcrystalline cellulose
• Hypromellose
• Ethylcellulose
• Colloidal anhydrous silica
• Dibutyl sebacate
• Gelatin
• Sodium laurilsulfate
• Shellac
• Propylene glycol
• Titanium dioxide (E171)
• Iron oxide (E172)
The capsules also contain the following
2 mg capsule – Quinoline yellow (E104)
4 mg capsule – Erythrosine (E127) and
indigo carmine (E132)
8 mg capsule – Erythrosine (E127)
16 mg capsule – Iron oxide (E172)
24 mg capsule – Indigo carmine (E132)

What Palladone SR capsules look like
and the contents of the pack
The capsules have a hard gelatin
shell containing spherical pellets. The
capsules are marked HCR followed
by the strength (e.g. 2, 4 etc.) and are
coloured as follows: 2 mg – yellow/
4 mg – pale blue/clear,
8 mg – pink/clear, 16 mg – brown/clear,
24 mg – dark blue/clear.
In each box there are 56 capsules.

Marketing Authorisation Holder and
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 SR prolonged-release capsules
Reference number: 16950/0051
This leaflet was last revised in November 2016.
® Palladone, NAPP and the NAPP logo are registered trade marks.
© 2011-2014 Napp Pharmaceuticals Limited.

11/01/2017 13:06

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