PALLADONE SR 2MG PROLONGED-RELEASE CAPSULES

Active substance: HYDROMORPHONE HYDROCHLORIDE

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7354-9

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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.
• 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 symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Palladone SR capsules are and
what they are used for
2. 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. Further information

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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. Before you take Palladone SR
capsules
Do not take Palladone SR capsules if you:
• are allergic (hypersensitive) to
hydromorphone or any of the other
ingredients of the capsules (see section
6 ‘Further Information’);
• 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 tranylcypromide,
phenelzine, isocarboxazid,
moclobemide and linezolid), or you
have taken this type of medicine in the
last two weeks;
• 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;
• are or have ever been addicted to alcohol;
• 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.

Take special care with Palladone SR
capsules
Before treatment with these capsules tell
your doctor or pharmacist 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 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 addicted to drugs 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.

Very rarely you may experience
increased sensitivity to pain despite the
fact that you are taking increasing doses
of these capsules (hyperalgesia). Your
doctor will decide whether you need a
change in dose or a change in strong
analgesic (‘painkiller’).

• 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.

Taking other medicines
Please tell your doctor or pharmacist
if you are taking or have recently
taken any other medicines, including
medicines obtained without a
prescription. 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
take…’).
Tell your doctor or pharmacist if you are
taking:
• 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;

Taking 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’re taking Palladone SR.
Pregnancy and breastfeeding
Do not take these capsules if you are
pregnant or breastfeeding.
Ask your doctor or pharmacist for
advice before taking any 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.

3. How to take Palladone SR 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 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
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. Do not crush
or chew the capsule or the capsule
contents.

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Palladone SR capsules are designed to
work properly over 12 hours. If the
capsule contents are crushed, dissolved
or chewed, the entire 12-hour 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 fatal.
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.
If you take more Palladone SR
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 SR
capsules
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

PALLADONE SR CAPS PIL UK 7354-9 V2.indd 3

doctor or pharmacist for advice. Do
not take a double dose to make up for a
forgotten capsule.
If you stop taking Palladone SR
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.
All medicines can very rarely 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
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.
Common side effects (Probably
affecting more than 1 in 100 people
taking these capsules)
• Constipation (your doctor can
prescribe a laxative to overcome this
problem).
• Loss of appetite, abdominal pain or
discomfort.
• 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 first start taking your capsules or
when your dose is increased, but it
should wear off after a few days).
• Difficulty in sleeping, feeling more
sleepy that usual.
• Low blood pressure.
• Dry mouth.
• Anxiety, confusion.

• A feeling of unusual weakness,
confusion or dizziness.
• Rash or itchy skin.
• Sweating.
• Difficulty in passing urine.
Uncommon side effects (Probably
affecting fewer than 1 in 100 people
taking these capsules)
• A condition where the small bowel
(part of your gut) does not work
properly (paralytic ileus), abdominal
pain or discomfort, diarrhoea,
changes in taste.
• Swelling of the hands, ankles or feet.
• Tingling or numbness.
• A fast heart beat
• A feeling of extreme happiness,
mood changes or agitation.
• Hallucinations, depression,
nightmares.
• Shortness of breath.
• Blurred vision or a reduction in size
of the pupils in the eye.
• Uncontrolled muscle movements,
muscle spasms.
• Impotence.
• Headache.
• Shaking.
• An increase in sensitivity to pain.
• Seizures, fits or convulsions.
• A need to take increasingly higher
doses to obtain the same level of
pain relief (tolerance).

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 SR
capsules
Keep out of the reach and sight 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.
Medicines should not be disposed of
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines no longer required.
These measures will help to protect the
environment.

6. Further information
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 dodecyl sulphate
• Shellac
• Propylene glycol
• Titanium dioxide (E171)
• Iron oxide (E172)
The capsules also contain the following
colourants:
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/white,
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
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 SR prolonged-release capsules
Reference number: 16950/0051
This leaflet was last revised in January 2014
® Palladone and the NAPP device (logo) are Registered Trade Marks.
© 2011-2014 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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