PALLADONE 2.6MG CAPSULES

Active substance: HYDROMORPHONE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.
• 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 capsules are and what they
are used for
2. Before you take Palladone capsules
3. How to take Palladone capsules
4. Possible side effects
5. How to store Palladone capsules
6. Further 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. Before you take Palladone capsules
Do not take Palladone 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 addicted to alcohol;
• are under 12 years of age.

Take special care with Palladone 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.
If you are going to have an operation, please tell
the doctor at the hospital that you are taking these
capsules.

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 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.

Taking Palladone capsules with alcohol
Drinking alcohol during your treatment
with these capsules may make you sleepy. If
you are affected you should avoid drinking
alcohol.
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.
Important information about some of the
ingredients of Palladone capsules
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.
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.
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.
All medicines can cause allergic reactions,
although serious allergic reactions are
uncommon. 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.
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).
• 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).
• Low blood pressure.
• Dry mouth.

• 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.
• Swelling of the hands, ankles or feet.
• A feeling of extreme happiness, mood
changes or agitation.
• Hallucinations.
• Blurred vision or a reduction in size of the
pupils in the eye.
• Uncontrolled muscle movements.
• 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).
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.

5. How to store Palladone 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.
EXP 08 2010 means that you should not take
the capsules after the last day of that month
i.e. August 2010.
Do not store your capsules above 25ºC. Store
in the original package.
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 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 dodecyl sulphate
• 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 05/2009

Palladone® capsules are protected by UK Patent No 2264640.
® Palladone and the NAPP device (logo) are Registered Trade Marks.
© 2009 Napp Pharmaceuticals Limited

Expand view ⇕

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.

Hide
(web5)