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OXYNORM 20MG CAPSULES

Active substance(s): OXYCODONE HYDROCHLORIDE

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Assessed against UK user tested PIL granted 06/07/2009

MOCK UP

By berrys at 12:32 pm, Feb 10, 2010

PACKAGE LEAFLET: INFORMATION FOR THE USER

ƒ

®

OXYNORM 20MG CAPSULES
(oxycodone hydrochloride)

Your medicine is available using the name OxyNorm 20mg
Capsules but will be referred to as OxyNorm throughout this
leaflet.

Read this leaflet carefully before you start
taking this medicine.
ƒ
ƒ
ƒ

ƒ

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
onto others. It may harm them, even if their symptoms are
the same as yours.
If any of the side effects becomes serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What OxyNorm are and what they are used for
Before you take OxyNorm
How to take OxyNorm
Possible side effects
How to store OxyNorm
Further information

1. What OxyNorm is and what it is used for
These capsules have been prescribed for you by your doctor to
relieve moderate to severe pain. They contain the active
ingredient oxycodone which belongs to a group of medicines
called strong analgesics or ‘painkillers’.

2. Before you take OxyNorm
Do not take OxyNorm if you:
ƒ

ƒ

ƒ

ƒ

ƒ
ƒ

ƒ

are allergic (hypersensitive) to oxycodone, or any of the
other ingredients of the capsules (see section 6 ‘Further
Information’);
have breathing problems, such as chronic obstructive
airways disease, chronic bronchial asthma or respiratory
depression. Your doctor will have told you if you have any of
these conditions. Symptoms may include breathlessness,
coughing or breathing more slowly or weakly than expected;
have a head injury that causes a severe headache or makes
you feel sick. This is because the capsules may make these
symptoms worse or hide the extent of the head injury;
have a condition where the small bowel does not work
properly (paralytic ileus), your stomach empties more slowly
than it should (delayed gastric emptying) or you have
severe pain in your abdomen;
have a heart problem after long-term lung disease (cor
pulmonale);
have severe kidney problems or moderate to severe liver
problems. If you have other long-term kidney or liver
problems you should only take these capsules if
recommended by your doctor;
have ongoing problems with constipation;

ƒ

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;
are under 18 years of age.

Take special care with OxyNorm

Before treatment with these capsules tell your doctor or
pharmacist if you:
ƒ
have an under-active thyroid gland (hypothyroidism), as you
may need a lower dose;
ƒ
have a severe headache or feel sick as this may indicate that
the pressure in your skull is increased;
ƒ
have low blood pressure (hypotension);
ƒ
have a mental disorder as a result of an infection (toxic
psychosis);
ƒ
have inflammation of the pancreas (which causes severe
pain in the abdomen and back) or problems with your gall
bladder;
ƒ
have inflammatory bowel disease;
ƒ
have prostrate problems;
ƒ
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);
ƒ
have breathing problems such as severe pulmonary disease.
Your doctor will have told you if you have this condition.
Symptoms may include breathlessness and coughing;
ƒ
are or ever have been addicted to alcohol or drugs;
ƒ
have previously suffered from withdrawal symptoms such as
agitation, anxiety, shaking or sweating, upon stopping
taking 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 these 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 on the
last two weeks (see Section 2 “Do not take…”).

Tell your doctor or pharmacist if you are taking:
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

medicines to help you sleep (for example tranquilisers,
hypnotics or sedatives);
medicines to treat depression;
medicines to treat psychiatric or mental disorders (such as
phenothiazines or neuroleptic drugs);
Other strong analgesics or ‘painkillers’;
muscle relaxants;
medicines to treat high blood pressure;
quinidine (a medicine to treat a fast heart beat);
cimetidine (a medicine for stomach ulcers, indigestion or
heartburn);
antifungal medicines (such as ketoconazole);
antibiotics (such as erythromycin).

Also tell your doctor if you have recently been given an
anaesthetic.
Page 1 of 2

Taking OxyNorm 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 may 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.

3. How to take OxyNorm
Always take these 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 (over 18 years of age)

The usual starting dose is one 5mg capsule every 4 to 6 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

Children and adolescents under 18 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 water. Do not chew or crush
them.
You must only take the capsules by mouth. The capsules contents
should never be injected as this may lead to serious side effects,
which may be fatal.

If you take more OxyNorm 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 to the doctor.

If you forget to take OxyNorm

If you miss a dose you should take the next dose as soon as you
remember then carry on as before. Do not take two doses within
4 hours. Do not take a double dose to make up for forgotten
capsules.

If you stop taking OxyNorm

You should not suddenly 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 effects. Withdrawal symptoms such as
agitation, anxiety, palpitations, 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 rare. 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.

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Uncommonly, these capsules may affect the results of blood tests
to check that your liver is working properly.
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 OxyNorm
ƒ

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 that you may become
addicted or reliant on these capsules.

ƒ
ƒ

Common side effects

ƒ

(Probably affecting more than 1 in 100 people taking these
capsules.)
ƒ
Constipation (your doctor can prescribe a laxative to
overcome this problem).
ƒ
Feeling or being sick (this should normally wear off after a
few days, however your doctor can prescribe an antisickness medicine if it continues to be a problem).
ƒ
Drowsiness (this is most likely when you start taking your
capsules or when your dose is increased, but it should wear
off after a few days).
ƒ
Dry mouth, loss of appetite, indigestion, abdominal pain or
discomfort, diarrhoea.
ƒ
Headache, confusion, a feeling of unusual weakness,
dizziness, anxiety, nervousness, twitching, difficulty in
sleeping, abnormal thoughts or dreams.
ƒ
Difficulty in breathing or wheezing, shortness of breath,
decreased cough reflex.
ƒ
Rash, itchy skin.
ƒ
Sweating, chills.

Uncommon side effects

(Probably affecting fewer than 1 in 100 people taking these
capsules)
ƒ
Difficulty in swallowing, belching, hiccups, wind,
gastrointestinal disorders (e.g. upset stomach), changes in
taste.
ƒ
A feeling of dizziness or ‘spinning’, a feeling of ‘faintness’
especially on standing up, hallucinations, mood changes,
depression, a feeling of extreme happiness, restlessness,
agitation, generally feeling unwell, loss of memory, shaking,
difficulties with speech, reduced sensitivity to pain or touch,
tingling or numbness, seizures, fits or convulsions, blurred
vision.

Difficulty in passing urine, impotence, decreased sexual
drive, absence of menstrual periods.
Fast, irregular heart beat, low blood pressure, flushing of the
skin.
Dehydration, thirst, swelling of the hands, ankles or feet.
Dry skin, severe flaking or peeling of the skin.
Redness of the face, reduction in size of the pupils in the
eye, muscle spasm, high temperature.
A need to take increasingly higher doses to obtain the same
level of pain relief (tolerance).

ƒ

There is a 'use-by' date on the label. For example, EXP
8.2005 means that you should not take the capsules after
the end of August 2005. After the 'use-by' date, or if you
have any unused capsules, take them to a pharmacy for safe
disposal.
Do not store above 30°C.
Keep out of the reach and sight of children. Accidental
overdose by a child is dangerous and may be fatal.
If your capsules appear discoloured or show any other signs
of deterioration, take them to your pharmacist who will
advise you.
If your doctor tells you to stop taking the capsules, please
take them back to the pharmacist for safe disposal. Only
keep the capsules if your doctor tells you to.

6. Further information
What OxyNorm contains

Each hard capsule contains the active ingredient oxycodone as
20mg of oxycodone hydrochloride.
The following ingredients are also included in OxyNorm, but they
are not medicines:
ƒ
Cellulose microcrystalline
ƒ
Indigo carmine (E132)
ƒ
Yellow iron oxide
ƒ
Red iron oxide
ƒ
Sodium lauryl sulphate
ƒ
Titanium dioxide (E171)
ƒ
Gelatin
ƒ
Magnesium stearate

What OxyNorm looks like and the contents of the
pack
In each box there are blister packs of 14 or 56 capsules.

OxyNorm 20mg capsules are hard capsules with a pink body
printed with '20' in black ink and a beige cap with 'ONR' printed in
black ink.

Page 2 of 2

Who makes your medicine

The capsules are manufactured by: Bard Pharmaceuticals Ltd,
Cambridge Science Park, Milton Road, Cambridge,
Cambridgeshire, CB4 0GW, United Kingdom.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR
CD

POM

PL No: 08929/0520

Leaflet issue and revision date (Ref): 08.02.10
OxyNorm® is a registered trademark of Mundipharma AG.
This leaflet is also available in large print, Braille or audio. To
request a copy, please call 01302 554841. You will need to give
details of the product name and reference number.
These are as follows:
Product name:
OxyNorm 20mg Capsules
Reference number: 08929/0520

PACKAGE LEAFLET: INFORMATION FOR THE USER

ƒ

OXYCODONE 20MG CAPSULES
(oxycodone hydrochloride)

Your medicine is available using the name Oxycodone 20mg
Capsules but will be referred to as Oxycodone throughout this
leaflet.

Read this leaflet carefully before you start
taking this medicine.
ƒ
ƒ
ƒ

ƒ

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
onto others. It may harm them, even if their symptoms are
the same as yours.
If any of the side effects becomes serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Oxycodone are and what they are used for
Before you take Oxycodone
How to take Oxycodone
Possible side effects
How to store Oxycodone
Further information

1. What Oxycodone is and what it is used for
These capsules have been prescribed for you by your doctor to
relieve moderate to severe pain. They contain the active
ingredient oxycodone which belongs to a group of medicines
called strong analgesics or ‘painkillers’.

2. Before you take Oxycodone
Do not take Oxycodone if you:
ƒ

ƒ

ƒ

ƒ

ƒ
ƒ

ƒ

are allergic (hypersensitive) to oxycodone, or any of the
other ingredients of the capsules (see section 6 ‘Further
Information’);
have breathing problems, such as chronic obstructive
airways disease, chronic bronchial asthma or respiratory
depression. Your doctor will have told you if you have any of
these conditions. Symptoms may include breathlessness,
coughing or breathing more slowly or weakly than expected;
have a head injury that causes a severe headache or makes
you feel sick. This is because the capsules may make these
symptoms worse or hide the extent of the head injury;
have a condition where the small bowel does not work
properly (paralytic ileus), your stomach empties more slowly
than it should (delayed gastric emptying) or you have
severe pain in your abdomen;
have a heart problem after long-term lung disease (cor
pulmonale);
have severe kidney problems or moderate to severe liver
problems. If you have other long-term kidney or liver
problems you should only take these capsules if
recommended by your doctor;
have ongoing problems with constipation;

ƒ

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;
are under 18 years of age.

Take special care with Oxycodone

Before treatment with these capsules tell your doctor or
pharmacist if you:
ƒ
have an under-active thyroid gland (hypothyroidism), as you
may need a lower dose;
ƒ
have a severe headache or feel sick as this may indicate that
the pressure in your skull is increased;
ƒ
have low blood pressure (hypotension);
ƒ
have a mental disorder as a result of an infection (toxic
psychosis);
ƒ
have inflammation of the pancreas (which causes severe
pain in the abdomen and back) or problems with your gall
bladder;
ƒ
have inflammatory bowel disease;
ƒ
have prostrate problems;
ƒ
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);
ƒ
have breathing problems such as severe pulmonary disease.
Your doctor will have told you if you have this condition.
Symptoms may include breathlessness and coughing;
ƒ
are or ever have been addicted to alcohol or drugs;
ƒ
have previously suffered from withdrawal symptoms such as
agitation, anxiety, shaking or sweating, upon stopping
taking 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 these 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 on the
last two weeks (see Section 2 “Do not take…”).

Tell your doctor or pharmacist if you are taking:
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

medicines to help you sleep (for example tranquilisers,
hypnotics or sedatives);
medicines to treat depression;
medicines to treat psychiatric or mental disorders (such as
phenothiazines or neuroleptic drugs);
Other strong analgesics or ‘painkillers’;
muscle relaxants;
medicines to treat high blood pressure;
quinidine (a medicine to treat a fast heart beat);
cimetidine (a medicine for stomach ulcers, indigestion or
heartburn);
antifungal medicines (such as ketoconazole);
antibiotics (such as erythromycin).

Also tell your doctor if you have recently been given an
anaesthetic.
Page 1 of 2

Taking Oxycodone 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 may 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.

3. How to take Oxycodone
Always take these 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 (over 18 years of age)

The usual starting dose is one 5mg capsule every 4 to 6 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

Children and adolescents under 18 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 water. Do not chew or crush
them.
You must only take the capsules by mouth. The capsules contents
should never be injected as this may lead to serious side effects,
which may be fatal.

If you take more Oxycodone 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 to the doctor.

If you forget to take Oxycodone

If you miss a dose you should take the next dose as soon as you
remember then carry on as before. Do not take two doses within
4 hours. Do not take a double dose to make up for forgotten
capsules.

If you stop taking Oxycodone

You should not suddenly 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 effects. Withdrawal symptoms such as
agitation, anxiety, palpitations, 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 rare. 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.

ƒ
ƒ
ƒ
ƒ
ƒ
ƒ

Uncommonly, these capsules may affect the results of blood tests
to check that your liver is working properly.
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 Oxycodone
ƒ

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 that you may become
addicted or reliant on these capsules.

ƒ
ƒ

Common side effects

ƒ

(Probably affecting more than 1 in 100 people taking these
capsules.)
ƒ
Constipation (your doctor can prescribe a laxative to
overcome this problem).
ƒ
Feeling or being sick (this should normally wear off after a
few days, however your doctor can prescribe an antisickness medicine if it continues to be a problem).
ƒ
Drowsiness (this is most likely when you start taking your
capsules or when your dose is increased, but it should wear
off after a few days).
ƒ
Dry mouth, loss of appetite, indigestion, abdominal pain or
discomfort, diarrhoea.
ƒ
Headache, confusion, a feeling of unusual weakness,
dizziness, anxiety, nervousness, twitching, difficulty in
sleeping, abnormal thoughts or dreams.
ƒ
Difficulty in breathing or wheezing, shortness of breath,
decreased cough reflex.
ƒ
Rash, itchy skin.
ƒ
Sweating, chills.

Uncommon side effects

(Probably affecting fewer than 1 in 100 people taking these
capsules)
ƒ
Difficulty in swallowing, belching, hiccups, wind,
gastrointestinal disorders (e.g. upset stomach), changes in
taste.
ƒ
A feeling of dizziness or ‘spinning’, a feeling of ‘faintness’
especially on standing up, hallucinations, mood changes,
depression, a feeling of extreme happiness, restlessness,
agitation, generally feeling unwell, loss of memory, shaking,
difficulties with speech, reduced sensitivity to pain or touch,
tingling or numbness, seizures, fits or convulsions, blurred
vision.

Difficulty in passing urine, impotence, decreased sexual
drive, absence of menstrual periods.
Fast, irregular heart beat, low blood pressure, flushing of the
skin.
Dehydration, thirst, swelling of the hands, ankles or feet.
Dry skin, severe flaking or peeling of the skin.
Redness of the face, reduction in size of the pupils in the
eye, muscle spasm, high temperature.
A need to take increasingly higher doses to obtain the same
level of pain relief (tolerance).

ƒ

There is a 'use-by' date on the label. For example, EXP
8.2005 means that you should not take the capsules after
the end of August 2005. After the 'use-by' date, or if you
have any unused capsules, take them to a pharmacy for safe
disposal.
Do not store above 30°C.
Keep out of the reach and sight of children. Accidental
overdose by a child is dangerous and may be fatal.
If your capsules appear discoloured or show any other signs
of deterioration, take them to your pharmacist who will
advise you.
If your doctor tells you to stop taking the capsules, please
take them back to the pharmacist for safe disposal. Only
keep the capsules if your doctor tells you to.

6. Further information
What Oxycodone contains

Each hard capsule contains the active ingredient oxycodone as
20mg of oxycodone hydrochloride.
The following ingredients are also included in Oxycodone, but
they are not medicines:
ƒ
Cellulose microcrystalline
ƒ
Indigo carmine (E132)
ƒ
Yellow iron oxide
ƒ
Red iron oxide
ƒ
Sodium lauryl sulphate
ƒ
Titanium dioxide (E171)
ƒ
Gelatin
ƒ
Magnesium stearate

What Oxycodone looks like and the contents of the
pack
In each box there are blister packs of 14 or 56 capsules.

Oxycodone 20mg capsules are hard capsules with a pink body
printed with '20' in black ink and a beige cap with 'ONR' printed in
black ink.

Page 2 of 2

Who makes your medicine

The capsules are manufactured by: Bard Pharmaceuticals Ltd,
Cambridge Science Park, Milton Road, Cambridge,
Cambridgeshire, CB4 0GW, United Kingdom.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd, Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR
CD

POM

PL No: 08929/0520

Leaflet issue and revision date (Ref): 08.02.10
This leaflet is also available in large print, Braille or audio. To
request a copy, please call 01302 554841. You will need to give
details of the product name and reference number.
These are as follows:
Product name:
Oxycodone 20mg Capsules
Reference number: 08929/0520

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.

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