OXYCODONE HYDROCHLORIDE 5MG/5ML ORAL SOLUTION

Active substance: OXYCODONE HYDROCHLORIDE

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521376-525525
Artwork No.

english
Language

10/07/2014

uk
Market

Date

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

7pt
Min. Point Size

4

148 x 210mm
Size

matt.pirie-scott

W-LFT014

Profile

Proof No.

105259-3
Item Code

Proof By

Oxycodone 5mg/5ml oral solution leaflet
Description

Pharma
Code

FPO

Keyline (non-printing)

Process Black

Colours Used

Text Free Area (non-printing)

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Your doctor will determine the dose you require.
Adults (over 18 years of age)
The usual starting dose is 5mg every four to six hours.
However, your doctor will prescribe the dose required to treat
your pain. If you find that you are still in pain whilst taking this
medicine discuss this with your doctor.
Patients with kidney and liver disease
The dosage should follow a conservative approach.The usual
starting dose is 2.5mg every 6 hours.
Do not exceed the dose recommended by your doctor.

Wockhardt UK Limited

You should not take Oxycodone 5mg/5ml Solution if you:
are
•  allergic (hypersensitive) to oxycodone or to any of the
other ingredients in Oxycodone 5mg/5ml Solution
(see section 6, Further information).
• are having difficulty breathing
•  taking drugs called monoamine oxidase inhibitors
are
(MAOIs) for depression (examples include tranylcypromine,
phenelzine, isocarboxazid, moclobemide and linezolid) or
have taken them in the last 2 weeks
• are pregnant or breastfeeding
• 
have a head injury that causes a severe headache or makes
you feel sick. This is because this medicine may make these
symptoms worse or hide the extent of the head injury
have a condition where your small bowel ceases to function
• 
(paralytic ileus), your stomach empties more slowly than
it should (delayed gastric emptying) or you have a severe
pain in your abdomen
• have moderate to severe liver or kidney disease
have an abnormally high level of carbon dioxide circulating
• 
in the blood (a condition known as hypercarbia)
suffer from a disease of the lung known as chronic
• 
obstructive pulmonary disease
suffer from heart failure resulting from lung disease
• 
(cor pulmonale)
• suffer from chronic constipation
• suffer from asthma.
Talk to your doctor before using Oxycodone 5mg/5ml
Solution if you:
• suffer from any problems with your breathing
• suffer from an underactive thyroid gland
• suffer from disease of the gall bladder and bile ducts
• suffer from inflammation of the bowel
• suffer from diseases of the adrenal glands
• 
suffer from pancreatitis (inflammation of the pancreas,
which causes severe pain in the abdomen and back)
• have low blood pressure or low blood volume
• 
have toxic psychoses (mental illness as a reaction to drugs,
toxins or severe illness)
• have an enlarged prostate gland

Customer

The name of your medicine is Oxycodone 5mg/5ml Solution.
Oxycodone belongs to a group of medicines known as opioid
analgesics. These are strong painkillers (analgesics).
Oxycodone 5mg/5ml Solution is used in the treatment of pain
requiring the use of a strong painkiller:
• moderate to severe pain in patients with cancer
• pain following an operation.
2. Before you take Oxycodone 5mg/5ml Solution

• 
have a severe headache or feel sick as this may indicate
that the pressure in your skull is increased (have raised
intracranial pressure)
• have kidney or liver disease
• are intoxicated with alcohol
• are suffering from withdrawal symptoms of alcohol
Special care should be taken with elderly, debilitated and
weak patients as well as patients with a history of drug
or alcohol abuse. This medicine can cause dependence,
if you have any concerns about whether this medicine is
suitable for you speak to your doctor or nurse.
If you are going to have an operation, please tell the
doctor at the hospital that you are taking this medicine.
Taking other medicines
Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription. The following medicines can affect or be affected
by treatment with Oxycodone 5mg/5ml Solution:
• tranquilisers and sleeping tablets
• anaesthetics
• anti-depressants
• 
phenothiazines (often used to treat severe mental illness)
• 
neuroleptic drugs (often used to treat severe mental
illnesses such as psychosis and schizophrenia)
• alcohol
• other opioid 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)
• 
monoamine oxidase inhibitors (MAOIs) (used in
depression) – wait at least 2 weeks after stopping MAOIs
before using this medicine.
Taking Oxycodone 5mg/5ml Solution with food and drink
As with all medicines that act on the central nervous system, it is
advised that you do not drink alcohol while taking this medicine.
Pregnancy and breast-feeding
You should not take this medicine if you are pregnant or breast
feeding. Babies born to women dependent on this medicine may
experience withdrawal symptoms as well as breathing difficulties.
Driving and using machinery
Oxycodone 5mg/5ml Solution may cause drowsiness and
reduced alertness, do not drive or operate machinery while
taking this medicine.
This medicine can affect your ability to drive.
Do not drive whilst taking this medicine until you know how this
medicine affects you.
It may be an offence to drive if your ability to drive safely is
affected.
There is further information for patients who are intending to
drive in Great Britain - go to http://www.gov.uk/drug-driving-law
Important information about some of the ingredients in
Oxycodone 5mg/5ml Solution
A total daily dose of 400mg of this medicine contains
approximately 277mg sodium. To be taken into consideration
in patients on a controlled sodium diet.
3. How to take Oxycodone 5mg/5ml Solution

Measure bar should be 150mm at 100% scale

PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxycodone Hydrochloride 5mg/5ml
Oral Solution
(referred to as Oxycodone 5mg/5ml Solution in this leaflet)
Read all of this leaflet carefully before you start to use
this medicine.
Keep this leaflet. You may need to read it again while you
- 
are receiving your treatment.
If
-  you have any further questions, please 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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
What Oxycodone 5mg/5ml Solution is and what it is used for
1. 
2. Before you take Oxycodone 5mg/5ml Solution
3. How to take Oxycodone 5mg/5ml Solution
4. Possible side effects
5. How to store Oxycodone 5mg/5ml Solution
6. Further information

1. What Oxycodone 5mg/5ml Solution is and what it is
used for

PL 29831/0458

This is a service provided by the Royal National Institute of
Blind People.
Leaflet Prepared: March 2014

23LF00890PW
105259/3

521376-525525
Artwork No.

english
Language

10/07/2014

uk
Market

Date

7pt
Min. Point Size

4

148 x 210mm
Size

matt.pirie-scott

W-LFT014

Profile

Proof No.

105259-3
Item Code

Proof By

Oxycodone 5mg/5ml oral solution leaflet

Pharma
Code

FPO

Keyline (non-printing)

Process Black

Colours Used

Text Free Area (non-printing)

IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.

Reference number

Warning! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.

Product name
Oxycodone Hydrochloride
5mg/5ml Oral Solution

Description

What Oxycodone 5mg/5ml Solution contains
The active ingredient is oxycodone hydrochloride. Each 5ml
contains oxycodone hydrochloride 5mg (equivalent to 4.5mg
oxycodone base).
The other ingredients are: citric acid monohydrate, sodium
citrate, sodium benzoate, sodium saccharin, hypromellose
(methocel-E15 premium LV) and purified water.
What Oxycodone 5mg/5ml Solution looks like and the
contents of the pack
This medicine is a clear colourless solution. Each bottle
contains 250ml of solution.
Marketing Authorisation Holder: Wockhardt UK Ltd,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Ltd, Ash Road North,
Wrexham, LL13 9UF, UK.
This medicinal product is authorised in the Member States of
the EEA under the following names:
UK: Oxycodone Hydrochloride 5mg/5ml Oral Solution
Malta: Oxycodone Hydrochloride 5mg/5ml Oral Solution
Other formats:
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge: 0800 198 5000
(UK Only). Please be ready to give the following information:

Wockhardt UK Limited

Keep out of the reach and sight of children.
• Do not store above 25°C.
Store in the original package in order to protect from light.
• 
•  not use after the expiry date (shown as Exp. on the
Do
packaging). The expiry date refers to the last day of the
month, your doctor or nurse will check for this.
• 
Once opened this medicine must be used within 1 month.
• Consult a pharmacist if signs of deterioration of the
product are observed.
Medicines should not be disposed of via wastewater or
household waste. These measures will help protect the
environment.
6. Further information

Customer

Like all medicines, Oxycodone 5mg/5ml Solution can cause
side effects, although not everybody gets them. As can happen
with any medicine, a few people may develop an allergic
reaction. If you experience any of the following, seek medical
help immediately:
rash, itching, difficulty breathing, problems swallowing,
• 
anaphylaxis (severe allergy).
Side effects that have been reported with Oxycodone 5mg/5ml
Solution are:
Common (occurs in more than 1 in 100 patients)
• dizziness
• sleepiness
• constipation
• nausea
• vomiting
• itching
• abnormal thinking
• breathlessness
• stomach pains
• wheezing
• loss of appetite
• diarrhoea
• dry mouth
• indigestion
• sweating
• rash
• problems passing water
• fever
• abnormal dreams
• chills
• anxiety
• confusion
• problems sleeping
• faintness
• extreme fatigue
• headache
• nervousness
• low blood pressure on
• anorexia standing
Uncommon (occurs in fewer than 1 in 100 patients)
• hormone disturbances
• mouth ulcers
• weight change
• change of taste
• inflammation of the mouth
• decreased sex-drive
• hives or itchy rash
• hallucinations
• memory loss
• impotence
• fits
• chest pain
• euphoria
• anaphylaxis
• dehydration
• twitching
• speech problems
• swelling of the legs
• depression
• decreased muscle tone
• excitedness
• problems walking
• agitation
• mood changes
• general malaise
• vertigo

• constricted pupils
• depersonalisation
• ringing in the ears
• involuntary movements
• low blood pressure
• increased muscle tone
• dilated blood vessels
• drug dependence
• unresponsiveness
• hiccups
• difficulty breathing
• withdrawal
• flatulence
• running eyes
• abnormal vision
• problems swallowing
• abnormal heart rhythm
• inflammation of stomach
• belching
• blackouts
• nosebleeds
• stops menstrual period
• voice alteration
• allergy
• gall bladder problems
• changed or reduced
• dry skin or severe flaking sensation
of skin
• inability to pass water
• facial flushing
• Increase in liver enzymes
If you experience any side effects or feel that the medicine is
affecting you badly tell your doctor or nurse immediately.
5. How to store Oxycodone 5mg/5ml Solution

Measure bar should be 150mm at 100% scale

You must only take this medicine by mouth. This medicine
should never be injected as this may lead to serious side
effects, which may be fatal.
Not to be used in patients under 18 years of age.
If you take more Oxycodone 5mg/5ml Solution than you
should
Call your doctor or hospital immediately. 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. Make
sure you take this leaflet and any remaining medicine with you
to show the doctor.
If you forget to take Oxycodone 5mg/5ml Solution
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 four hours. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Oxycodone 5mg/5ml Solution
Patients can become tolerant to the effects of oxycodone if
used over a long time or if they are already using Oxycodone
and may require progressively higher doses in order to
maintain pain control.
Prolonged use of this medicine may lead to dependence and
if treatment is stopped abruptly you may experience withdrawal
symptoms. These symptoms include restlessness, running
nose and eyes, yawning, sweating, chills, muscle pain,
abdominal pain, diarrhoea and prolonged dilation of the pupils.
You should not suddenly stop taking this medicine unless your
doctor tells you to. If you want to stop taking this medicine,
discuss this with your doctor first. They will tell you to stop
treatment gradually over some time in order to prevent
unpleasant symptoms.
4. Possible side effects

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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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