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OXELTRA 10MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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Package leaflet: Information for the user
Oxeltra 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg,
60 mg and 80 mg
Prolonged-Release Tablets
Oxycodone 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 only. 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.
What is in this leaflet:
1. What Oxeltra tablets are and what they are used for
2. What you need to know before you take Oxeltra tablets
3. How to take Oxeltra tablets
4. Possible side effects
5. How to store Oxeltra tablets
6. Contents of the pack and other information

XXX

1. What Oxeltra tablets are and what they are used for
These tablets have been prescribed for you by your doctor to
relieve moderate to severe pain over a period of 12 hours.
They contain the active ingredient oxycodone which belongs
to a group of medicines called strong analgesics or ‘painkillers’.
2. What you need to know before you take Oxeltra tablets
Do not take Oxeltra tablets if you:
• are allergic (hypersensitive) to oxycodone, or any of the
other ingredients of the tablets (listed in section 6);
• have breathing problems, such as severe chronic obstructive
airways disease, severe bronchial asthma or severe
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 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 moderate to severe liver problems. If you have other
long-term liver problems you should only take these tablets
if recommended by your doctor;
• have ongoing problems with constipation;
• are under 18 years of age.

If you are going to have an operation, please tell the doctor at
the hospital that you are taking these tablets.
Other medicines and Oxeltra tablets
Please tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. If you take
these tablets with some other medicines, the effect of these
tablets or the other medicine may be changed.
Tell your doctor or pharmacist if you are taking:
• a type of medicine known as monoamine oxidase inhibitor or
you have taken this type of medicine in the last two weeks;
• medicines to help you sleep or stay calm (for example
tranquillisers, hypnotics or sedatives);
• medicines to treat depression (such as paroxetine);
• 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, voriconazole,
itraconazole and posaconazole);
antibiotics (such as clarithromycin, erythromycin or
telithromycin);
medicines known as ‘protease inhibitors’ to treat HIV (e.g.
boceprevir, ritonavir, indinavir, nelfinavir or saquinavir);
rifampicin (used to treat tuberculosis);
carbamazepine (used to treat seizures, fits or convulsions);
phenytoin (used to treat seizures, fits or convulsions);
a herbal remedy called St John’s Wort (also known as
Hypericum perforatum);
antihistamines;
medicines to treat Parkinson’s disease.

Also tell your doctor if you have recently been given an
anaesthetic.
Taking Oxeltra tablets with food, drink and alcohol
Drinking alcohol whilst taking Oxeltra tablets 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 while you’re taking Oxeltra tablets.
You should avoid drinking grapefruit juice while you are
taking these tablets.
Pregnancy and breastfeeding
Do not take these tablets if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking any
medicine.
Driving and using machines
These tablets 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 tablets,
or when changing to a higher dose. If you are affected you
should not drive or use machinery.
The 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 if this medicine affects your ability to
drive.
• However, you would not be committing an offence if:
o The medicine has been prescribed to treat a medical or
dental problem and
o You have taken it according to the instructions given by
the prescriber or in the information provided with the
medicine and
o It was not affecting your ability to drive safely
There is further information for patients who are intending to
drive in Great Britain - go to: http://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.
Oxeltra tablets contain lactose
These tablets 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 tablets.
3. How to take Oxeltra tablets
Always take these tablets exactly as your doctor has told you.
The label on your medicine will tell you how many tablets to
take and how often.
Adults (over 18 years of age)
The usual starting dose is one 10 mg tablet 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 tablets, discuss this with your doctor.
Do not exceed the dose recommended by your doctor. You
should check with your doctor or pharmacist if you are not sure.

XXX

Warnings and precautions
Talk to your doctor or pharmacist before taking Oxeltra tablets
if you:
• are elderly and weakened;
• have an under-active thyroid gland (hypothyroidism), as you
may need a lower dose;
• have myxoedema (a thyroid disorder with dryness, coldness
and swelling (‘puffiness’) of the skin affecting the face and
limbs);
• have a head injury, severe headache or feel sick as this may
indicate that the pressure in your skull is increased;
• have low blood pressure (hypotension);
• have low blood volume (hypovolaemia); this can happen
with severe external or internal bleeding, severe burns,
excessive sweating, severe diarrhoea or vomiting;
• 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 problems with your gall bladder or bile duct;
• have inflammatory bowel disorders;
• have an enlarged prostate gland, which causes difficulty in
passing urine (in men);
• 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), e.g.
Addison’s disease;
• 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;
• have liver or kidney problems;
• have previously suffered from withdrawal symptoms such as
agitation, anxiety, shaking or sweating, upon stopping
taking alcohol or drugs;
• are or have ever been addicted to alcohol or drugs or have a
known opioid dependence;
• have an increased sensitivity to pain;
• need to take increasingly higher doses of Oxeltra to gain the
same level of pain relief (tolerance).







Swallow your tablets whole with water. Do not crush,
dissolve or chew them.
Oxeltra tablets are designed to work properly over
12 hours when swallowed whole. If a tablet is broken,
crushed, dissolved or chewed, the entire 12-hour dose
may be absorbed rapidly into your body. This can be
dangerous, causing serious problems such as an overdose,
which may be fatal.
You should take your tablets every 12 hours. For instance, if
you take a tablet at 8 o’clock in the morning, you should take
your next tablet at 8 o’clock in the evening.
You must only take the tablets by mouth. The tablets should
never be crushed or injected as this may lead to serious side
effects, which may be fatal.
Use in children
Children and adolescents under 18 years of age should not
take the tablets.
Patients with kidney or liver problems
Please tell your doctor if you suffer from kidney or liver
problems as they may prescribe a lower dose depending on
your condition.

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ART WORK CHECK BOX
PRODUCT :
CUSTOMER :
FP CODE:

Process
Black

Oxeltra Tablets (Oxycodone Hydrochloride) - Common
Wockhardt UK
FP3997; FP3998; FP3999; FP4000; FP4001; FP4002;
FP4003; FP4004
DIMENSIONS :
(w)190mm x (h)380mm
TEXT FONT SIZE :
9pt.
PHARMACODE No. : XXX (Dummy)
FILE NAME :
Oxycodone_5mg_Leaflet_106745-2.ai
SOFTWARE :
Adobe Illustrator CS5
TYPEFACES :
Myriad Pro Regular / Bold
ARTWORK (DETAILS) 3rd August, 2016
RECEIVED ON :
PROOF REVISION :
R 1st PDF sent on - 17TH AUG. 2016
R 2nd PDF sent on - 18TH AUG. 2016
CHANGE CONTROL : Version changes due to change in:
Size/Layout
Regulatory
Changes in detail: • Regulatory text amends

Non-Regulatory

If you take more Oxeltra tablets than you should or if
someone accidentally swallows your tablets
Call your doctor or hospital straight away. People who have
taken an overdose may feel very sleepy, sick or dizzy, or have
hallucinations. 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 tablets with you to show to the doctor.
If you forget to take your Oxeltra tablets
If you remember within 4 hours of the time your tablet was
due, take your tablet straight away. Take your next tablet 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 tablet.
If you stop taking Oxeltra tablets
You should not suddenly stop taking these tablets unless your
doctor tells you to. If you want to stop taking your tablets,
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 tablets.

XXX

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 tablets 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.
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 tablets.
Other possible side effects
Very common (may affect more than 1 in 10 people):
• 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 start taking your
medicine or when your dose is increased, but it should wear
off after a few days)
• dizziness
• headache
• itchy skin.
Common (may affect up to 1 in 10 people):
• dry mouth, loss of appetite, indigestion, abdominal pain or
discomfort, diarrhoea
• confusion, depression, a feeling of unusual weakness,
shaking, lack of energy, tiredness, anxiety, nervousness,
difficulty in sleeping, abnormal thoughts or dreams
• difficulty in breathing or wheezing, shortness of breath,
decreased cough reflex
• rash
• sweating.

Rare (may affect up to 1 in 1,000 people):
• low blood pressure
• a feeling of ‘faintness’ especially on standing up
• hives (nettle rash).
Frequency not known (frequency cannot be estimated
from the available data):
• increased sensitivity to pain.
• aggression
• tooth decay
• absence of menstrual periods
• a blockage in the flow of bile from the liver (cholestasis). This
can cause itchy skin yellow skin, very dark urine and very
pale stools
• long term use of Oxeltra during pregnancy may cause
life-threatening withdrawal symptoms in the newborn.
Symptoms to look for in the baby include irritability,
hyperactivity and abnormal sleep pattern, high pitched cry,
shaking, being sick, diarrhoea and not putting on weight.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card
Scheme at http://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 Oxeltra tablets
Keep this medicine out of the sight and reach of children.
Accidental overdose by a child is dangerous and may be fatal.
Do not use any tablets after the expiry date which is stated on
the blister and carton or bottle label. The expiry date refers to
the last day of that month.
Do not store above 25°C.
Do not take your tablets 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 away
medicines you no longer use. These measures will help to
protect the environment.
6. Contents of the pack and other information
What Oxeltra tablets contain
The active ingredient is oxycodone hydrochloride. Each tablet
contains 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg or
80 mg of oxycodone hydrochloride.
The other ingredients are: lactose monohydrate, hypromellose
(E464), povidone, stearic acid, magnesium stearate and
anhydrous silica colloidal.
In addition, the tablet coatings contain the following:
5 mg – polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol (E1521), talc (E553b), indigo carmine aluminium lake
(E132) and iron oxide yellow (E172).
10 mg – hypromellose (E464), titanium dioxide (E171),
macrogol (E1521), polysorbate (E433).
15 mg – polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol (E1521), talc (E553b), iron oxide black (E172) and
iron oxide yellow (E172).
20 mg - polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol (E1521), talc (E553b) and iron oxide red (E172).
30 mg - polyvinyl alcohol (E1203), macrogol (E1521), talc
(E553b), iron oxide red (E172), iron oxide black (E172) and
indigo carmine aluminium lake (E132).
40 mg - polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol (E1521), talc (E553b) and iron oxide yellow (E172).
60 mg – polyvinyl alcohol (E1203), macrogol (E1521), talc
(E553b), iron oxide red (E172), carmine and iron oxide black
(E172).
80 mg – polyvinyl alcohol (E1203), titanium dioxide (E171),
macrogol (E1521), talc (E553b), indigo carmine aluminium lake
(E132) and iron oxide yellow (E172).
What Oxeltra tablets look like and the contents of the pack
The tablets are marked OX along with the strength (5, 10, etc)
on one side. All strengths are round, bi-convex, film coated
tablets.
The tablets are all film coated in the following colours:
5 mg - blue, 10 mg - white, 15 mg – grey, 20 mg - pink,
30 mg – brown, 40 mg - yellow, 60 mg – red, 80 mg – green.
Oxeltra 5mg Tablets are available in cartons containing 28 or
100 tablets.
Oxeltra 10mg, 15mg, 20mg, 30mg, 40mg, 60mg and 80mg
Tablets are available in cartons containing 56 or 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK
Manufacturer
CP Pharmaceuticals Ltd, Ash Road North, Wrexham, LL13 9UF,
UK

XXX

Uncommon (may affect up to 1 in 100 people):
• difficulty in swallowing, belching, hiccups, wind, a condition
where the bowel does not work properly (ileus),
inflammation of the stomach, changes in taste
• a feeling of dizziness or ‘spinning’, hallucinations, mood
changes, unpleasant or uncomfortable mood, a feeling of
extreme happiness, restlessness, agitation, generally feeling
unwell, loss of memory, difficulty in speaking, reduced
sensitivity to pain or touch, tingling or numbness, seizures,
fits or convulsions, blurred vision, fainting, unusual muscle
stiffness or slackness, involuntary muscle contractions.
• difficulty in passing urine, impotence, decreased sexual
drive, low levels of sex hormones in the blood
(‘hypogonadism’, seen in a blood test)
• fast, irregular heart beat, flushing of the skin.
• dehydration, thirst, chills, 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 of this medicine to
obtain the same level of pain relief (tolerance).
• colicky abdominal pain or discomfort.
• a worsening of liver function tests (seen in a blood test).

You may see the remains of the tablets in your faeces. This
should not affect how the tablets work.

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:
Product name
Reference number
Oxeltra 5mg Prolonged-Release Tablets
PL 29831/0630
Oxeltra 10mg Prolonged-Release Tablets
PL 29831/0631
Oxeltra 15mg Prolonged-Release Tablets
PL 29831/0632
Oxeltra 20mg Prolonged-Release Tablets
PL 29831/0633
Oxeltra 30mg Prolonged-Release Tablets
PL 29831/0634
Oxeltra 40mg Prolonged-Release Tablets
PL 29831/0635
Oxeltra 60mg Prolonged-Release Tablets
PL 29831/0636
Oxeltra 80mg Prolonged-Release Tablets
PL 29831/0637
This is a service provided by the Royal National Institute of
Blind People.
This leaflet was last revised in 08/2016
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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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