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RELTEBON 15MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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• difficulty in passing urine
• disturbances of sexual function, impotence
• injuries due to accidents
• pain (e.g. chest pain); excessive fluid in the tissues
(oedema); chills; thirst; migraine; physical dependence
with withdrawal symptoms
• changes in tear secretion, constriction of the pupil,
visual impairment.
Rare (may affect up to 1 in 1,000 people):
• lymph node disease
• lowering of blood pressure, dizziness when standing
up from a sitting or lying position
• muscle spasms (involuntary contraction of the muscle)
• gum bleeding; increased appetite; tarry stool; tooth
staining
• herpes simplex (disorder of the skin and mucosa)
• itchy skin rash (hives)
• blood in urine
• changes in body weight (loss or rise); cellulitis.
Not known (frequency cannot be estimated from the
availible data):
• severe hypersensitivity reactions (anaphylactic
reactions)
• aggression
• increased sensitivity to pain which cannot be
improved by increasing the dose
• tooth decay
• pain on the right side of the abdomen, itchiness and
jaundice caused by inflammation of the gall bladder.
• absence of menstrual bleeding
Counteractive measures
If you observe any of the above listed side effects your
doctor will usually take appropriate measures.
The side effect constipation may be prevented by fiber
enriched diet and increased intake of fluids.
If you are suffering from sickness or vomiting your doctor
may prescribe you an appropriate medicine.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any side effects not listed in
this leaflet. You can also report side effects directly via
the Yellow Card Scheme, Website: www.mhra.gov.uk/
yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine

6  Contents of the pack and other information
What Reltebon contains

5  How to store Reltebon

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the blister, carton and container after “EXP”. The
expiry date refers to the last day of that month. Do not
store above 25°C. 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 protect the environment.

• The active substance is oxycodone hydrochloride.
Each prolonged-release tablet contains 5mg, 10mg,
15mg, 20mg, 30mg, 40mg, 60mg, 80mg oxycodone
hydrochloride.
• The other ingredients are:
Tablet core: Lactose monohydrate, hypromellose,
povidone, stearic acid, magnesium stearate, colloidal
anhydrous silica.
Tablet coating:
5mg tablets: Polyvinyl alcohol, titanium dioxide (E171),
macrogol, talc, blue Indigo Carmine Aluminium Lake
(E132), yellow iron oxide (E172).
10mg tablets: Titanium dioxide (E171), hypromellose,
macrogol, polysorbate 80
15mg tablets: Polyvinyl alcohol, titanium dioxide
(E171), macrogol, talc, yellow iron oxide (E172), black
iron oxide (E172).
20mg tablets: Polyvinyl alcohol, titanium dioxide
(E171), macrogol, talc, red iron oxide (E172).
30mg tablets: Polyvinyl alcohol, macrogol, talc, red
iron oxide (E172), black iron oxide (E172), blue Indigo
Carmine Aluminium Lake (E132)
40mg tablets: Polyvinyl alcohol, titanium dioxide
(E171), macrogol, talc, yellow iron oxide (E172).
60mg tablets: Polyvinyl alcohol, macrogol, talc, red iron
oxide (E172), carmine (E120), black iron oxide (E172).
80mg tablets: Polyvinyl alcohol, titanium dioxide
(E171), macrogol, talc, blue Indigo Carmine Aluminium
Lake (E132), yellow iron oxide (E172).
What Reltebon looks like and contents of the pack
Reltebon 5mg prolonged-release tablets are blue, round,
biconvex tablets, 7 mm in diameter, with ‘OX 5’ debossed
on one side. Reltebon 10mg prolonged-release tablets
are white, round, biconvex tablets, 9 mm in diameter,
with ‘OX 10’ debossed on one side. Reltebon 15mg
prolonged-release tablets are grey, round, biconvex
tablets, 9 mm in diameter, with ‘OX 15’ debossed on one
side. Reltebon 20mg prolonged-release tablets are pink,
round, biconvex tablets, 7 mm in diameter, with ‘OX
20’ debossed on one side. Reltebon 30mg prolongedrelease tablets are brown, round, biconvex tablets, 9
mm in diameter, with ‘OX 30’ debossed on one side.
Reltebon 40mg prolonged-release tablets are yellow,
round, biconvex tablets, 7 mm in diameter, with ‘OX
40’ debossed on one side. Reltebon 60mg prolongedrelease tablets are red, round, biconvex tablets, 9
mm in diameter, with ‘OX 60’ debossed on one side.
Reltebon 80mg prolonged-release tablets are green,
round, biconvex tablets, 9 mm in diameter, with ‘OX 80’
debossed on one side. Reltebon are available in blister
packs (PVC/Aluminium) of 28s and 56s.
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavíkurvegi 76-78,
220 Hafnarfjörður, Iceland
Manufacturer: Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in December 2015

If you would like a leaflet with
larger text, please contact
01271 385257.
Actavis, Barnstaple, EX32 8NS, UK

50879789 AAAI5496

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Reltebon Tablets
all strengths x 28 x 56’s (UK)
JDE No.:

Package leaflet: Information for the patient

Reltebon 5mg, 10mg, 15mg, 20mg, 30mg, 40mg,
60mg and 80mg 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 Reltebon is and what it is used for
2 What you need to know before you take Reltebon
3 How to take Reltebon
4 Possible side effects
5 How to store Reltebon
6 Contents of the pack and other information

1 What Reltebon is and what it is used for

Reltebon contains the active ingredient oxycodone
hydrochloride which belongs to a group of medicines
called opioids. These are strong painkillers.
Reltebon is used to relieve severe pain, which can
only be controlled by opioid analgesics in adults and
adolescents 12 years of age and older.

2  What you need to know before you take

Reltebon

Do not take Reltebon

• if you are allergic to oxycodone hydrochloride or any of
the other ingredients of this medicine (listed in section
6)
• if you have severe problems breathing, low amounts
of oxygen in your blood (hypoxia) or too much carbon
dioxide in your blood
• if you suffer from severe chronic obstructive lung
disease, cor pulmonale (cardiac changes due to
chronic overload of lung circulation) or acute, severe
bronchial asthma
• if you suffer from intestinal paralysis
• if you have an acute abdomen or suffer from a
delayed gastric emptying.

Warnings and precautions

Talk to your doctor or pharmacist before taking Reltebon
• if you are older or debilitated
• if you have lung, liver or kidney problems
• if you suffer from certain illnesses of the thyroid
gland, impaired function of the thyroid gland
• if you suffer from adrenal insufficiency (Addison’s
disease)
• if you suffer from enlargement of the prostate
• if you suffer from alcoholism or are undergoing
alcohol withdrawal

page 4

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Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

Oxycodone Hydrochloride (Reltebon) All Strengths Tablets PIL - UK

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters

Date Sent:
23/11/15
Technologist: R.Wrey

Other medicines and Reltebon

page 1

50879789

Pharmacode: 1956

• if you suffer from known opioid-dependence
• if you suffer from inflammation of the pancreas
• in conditions with increased brain pressure such as
head injury
• if you suffer from disturbances of circulatory
regulation
• if you suffer from colic of the bile duct and ureter
• if you suffer from low blood pressure or reduced
blood volume
• if you suffer from epilepsy or have a seizure tendency
• if you take MAO inhibitors (for the treatment of
depression)
• if you suffer from an inflammatory bowel disorder
• if you have recently had abdominal surgery.
Please talk to your doctor if any of these apply to you or if
any of these conditions applied to you in the past.
Reltebon has a primary dependence potential. When
used for a long time, tolerance to the effects may
develop and progressively higher doses may be required
to maintain pain control.
Chronic use of Reltebon may lead to physical
dependence and a withdrawal syndrome may occur
upon abrupt cessation. When a patient no longer
requires therapy with oxycodone hydrochloride, it may
be advisable to taper the dose gradually to prevent
symptoms of withdrawal.
When used as directed in patients suffering from chronic
pain the risk of developing physical or psychological
dependence is markedly reduced and needs to be
weighed against the potential benefit. Please discuss this
with your doctor.
Increased sensitivity to pain that does not respond
to dose increases can rarely develop. If this happens,
your doctor will reduce your dose or switch you to an
alternative opioid painkiller.
Reltebon is not recommended for use before an
operation or in the 24 hours after an operation.
Reltebon should be used with particular care in patients
with a history of or present alcohol and drug abuse.
You should not drink alcohol while you are taking
Reltebon. Drinking alcohol whilst taking Reltebon 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.
Children and adolescents
Oxycodone has not been investigated in children under
12 years. Safety and efficacy have not been established
and therefore use in children under 12 years of age is not
recommended.
Elderly patients
If kidney or liver function is not impaired, a dose
adjustment is usually not necessary for elderly patients.

item no: AAAI5496

dimensions: 296 x 210 Reel Fed

print proof no: 02

pharmacode:

origination date: 25.11.15

min pt size: 8.5

1. Black
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originated by: S.Anson
approved for print/date

colours/plates:

revision date: 08-12-2015

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date sent: n/a

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The following medicines may influence the effect or side
effects of Reltebon
• sleeping pills or tranquillizers (sedatives, hypnotics)
• anti-depressants
• anaesthetics
• muscle relaxants
• other opioids or alcohol can enhance the side effects
of oxycodone, in particular depressed breathing
(respiratory depression).
• other medicines that act against parasympathetic and
cholinergic nerve fibres on the central nervous system
• medicines used to treat allergies (antihistamines)
• medicines used to treat vomiting (antiemetics)
• medicines used to treat Parkinson’s disease can enhance
certain side effects of oxycodone (e.g. constipation, dry
mouth or urinary disturbances)
• anticoagulants of the coumarin type (medicines used to
reduce blood clotting)
• monoamine oxidase inhibitors (MAOIs) such as
moclobemide, phenelzine, isoniazid, tranylcypromine
or selegiline as these can enhance some side effects
of oxycodone (e.g. excitation, decrease or increase in
blood pressure).
• St John’s Wort (herbal medicine).
• medicines used to treat epilepsy (Carbamazepine,
phenytoin).
• medicines used to treat tuberculosis such as rifampicin.
The following medicines may possibly increase the blood
levels of oxycodone and your doctor may need to reconsider the dose of Reltebon;
• Medicines used to treat infections (e.g. clarithromycin,
erythromycin and telithromycin) or to treat fungal
infections (e.g. ketoconazole, voriconazole, itraconazole,
and posaconazole).
• Medicines used to treat HIV (e.g. boceprevir, ritonavir,
indinavir, nelfinavir and saquinavir).
• Cimetidine (to treat heart burn).
• Medicines such as paroxetine and fluoxetine
(antidepressants).
• Quinidine (used in the treatment of heart diseases).
Grapefruit juice may also increase the blood levels of
oxycodone.

Breast-feeding
Oxycodone may pass into breast milk and may cause
breathing difficulties in the newborn. Reltebon should
therefore not be used during breast-feeding.

Driving and using machines

Oxycodone may affect your ability to drive and use
machines.
With stable therapy, a general ban on driving a vehicle
may be not necessary. The treating physician must assess
the individual situation. Please discuss with your doctor
whether or under what conditions you can drive a vehicle.
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:
- 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 or in the information provided with
the medicine and
- It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure
whether it is safe for you to drive while taking this
medicine.

Reltebon contains lactose

This medicinal product contains lactose. If you have been
told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3  How to take Reltebon

Reltebon with food, drink and alcohol

You should not drink alcohol while you are taking
Reltebon. Drinking alcohol whilst taking Reltebon may
make you feel sleepier or increase the risk of serious side
effects such as shallow breathing with a risk of stopping
breathing, and loss of consciousness.
Grapefruit juice can inhibit the metabolism of oxycodone
which will increase its effect. Therefore you should avoid
drinking grapefruit juice while taking Reltebon.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
Pregnancy
There is limited data from the use of oxycodone in
pregnant women. Oxycodone passes through the
placenta into the blood circulation of the baby.
Use of oxycodone during pregnancy may cause
withdrawal symptoms in newborns. Infants born to
mothers who have received oxycodone during the last 3-4
weeks before labour should be monitored for respiratory
depression. Use of oxycodone during childbirth can cause
severe breathing difficulties in the newborn. Reltebon
should only be used during pregnancy if the benefit
outweighs the possible risks to the baby.

296x210 Leaflet Reel Fed Bi Fold Profile (BST)

Reltebon Tablets
all strengths x 28 x 56’s (UK)
JDE No.:

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Adults and adolescents (12 years of age and older)
The recommended initial dose is 5 or 10 mg oxycodone
hydrochloride, in 12 hourly intervals. However, your
doctor will prescribe the dose required to treat pain.
Further determination of the daily dose, the division into
the single doses and any dose adjustments during the
further course of therapy are performed by the treating
physician and depend on the previous dosage.
Patients who have already taken opioids can start
treatment with higher dosages taking into account their
experience with opioid treatment.
Some patients who receive Reltebon according to a
fixed schedule need rapidly acting painkillers as rescue
medication to control breakthrough pain. Reltebon is not
intended for the treatment of breakthrough pain.
For the treatment of non cancer pain a daily dose of 40 mg
of oxycodone hydrochloride (20 mg given twice a day) is
generally sufficient, but higher dosages may be necessary.
Patients with cancer pain usually require dosages from
80 to 120 mg of oxycodone hydrochloride which may be
increased up to 400 mg in individual cases.
The treatment needs to be controlled regularly with
regard to pain relief and other effects in order to achieve
the best pain therapy possible as well as to be able to treat
any occurring side effects in good time and to decide
whether treatment should be continued.
Kidney/liver impairment or low body weight
If you have impaired kidney and/or liver function or if
you have a low body weight your doctor may prescribe a
lower starting dose.

Method and duration of administration
Swallow the prolonged-release tablets whole with
a sufficient amount of liquid (½ glass of water) with
or without food in the morning and in the evening
following a fixed schedule (e.g. at 8 a.m. and 8 p.m.).
The tablets must not be broken, crushed or chewed as
this leads to rapid oxycodone release due to the damage
of the prolonged release properties. The administration
of broken, chewed or crushed Reltebon leads to a
rapid release and absorption of a potentially fatal dose
of oxycodone (see section “If you take more Reltebon
than you should”). Reltebon are for oral use only. In
case of abusive injection (injection in a vein) the tablet
excipients may lead to destruction (necrosis) of the local
tissue, change of lung tissue (granulomas of the lung) or
other serious, potentially fatal events.
Your doctor will adjust the dosage depending on the
pain intensity and how you respond to the treatment.
Take the number of prolonged-release tablets
determined by your doctor twice daily.

If you take more Reltebon than you should

If you have taken more Reltebon than prescribed you
should inform your doctor or your local poison control
center immediately. The following symptoms may
occur: constricted pupils, depressed breathing, skeletal
muscle flaccidity, drowsiness and drop in blood pressure.
In severe cases circulatory collapse, mental and motor
inactivity, unconsciousness, slowing of the heart rate,
accumulation of water in the lungs, low blood pressure
and death may occur; abuse of high doses of strong
opioids such as oxycodone can be fatal. In no case
should you expose yourself to situations requiring
elevated concentration e.g. driving a car.

If you forget to take Reltebon

If you use a smaller dose of Reltebon than directed
or you miss the intake of the tablets, pain relief will
consequently be insufficient or cease altogether.
You can make up for a forgotten tablet if the next regular
intake is not due for at least another 8 hours. You can
then continue to take the tablets as directed.
You should also take the prolonged-release tablets if the
time to the regular next intake is shorter, but postpone
the next intake by 8 hours. In principle, you should not
take Reltebon more than once every 8 hours.
Do not take a double dose to make up for a forgotten
tablet.

If you stop taking Reltebon

Do not stop treatment without informing your doctor.
When a patient no longer requires therapy with
Reltebon, it may be advisable to taper the dose gradually
to prevent symptoms of withdrawal.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4 P
 ossible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Significant side effects or signs to consider and measures
to be taken when these side effects or signs occur:
If you experience any of the following side effects,
stop taking Reltebon and contact your doctor
immediately.

page 2

page 3

Oxycodone Hydrochloride (Reltebon) All Strengths Tablets PIL - UK

50879789

Dimensions: 296x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 1956
Date Sent:
23/11/15
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Depressed breathing is the most significant risk induced
by opioids and is most likely to occur in elderly or
debilitated patients. As a consequence, in predisposed
patients opioids can cause severe drops in blood
pressure.
Apart from this oxycodone can cause constricted pupils,
bronchial spasms and spasms in smooth muscles and
suppress the cough reflex.
Other possible side effects
Very common (may affect more than 1 in 10 people):
• sedation (tiredness to drowsiness) – this is most likely
when you start taking your tablets or when your dose
is increased, but it should wear off after a few days.
• dizziness
• headache
• constipation
• feeling sick (nausea)
• being sick (vomiting)
• itching.
Common (may affect up to 1 in 10 people):
• feeling weak (asthenia)
• several psychological side effects such as
- changes in mood (e.g. anxiety, depression)
- changes in activity (nervousness and insomnia)
- changes in performance (abnormal thinking,
confusion, amnesia, isolated cases of speech
disorders)
• involuntary trembling or shaking
• depressed breathing
• difficulty in breathing or wheezing
• dry mouth, rarely accompanied by thirst;
gastrointestinal disorders such as stomach pain;
diarrhoea; upset stomach; loss of appetite
• skin disorders such as rash, rarely increased sensitivity
to light (photosensitivity), in isolated cases itchy or
scaly rash, excessive sweating
• urinary disorders (frequent urination).
Uncommon (may affect up to 1 in 100 people):
• allergic reactions
• dehydration
• agitation
• change in perception such as emotional instability,
depersonalisation, a feeling of extreme happiness,
hallucinations, change in taste, visual disturbances,
abnormally acute sense of hearing, feeling of dizziness
or spinning, decreased sex drive; drug dependence
(see section 2)
• abnormal production of antidiuretic hormone
• loss of memory, fits, increased tightness and difficulty
in stretching muscles, both increased and decreased
muscle tone; tics; reduced sense of touch; coordination
disturbances; speech disorders; fainting; tingling or
pins and needles
• feeling unwell, accelerated pulse, being aware of the
heart beat
• widening of the blood vessels
• increased coughing; pharyngitis; runny nose; voice
changes; difficulty breathing
• oral ulcers; inflammation of the gums, inflamed
mouth; difficulty swallowing, wind, flatulence,
intestinal obstruction
• increased liver enzymes
• dry skin

item no: AAAI5496

dimensions: 296 x 210 Reel Fed

print proof no: 02

pharmacode:

origination date: 25.11.15

min pt size: 8.5

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 08-12-2015

Technical Approval

revised by: NM

date sent: n/a

supplier: Actavis UK

technically app. date:

Non Printing Colours
1.
2.
3.

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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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