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ALIVIO 5 MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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Alivio™ 5 mg prolonged-release tablets
Alivio™ 10 mg prolonged-release tablets
Alivio™ 20 mg prolonged-release tablets
Alivio™ 30 mg prolonged-release tablets
Alivio™ 40 mg prolonged-release tablets
Alivio™ 60 mg prolonged-release tablets
Alivio™ 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 Alivio™ is and what it is used for
2. What you need to know before you take Alivio™
3. How to take Alivio™
4. Possible side effects
5. How to store Alivio™
6. Contents of the pack and other information

1. What Alivio™ is and what it is used for
Alivio™ is a centrally acting, strong painkiller from the group of opioids.
Alivio™ is used to treat severe pain in adults and adolescents aged 12 years
and older, which can be adequately managed only with opioid analgesics.

2. What you need to know before you take Alivio™
Do not take Alivio™
- if you are allergic to oxycodone hydrochloride or any of the other ingredients
of this medicine (listed in section 6)
- if you suffer from severely depressed breathing (respiratory depression)
with too little oxygen in the blood (hypoxia) and/or too much carbon dioxide
(hypercapnia) in the 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 (paralytic ileus)
Warnings and precautions
Talk to your doctor or pharmacist before taking Alivio™ :
- if you are older or debilitated
- if your lung, liver or kidney function is severely impaired (see also section
3 “Risk patients”)
- if you suffer from myxoedema (certain illnesses of the thyroid gland), or an
impaired function of the thyroid gland
- if you suffer from adrenal insufficiency (Addison’s disease)

SAME SIZE ARTWORK
480 mm x 210 mm

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suffer from toxic psychosis (e.g. alcohol),
suffer from enlargement of the prostate (prostate hypertrophy)
suffer from alcoholism or are undergoing alcohol withdrawal
suffer from known opioid-dependence
suffer from inflammation of the pancreas (pancreatitis)
suffer from diseases of the biliary tract,
suffer from inflammatory bowel disorders
suffer from low blood pressure
suffer from decreased blood volume (hypovolaemia)
suffer from head injury
suffer from epilepsy or have a seizure (fits) tendency
take MAO inhibitors (for the treatment of depression).

Long term treatment and abuse
Alivio™ has 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 Alivio™ may lead to physical dependence and a withdrawal
syndrome may occur upon abrupt cessation of therapy. 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.
Alivio™ is for oral use only. In case of abusive injection (injection in a vein) the
other tablet ingredients may lead to destruction (necrosis) of the local tissue,
change of lung tissue (granulomas of the lung) or other serious, potentially
lethal events.
Anti-doping warning
Athletes should be aware that this medicine may cause a positive reaction to
“anti-doping tests”. Use of Alivio™ as a doping agent may become a health
hazard.
Children under 12 years of age
Alivio™ should not be used in children under 12 years of age because of
safety and efficacy concerns.
Elderly patients
In elderly patients without impairment of kidney and/or liver function a dose
adjustment is usually not necessary.
Other medicines and Alivio™
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
- Medicines that dampen the activity of the central nervous system, e.g.
• sleeping pills or tranquillisers (sedatives, hypnotics)
• other medicines that act on the nervous system (phenothiazines,
neuroleptics, anaesthetics, antidepressants, muscle relaxants)
• other opiods or alcohol can enhance the side effects of oxycodone, in
particular depressed breathing (respiratory depression).
- Medicines with an anticholinergic effect, e.g.
• other medicines that act against parasympathetic and cholinergic nerve
fibres on the central nervous system (psychotropic medicines)
• medicines used to treat allergies (antihistamines) or vomiting (antiemetics)
• medicines used to treat Parkinson’s disease can enhance certain side

effects of oxycodone (e.g. constipation, dry mouth or urinary disturbances).
- Inhibitors of CYP3A4, such as macrolide antibiotics, azolantifungals, protease
inhibitors, cimetidine and grapefruit juice may cause a reduced clearance
of oxycodone that could cause an increase of the plasma concentrations of
oxycodone. The influence of other medicines that can markedly affect the
metabolism of oxycodone has not been investigated.
- Strong inhibitors of CYP2D6 may affect the elimination of oxycodone. The
influence of other isoenzyme inhibitors that can markedly affect the
metabolism of oxycodone is not known.
- CYP3A4 inducers such as rifampicin, carbamazepin, phenytoin and St
John´s Wort may induce the metabolism of oxycodone and cause an
increased clearance of oxycodone that could cause a reduction of the
plasma concentrations of oxycodone.
- Monoamine oxidase inhibitors (MAOIs) can enhance the side effects of
oxycodone (e.g. excitation, decrease or increase in blood pressure).
- In individuals a clinically relevant increase or decrease of blood clotting
have been observed if anticoagulants of the coumarin type (medicinal
products against blood clotting) are co-applied with Alivio™ .
Alivio™ with alcohol
Drinking alcohol whilst taking Alivio™ 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 are taking Alivio™.
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 any medicine.
Pregnancy
Alivio™ should not be used in pregnancy unless clearly necessary. There are
limited data regarding the use of oxycodone in pregnant women. Oxycodone
crosses the placenta into the blood circulation of the baby.
Prolonged use of oxycodone during pregnancy can cause withdrawal
symptoms in newborns. Use of oxycodone during delivery can cause breathing
problems (respiratory depression) in the newborn.
Breast-feeding
Breast-feeding should be discontinued during treatment with Alivio™. Oxycodone
passes into breast milk and may affect your suckling child, especially following
the intake of multiple doses.
Driving and using machines
Oxycodone impairs alertness and reactivity to such an extent that the ability
to drive and operate machinery is affected or ceases altogether. In these
circumstances Alivio™ has moderate to major influence on the ability to drive
and use machines.
With stable therapy, a general ban on driving a vehicle may be not necessary.
In these circumstances Alivio™ has minor influence on the ability to drive and
use machines. The treating physician must assess the individual situation.
Please discuss with your doctor whether or under what conditions you can
drive a vehicle.
Alivio™ contains sucrose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

3. How to take Alivio™
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
For doses not realisable/practicable with this medicinal product other strengths
and medicinal products are available.
The recommended dose is
Adults and adolescents (aged 12 years and older)
The usual initial dose is 10 mg of oxycodone hydrochloride in
12 hourly intervals. Some patients may benefit from a starting dose of 5 mg to
minimise the incidence of adverse reactions.
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 Alivio™ according to a fixed schedule need
rapidly acting painkillers as rescue medication to control breakthrough pain.
Alivio™ 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 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.
Risk patients
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.
Route and method of administration
Oral use. It is not recommended to take Alivio™ with alcoholic beverages.
Swallow the prolonged-release tablets 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.).
Alivio™ 5 mg prolonged-release tablets
Alivio™ must not be taken divided, broken, chewed or crushed as this leads
to rapid oxycodone release due to the damage of the prolonged-release
properties. The administration of divided, broken, chewed or crushed Alivio™
leads to a rapid release and absorption of a potentially fatal dose of oxycodone
(see section “If you take more Alivio™ than you should”)
Alivio™ 10 mg prolonged-release tablets
Alivio™ 20 mg prolonged-release tablets
Alivio™ 30 mg prolonged-release tablets
Alivio™ 40 mg prolonged-release tablets
Alivio™ 60 mg prolonged-release tablets
Alivio™ 80 mg prolonged-release tablets
The prolonged-release tablet can be divided into equal doses.
The prolonged-release tablets must not be broken, chewed or crushed as this

leads to rapid oxycodone release due to the damage of the prolonged-release
properties. The administration of broken, chewed or crushed Alivio™ leads to
a rapid release and absorption of a potentially fatal dose of oxycodone (see
section “If you take more Alivio™ than you should”).
Opening instruction for the blister
This medicinal product is packed in a child-resistant perforated unit dose
blister. You cannot press out the prolonged-release tablets through the blister.
Please observe the following opening instruction for the blister:

1. Tear off a single dose along the perforation line of the blister.
2. Hereby an unsealed area is accessible which is located at the position,
where the perforation lines have crossed.
3. Pull at the unsealed “strap” to peel off the cover seal.
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 Alivio™ than you should
If you have taken more Alivio™ as prescribed you should inform your doctor
or your local poison control centre immediately. The following symptoms may
occur: constricted pupils (miosis), depressed breathing (respiratory depression),
skeletal muscle flaccidity and drop in blood pressure. In severe cases circulatory
collapse, mental and motor inactivity (torpor), unconsciousness (coma),
slowing of the heart rate and accumulation of water in the lungs (non-cardiogenic
lung oedema) may occur; abuse of high doses of strong opioids such as
oxycodone can be fatal. In no case you should expose yourself to situations
requiring elevated concentration e.g. driving a car.
If you forget to take Alivio™
If you use a smaller dose of Alivio™ than directed or you miss the intake of
Alivio™, pain relief will consequently be insufficient or cease altogether.
You can make up for a forgotten dose if the next regular intake is not due for at
least another 8 hours. You can then continue to take your recommended dose
as directed.
You should also take Alivio™ if the time to the regular next intake is shorter, but
postpone the next intake by 8 hours. In principle, you should not take Alivio™
more than once every 8 hours.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Alivio™
Do not stop treatment without informing your doctor.
When a patient no longer requires therapy with Alivio™, it may be advisable
to taper the dose gradually to prevent symptoms of withdrawal.
A withdrawal syndrome may occur upon abrupt cessation of therapy. For
symptoms of the withdrawal syndrome see section 4.
If you have any further questions on the use of this medicine, ask your doctor
or pharmacist.
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Package leaflet: Information for the user

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 of signs occur.
If you experience any of the following side effects, stop taking Alivio™ and
contact your doctor immediately.
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), dizziness, headache
- constipation, feeling or being sick
- itching
Common (may affect up to 1 in 10 people)
- loss of appetite
- anxiety, confusional state, depression
- sleeplessness, nervousness, abnormal thinking
- trembling (tremor)
- depressed breathing (dyspnoea)
- dry mouth
- bellyache, diarrhoea, upset stomach (dyspepsia),
- skin disorders such as rash,
- sweating including abnormally increased sweating
- powerlessness
Uncommon (may affect up to 1 in 100 people)
- hypersensitivity
- lack of water in the body (dehydration)
- agitation, emotional lability, euphoric mood, hallucinations
- disturbances of sexual function (reduced sexual desire and erectile
dysfunction)
- drug dependence with withdrawal symptoms like palpitations
- loss of memory (amnesia), convulsion
- increased muscle tone, involuntary muscle contractions
- reduced sense of touch (hypaesthesia)
- speech disorders
- fainting, paraesthesia, change in taste
- visual impairment, constriction of the pupil
- vertigo
- widening of the blood vessels (vasodilatation)
- respiratory depression
- dysphagia, flatulence, burping, obstruction in the gut (ileus)
- increased hepatic enzymes
- dry skin
- urinary disorders (urinary retention)
- chills, general discomfort, thirst
- drug tolerance
- swelling of any organ or tissue due to accumulation of excess fluid (oedema)

SAME SIZE ARTWORK
480 mm x 140 mm

Rare (may affect up to 1 in 1,000 people)
- hypotension, orthostatic hypotension
- urticaria
Frequency not known (cannot be estimated from the available data)
- anaphylactic responses
- aggression
- hyperalgesia
- dental caries
- cholestasis, biliary colic
- absence of menstrual bleeding (amenorrhoea)
Tolerance and dependence may develop with chronic use and a withdrawal
syndrome may occur upon abrupt cessation of therapy. The withdrawal
syndrome is characterised by some or all of the following: restlessness,
increased production of tears, runny nose, yawning, sweating, chills, muscle
pain, abnormal dilatation of the pupil and sensation of irregular and forceful
heartbeat. Other symptoms may also develop, including: irritability, anxiety,
backache, joint pain, weakness, belly cramps, sleeplessness, feeling sick,
lack of appetite, vomiting, diarrhoea, or increased blood pressure, breathing
rate or heart rate.
Counteractive measures
If you observe any of the above listed side effects your doctor usually will take
appropriate measures. The side effect constipation may be prevented by fibre
enriched diet and increased drinking. If you are suffering from sickness or
vomiting your doctor will prescribe you an appropriate medicine.
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 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.

5. How to store Alivio™
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 or
label, and the carton after “EXP”. The expiry date refers to the last day of that
month.
This medicinal product does not require any special storage conditions.
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.
6. Contents of the pack and other information
What Alivio™ contains
- The active substance is oxycodone hydrochloride.
Alivio™ 5 mg prolonged-release tablets:
Each prolonged-release tablet contains 5 mg oxycodone hydrochloride as
active substance, equivalent to 4.5 mg oxycodone.
- The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch), Hypromellose, Talc,
Ethyl cellulose, Hydroxypropylcellulose, Propylene glycol, Carmellose sodium,

Cellulose microcrystalline, Magnesium stearate (Ph. Eur.), Silica colloidal
anhydrous
Tablet coating:
Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350, Talc
Alivio™ 10 mg prolonged-release tablets:
Each prolonged-release tablet contains 10 mg oxycodone hydrochloride as
active substance, equivalent to 9 mg oxycodone.
- The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch), Hypromellose, Talc,
Ethyl cellulose, Hydroxypropylcellulose, Propylene glycol, Carmellose sodium,
Cellulose microcrystalline, Magnesium stearate (Ph. Eur.), Silica colloidal
anhydrous
Tablet coating: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350,
Iron oxide red (E172), Talc
Alivio™ 20 mg prolonged-release tablets:
Each prolonged-release tablet contains 20 mg oxycodone hydrochloride as
active substance, equivalent to 17.9 mg oxycodone.
- The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch), Hypromellose, Talc,
Ethyl cellulose, Hydroxypropylcellulose, Propylene glycol, Carmellose sodium,
Cellulose microcrystalline, Magnesium stearate (Ph. Eur.), Silica colloidal
anhydrous
Tablet coating: Polyvinyl alcohol, Titanium dioxide (E171), Macrogol 3350,
Talc
Alivio™ 30 mg prolonged-release tablets:
Each prolonged-release tablet contains 30 mg oxycodone hydrochloride as
active substance, equivalent to 26.9 mg oxycodone.
- The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch), Hypromellose, Talc,
Ethyl cellulose, Hydroxypropylcellulose, Propylene glycol, Carmellose sodium,
Cellulose microcrystalline, Magnesium stearate (Ph. Eur.), Silica colloidal
anhydrous
Tablet coating: Polyvinyl alcohol, Titanium dioxide (E171), Iron oxide yellow
(E172), Macrogol 3350, Talc
Alivio™ 40 mg prolonged-release tablets:
Each prolonged-release tablet contains 40 mg oxycodone hydrochloride as
active substance, equivalent to 36 mg oxycodone.
- The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch), Hypromellose, Talc,
Ethyl cellulose, Hydroxypropylcellulose, Propylene glycol, Carmellose sodium,
Cellulose microcrystalline, Magnesium stearate (Ph. Eur.), Silica colloidal
anhydrous
Tablet coating: Polyvinyl alcohol, Titanium dioxide (E171), Iron oxide red
(E172), Macrogol 3350, Talc
Alivio™ 60 mg prolonged-release tablets:
Each prolonged-release tablet contains 60 mg oxycodone hydrochloride as
active substance, equivalent to 53.8 mg oxycodone.
- The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch), Hypromellose, Talc,
Ethyl cellulose, Hydroxypropylcellulose, Propylene glycol, Carmellose sodium,

Cellulose microcrystalline, Magnesium stearate (Ph. Eur.), Silica colloidal
anhydrous
Tablet coating: Polyvinyl alcohol, Macrogol 3350, Iron oxide yellow (E172),
Talc
Alivio™ 80 mg prolonged-release tablets:
Each prolonged-release tablet contains 80 mg oxycodone hydrochloride as
active substance, equivalent to 72 mg oxycodone.
- The other ingredients are:
Tablet core: Sugar spheres (sucrose, maize starch), Hypromellose, Talc,
Ethyl cellulose, Hydroxypropylcellulose, Propylene glycol, Carmellose sodium,
Cellulose microcrystalline, Magnesium stearate (Ph. Eur.), Silica colloidal
anhydrous
Tablet coating: Polyvinyl alcohol, Iron oxide red (E172), Macrogol 3350, Talc
What Alivio™ looks like and contents of the pack
Alivio™ 5 mg prolonged-release tablets
White to off-white, round, biconvex, film coated tablets. The height of the tablet
is between 3.3 and 4.3 mm, the diameter is 5.2 mm.
Alivio™ 10 mg prolonged-release tablets
Pink, oblong, biconvex, film coated tablets with break scores on both sides.
The height of the tablet is between 4 and 5 mm, the width is 4.8 mm and the
length is 10.3 mm.
The tablet can be divided into equal doses.
Alivio™ 20 mg prolonged-release tablets
White to off-white, oblong, biconvex, film coated tablets with break scores on
both sides. The height of the tablet is between 3.3 and 4.3 mm, the width is 4.8
mm and the length is 10.3 mm.
The tablet can be divided into equal doses.
Alivio™ 30 mg prolonged-release tablets
Yellow, oblong, biconvex, film coated tablets with break scores on both sides.
The height of the tablet is between 3.8 and 4.8 mm, the width is 5.3 mm and
the length is 11.3 mm.
The tablet can be divided into equal doses.

Pack sizes:
10x1, 14x1, 20x1, 28x1, 30x1, 50x1, 56x1, 98x1, 100x1 prolonged-release
tablets in child resistant, white opaque perforated unit dose blister.
10, 20, 30, 50, 100 prolonged-release tablets in bottles with child-resistant
closure.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Bristol Laboratories Ltd,
Unit 3, Canalside,
Northbridge Road, Berkhamsted,
Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax:
0044 (0)1442 873717
Email:
info@bristol-labs.co.uk
Manufacturer
Develco Pharma GmbH
Grienmatt 42
79650 Schopfheim
Deutschland
Alivio™
Alivio™
Alivio™
Alivio™
Alivio™
Alivio™
Alivio™

5mg prolonged-release tablets; PL 17907/0558
10mg prolonged-release tablets; PL 17907/0559
20mg prolonged-release tablets; PL 17907/0560
30mg prolonged-release tablets; PL 17907/0561
40mg prolonged-release tablets; PL 17907/0562
60mg prolonged-release tablets; PL 17907/0563
80mg prolonged-release tablets; PL 17907/0564

This leaflet was last revised in January 2016.
To request a copy of this leaflet in Braille, large print or audio format then please
contact the licence holder at the address (or telephone, fax, email) above.

Alivio™ 40 mg prolonged-release tablets
Pink, oblong, biconvex, film coated tablets with break scores on both sides.
The height of the tablet is between 4.8 and 5.8 mm, the width is 5.8 mm and
the length is 12.4 mm.
The tablet can be divided into equal doses.
Alivio™ 60 mg prolonged-release tablets
Dark yellow, oblong, biconvex, film coated tablets with break scores on both
sides. The height of the tablet is between 5 and 6 mm, the width is 6.8 mm and
the length is 14.5 mm.
The tablet can be divided into equal doses.
Alivio™ 80 mg prolonged-release tablets
Red, oblong, biconvex, film coated tablets with break scores on both sides.
The height of the tablet is between 5.8 and 6.8 mm,
the width is 7.4 mm and the length is 15.5 mm.
The tablet can be divided into equal doses.
V8 24-05-16 D0

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4. Possible side effects

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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