Oxycodone Depot Teva Sweden 40 mg Depottablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

22-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-04-2018

Aktiva substanser:
oxikodonhydroklorid
Tillgänglig från:
Teva Sweden AB
ATC-kod:
N02AA05
INN (International namn):
oxycodone hydrochloride
Dos:
40 mg
Läkemedelsform:
Depottablett
Sammansättning:
laktosmonohydrat Hjälpämne; oxikodonhydroklorid 40 mg Aktiv substans
Receptbelagda typ:
Receptbelagt
Produktsammanfattning:
Förpacknings: Blister, 10 tabletter; Blister, 25 tabletter; Blister, 28 tabletter; Blister, 30 tabletter; Blister, 50 tabletter; Blister, 56 tabletter; Blister, 60 tabletter; Blister, 98 tabletter; Blister, 100 tabletter; Blister, 14 tabletter; Burk, 50 tabletter; Burk, 100 tabletter
Bemyndigande status:
Godkänd
Godkännandenummer:
53287
Tillstånd datum:
2016-07-06

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

21-11-2019

Produktens egenskaper Produktens egenskaper - engelska

21-11-2019

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

12-10-2016

Läs hela dokumentet

Package leaflet: Information for the patient

Oxycodone Depot Teva Sweden 5 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 10 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 15 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 20 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 30 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 40 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 60 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 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

What Oxycodone Depot Teva Sweden is and what it is used for

What you need to know before you take Oxycodone Depot Teva Sweden

How to take Oxycodone Depot Teva Sweden

Possible side effects

How to store Oxycodone Depot Teva Sweden

Contents of the pack and other information

1.

What Oxycodone Depot Teva Sweden is and what it is used for

Oxycodone Depot Teva Sweden contains the active ingredient oxycodone hydrochloride, which

belongs to a group of medicines called opioids. These are strong painkillers.

Oxycodone Depot Teva Sweden 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 Oxycodone Depot Teva Sweden

Do not take Oxycodone Depot Teva Sweden if you:

are allergic to oxycodone hydrochloride or any of the other ingredients of this medicine (listed

in section 6)

have severe breathing problems, low amounts of oxygen in your blood (hypoxia) or too much

carbon dioxide in your blood

suffer from severe chronic obstructive lung disease,

cor pulmonale

(cardiac changes due to

chronic overload of lung circulation) or acute, severe bronchial asthma

suffer from intestinal paralysis

have a sudden, severe abdominal pain or suffer from a delayed gastric emptying.

Warnings and precautions

Talk to your doctor or pharmacist before taking Oxycodone Depot Teva Sweden if you:

are older or debilitated

have lung, liver or kidney problems

suffer from certain illnesses of the thyroid gland, impaired function of the thyroid gland

have poor adrenal gland function (your adrenal gland is not working properly) for example

Addison’s disease

suffer from enlargement of the prostate

suffer from alcoholism or are undergoing alcohol withdrawal

suffer from known opioid-dependence

suffer from inflammation of the pancreas

have conditions with increased brain pressure such as head injury

suffer from disturbances of circulatory regulation

suffer from colic of the bile duct and ureter

suffer from low blood pressure or reduced blood volume

suffer from epilepsy or have a seizure tendency

take monoamine oxidase inhibitors, also referred to as MAOIs (for the treatment of depression)

suffer from an inflammatory bowel disorder

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.

When used for a long time, your body may develop tolerance to the effects of this medicine and as a

result, progressively higher doses may be required to control the pain.

Chronic use of Oxycodone Depot Teva Sweden may lead to physical dependence and a withdrawal

syndrome may occur when you stop taking it suddenly. When you no longer require therapy with

oxycodone, it may be advisable to reduce 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 significantly reduced and needs to be weighed against the potential benefit

of taking this medicine. 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.

Oxycodone Depot Teva Sweden is NOT recommended for use before an operation or in the 24 hours

after an operation.

Oxycodone Depot Teva Sweden should be used with particular care in patients with a history of or

present alcohol and drug abuse.

Similar to other opioids, Oxycodone Depot Teva Sweden may affect the normal production of

hormones in the body such as cortisol or sex hormones, particularly if you have taken high doses for

long periods of time. Symptoms may be feeling or being sick, loss of appetite, tiredness, dizziness or

disturbances of sexual function, changes in menstrual bleeding or impotence. Please discuss this with

your doctor.

Children and adolescents

The effects of oxycodone have 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.

Other medicines and Oxycodone Depot Teva Sweden

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, furthermore the risk of side effects may be increased. Tell your doctor or

pharmacist if you are taking:

a type of medicine known as a monoamine oxidase inhibitor (such as moclobemide,

phenelzine, isoniazid, tranylcypromine or selegiline) or you have taken this type of medicine in

the last two weeks (see ‘Warnings and precautions),

medicines to help you sleep or stay calm (for example hypnotics or sedatives, including

benzodiazepines),

medicines to treat depression (for example paroxetine or fluoxetine),

medicines to treat psychiatric or mental disorders (such as phenothiazines or neuroleptic

drugs),

other strong analgesics (‘opioids’),

muscle relaxants,

quinidine (a medicine to treat a fast heartbeat),

cimetidine (a medicine for stomach ulcers, indigestion or heartburn),

medicines to treat fungal infections (such as ketoconazole, voriconazole, itraconazole, or

posaconazole),

medicines used to treat bacterial infections (such as clarithromycin, erythromycin or

telithromycin),

a specific type of medicine known as a protease inhibitor to treat HIV (examples include

boceprevir, ritonavir, indinavir, nelfinavir or saquinavir),

rifampicin to treat tuberculosis,

carbamazepine (a medicine to treat seizures, fits or convulsions and certain pain conditions),

phenytoin (a medicine to treat seizures, fits or convulsions),

a herbal remedy called St John’s Wort (also known as Hypericum perforatum),

medicines used to treat allergies (antihistamines) or vomiting (antiemetics),

medicines to treat Parkinson’s disease,

anticoagulants of the coumarin type (medicines used to reduce blood clotting).

Also, tell your doctor if you have recently been given an anaesthetic.

Concomitant use of Oxycodone Depot Teva Sweden and sedative medicines such as benzodiazepines

or related drugs increases the risk of drowsiness, difficulties in breathing (respiratory depression),

coma and may be life-threatening. Because of this, concomitant use should only be considered when

other treatment options are not possible.

However if your doctor does prescribe Oxycodone Depot Teva Sweden together with sedative

medicines the dose and duration of concomitant treatment should be limited by your doctor.

Please tell your doctor about all sedative medicines you are taking, and follow your doctor´s dose

recommendation closely. It could be helpful to inform friends or relatives to be aware of the signs and

symptoms stated above. Contact your doctor when experiencing such symptoms.

The risk of side effects increases, if you use antidepressants (such as citalopram, duloxetine,

escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine). These medicines may

interact with oxycodone and you may experience symptoms such as involuntary, rhythmic

contractions of muscles, including the muscles that control movement of the eye, agitation,

excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature

above 38°C. Contact your doctor when experiencing such symptoms.

Oxycodone Depot Teva Sweden with food, drink and alcohol

You should NOT drink alcohol while you are taking Oxycodone Depot Teva Sweden. Drinking

alcohol whilst taking Oxycodone Depot Teva Sweden 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.

Grapefruit juice can increase the effect of oxycodone. Therefore, you should avoid drinking grapefruit

juice while taking Oxycodone Depot Teva Sweden.

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 are 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. Oxycodone Depot Teva Sweden should only be used during pregnancy if the benefit

outweighs the possible risks to the baby.

Breast-feeding

Oxycodone may pass into breast milk and may cause breathing difficulties in the newborn. Oxycodone

Depot Teva Sweden 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 not be necessary. The treating physician

must assess the individual situation. Please discuss with your doctor whether or under what conditions

you can drive a vehicle.

Oxycodone Depot Teva Sweden 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 Oxycodone Depot Teva Sweden

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, twice a day (every 12 hours).

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 Oxycodone Depot Teva Sweden according to a fixed schedule need rapidly

acting painkillers as rescue medication to control breakthrough pain. Oxycodone Depot Teva Sweden

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 doses may be necessary. Patients with cancer pain

usually require doses 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

efficiently 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

Oxycodone Depot Teva Sweden leads to a rapid release and absorption of a potentially fatal dose of

oxycodone (see section “If you take more Oxycodone Depot Teva Sweden than you should”).

Oxycodone Depot Teva Sweden are for oral use only. In case of abusive injection (injection in a vein),

the inactive ingredients in the tablet may cause destruction (necrosis) of the local tissue, change of

lung tissue (granulomas of the lung) or other serious, potentially fatal events.

[For child resistant blister packs only:]

Instructions for use of child resistant blisters:

1. Do not push the tablet directly out of the pocket.

2. Separate one blister cell from the strip at the perforations.

3. Carefully peel off the backing to open the pocket.

[Instructions for use of child resistant HDPE containers:]

Push down the lid and turn to open

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 Oxycodone Depot Teva Sweden than you should

If you have taken more Oxycodone Depot Teva Sweden than prescribed, you should inform your

doctor or your local poison control centre immediately.

The following symptoms may occur: constricted pupils, depressed breathing, floppy muscles 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. If you have taken too much

Oxycodone Depot Teva Sweden, DO NOT expose yourself to situations requiring elevated

concentration e.g. driving a car.

If you forget to take Oxycodone Depot Teva Sweden

If you use a smaller dose of Oxycodone Depot Teva Sweden than directed or you miss the intake of

the tablets, pain relief will consequently be insufficient or stop 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 Oxycodone Depot Teva

Sweden more than once every 8 hours.

Do NOT take a double dose to make up for a forgotten tablet.

If you stop taking Oxycodone Depot Teva Sweden

DO NOT stop treatment without informing your doctor.

When a patient no longer requires therapy with Oxycodone Depot Teva Sweden, it may be advisable

to reduce the dose gradually to prevent symptoms of withdrawal (see section 2, “What you need to

know before you take Oxycodone Depot Teva Sweden”)

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, STOP taking Oxycodone Depot Teva Sweden

and contact your doctor immediately:

depressed (shallow) breathing

, especially in elderly or debilitated patients, which can cause

severe drop in blood pressure

severe hypersensitivity reactions (anaphylactic reactions)

which may cause nettle rash,

swelling of the face, lips, mouth, tongue or throat or difficulty in breathing

constricted pupils

sudden constriction of the airways

causing difficulty in breathing (bronchospasm)

abdominal cramps

suppression of 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

shortness of breath, 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,

“What you need to know before you take Oxycodone Depot Teva Sweden”)

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, depressed breathing

oral ulcers, inflammation of the gums, inflamed mouth, difficulty swallowing, wind, flatulence,

intestinal obstruction

increased liver enzymes

dry skin

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 available 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

long term use of Oxycodone Depot Teva Sweden during pregnancy may cause life-threatening

withdrawal symptoms in the new-born. 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..

Counteractive measures

If you observe any of the above listed side effects, your doctor will usually take appropriate measures.

Constipation may be prevented by fibre 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 or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via

the national reporting system

listed in Appendix V

By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Oxycodone Depot Teva Sweden

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.

Blister packs:

Do not store above 25°C.

HDPE container:

5 mg, 10 mg, 15 mg: Do not store above 30°C.

20 mg, 30 mg, 40 mg, 60 mg, 80 mg: 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 Oxycodone Depot Teva Sweden contains

The active substance is oxycodone hydrochloride. Each prolonged-release tablet contains 5, 10, 15, 20,

30, 40, 60 or 80 mg oxycodone hydrochloride.

The other ingredients are:

Tablet core

: Lactose monohydrate (see section 2 Oxycodone Depot Teva Sweden contains lactose),

hypromellose, povidone, stearic acid, magnesium stearate, colloidal anhydrous silica.

Tablet coating

5 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, Indigo Carmine Aluminium

Lake (E132), yellow iron oxide (E172).

10 mg tablets: Titanium dioxide (E171), hypromellose, macrogol, polysorbate 80.

15 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172),

black iron oxide (E172).

20 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172).

30 mg tablets: Polyvinyl alcohol, macrogol, talc, red iron oxide (E172), black iron oxide (E172),

Indigo Carmine Aluminium Lake (E132)

40 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172).

60 mg tablets: Polyvinyl alcohol, macrogol, talc, red iron oxide (E172), carmine (E120), black iron

oxide (E172).

80 mg tablets: Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, Indigo Carmine Aluminium

Lake (E132), yellow iron oxide (E172).

What Oxycodone Depot Teva Sweden looks like and contents of the pack

Oxycodone Depot Teva Sweden 5 mg prolonged-release tablets are blue, round, biconvex tablets, 7

mm in diameter, with ‘OX 5’

debossed on one side.

Oxycodone Depot Teva Sweden

10 mg prolonged-release tablets are white, round, biconvex tablets, 9

mm in diameter, with ‘OX 10’debossed on one side.

Oxycodone Depot Teva Sweden

15 mg prolonged-release tablets are grey, round, biconvex tablets, 9

mm in diameter, with ‘OX 15’

debossed on one side.

Oxycodone Depot Teva Sweden

20 mg prolonged-release tablets are pink, round, biconvex tablets, 7

mm in diameter, with ‘OX 20’debossed on one side.

Oxycodone Depot Teva Sweden 30 mg prolonged-release tablets are brown, round, biconvex tablets,

9 mm in diameter, with ‘OX 30’debossed on one side.

Oxycodone Depot Teva Sweden 40 mg prolonged-release tablets are yellow, round, biconvex tablets,

7 mm in diameter, with ‘OX 40’debossed on one side.

Oxycodone Depot Teva Sweden 60 mg prolonged-release tablets are red, round, biconvex tablets, 9

mm in diameter, with ‘OX 60’debossed on one side.

Oxycodone Depot Teva Sweden 80 mg prolonged-release tablets are green, round, biconvex tablets,

9 mm in diameter, with ‘OX 80’debossed on one side.

Oxycodone Depot Teva Sweden are available in child-resistant blister packs (PVC/Al/PET/paper) and

non-child-resistant blister packs (PVC/Aluminium) of:

5 mg: 14, 25, 28, 30, 56, 60, 98, 100 prolonged-release tablets.

10 mg, 20 mg, 40 mg, 80 mg: 10, 14, 25, 28, 30, 50, 56, 60, 98, 100 prolonged-release tablets.

15 mg: 28, 30, 56, 98,100 prolonged-release tablets.

30 mg, 60 mg: 10, 30, 56, 60, 100 prolonged-release tablets.

Oxycodone Depot Teva Sweden are also available in white, round, child-resistant, HDPE tablet

containers with PP caps containing:

5 mg, 10 mg: 98 and 100 prolonged-release tablets.

15 mg, 60 mg: 100 prolonged-release tablets.

20mg, 40 mg, 80 mg: 50 and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

<[To be completed nationally]>

This medicinal product is authorised in the Member States of the EEA under the following

names:

BE:

Oxycodone Teva 5, 10, 20, 40, 80 mg tabletten met verlengde afgifte / comprimés à libération

prolongée / Retardtabletten

NL:

Oxycodon HCL Retard Teva 5, 10, 15, 20, 30, 40, 60, 80 mg, tabletten met verlengde afgifte

SE:

Oxycodone Depot Teva Sweden

This leaflet was last revised in 2019-11-21

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SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE MEDICINAL PRODUCT

Oxycodone Depot Teva Sweden 5 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 10 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 15 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 20 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 30 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 40 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 60 mg prolonged-release tablets

Oxycodone Depot Teva Sweden 80 mg prolonged-release tablets

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Oxycodone Depot Teva Sweden

5 mg prolonged-release tablets:

Each prolonged-release tablet contains 5 mg oxycodone hydrochloride corresponding to 4.5 mg of

oxycodone.

Oxycodone Depot Teva Sweden

10 mg prolonged-release tablets:

Each prolonged-release tablet contains 10 mg oxycodone hydrochloride corresponding to 9 mg of

oxycodone.

Oxycodone Depot Teva Sweden

15 mg prolonged-release tablets:

Each prolonged-release tablet contains 15 mg oxycodone hydrochloride corresponding to 13.5 mg of

oxycodone.

Oxycodone Depot Teva Sweden

20 mg prolonged-release tablets:

Each prolonged-release tablet contains 20 mg oxycodone hydrochloride corresponding to 18 mg of

oxycodone.

Oxycodone Depot Teva Sweden

30 mg prolonged-release tablets:

Each prolonged-release tablet contains 30 mg oxycodone hydrochloride corresponding to 27 mg of

oxycodone.

Oxycodone Depot Teva Sweden

40 mg prolonged-release tablets:

Each prolonged-release tablet contains 40 mg oxycodone hydrochloride corresponding to 36 mg of

oxycodone.

Oxycodone Depot Teva Sweden

60 mg prolonged-release tablets:

Each prolonged-release tablet contains 60 mg oxycodone hydrochloride corresponding to 54 mg of

oxycodone.

Oxycodone Depot Teva Sweden

80 mg prolonged-release tablets:

Each prolonged-release tablet contains 80 mg oxycodone hydrochloride corresponding to 72 mg of

oxycodone.

Excipient with known effect:

Oxycodone Depot Teva Sweden

5 mg prolonged-release tablets:

Each prolonged-release tablet contains 31.6 mg lactose monohydrate

Oxycodone Depot Teva Sweden 10 mg prolonged-release tablets:

Each prolonged-release tablet contains 63.2 mg lactose monohydrate

Oxycodone Depot Teva Sweden 15 mg prolonged-release tablets:

Each prolonged-release tablet contains 63.2 mg lactose monohydrate

Oxycodone Depot Teva Sweden 20 mg prolonged-release tablets:

Each prolonged-release tablet contains 31.6 mg lactose monohydrate

Oxycodone Depot Teva Sweden 30 mg prolonged-release tablets:

Each prolonged-release tablet contains 63.2 mg lactose monohydrate

Oxycodone Depot Teva Sweden 40 mg prolonged-release tablets:

Each prolonged-release tablet contains 31.6 mg lactose monohydrate

Oxycodone Depot Teva Sweden 60 mg prolonged-release tablets:

Each prolonged-release tablet contains 63.2 mg lactose monohydrate

Oxycodone Depot Teva Sweden 80 mg prolonged-release tablets:

Each prolonged-release tablet contains 63.2 mg lactose monohydrate

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Prolonged-release tablet.

Oxycodone Depot Teva Sweden

5 mg prolonged-release tablets:

Blue, round, biconvex tablets, 7 mm in diameter, with ‘OX 5’ debossed on one side.

Oxycodone Depot Teva Sweden 10 mg prolonged-release tablets:

White, round, biconvex tablets, 9 mm in diameter, with ‘OX 10’ debossed on one side.

Oxycodone Depot Teva Sweden

15 mg prolonged-release tablets:

Grey, round, biconvex tablets, 9 mm in diameter, with ‘OX 15’ debossed on one side.

Oxycodone Depot Teva Sweden

20 mg prolonged-release tablets:

Pink, round, biconvex tablets, 7 mm in diameter, with ‘OX 20’ debossed on one side.

Oxycodone Depot Teva Sweden

30 mg prolonged-release tablets:

Brown, round, biconvex tablets, 9 mm in diameter, with ‘OX 30’ debossed on one side.

Oxycodone Depot Teva Sweden

40 mg prolonged-release tablets:

Yellow, round, biconvex tablets, 7 mm in diameter, with ‘OX 40’ debossed on one side.

Oxycodone Depot Teva Sweden

60 mg prolonged-release tablets:

Red, round, biconvex tablets, 9 mm in diameter, with ‘OX 60’ debossed on one side.

Oxycodone Depot Teva Sweden

80 mg prolonged-release tablets:

Green, round, biconvex tablets, 9 mm in diameter, with ‘OX 80’ debossed on one side.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Severe pain, which can be adequately managed only with opioid analgesics.

Oxycodone Depot Teva Sweden is indicated in adults and adolescents aged 12 years and older.

4.2

Posology and method of administration

Posology

The dosage depends on the intensity of pain and the patient’s individual susceptibility to the treatment.

The following general dosage recommendations apply:

Adults and adolescents 12 years of age and older

Dose titration and adjustment

In general, the initial dose for opioid naïve patients is 10 mg oxycodone hydrochloride given at

intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg to minimize the incidence

of side effects.

Patients already receiving opioids may start treatment with higher dosages taking into account their

experience with former opioid therapies.

For doses not realisable/practicable with these strengths, other strengths are available.

According to well-controlled clinical studies 10-13 mg oxycodone hydrochloride correspond to

approximately 20 mg morphine sulphate, both in the prolonged-release formulation.

Because of individual differences in sensitivity for different opioids, it is recommended that patients

should start conservatively with Oxycodone Depot Teva Sweden prolonged-release tablets after

conversion from other opioids, with 50-75% of the calculated oxycodone dose.

Some patients who take Oxycodone Depot Teva Sweden prolonged-release tablets following a fixed

schedule need rapid release analgesics as rescue medication in order to control breakthrough pain.

Oxycodone Depot Teva Sweden prolonged-release tablets are not indicated for the treatment of acute

pain and/or breakthrough pain. The single dose of the rescue medication should amount to 1/6 of the

equianalgesic daily dose of Oxycodone Depot Teva Sweden prolonged-release tablets. Use of the

rescue medication more than twice daily indicates that the dose of Oxycodone Depot Teva Sweden

prolonged-release tablets needs to be increased. The dose should not be adjusted more often than once

every 1-2 days until a stable twice daily administration has been achieved.

Following a dose increase from 10 mg to 20 mg taken every 12 hours dose adjustments should be made

in steps of approximately one third of the daily dose. The aim is a patient- specific dosage which, with

twice daily administration, allows for adequate analgesia with tolerable undesirable effects and as little

rescue medication as possible as long as pain therapy is needed.

Even distribution (the same dose mornings and evenings) following a fixed schedule (every 12 hours)

is appropriate for the majority of the patients. For some patients it may be advantageous to distribute

the doses unevenly. In general, the lowest effective analgesic dose should be chosen. For the treatment

of non- malignant pain a daily dose of 40 mg is generally sufficient; but higher dosages may be

necessary. Patients with cancer- related pain may require dosages of 80 to 120 mg, which in individual

cases can be increased to up to 400 mg. If even higher doses are required, the dose should be decided

individually balancing efficacy with the tolerance and risk of undesirable effects.

Duration of administration

Oxycodone Depot Teva Sweden prolonged-release tablets should not be taken longer than necessary. If

long- term treatment is necessary due to the type and severity of the illness careful and regular

monitoring is required to determine whether and to what extent treatment should be continued.

Discontinuation of treatment

When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose

gradually to prevent symptoms of withdrawal.

Paediatric population

There have been no studies in patients under 12 years of age; therefore oxycodone hydrochloride

should not be used in patients under 12 years.

Elderly patients

A dose adjustment is not usually necessary in elderly patients.

Patients with renal or hepatic impairment

The dose initiation should follow a conservative approach in these patients. The recommended adult

starting dose should be reduced by 50% (for example a total daily dose of 10 mg orally in opioid naïve

patients), and each patient should be titrated to adequate pain control according to their clinical

situation.

Risk patients

Risk patients, for example patients with low body weight or slow metabolism of medicinal products,

should initially receive half the recommended adult dose if they are opioid naïve. Dose titration should

be performed in accordance with the individual clinical situation.

Method of administration

For oral use.

Oxycodone Depot Teva Sweden prolonged-release tablets should be taken twice daily based on a fixed

schedule at the dosage determined.

The prolonged-release tablets may be taken with or independent of meals with a sufficient amount of

liquid. Oxycodone Depot Teva Sweden prolonged release tablets must be swallowed whole, not

chewed.

For instructions how to open the child resistant blisters and HDPE containers, see section 6.6.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Severe respiratory depression with hypoxia and/or hypercapnia.

Severe chronic obstructive pulmonary disease.

Cor pulmonale.

Severe bronchial asthma.

Elevated carbon dioxide levels in the blood.

Paralytic ileus.

Acute abdomen, delayed gastric emptying.

4.4

Special warnings and precautions for use

Paediatric population

Oxycodone Depot Teva Sweden prolonged-release tablets have not been studied in children younger

than 12 years of age. The safety and efficacy of the tablets have not been demonstrated and the use in

children younger than 12 years of age is therefore not recommended.

Elderly or debilitated patients

The major risk of opioid excess is respiratory depression. Caution is required in elderly or debilitated

patients, in patients with severe impairment of lung, liver or kidney function, myxoedema,

hypothyroidism, Addison’s disease (adrenal insufficiency), intoxication psychosis (e.g. alcohol),

prostatic hypertrophy, adrenocortical insufficiency, alcoholism, known opioid dependence, delirium

tremens, pancreatitis, diseases of the biliary tract, inflammatory bowel disorders, biliary or ureteric

colic, hypotension, hypovolaemia, conditions with increased brain pressure such as head injury,

disturbances of circulatory regulation, epilepsy or seizure tendency and in patients taking MAO

inhibitors.

Patients undergoing abdominal surgery

As with all opioid preparations, oxycodone products should be used with caution following abdominal

surgery as opioids are known to impair intestinal motility and should not be used until the physician is

assured of normal bowel function.

Hepatic impairment

Patients with severe hepatic impairment should be closely monitored.

Respiratory depression

Respiratory depression is the most significant risk induced by opioids and is most likely to occur in

elderly or debilitated patients. The respiratory depressant effect of oxycodone can lead to increased

carbon dioxide concentrations in blood and hence in cerebrospinal fluid. In predisposed patients

opioids can cause severe decrease in blood pressure.

Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs

Concomitant use of Oxycodone Depot Teva Sweden and sedative medicines such as benzodiazepines

or related drugs may result in sedation, respiratory depression, coma and death.

Because of these risks, concomitant prescribing with these sedative medicines should be reserved for

patients for whom alternative treatment options are not possible.

If a decision is made to prescribe Oxycodone Depot Teva Sweden concomitantly with sedative

medicines, the lowest effective dose should be used, and the duration of treatment should be as short

as possible.

The patients should be followed closely for signs and symptoms of respiratory depression and

sedation. In this respect, it is strongly recommended to inform patients and their caregivers to be

aware of these symptoms (see section 4.5).

Long-term use, tolerance and withdrawal

The patient may develop tolerance to the drug with chronic use and require progressively higher doses

to maintain pain control. Prolonged use of this product 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, it may be advisable to taper the dose gradually to prevent symptoms of

withdrawal. Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor,

hyperhidrosis, anxiety, agitation, convulsions and insomnia.

Hyperalgesia

Hyperalgesia that will not respond to a further dose increase of oxycodone may very rarely occur,

particularly in high doses. An oxycodone dose reduction or change to an alternative opioid may be

required.

Dependence potential

Oxycodone Depot Teva Sweden prolonged-release tablets have a primary dependence potential.

Oxycodone has an abuse profile similar to other strong agonist opioids. Oxycodone may be sought and

abused by people with latent or manifest addiction disorders. There is potential for development of

psychological dependence [addiction] to opioid analgesics, including oxycodone. However, when

used as directed in patients with chronic pain the risk of developing physical or psychological

dependence is markedly reduced or needs to be assessed in a differentiated manner. There are no data

available on the actual incidence of psychological dependence in chronic pain patients. In patients with

a history of alcohol and drug abuse the medicinal product must be prescribed with special care.

Pre-operative use

Oxycodone Depot Teva Sweden prolonged release tablets are not recommended for pre-operative use or

within the first 12-24 hours post operatively.

Abusive parenteral venous injection

In case of abusive parenteral venous injection the tablet excipients may lead to necrosis of the local

tissue, infection, increased risk of endocarditis, and valvular heart injury which may be fatal,

granulomas of the lung or other serious, potentially fatal events.

Endocrine effects

Opioids, such as oxycodone hydrochloride, may influence the hypothalamic-pituitary-adrenal or –

gonadal axes. Some changes that can be seen include an increase in serum prolactin and decreases in

plasma cortisol and testosterone. Clinical symptoms may manifest from these hormonal changes.

Tablets must not be chewed or crushed

To avoid damage to the controlled release properties of the tablets the prolonged release tablets must be

swallowed whole, and not broken, chewed or crushed. The administration of broken, chewed or crushed

controlled release oxycodone tablets leads to rapid release and absorption of a potentially fatal dose of

oxycodone (see section 4.9).

Alcohol

Concomitant use of alcohol and oxycodone hydrochloride may increase the undesirable effects of

oxycodone hydrochloride; concomitant use should be avoided.

Oxycodone Depot Teva Sweden contains lactose

This medicinal product contains lactose. Patients with rare hereditary problems of galactose

intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

There can be an enhanced CNS depressant effect during concomitant therapy with drugs which affect

the CNS such as other opioids, sedatives, hypnotics, anti-depressants, phenothiazines, neuroleptic

drugs, antipsychotics, anaesthetics, muscle relaxants, antihistamines and antiemetics. MAO-inhibitors

are known to interact with opioid analgesics. MAO-inhibitors causes CNS-excitation or depression

associated with hypertensive or hypotensive crisis (see section 4.4). Oxycodone should be used with

caution in patients administered MAO-inhibitors or who have received MAO-inhibitors during the last

two weeks (see section 4.4).

Sedative medicines such as benzodiazepines or related drugs

The concomitant use of opioids with sedative medicines such as benzodiazepines or related drugs

increases the risk of sedation, respiratory depression, coma and death because of additive CNS

depressant effect. The dose and duration of concomitant use should be limited (see section 4.4).

Concomitant administration of oxycodone with serotonin agents, such as a Selective Serotonin Re-

uptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) may cause

serotonin toxicity. The symptoms of serotonin toxicity may include mental-status changes (e.g.,

agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure,

hyperthermia), neuromuscular abnormalities (e.g., hyperreflexia, incoordination, rigidity), and/or

gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea). Oxycodone should be used with caution

and the dosage may need to be reduced in patients using these medications.

Alcohol may enhance the pharmacodynamic effects of oxycodone; concomitant use should be avoided.

Anticholinergics (e.g. antipsychotics, antihistamines, antiemetics, antiparkinson drugs) can enhance the

anticholinergic undesirable effects of oxycodone (such as constipation, dry mouth or micturition

disorders).

Oxycodone is metabolised mainly by CYP3A4, with a contribution from CYP2D6. The activities of

these metabolic pathways may be inhibited or induced by various co-administered drugs or dietary

elements.

CYP3A4 inhibitors, such as macrolide antibiotics (e.g. clarithromycin, erythromycin and

telithromycin), azol-antifungals (e.g. ketoconazole, voriconazole, itraconazole, and posaconazole),

protease inhibitors (e.g. boceprevir, ritonavir, indinavir, nelfinavir and saquinavir), cimetidine and

grapefruit juice may cause a reduced clearance of oxycodone that could cause an increase of the

plasma concentrations of oxycodone. Therefore the oxycodone dose may need to be adjusted

accordingly.

Some specific examples are provided below:

Itraconazole, a potent CYP3A4 inhibitor, administered 200 mg orally for five days, increased

the AUC of oral oxycodone. On average, the AUC was approximately 2.4 times higher (range

1.5-3.4).

Voriconazole, a CYP3A4 inhibitor, administered 200 mg twice-daily for four days (400 mg

given as first two doses), increased the AUC of oral oxycodone. On average, the AUC was

approximately 3.6 times higher (range 2.7-5.6).

Telithromycin, a CYP3A4 inhibitor, administered 800 mg orally for four days, increased the

AUC of oral oxycodone. On average, the AUC was approximately 1.8 times higher (range

1.3-2.3).

Grapefruit Juice, a CYP3A4 inhibitor, administered as 200 ml three times a day for five days,

increased the AUC of oral oxycodone. On average, the AUC was approximately 1.7 times

higher (range 1.1-2.1).

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. The oxycodone dose may need to be adjusted accordingly.

Some specific examples are provided below:

St Johns Wort, a CYP3A4 inducer, administered as 300 mg three times a day for fifteen days,

reduced the AUC of oral oxycodone. On average, the AUC was approximately 50% lower

(range 37-57%).

Rifampicin, a CYP3A4 inducer, administered as 600 mg once-daily for seven days, reduced the

AUC of oral oxycodone. On average, the AUC was approximately 86% lower.

Drugs that inhibit CYP2D6 activity, such as paroxetine, fluoxetine and quinidine, may cause

decreased clearance of oxycodone which could lead to an increase in oxycodone plasma

concentrations.

The effect of other relevant isoenzyme inhibitors on the metabolism of oxycodone is not known.

Potential interactions should be taken into account.

Clinically relevant changes in International Normalized Ratio (INR) in both directions have been

observed in individuals if coumarin anticoagulants are co-applied with oxycodone hydrochloride.

There are no studies investigating the effect of oxycodone on CYP catalysed metabolism of other

drugs.

4.6

Fertility, pregnancy and lactation

Use of this medicinal product should be avoided to the extent possible in patients who are pregnant or

lactating.

Pregnancy

There are limited data from the use of oxycodone in pregnant women. Infants born to mothers who

have received opioids during the last 3 to 4 weeks before giving birth should be monitored for

respiratory depression. Withdrawal symptoms may be observed in the newborn of mothers undergoing

treatment with oxycodone.

Breastfeeding

Oxycodone may be secreted in breast milk and may cause respiratory depression in the newborn.

Oxycodone should, therefore, not be used in breastfeeding mothers.

4.7

Effects on ability to drive and use machines

Oxycodone may impair the ability to drive and use machines.

With stable therapy, a general ban on driving a vehicle is not necessary. The treating physician must

assess the individual situation.

4.8

Undesirable effects

Oxycodone can cause respiratory depression, miosis, bronchial spasms and spasms of the smooth

muscles and can suppress the cough reflex.

The adverse events considered at least possibly related to treatment are tabulated below by system

organ class and absolute frequency.

Body System Very

common

(

1/10)

Common

(

1/100

to

<1/10)

Uncommon

(

1/1,000

to

<1/100)

Rare

(

1/10,000

to

<1/1,000)

Frequency

unknown

(Cannot be

estimated

from the

available

data)

Blood and

lymphatic

system

disorders

lymphadenopathy

Immune system

disorders

hypersensitivity

anaphylactic

responses

Endocrine

disorders

syndrome of

inappropriate

antidiuretic

hormone

secretion

Metabolism and

nutrition

disorders

decreased

appetite

dehydration

Psychiatric

disorders

anxiety,

confusional

state,

depression,

insomnia,

nervousness.

abnormal

thinking,

amnesia,

isolated cases of

speech disorders

agitation, affect

lability, euphoric

mood,

hallucinations,

decreased libido,

drug dependence

(see section 4.4),

depersonalisation,

change in taste,

visual

disturbances,

hyperacousis

aggression

Body System Very

common

(

1/10)

Common

(

1/100

to

<1/10)

Uncommon

(

1/1,000

to

<1/100)

Rare

(

1/10,000

to

<1/1,000)

Frequency

unknown

(Cannot be

estimated

from the

available

data)

Nervous system

disorders

somnolence,

dizziness,

headache

asthenia, tremor

amnesia,

convulsion,

hypertonia, both

increased and

decreased muscle

tone, involuntary

muscle

contractions;

hypoesthesia;

coordination

disturbances;

malaise; speech

disorder, syncope,

paraesthesia,

dysgeusia

hyperalgesia

Eye disorders

visual impairment,

lacrimation

disorder, miosis

Ear and

labyrinth

disorders

vertigo

Cardiac

disorders

supraventricular

tachycardia;

palpitations (in

the context of

withdrawal

syndrome)

Vascular

disorders

vasodilatation

hypotension,

orthostatic

hypotension

Respiratory,

thoracic and

mediastinal

disorders

dyspnoea,

bronchospasm

increased

coughing;

pharyngitis;

rhinitis; voice

changes,

respiratory

depression

Gastrointestinal

disorders

constipation,

nausea,

vomiting

dry mouth, rarely

accompanied by

thirst;

gastrointestinal

disorders such as

abdominal pain;

diarrhoea;

dyspepsia; loss of

appetite

oral ulcers;

gingivitis;

stomatitis;

flatulence,

dysphagia,

eructation, ileus

gum bleeding;

increased

appetite; tarry

stool; tooth

staining

dental caries

Body System Very

common

(

1/10)

Common

(

1/100

to

<1/10)

Uncommon

(

1/1,000

to

<1/100)

Rare

(

1/10,000

to

<1/1,000)

Frequency

unknown

(Cannot be

estimated

from the

available

data)

Hepato-biliary

disorders

increased hepatic

enzymes

cholestasis,

biliary colic

Skin and

subcutaneous

tissue disorders

pruritus

skin eruptions

including rash,

in rare cases

increased

photosensitivity,

in isolated cases

urticaria or

exfoliative

dermatitis,

hyperhidrosis

dry skin

herpes simplex,

urticaria

Renal and

urinary

disorders

micturition

disturbances

(increased urge

to urinate)

urinary retention

haematuria

Reproductive

system and

breast

disorders

reduced libido;

erectile

disfunction

amenorrhoea

General

disorders and

administration

site conditions

sweating,

asthenic

conditions

accidental

injuries; pain

(e.g. chest pain);

oedema;

migraine;

physical

dependence with

withdrawal

symptoms; drug

tolerance, chills,

malaise,

peripheral

oedema, thirst.

weight changes

(increase or

decrease);

cellulitis

drug

withdrawal

syndrome

neonatal

Tolerance and dependence may develop.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare

professionals are asked to report any suspected adverse reactions via

the national reporting system

listed in Appendix V

4.9

Overdose

Symptoms

Miosis, respiratory depression, somnolence, reduced skeletal muscle tone and drop in blood pressure.

In severe cases circulatory collapse, stupor, coma, hypotonia, bradycardia, non- cardiogenic lung

oedema, hypotension, and death may occur; abuse of high doses of strong opioids such as oxycodone

can be fatal.

Therapy

Primary attention should be given to the establishment of a patent airway and institution of assisted or

controlled ventilation

In the event of overdosing intravenous administration of an opiate antagonist (e.g. 0.4-2 mg

intravenous naloxone) may be indicated. Administration of single doses must be repeated depending

on the clinical situation at intervals of 2 to 3 minutes. Intravenous infusion of 2 mg of naloxone in 500

ml isotonic saline or 5% dextrose solution (corresponding to 0.004 mg naloxone/ml) is possible. The

rate of infusion should be adjusted to the previous bolus injections and the response of the patient.

Gastric lavage can be taken into consideration. Consider activated charcoal (50 g for adults, 10 -15 g

for children), if a substantial amount has been ingested within 1 hour, provided the airway can be

protected. It may be reasonable to assume that late administration of activated charcoal may be

beneficial for prolonged release preparations; however there is no evidence to support this.

For speeding up the passage a suitable laxative (e.g. a PEG based solution) may be useful.

Supportive measures (artificial respiration, oxygen supply, administration of vasopressors and infusion

therapy) should, if necessary, be applied in the treatment of accompanying circulatory shock. Upon

cardiac arrest or cardiac arrhythmias cardiac massage or defibrillation may be indicated. If necessary,

assisted ventilation as well as maintenance of water and electrolyte balance.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Natural opium alkaloids

ATC-Code: N02A A05

Oxycodone shows an affinity to kappa, mu and delta opioid receptors in the brain and spinal cord. It

acts at these receptors as an opioid agonist without an antagonistic effect. The therapeutic effect is

mainly analgesic and sedative. Compared to rapid-release oxycodone, given alone or in combination

with other substances, the prolonged-release tablets provide pain relief for a markedly longer period

without increased occurrence of undesirable effects.

Other pharmacological effects

In- vitro and animal studies indicate various effects of natural opioids, such as morphine, on

components of the immune system; the clinical significance of these findings is unknown. Whether

oxycodone, a semisynthetic opioid, has immunological effects similar to morphine is unknown.

Clinical studies

The efficacy of oxycodone prolonged-release tablets has been demonstrated in cancer pain, post-

operative pain and severe non-malignant pain such as diabetic neuropathy, postherpetic neuralgia, low

back pain and osteoarthritis. In the latter indication, treatment was continued for up to 18 months and

proved effective in many patients for whom NSAIDs alone provided inadequate relief. The efficacy of

Oxycodone prolonged- release tablets in neuropathic pain was confirmed by three placebo-controlled

studies.

In patients with chronic non-malignant pain, maintenance of analgesia with stable dosing was

demonstrated for up to three years.

5.2

Pharmacokinetic properties

Absorption

The relative bioavailability of Oxycodone Depot Teva Sweden prolonged-release tablets is comparable

to that of rapid release oxycodone with maximum plasma concentrations being achieved approximately

3 hours after intake of the prolonged-release tablets compared to 1 to 1.5 hours. Peak plasma

concentrations and oscillations of the concentrations of oxycodone from the prolonged-release and

rapid-release formulations are comparable when given at the same daily dose at intervals of 12 and 6

hours respectively.

A fat-rich meal before the intake of the tablets does not affect the maximum concentration or the extent

of absorption of oxycodone.

The tablets must not be crushed, divided or chewed as this leads to rapid oxycodone release and

absorption of a potentially fatal dose of oxycodone due to the damage of the prolonged release

properties.

Distribution

The absolute bioavailability of oxycodone is approximately two thirds relative to parenteral

administration. In

steady state,

the volume of distribution of oxycodone amounts to 2.6 l/kg; plasma

protein binding to 38-45%; the elimination half-life to 4 to 6 hours and plasma clearance to 0.8 l/min.

Biotransformation

Oxycodone is metabolised in the intestine and liver to noroxycodone and oxymorphone as well as to

several glucuronide conjugates. CYP3A4 and CYP2D6 are probably involved in the formation of

noroxycodone and oxymorphone respectively. Oxymorphone has analgesic activity but is present in

the plasma in low concentrations and is not considered to contribute to oxycodone´s pharmacological

effect.

Elimination

Oxycodone and its metabolites are excreted via urine and faeces. Oxycodone crosses the placenta and is

found in breast milk.

Linearity/non-linearity

The prolonged-release tablets are bioequivalent in a dose proportional manner with regard to the

amount of active substance absorbed as well as comparable with regard to the rate of absorption.

Elderly

The plasma concentration of oxycodone in elderly subjects is 15% greater when compared with young

subjects.

Gender

Female subjects have, on average, plasma oxycodone concentrations up to 25% higher than males on a

body weight adjusted basis. The reason for this difference is unknown.

Patients with renal impairment

Patients with mild, moderate and severe renal impairment showed 1.1-, 1.4- and 1.7- fold increased

plasma concentrations respectively compared to patients with normal renal function. AUC increased

on average 1.5-, 1.7- and 2.3-fold respectively compared to patients with normal renal function. The

elimination half-life for oxycodone increased 1.5-, 1.2- and 1.4- fold respectively compared to patients

with normal renal function.

Patients with hepatic impairment

Patients with mild, moderate and severe hepatic impairment showed 1.2-, 2.0- and 1.9- fold increased

plasma concentrations respectively compared to patient with normal hepatic function. AUC increased

on average 1.4-, 3.2- and 3.2- fold respectively compared to patients with normal hepatic function.

The elimination half- life of oxycodone increased 1.1-, 1.8- and 1.8- fold respectively compared to

patients with normal hepatic function.

5.3

Preclinical safety data

Teratogenicity

Oyxcodone had no effect on fertility and early embryonic development in male and female rats in

doses of up to 8 mg/kg body weight and induced no malformations in rats in doses of up to 8 mg/kg

and in rabbits in doses of 125 mg/kg bodyweight. However, in rabbits, when individual foetuses were

used in statistical evaluation, a dose related increase in developmental variations was observed

(increased incidences of 27 presacral vertebrae, extra pairs of ribs). When these parameters were

statistically evaluated using litters, only the incidence of 27 presacral vertebrae was increased and only

in the 125 mg/kg group, a dose level that produced severe pharmacotoxic effects in the pregnant

animals. In a study on pre- and postnatal development in rats F1 body weights were lower at 6 mg/kg/d

when compared to body weights of the control group at doses which reduced maternal weight and food

intake (NOAEL 2 mg/kg body weight). There were neither effects on physical, reflexological, and

sensory developmental parameters nor on behavioural and reproductive indices.

In a study of peri- and postnatal development in rats, maternal body weight and food intake parameters

were reduced for doses ≥ 2 mg/kg/d compared to the control group. Body weights were lower in the F1

generation from maternal rats in the 6 mg/kg/d dosing group. There were no effects on physical,

reflexological, or sensory developmental parameters or on behavioural and reproductive indices in the

F1 pups (the NOAEL for F1 pups was 2 mg/kg/d based on body weight effects seen at 6 mg/kg/d).

There were no effects on the F2 generation at any dose in the study.

Carcinogenicity

Long-term carcinogenicity studies were not performed.

Mutagenicity

The results of

in-vitro

in-vivo

studies indicate that the genotoxic risk of oxycodone to humans is

minimal or absent at the systemic oxycodone concentrations that are achieved therapeutically.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Tablet core

Lactose monohydrate

Hypromellose

Povidone K30

Stearic acid

Magnesium stearate

Colloidal anhydrous silica

Tablet coating

5 mg:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Talc

Indigo Carmine Aluminium Lake (E132)

Iron oxide, yellow (E172)

10 mg:

Titanium dioxide (E171)

Hypromellose

Macrogol 400

Polysorbate 80

15 mg:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Talc

Iron oxide, black (E172)

Iron oxide, yellow (E172)

20 mg:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Talc

Iron oxide, red (E172)

30 mg:

Polyvinyl alcohol

Macrogol 3350

Talc

Iron oxide, red (E172)

Iron oxide, black (E172)

Indigo Carmine Aluminium Lake (E132)

40 mg:

Polyvinyl alcohol

Titanium dioxide (E171)

Macrogol 3350

Talc

Iron oxide, yellow (E172)

60 mg:

Polyvinyl alcohol

Macrogol 3350

Talc

Iron oxide, red (E172)

Carmine (E120)

Iron oxide, black (E172)

80 mg:

Polyvinyl alcohol

Macrogol 3350

Talc

Titanium dioxide (E171)

Indigo Carmine Aluminium Lake (E132)

Iron oxide, yellow (E172)

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

3 years.

6.4

Special precautions for storage

Blister packs:

Do not store above 25°C.

HDPE container:

5 mg, 10 mg, 15 mg: Do not store above 30°C.

20 mg, 30 mg, 40 mg, 60 mg, 80 mg: This medicinal product does not require any special storage

conditions.

6.5

Nature and contents of container

Child- resistant blister packs (PVC/Al/PET/paper) and non-child -resistant blister packs (PVC/Al) in

cartons.

Pack sizes:

5 mg: 14, 25, 28, 30, 56, 60, 98, 100 prolonged-release tablets

10 mg, 20 mg, 40 mg, 80 mg: 10, 14, 25, 28, 30, 50, 56, 60, 98, 100 prolonged-release tablets

15 mg: 28, 30, 56, 98,100 prolonged-release tablets

30 mg, 60 mg: 10, 30, 56, 60, 100 prolonged-release tablets

White, round, child-resistant, HDPE tablet containers with PP caps.

Pack size:

5 mg, 10 mg: 98 and 100 prolonged-release tablets

15 mg, 60 mg: 100 prolonged-release tablets

20 mg, 40 mg, 80 mg: 50 and 100 prolonged-release tablets

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.

Instructions for use of child resistant blisters:

1. Do not push the tablet directly out of the pocket

2. Separate one blister cell from the strip at the perforations

3. Carefully peel off the backing to open the pocket

Instructions for use of containers:

1. Push down firmly on the cap

2. Turn the cap anti-clockwise

3. The child-resistant cap should be replaced after use.

7.

MARKETING AUTHORISATION HOLDER

<[To be completed nationally]>

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

8.

MARKETING AUTHORISATION NUMBER(S)

<[To be completed nationally]>

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: {DD month YYYY}>

<Date of latest renewal: {DD month YYYY}>

<[To be completed nationally]>

10.

DATE OF REVISION OF THE TEXT

2019-11-21

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