PACKAGE INSERT OXYNORM CAPSULES SCHEDULING STATUS … · 2017-07-31 · PACKAGE INSERT . OXYNORM® CAPSULES . SCHEDULING STATUS . PROPRIETARY NAMES andDOSAGE FORM . OxyNorm ® 5 mg

PACKAGE INSERT

OXYNORM® CAPSULES SCHEDULING STATUS PROPRIETARY NAMES and DOSAGE FORM OxyNorm® 5 mg Capsules OxyNorm® 10 mg Capsules OxyNorm® 20 mg Capsules COMPOSITION OxyNorm® 5 mg Capsules contains 5 mg of oxycodone hydrochloride each.

OxyNorm® 10 mg Capsules contains 10 mg of oxycodone hydrochloride each.

OxyNorm® 20 mg Capsules contains 20 mg of oxycodone hydrochloride each.

Inactive ingredients: gelatine, indigo carmine, iron oxide, magnesium stearate, microcrystalline

cellulose, sodium laurylsulphate, Sunset Yellow, and titanium dioxide.

The capsules are sugar free.

PHARMACOLOGICAL CLASSIFICATION A 2.9 Other Analgesics.

PHARMACOLOGICAL ACTION Pharmacodynamic properties Oxycodone is a full opioid agonist with no antagonistic properties. It has affinity for kappa, mu

and delta opiate receptors in the brain and spinal cord. Oxycodone is similar to morphine in

its action. The therapeutic effect is mainly analgesic, anxiolytic and sedative (see

INDICATIONS).

Pharmacokinetic properties Oxycodone has an absolute bioavailability of up to 87 % following oral administration. Oxycodone is metabolised primarily to noroxycodone and oxymorphone via CYP450-3A and

CYP450-2D6 respectively. Oxymorphone has some analgesic activity but is present in

plasma in low concentrations and is not considered to contribute to oxycodone’s

pharmacological effect. Oxycodone has an elimination half-life of approximately 3 hours. Elderly: The AUC in elderly subjects is 15 % greater when compared with younger 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.

S6

1

Patients with renal impairment: Preliminary data from a study of patients with mild to

moderate renal dysfunction show peak plasma oxycodone and noroxycodone concentrations

approximately 50 % and 20 % higher, and AUC values of oxycodone, noroxycodone and

oxymorphone approximately 60 %, 60 % and 40 % higher than normal subjects, respectively.

There was an increase in t1/2 of elimination for oxycodone of only one hour.

Patients with mild to moderate hepatic impairment: Patients with mild to moderate

hepatic dysfunction showed peak plasma oxycodone and noroxycodone concentrations

approximately 50 % and 20 % higher, respectively, than normal subjects. AUC values were

approximately 95 % and 75 % higher, respectively. Oxymorphone peak plasma

concentrations and AUC values were lower by 15 % to 50 %. The t1/2 elimination for

oxycodone increased by 2,3 hours.

INDICATIONS OxyNorm® Capsules are indicated for the treatment of moderate to severe pain in patients

with cancer and post-operative pain after gastrointestinal function has returned.

OxyNorm® Capsules are indicated for the treatment of severe pain requiring the use of a

strong opioid analgesic.

CONTRAINDICATIONS OxyNorm® Capsules are contraindicated in patients with known hypersensitivity to

oxycodone or to any of the excipients (see COMPOSITION) or in any situation where opioids

are contraindicated.

OxyNorm® Capsules are contraindicated in patients who are pregnant or breast-feeding; or

patients on concurrent administration of monoamine oxidase inhibitors or within 2 weeks of

discontinuation of their use.

OxyNorm® Capsules are contraindicated in patients suffering from:

• respiratory depression;

• head injury;

• paralytic ileus;

• acute abdomen;

• delayed gastric emptying;

• chronic obstructive airways disease;

• cor pulmonale;

• chronic bronchial asthma;

• hypercarbia;

• moderate to severe hepatic impairment;

• severe renal impairment (creatinine clearance < 10 ml/min);

• chronic constipation; 2

WARNINGS and SPECIAL PRECAUTIONS OxyNorm® Capsules should be swallowed whole and not chewed or crushed. Abuse of oral

dosage forms by parenteral administration can be expected to result in other serious adverse

events that might be fatal.

The major risk of all opioid excess is respiratory depression.

A reduction in dosage may be advisable in hypothyroidism.

OxyNorm® Capsules should be used with caution in patients with:

• opioid dependence;

• raised intracranial pressure;

• hypotension;

• hypovolaemia;

• toxic psychosis;

• disease of the biliary tract;

• pancreatitis;

• inflammatory bowel disorders;

• prostatic hypertrophy;

• adrenocortical insufficiency;

• acute alcoholism;

• delirium tremens;

• chronic renal and hepatic disease;

• severe pulmonary disease;

• debilitated elderly and infirm patients.

OxyNorm® Capsules should not be used where there is a possibility of paralytic ileus

occurring. Should paralytic ileus occur, or be suspected during use, OxyNorm® Capsules

should be discontinued immediately.

Patients who are to undergo cordotomy or other pain relieving surgical procedures should

not receive OxyNorm® Capsules for 6 hours before surgery. If further treatment with

OxyNorm® Capsules is then indicated, the dosage should be adjusted to the new post-

operative requirement.

OxyNorm® Capsules 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.

For patients who suffer from chronic non-malignant pain, opioids should be used as part of a

comprehensive treatment programme involving other medications and treatment modalities.

A crucial part of the assessment of a patient with chronic non-malignant pain is the patient’s

addiction and substance abuse history. 3

OxyNorm® Capsules should be used with particular care in patients with a history of alcohol and drug abuse.

If opioid treatment is considered appropriate for the patient, then the main aim of treatment is

not to minimise the dose, but rather to achieve a dose that provides adequate pain relief with

minimum side effects.

There must be frequent contact between the physician and the patient so that the dosage

adjustments can be made. It is strongly suggested that the physician defines treatment

outcomes in accordance with pain management guidelines. The physician and patient can

then agree to discontinue treatment if these objectives are not met.

OxyNorm® Capsules has an abuse liability similar to other strong opioids and may be

sought and abused by people with latent or manifest addiction disorders.

Tolerance and dependence: The patient may develop tolerance to the medicine with chronic use which will require

progressively higher doses to maintain pain control. Prolonged use of OxyNorm® Capsules

may also lead to physical dependence and a withdrawal syndrome may occur upon abrupt

cessation of therapy. When a patient no longer requires therapy with OxyNorm® Capsules,

it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

The development of psychological dependence (addiction) to opioid analgesics in properly

managed patients has been reported to be rare. However, data are not available to establish

the true incidence of psychological dependence (addiction) in chronic pain patients. For more

information on tolerance and dependence please refer to DOSAGE AND DIRECTIONS FOR USE as well as SIDE EFFECTS.

Effects on the ability to drive and use machines OxyNorm® Capsules may modify patients’ reactions to a varying extent depending on the

dosage and individual susceptibility. Therefore, patients should not drive or operate

machinery if affected.

INTERACTIONS OxyNorm® Capsules potentiates the effects of tranquillisers, anaesthetics, hypnotics, anti-

depressants, sedatives, phenothiazines, neuroleptic drugs, alcohol, other opioids, muscle

relaxants and antihypertensives.

4

Monoamine oxidase inhibitors are known to interact with narcotic analgesics, producing CNS

excitation or depression with hypertensive or hypotensive crisis (see

CONTRAINDICATIONS).

Concurrent administration of quinidine, an inhibitor of cytochrome P450-2D6, resulted in an

increase in oxycodone Cmax by 11 %, AUC by 13 % and t1/2 elimination by 14 %. Also, an

increase in noroxycodone level was observed (Cmax by 50%, AUC by 85 % and t1/2

elimination by 42 %). The pharmacodynamic effects of oxycodone were not altered. This

interaction may be observed for other potent inhibitors of cytochrome P450-2D6 enzyme.

Cimetidine and inhibitors of cytochrome P450-3A such as ketoconazole and erythromycin

may inhibit the metabolism of oxycodone.

PREGNANCY AND LACTATION OxyNorm® Capsules are not recommended for the use in pregnancy nor during labour (see

CONTRAINDICATIONS). Infants born to mothers who have received opioids during

pregnancy should be monitored for respiratory depression and withdrawal symptoms.

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

newborn. OxyNorm® Capsules should therefore not be used by breast-feeding mothers.

DOSAGE AND DIRECTIONS FOR USE The need for continued treatment should be assessed at regular intervals.

Elderly and adults over 18 years: OxyNorm® Capsules should be taken at 4-6 hourly intervals. The dosage is dependent on

the severity of the pain and the patient’s previous history of analgesic requirements.

Increasing severity of pain will require an increased dose of OxyNorm® Capsules. The correct dosage for any individual patient is that which controls the pain and is well

tolerated throughout the dosing period. Patients should be titrated to pain relief unless

unmanageable adverse drug reactions prevent this.

The usual starting dose for opioid naïve patients or patients presenting with severe pain

uncontrolled by weaker opioids is 5 mg, 4-6 hourly.

The dose should then be carefully titrated, as frequently as once a day, if necessary, to

achieve pain relief. The majority of patients will not require a daily dose greater than 400 mg.

However, a few patients may require higher doses.

Patients receiving oral morphine before OxyNorm® Capsules therapy should have their daily

dose based on the following ratio: 10 mg of oral oxycodone is equivalent to 20 mg of oral

morphine. It must be emphasised that this is a guide to the dose of OxyNorm® Capsules

required. Inter-patient variability requires that each patient is carefully titrated to the

appropriate dose.

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Controlled pharmacokinetic studies in elderly patients (aged over 65 years) have shown that

compared with younger adults, the clearance of OxyNorm® Capsules is only slightly

reduced. No untoward adverse drug reactions were seen based on age, therefore adult

doses and dosage intervals are appropriate (see Pharmacokinetic properties under PHARMACOLOGICAL ACTION).

Children under 18 years: The safety and efficacy of OxyNorm® Capsules in patients under 18 years of age has not

been established.

Adults with mild to moderate renal impairment and mild hepatic impairment: The plasma concentration in this population may be increased. Therefore dose initiation

should follow a conservative approach. Opioid naïve patients should be started on

OxyNorm® 5 mg Capsules 6 hourly.

Cessation of therapy: When a patient no longer requires therapy with OxyNorm® Capsules, it may be advisable to

taper the dose gradually to prevent symptoms of withdrawal (see also WARNINGS AND SPECIAL PRECAUTIONS as well as SIDE EFFECTS).

SIDE EFFECTS Adverse drug reactions are typical of full opioid agonists.

Tolerance and dependence may also occur (see WARNINGS AND SPECIAL PRECAUTIONS).

Constipation may be prevented with an appropriate laxative. If nausea and vomiting are

troublesome, OxyNorm® Capsules may be combined with an anti-emetic.

The reactions are listed as MeDRA preferred term by system organ class and absolute

frequency.

Body System Frequency of Occurrence

Very Common

> 10 %

Common

> 1 % and

< 10 %

Uncommon

> 0.1 % and

< 1 %

Rare

> 0.01 % and

< 0.1 %

Very Rare

< 0.01 %

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Gastrointestinal disorders

constipation,

nausea,

vomiting

abdominal

pain,

diarrhoea,

dry mouth,

hiccups,

dyspepsia

mouth

ulceration,

stomatitis,

flatulence

melaena,

tooth

disorder,

gingival

bleeding,

dysphagia

ileus

Hepatobiliary disorders

biliary colic hepatic

enzymes

increased

Metabolism and nutrition disorders

decreased

appetite up

to loss of

appetite

dehydration,

increased

appetite

Nervous system disorders

headache,

dizziness,

sedation

(somnolence

up to a

depressed

level of

consciousness)

syncope,

paraesthesia

concentration

impaired,

migraine,

dysgeusia,

hypermyotonia,

tremor,

involuntary

muscle

contractions,

hypoaesthesia,

abnormal

coordination

convulsions

(especially in

persons with

epileptic

disorder or

predisposition

to

convulsions),

amnesia

speech

disorder

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Psychiatric disorders

altered mood

and

personality

change (e.g.

anxiety,

depression,

euphoric

mood),

decreased

activity,

restlessness,

psychomotor

hyperactivity,

agitation,

nervousness,

insomnia,

abnormal

thinking,

confusion

perception

disturbances

(e.g.

hallucination,

derealisation),

reduced libido

Infections and infestations

herpes

simplex

Immune system disorders

hypersensitivity anaphylactic

reaction

Eye disorders visual

disturbances

Ear and labyrinth disorders

hearing

impaired

Renal and urinary disorders

urinary

retention,

dysuria,

micturition

urgency

Reproductive system and breast disorders

erectile

dysfunction

amenorrhoea

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Cardiac disorders

tachycardia palpitations

Vascular disorders

hypotension vasodilatation

Respiratory, thoracic and mediastinal disorders

dyspnoea

dysphonia,

cough

Skin and subcutaneous tissue disorders

pruritus skin

reactions /

rash

dry skin urticaria

Injury, poisoning and procedural complications

injury from

accidents

General disorders and administration site conditions

hyperhidrosis

up to chills,

asthenia

physical

dependence

with drug

withdrawal

syndrome, pain

(e.g. chest

pain), malaise,

oedema

weight

increase,

weight

decrease,

thirst

The opioid abstinence or withdrawal syndrome (see also WARNINGS AND SPECIAL PRECAUTIONS as well as DOSAGE AND DIRECTIONS FOR USE) is characterised by

some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration,

chills, myalgia and mydriasis. Other symptoms may also develop, which includes: irritability,

anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia,

vomiting, diarrhoea or increased blood pressure, increased respiratory rate or increased

heart rate.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT Signs of oxycodone toxicity and overdosage are pin-point pupils, respiratory depression and

hypotension. Circulatory failure and somnolence progressing to stupor or deepening coma,

skeletal muscle flaccidity, bradycardia and death may occur in more severe cases.

9

Treatment of overdosage: primary attention should be given to the establishment of a

patent airway and the institution of assisted or controlled ventilation.

In case of massive overdosage (if the patient is in a coma or respiratory depression is

present), administer naloxone intravenously (0,4 to 2 mg for an adult and 0,01 mg/kg body

weight for children). Repeat the dose at 2 minute intervals if there is no response. If repeat

doses are required then an infusion of 60 % of the initial dose per hour is a useful starting

point. A solution of 10 mg made up in 50 ml dextrose will produce 200 micrograms/ml for

infusion using an IV pump (dose adjusted to the clinical response). Infusions are not a

substitute for frequent review of the patient’s clinical state. Intramuscular naloxone is an

alternative in the event that IV access is not possible.

As the duration of action of naloxone is relatively short, the patient must be carefully

monitored until spontaneous respiration is reliably re-established. Naloxone is a competitive

antagonist and large doses (4 mg) may be required in seriously poisoned patients.

For a less severe overdosage, administer naloxone 0,2 mg intravenously followed by

increments of 0,1 mg every 2 minutes if required.

Naloxone should be administered in the absence of clinically significant respiratory or

circulatory depression secondary to oxycodone overdosage. Naloxone should be

administered cautiously to persons who are known, or suspected, to be physically dependant

on oxycodone. In such cases, an abrupt or complete reversal of opioid effects may

precipitate pain and an acute withdrawal syndrome. Additional/other considerations: 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.

IDENTIFICATION OxyNorm® 5 mg Capsules (capsule size 4) has an orange body and beige cap imprinted

with ONR 5 in black ink, and filled with white to off-white powder.

OxyNorm® 10 mg Capsules (capsule size 4) has a white body and beige cap imprinted with

ONR 10 in black ink, and filled with white to off-white powder.

OxyNorm® 20 mg Capsules (capsule size 4) has a pink body and beige cap imprinted with

ONR 20 in black ink, and filled with white to off-white powder.

PRESENTATION OxyNorm® 5 mg Capsules are supplied in clear PVdC coated PVC and aluminium foil

blister packs of 28.

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OxyNorm® 10 mg Capsules are supplied in clear PVdC coated PVC and aluminium foil


OxyNorm® 20 mg Capsules are supplied in clear PVdC coated PVC and aluminium foil


STORAGE INSTRUCTIONS Store at or below 30 °C.

Store in original package in the outer carton in order to protect from light.

Store this medicine out of the reach of children.

REGISTRATION NUMBERS

South Africa: S6

OxyNorm® 5 mg Capsules: 41/2.9/1103



Namibia: S4




Botswana: S1A

OxyNorm® 5 mg Capsules: BOT1402578



NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION Mundipharma (Pty) Ltd

2nd floor Mariendahl House

Newlands on Main

Claremont

7708

South Africa

www.mundipharma.co.za

DATE OF PUBLICATION OF THE PACKAGE INSERT: 14 August 2009

11

http://www.mundipharma.co.za/

® = OxyNorm is a registered trademark

12

VOUBILJET

OXYNORM® CAPSULES

SKEDULERINGSTATUS EIENDOMSNAME EN DOSEERVORM OxyNorm® 5 mg Capsules (Kapsules) OxyNorm® 10 mg Capsules (Kapsules)

OxyNorm® 20 mg Capsules (Kapsules)

SAMESTELLING OxyNorm® 5 mg Capsules bevat 5 mg oksikodoonhidrochloried per kapsule.

OxyNorm® 10 mg Capsules bevat 10 mg oksikodoonhidrochloried per kapsule.

OxyNorm® 20 mg Capsules bevat 20 mg oksikodoonhidrochloried per kapsule.

Onaktiewe bestanddele: gelatien, indigo carmine kleurstof, magnesiumstearaat,

mikrokristallyne sellulose, natrium laurielsulfaat, Sunset Yellow kleurstof, titaandioksied.

Die kapsules is suikervry.

FARMAKOLOGIESE KLASSIFIKASIE A 2.9 Ander Analgetika.

FARMAKOLOGIESE WERKING Farmakodinamiese eienskappe Oksikodoon is 'n vol opioïed agonis wat geen antagonistiese eienskappe het nie. Dit het

affiniteit vir kappa-, mu- en delta-opiaatreseptore in die brein en rugmurg. Oksikodoon is

soortgelyk aan morfien in sy werking. Die terapeutiese effek is hoofsaaklik analgeties,

angsiolities en sederend (sien INDIKASIES).

Farmakokinetiese eienskappe Oksikodoon het 'n absolute biobeskikbaarheid van tot en met 87 % na orale toediening.

Oksikodoon word hoofsaaklik na noroksikodoon en oksimorfoon via CYP450-3A en CYP450-

2D6 onderskeidelik gemetaboliseer. Oksimorfoon het minimale analgetiese werking en is in

lae konsentrasies in plasma teenwoordig maar dit word nie verwag om tot oksikodoon se

farmakologiese effek by te dra nie. Oksikodoon het 'n eliminasie halfleeftyd van ongeveer 3

uur.

Bejaardes: Die AOK by bejaarde persone is 15 % hoër wanneer vergelyk word met jonger

persone.

S6

13

Geslag: Vroulike persone het gemiddeld tot en met 25 % hoër oksikodoon

plasmakonsentrasies as mans op 'n liggaamsgewig aangepaste basis. Die rede vir die

verskil is onbekend.

Pasiënte met renale inkorting: Voorlopige data van 'n studie van pasiënte met ligte tot

matige renale inkorting wys piek plasma oksikodoon- en noroksikodoonkonsentrasies van

ongeveer 50 % en 20 % hoër as normale persone. Daarmee saam is AOK waardes van

oksikodoon, noroksikodoon en oksimorfoon ongeveer 60 %, 60 % en 40%, onderskeidelik,

hoër as in normale persone. Daar was 'n verhoging van slegs een uur in t1/2 van eliminasie

vir oksikodoon.

Pasiënte met ligte tot matige hepatiese inkorting: Pasiënte met ligte tot matige hepatiese

inkorting wys piek plasma oksikodoon- en noroksikodoonkonsentrasies van ongeveer 50 %

en 20 %, onderskeidelik, hoër as in normale persone. AOK waardes was ook,

onderskeidelik, ongeveer 95 % en 75 % hoër as in normale persone. Oksimorfoon piek

plasmakonsentrasies en AOK waardes was met 15 % tot 50 % laer. Die t1/2 eliminasie vir

oksikodoon het met 2,3 uur verhoog.

INDIKASIES OxyNorm® Capsules is aangedui vir die behandeling van matige tot erge pyn by pasiënte

met kanker en post-operatiewe pyn nadat die gastroïntestinale funksie teruggekeer het.

OxyNorm® Capsules is ook aangedui vir die behandeling van erge pyn wat die gebruik van

'n sterk opioïed analgetikum vereis.

KONTRA-INDIKASIES OxyNorm® Capsules is teenaangedui by pasiënte met bekende hipersensitiwiteit teenoor

oksikodoon of enige van die ander bestanddele (sien SAMESTELLING) of in enige situasie

waar opioïede teenaangedui is.

OxyNorm® Capsules is teenaangedui by pasiënte wat swanger is, borsvoed, of wat

gelyktydig monoamienoksidaseïnhibeerders ontvang/neem of binne 2 weke van staking

daarvan.

OxyNorm® Capsules is teenaangedui by pasiënte wat ly aan:

• respiratoriese onderdrukking;

• hoofbesering;

• paralitiese ileus;

• akute abdomen;

• vertraagde gastriese lediging;

• kroniese obstruktiewe lugwegsiekte;

• cor pulmonale;

• kroniese brongiale asma; 14

• hiperkarbie;

• matige tot erge hepatiese inkorting;

• erge renale inkorting (kreatinien opruiming < 10 ml/min);

• kroniese konstipasie;

WAARSKUWINGS en VOORSORGMAATREËLS OxyNorm® Capsules moet heel ingesluk word en nie gebreek, gekou of fyngedruk word nie.

Dit is te verwagte dat die misbruik van die kapsules deur dit parenteraal toe te dien, ander

ernstige nadelige effekte, wat fataal mag wees, tot gevolg kan hê.

Die groot risiko van alle opioïed oormaat is respiratoriese onderdrukking.

Dit mag nodig wees om die dosis te verlaag in gevalle van hipotireose.

OxyNorm® Capsules moet versigtig gebruik word deur pasiënte met:

• opioïedafhanklikheid;

• verhoogde intrakraniale druk;

• hipotensie;

• hipovolemie;

• toksiese psigose;

• siekte van die biliêre kanaal;

• pankreatitis;

• inflammatoriese ingewandsafwykings;

• prostatiese hipertrofie;

• adrenokortikale ontoereikendheid;

• akute alkoholisme;

• delirium tremens;

• kroniese renale en hepatiese siekte;

• erge pulmonale siekte;

• verswakte bejaardes en sieklike pasiënte.

OxyNorm® Capsules moet nie gebruik word waar daar 'n moontlikheid van paralitiese ileus

is nie. Indien paralitiese ileus vermoed word, of ontwikkel tydens die gebruik van OxyNorm® Capsules, moet dit onmiddellik gestaak word.

Pasiënte wat kordotomie of ander pynverligtingde chirurgiese prosedures moet ondergaan,

moet nie OxyNorm® Capsules vir 6 uur voor chirurgie ontvang nie. Indien verdere

behandeling met OxyNorm® Capsules dan aangedui is, moet die dosis na die nuwe post-

operatiewe vereistes aangepas word.

15

OxyNorm® Capsules moet met sorg gebruik word na abdominale chirurgie, aangesien

opioïede bekend is daarvoor om intestinale motiliteit in te kort. OxyNorm® Capsules moet

nie gebruik word totdat die geneesheer seker is van normale ingewandsfunksie nie.

Vir sekere pasiënte wat aan kroniese nie-kwaadaardige pyn ly, moet opioïede as deel van 'n

omvattende behandelingsprogram wat ander medisyne en behandelingsmodaliteite insluit

gebruik word. Dit is belankrik om die geskiedenis van verslawing en misbruik te oorweeg

gedurende die evaluasie.

OxyNorm® Capsules moet veral met sorg by pasiënte met 'n geskiedenis van alkohol- en dwelmmisbruik, gebruik word.

Indien die behandeling met ‘n opioïed as geskik beskou word vir die pasiënt, is die hoofdoel

van behandeling nie om die dosis van die opioïed te verminder nie, maar eerder om 'n dosis

te bereik wat genoegsame pynverligting gee en terselfdetyd die minimum hoeveelheid newe-

effekte ontlok.

Daar moet dikwelse kontak tussen die geneesheer en pasiënt wees sodat dosisaanpassings

gemaak kan word. Daar word sterk aanbeveel dat die geneesheer 'n behandelingsuitkoms

bepaal wat in ooreenstemming is met pyn beheer riglyne. Die geneesheer en pasiënt kan

dan ooreenkom om behandeling te staak as hierdie doelwitte nie bereik word nie.

OxyNorm® Capsules het 'n misbruik profiel soortgelyk aan ander sterk opioïede en kan

gesoek en misbruik word deur persone met latente of duidelike verslawingsafwykings.

Toleransie en afhanklikheid: Die pasiënt mag toleransie vir die medisyne ontwikkel met kroniese gebruik daarvan en mag

hoër dosisse vereis om die pyn te beheer.

Langdurige gebruik van OxyNorm® Capsules kan tot fisiese afhanklikheid lei en 'n

onttrekkingsindroom kan voorkom sou dit skielik gestaak word. Wanneer die pasiënt nie

meer langer behandeling met OxyNorm® Capsules benodig nie, mag dit raadsaam wees

om die dosis geleidelik te verminder om die onttrekkingsindroom te voorkom.

Die ontwikkeling van psigologiese afhanklikheid (verslawing) by pasiënte waarvan die

behandeling goed gekontroleerd is, is seldsaam. Data om die ware voorkoms van

psigologiese afhanlikheid (verslawing) by kroniese pasiënte vas te stel, is egter nie

beskikbaar nie. Vir meer inligting oor die toleransie en afhanklikheid, verwys na DOSIS EN GEBRUIKSAANWYSINGS asook NEWE EFFEKTE.

Effekte op die vermoë om te bestuur en masjienerie te gebruik

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OxyNorm® Capsules kan die pasiënt se reaksie verander, afhangend van die dosis en die

individuele vatbaarheid van die pasiënt. Daarom moet pasiënte nie bestuur of met

masjienerie werk indien hul geaffekteer word nie.

INTERAKSIES OxyNorm® Capsules potensieer die effek van kalmeermiddels, anestetika, hipnotika, anti-

depressante, sedeermiddels, fenotiasiene, neuroleptiese geneesmiddels, alkohol, ander

opioïede, spierverslappers en antihipertensiewe middels.

Monoamienoksidaseïnhibeerders is bekend om met narkotiese analgetika te interageer, wat

SSS-prikkeling of -onderdrukking met hipertensiewe of hipotensiewe krisis kan veroorsaak

(sien KONTRA-INDIKASIES).

Gelyktydige toediening van kinidien, 'n inhibeerder van sitochroom P450-2D6, lei tot 'n

verhoging in oksikodoon Cmaks van 11 %, AOK van 13 % en t1/2 eliminasie van 14 %. Daar is

ook 'n verhoging in die noroksikodoonvlak opgemerk (Cmaks van 50 %, AOK van 85 % en t1/2

eliminasie van 42 %). Die farmakodinamiese effekte van oksikodoon was onveranderd.

Hierdie interaksie kan vir ander sterk inhibeerders van sitochroom P450-2D6 ensiem

waargeneem word.

Simetidien en inhibeerders van sitochroom P450-3A soos ketokonasool en eritromisien kan

die metabolisme van oksikodoon inhibeer.

SWANGERSKAP EN LAKTASIE OxyNorm® Capsules word nie aanbeveel vir die gebruik tydens swangerskap of kraam nie

(sien KONTRA-INDIKASIES). Babas wat gebore word aan moeders wie opioïede tydens

swangerskap ontvang het, moet gemoniteer word vir respiratoriese depressie en

ontrekkingsimptome.

OxyNorm® Capsules kan in borsmelk uitgeskei word en kan respiratoriese onderdrukking by

pasgeborenes veroorsaak. OxyNorm® Capsules moet daarom nie deur borsvoedende

moeders gebruik word nie.

DOSIS EN GEBRUIKSAANWYSINGS Die behoefte aan langdurige behandeling moet op gereelde intervalle oorweeg word.

Bejaardes en volwassenes ouer as 18 jaar: OxyNorm® Capsules moet in 4-6 uurlikse intervalle geneem word. Die dosis is afhanklik

van die erns van die pyn en die pasiënt se vorige geskiedenis van analgetiese behoefte.

Die intensiteit van die pyn bepaal die dosis van OxyNorm® Capsules wat vereis word.

Die korrekte dosis vir enige individuele pasiënt is dit wat die pyn genoegsaam beheer en

terselfdetyd goed verdra word vir die volle dosis periode. Pasiënte moet getitreer word tot

pynverligting tensy onbeheerde nadelige geneesmiddelreaksies dit verhoed.

17

Die gebruiklike aanvangsdosis vir opioïed naïewe pasiënte wat erge pyn vertoon wat nie

beheer kon word met swakker opioïede nie, is 5 mg, 4-6 uurliks.

Die dosis moet daarna versigtig getitreer word, so dikwels as een keer per dag, indien nodig,

om pynverligting te bereik. Die meerderheid van pasiënte sal nie ‘n daaglikse dosis groter as

400 mg benodig nie. Nogtans, kan 'n klein hoeveelheid pasiënte hoër dosisse benodig.

Pasiënte wat orale morfien ontvang het, voor die behandeling met OxyNorm® Capsules

begin is, se daaglikse dosis moet op die volgende verhouding baseer word: 10 mg van orale

oksikodoon is ekwivalent aan 20 mg van orale morfien. Dit moet beklemtoon word dat dit 'n

riglyn is tot die dosis van OxyNorm® Capsules. Inter-pasiënt variasie vereis dat elke pasiënt

versigtig getitreer moet word tot die geskikte dosis bereik is.

Gekontroleerde farmakokinetiese studies op bejaarde pasiënte (ouer as 65 jaar) het

aangetoon dat die opruiming van OxyNorm® Capsules slegs effens verlaag is in vergelyking

met jonger volwassenes. Geen newe effekte is as gevolg van ouderdom opgemerk nie,

volwasse dosisse en dosisintervalle is dus geskik vir bejaardes (sien Farmakokinetikiese eienskappe onder FARMAKOLOGIESE WERKING).

Kinders jonger as 18 jaar: Die veiligheid en effektiwiteit van OxyNorm® Capsules is nog nie vasgestel vir pasiënte

jonger as 18 jaar nie.

Volwassenes met ligte tot matige renale inkorting en matige hepatiese inkorting: Die plasmakonsentrasie in hierdie populasie kan verhoog wees. Daarom moet die aanvangs

dosis 'n konserwatiewe benadering volg. Opioïed naïewe pasiënte moet met OxyNorm® 5 mg Capsules 6 uurliks begin word.

Staking van behandeling:

Wanneer 'n pasiënt nie langer behandeling met OxyNorm® Capsules benodig nie, mag dit

raadsaam wees om die dosis geleidelik te verminder om onttrekkingsimptome te verhoed

(verwys ook na WAARSKUWINGS EN SPESIALE VOORSORGMAATREëLS asook NEWE EFFEKTE).

NEWE-EFFEKTE Nadelige medisyne reaksies is algemeen met die gebruik van vol opioïed agoniste.

Toleransies en afhanklikheid kan voorkom (verwys na WAARSKUWINGS EN SPESIALE VOORSORGMAATREëLS).

18

Konstipasie kan verhoed word met 'n geskikte purgeermiddel. Indien naarheid en braking ‘n

probleem is, kan OxyNorm® Capsules met anti-emetika gekombineer word.

Die reaksies is gelys as MeDRA voorkeurterme as stelsel-orgaanklas en absolute

frekwensie.

Liggaamstelsel Frekwensie van voorkoms

Baie

Algemeen>

10 %

Algemeen

> 1 % en< 10 %

Nie algemeen

> 0.1 % en< 1

%

Seldsaam

> 0.01 %

en< 0.1 %

Baie

Seldsaam

< 0.01 %

Gastroïntestinale afwykings

konstipasie,

naarheid,

braking

abdominale

pyn,

diarree,

droë mond, hik,

dispepsie

mond

ulserasie,

stomatitis,

winderigheid

melaena,

tandafwyking

, tandvleis-

bloeding,

disfagie

ileus

Hepatobiliêre afwykings

biliêre koliek verhoogde

hepatiese

ensieme

Metabolisme en voedings-afwykings

verlaagde aptyt

tot verlies aan

aptyt

dehidrasie,

verhoogde

aptyt

Senuweestelsel afwykings

hoofpyn,

duiseligheid,

sedasie

(slaperigheid

tot by vlak

van

bewusteloos-

heid)

sinkopie,

parestesie

ingekorte

konsentrasie,

migraine,

dysgeusie,

hipermiotonie,

bewing,

onwillekeurige

spiersame-

trekkings,

hipo-astesie,

abnormale

koördinasie

konvulsies

(veral by

persone met

epileptiese

afwyking of

neiging tot

konvulsies),

amnesie

spraak

afwyking

19

Psigiatriese afwykings

veranderde

gemoed en

persoonlikheids

-verandering

(bv. angs,

depressie,

euforiese

gemoed),

verlaagde

aktiwiteit,

rusteloosheid,

psigo-motoriese

hiper-aktiwiteit,

agitasie,

senuwee-

agtigheid,

insomnie,

abnormale

denke,

verwarring

persepsie

steurnisse

(bv.

hallusinasies,

de-realisering)

verlaagde

libido

Infeksies en infestasies

herpes

simplex

Immuunstelsel afwykings

hiper-

sensitiwiteit

anafilaktie

se reaksie

Oogafwykings visuele

steurnisse

Oor en Labarint- afwykings

gehoor

inkorting

Renale en urinêre afwykings

urinêre

retensie,

disurie,

mikturasie

dringendheid

Voortplanting stelsel en borsafwykings

erektiele

disfunksie

amenorree

20

Kardiale afwykings

tagikardie palpitasies

Vaskulêre afwykings

hipotensie vasodilatasie

Respiratoriese en torakale en mediastinale afwykings

dispnee

disfonie, hoes

Vel en subkutaneuse weefsel afwykings

pruritus velreaksies/

uitslag

droë vel urtikarie

Besering, vergiftiging en prosedure komplikasies

besering van

ongelukke

Algemene afwykings en toedieningsplek toestande

hiperhidrose tot

en met koue

rillings, astenie

fisiese

afhanklikheid

met

geneesmiddel

onttrekking-

sindroom, pyn

(bv. borspyn),

malaise,

edeem

gewigs-

toename,

gewigs-

verlies, dors

Die opioïed onthouding- of onttrekkingsindroom (verwys ook na WAARSKUWINGS EN SPESIALE VOORSORGMAATREëLS asook DOSIS EN GEBRUIKSAANWYSINGS) word gekarakteriseer deur sommige of almal van die volgende: rusteloosheid, lakrimasie,

rinorree, gaap, sweet, koue rillings, mialgie en midriase. Ander simptome soos

geïrriteerdheid, angs, rugpyn, gewrigspyn, swakheid, abdominale krampe, slapeloosheid,

naarheid, anoreksie, braking, diarree of verhoogde bloeddruk, verhoogde asemhalingstempo

of verhoogde hart tempo mag ook ontwikkel.

BEKENDE SIMPTOME VAN OORDOSIS EN DIE BESONDERHEDE VAN BEHANDELING DAARVAN

Oksikodoon toksisiteit en oordosis kan uitgeken word deur die volgende simptome:

speldepunt pupille, respiratoriese depressie en hipotensie. Sirkulatoriese versaking en 21

slaperigheid (wat tot stupor en verdiepte koma vorder), verslapping van skeletale spiere,

bradikardie en dood kan voorkom in meer erge gevalle.

Behandeling van oordosis: primêre aandag moet gegee word om 'n patente lugweg en

ondersteunende of beheerde ventilasie in te stel.

In die geval van massiewe oordosis (indien die pasiënt in 'n koma is of respiratoriese

onderdrukking teenwoordig is), moet naloksoon intraveneus toegedien word (0,4 tot 2 mg vir

'n volwassene en 0,01 mg/kg liggaamsgewig vir kinders). Herhaal die dosis met 2 minuut

intervalle indien daar geen respons is nie. Indien herhaalde dosisse nodig is, is 'n infusie van

60 % van die aanvanklike dosis per uur 'n goeie beginpunt. 10 mg wat opgemaak word tot

50 ml dekstrose sal 'n 200 mikrogram/ml oplossing vir infusie lewer wat toegedien kan word

met 'n IV pomp (dosis aangepas tot die kliniese respons). Infusies is nie 'n plaasvervanger

om die pasiënt se kliniese toestand gereeld na te gaan nie. Intramuskulêre naloksoon is 'n

alternatief in die geval waar IV toegang nie moontlik is nie.

Aangesien die werkingsduur van naloksoon relatief kort is, moet die pasiënt versigtig

gemoniteer word totdat spontane asemhaling op ‘n betroubare wyse hervat het. Naloksoon

is 'n kompeterende antagonis en groot dosisse (4 mg) mag nodig wees vir pasiënte wat

ernstig oordoseer is.

Vir ‘n minder ernstige oordosis, dien 0,2 mg naloksoon intraveneus toe, gevolg deur

inkremente van 0,1 mg elke 2 minute, indien nodig.

Naloksoon moet in die afwesigheid van kliniese beduidende respiratoriese of sirkulatoriese

onderdrukking sekondêr tot oksikodoon oordosis toegedien word. Naloksoon moet versigtig

toegedien word aan persone wat bekend is of verdink word van fisiese afhanklikheid aan

oksikodoon. In sulke gevalle kan 'n skielike of volledige omkering van opioïed effekte, pyn

en 'n akute onttrekkingsindroom veroorsaak.

Addisionele/ander oorwegings: Oorweeg geaktiveerde steenkool (50 g vir volwassenes,

10-15 g vir kinders), indien 'n groot hoeveelheid binne 1 uur ingeneem is, op voorwaarde dat

die lugweg beskerm kan word. Dit mag redelik wees om aan te neem, dat die laat toediening

van geaktiveerde steenkool voordelig kan wees vir verlengde vrystellingspreparate, alhoewel

daar nie bewys is om dit te ondersteun nie.

IDENTIFIKASIE OxyNorm® 5 mg Capsules (kapsule grootte 4) is oranje met ‘n beige dop met ONR 5 in

swart ink daarop gedruk en wat gevul is met wit tot naas-wit poeier.

OxyNorm® 10 mg Capsules (kapsule grootte 4) is wit met ‘n beige dop met ONR 10 in swart

ink daarop gedruk en wat gevul is met wit tot naas-wit poeier.

OxyNorm® 20 mg Capsules (kapsule grootte 4) is pienk met ‘n beige dop met ONR 20 in

swart ink daarop gedruk en wat gevul is met wit tot naas-wit poeier.

22

AANBIEDING OxyNorm® 5 mg Capsules word verskaf in deursigtige PVdC bedekte PVC en aluminium

foelie stulpverpakkings van 28.

OxyNorm® 10 mg Capsules word verskaf in deursigtige PVdC bedekte PVC en aluminium


OxyNorm® 20 mg Capsules word verskaf in deursigtige PVdC bedekte PVC en aluminium


BERGINGSINSTRUKSIES Bewaar by of benede 30 °C. Bewaar in oorspronkilke verpakking in die kartonhouer om teen

lig te beskerm. Bewaar hierdie medisyne buite die bereik van kinders.

REGISTRASIENOMMERS

Suid Afrika: S6




Namibië: S4




Botswana: S1A




NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAAT Mundipharma (Edms) Bpk

2de vloer, Mariendahl House

Newlands on Main

Claremont

7708

Suid Afrika

www.mundipharma.co.za

DATUM VAN PUBLIKASIE VAN DIE VOUBILJET

23

http://www.mundipharma.co.za/

14 Augustus 2009

® = OxyNorm is a registreerde handelsmerk

24

Documents

PACKAGE INSERT OXYNORM CAPSULES SCHEDULING STATUS … · 2017-07-31 · PACKAGE INSERT . OXYNORM® CAPSULES . SCHEDULING STATUS . PROPRIETARY NAMES andDOSAGE FORM . OxyNorm ® 5 mg