Oxynorm 5 Mg - Information for professionals (2023)

Document: 08.08.2007 Specialist information (German)change

1. NAME OF THE MEDICINAL PRODUCT

OxyNorm^®Capsules 5mg

OxyNorm^®Capsules 10mg

OxyNorm^®Capsules 20mg

2.QUALITATIVE AND QUANTITATIVE COMPOSITION

1Kapsel OxyNorm^®Capsules 5 mg contains 5 mg oxycodone hydrochloride.

1Kapsel OxyNorm^®Capsules 10 mg contains 10 mg oxycodone hydrochloride.

1Kapsel OxyNorm^®Capsules 20 mg contains 20 mg oxycodone hydrochloride.

Other ingredients:

OxyNorm^®Capsules 5 mg contain Yellow Orange S (E 110).

For a full list of excipients, see section 6.1.

3.PHARMACEUTICAL FORM

Heart capsule

OxyNorm^®Capsules 5 mg are orange/beige capsules, labeled “ONR 5”.

OxyNorm^®Capsules 10 mg are white/beige capsules, marked “ONR 10”.

OxyNorm^®Capsules 20 mg are pink/beige capsules, labeled “ONR 20”.

4. CLINICALPARTICULARS

4.1Areas of application

Severe to very severe pain.

4.2 Dosage, method and duration of use

The dosage should be adjusted to the pain intensity and the individual sensitivity of the patient.

For dose adjustment and treatment of breakthrough pain OxyNorm^®Capsules 5 mg, 10 mg and 20 mg available.

The following general dosage recommendations apply:

Adults and young people from 12 years:

Dose setting:

The starting dose for non-opioid addicted patients is generally 5 mg oxycodone hydrochloride every 6 hours.

Some patients receiving prolonged-release oxycodone on a fixed time schedule require rescue medication for immediate-release analgesics to manage breakthrough pain.OxyNorm^® Capsules are intended for the treatment of these breakthrough pains. The single dose of the required medication is to be determined individually. For the level of required medication, 1/6 of the daily dose of slow-release oxycodone can be assumed as a guide.

Dose adjustment:

The dose should then be carefully titrated daily until adequate pain relief is achieved. The dosing interval can vary from OxyNorm^®Capsules can be reduced to a 4 hour interval if necessary. However, the capsules should not be taken more than 6 times a day.

If rescue medication is required more than twice a day, this is an indication that an increase in the dose of prolonged-release oxycodone is required. The goal is a patient-specific dosage that allows adequate analgesia with tolerable side effects and as little rescue medication as possible with twice daily administration of slow-release oxycodone for as long as pain therapy is necessary.

Type of application

To take.

OxyNorm^®In the dosage determined, capsules are taken daily no more frequently than every 4-6 hours. When using OxyNorm^®Dose adjustment capsules should be taken on a fixed schedule (every 6 hours).

OxyNorm^®Capsules can either be taken with meals or taken independently with sufficient liquid.

Duration of intake

OxyNorm^®Capsules should not be taken longer than absolutely necessary. After or during dose adjustment, twice daily administration of delayed-release oxycodone should take place as soon as possible. If long-term treatment is necessary depending on the type and severity of the disease, careful and regular monitoring should ensure whether and to what extent further treatment is necessary. If opioid therapy is no longer indicated, it may be advisable to gradually reduce the daily dose to avoid the onset of withdrawal syndrome symptoms.

Children under 12 years old

OxyNorm^®Capsules are not recommended for use in children under the age of 12 due to a lack of data on safety and efficacy.

ElderlyPatients

In elderly patients without clinically manifest hepatic and/or renal dysfunction, dose adjustment is not usually necessary.

risk patients

In high-risk patients, e.g. Patients with renal or hepatic dysfunction, low body weight or slow metabolisers of drugs, should be given initially - if not opoid addicted - half the normally recommended dose for adults. The lowest dosage of 5 mg oxycodone hydrochloride every 6 hours as the starting dose recommended elsewhere in this product information is not suitable for such high-risk patients.

4.3Contraindications

• Hypersensitivity to oxycodone hydrochloride,Yellow orange S (E110) (only at the potency 5 mg) or one of the other ingredients,

• Severe respiratory depression with hypoxia and/or hypercapnia,

  See Also

  Oxynorm Caps 5 mg 30 pcs

• severe chronic obstructive pulmonary disease,

• corpulmonary,

• severe bronchial asthma,

• ParalytischerIleus,

• pregnancy (see section 4.6),

• Lactation (see section 4.6).

4.4 Special warnings and precautions for use

OxyNorm^®Capsules have not been studied in children under 12 years of age. Safety and effectiveness have therefore not been verified, so use in children under the age of 12 is not recommended.

Caution is advised in elderly or debilitated patients with severe impairment of lung, liver or kidney function, myxedema, hypothyroidism, Addison's disease (adrenal insufficiency), prostatic hypertrophy, intoxication psychosis (e.g. alcohol), alcoholism, delirium tremens, known opioid dependence,Pancreatitis, cholelithiasis, obstructive and inflammatory bowel disease, conditions with increased intracranial pressure, circulatory disorders, epilepsy or predisposition to seizures, use of MAO inhibitors. If paralytic ileus occurs or is suspectedOxyNorm^®capsules are discontinued immediately.

Respiratory depression is the most significant hazard of opioid overdose and is most likely to occur in elderly or debilitated patients, so special monitoring may be required. The respiratory depressant effect of oxycodone can lead to an increase in the carbon dioxide concentration in the blood and secondarily in the cerebrospinal fluid. In susceptible patients, opioids can cause severe falls in blood pressure.

With long-term use of OxyNorm^®Capsules may develop tolerance, requiring higher doses to achieve the desired analgesic effect. There is cross tolerance to other opioids. The chronic use ofOxyNorm^®Encapsulation can lead to physical dependence. Withdrawal syndrome may occur if therapy is stopped abruptly. When oxycodone therapy is no longer required, it may be advisable to gradually reduce the daily dose to avoid the onset of symptoms of a withdrawal syndrome.

OxyNorm^®Capsules possess a primary addiction potential. However, when used as directed in chronic pain patients, the risk of physical and psychological dependence is significantly reduced or assessed in a differentiated manner. However, data on the actual incidence of psychological dependence in chronic pain patients are lacking.In the case of a history of alcohol or drug abuse, the product should only be prescribed with particular caution.

Abusive parenteral administration of the capsule components can result in serious, potentially fatal, adverse events.

4.5 Drug Interactions and Other Interactions

Central depressant drugs (e.g. sedatives, hypnotics, phenothiazines, neuroleptics, antidepressants, antihistamines, antiemetics) and other opioids or alcohol can increase the side effects of oxycodone, especially respiratory depression.

Medicines with an anticholinergic effect (e.g. psychotropics, antihistamines, antiemetics, medicines for Parkinson's disease) can increase the anticholinergic side effects of oxycodone (such as constipation, dry mouth or urinary disorders).

In individual cases, a clinically relevant decrease or increase in the International Normalized Ratio (INR) was observed when oxycodone and coumarin anticoagulants were taken at the same time.

Cimetidine can inhibit the breakdown of oxycodone.

Inhibition of cytochrome P450 2D6 and 3A4 has no clinical relevance. The influence of other relevant isoenzyme inhibitors of the cytochrome system on the metabolism of oxycodone is not known. Possible interactions should be considered.

4.6pregnancyandlactation

OxyNorm^®Capsules should not be taken during pregnancy and lactation.

There is insufficient experience of oxycodone use in humans during pregnancy. Oxycodone crosses the placenta. Prolonged use of oxycodone during pregnancy may cause withdrawal symptoms in the newborn. Administered during labor may cause respiratory depression in the fetus.

Oxycodone passes into breast milk. A milk-to-plasma concentration ratio of 3.4:1 was measured.

4.7 Effects on ability to drive and use machines

Oxycodone can change alertness and the ability to react to such an extent that the ability to drive or use machines is impaired or no longer given. This is particularly to be expected at the start of oxycodone therapy, after increasing the dose or changing preparations, and when oxycodone interacts with alcohol or other CNS-depressant substances.

With a stable therapy, a general driving ban is not absolutely necessary. The assessment of the individual situation must be carried out by the attending physician.

4.8 Side Effects

Oxycodone can cause respiratory depression, miosis, bronchial and spasm smooth muscle spasms, and cough reflex vapors.

The most frequently reported side effects are nausea (especially at the beginning of therapy) and constipation.

Respiratory depression is the most significant hazard of opioid overdose and is most likely to occur in elderly or debilitated patients. In susceptible patients, opioids can cause severe falls in blood pressure.

The assessment of side effects is based on the following frequencies:

Very often(>10 %)

Frequently(>1 % - <10 %)

Occasionally(>0,1 % - <1 %)

Rarely(>0,01 % - <0,1 %)

Very rare (< 0.01% or unknown)

Within each frequency grouping, adverse reactions are presented in order of seriousness (decreasing).

Infections and parasitic diseases

Rare: herpes simplex

Immune System Diseases

Uncommon: Hypersensitivity reactions

Very rare: Anaphylactic reactions

Metabolic and nutritional disorders

Common: Decreased appetite up to loss of appetite

Rare: dehydration, increased appetite

Psychiatric Disorders

Frequently:Mood and personality changes (e.g. anxiety, depression, euphoric mood), decreased activity, restlessness, psychomotor hyperactivity, agitation, nervousness, Insomnia, thought disorders, confusional states

Occasionally: Perceptual disturbances (e.g. hallucinations, derealisation), decreased libido

Dependence can develop.

Diseases of the nervous system

Very often: sedation (somnolence to a clouded state of consciousness), dizziness, headache

Frequently:Syncope, paresthesia

Uncommon: trouble concentrating, Migraine,taste disorders,increased muscle tone, tremor, involuntary muscle contractions,hypoesthesia, incoordination

Rarely:convulsions (especially in people with epilepsy and predisposition to seizures),amnesia

Very rare: speech disorders

eye diseases

Uncommon: visual disturbances

Diseases of the ear and labyrinth

Uncommon: hearing impairment

heart diseases

Uncommon: tachycardia

Rare: palpitations

vascular diseases

Common: hypotension

Uncommon: vasodilation

Respiratory, thoracic and mediastinal diseases

Common: dyspnoea

Uncommon: dysphonia, cough

Gastrointestinal disorders

Very common: constipation, vomiting, nausea

Common: abdominal pain, diarrhea, dry mouth, hiccups, dyspepsia

Uncommon: mouth ulcerations, stomatitis, flatulence

Rare: melaena, dental disease, bleeding gums, dysphagia

Very rare: ileus

Liver and bile diseases

Uncommon: Biliary colic

Very rare: increase in liver-specific enzymes

Skin and subcutaneous tissue disorders

Very common: pruritus

Common: skin reactions/rash

Rare: Dry skin

Very rare: urticaria

Diseases of the kidneys and urinary tract

Common: urinary retention, dysuria, urinary urgency

Diseases of the genital organs and the mammary gland

Uncommon: Erectile dysfunction

Rare: amenorrhea

General disorders and administration site conditions

Common: hyperhidrosis leading to chills, asthenia

Uncommon: Physical dependence with drug withdrawal syndrome, pain (e.g. chest pain), malaise, oedema

Rare: weight gain or loss, thirst

Tolerance can develop.

Injury, poisoning and procedural complications

Uncommon: Accidental injuries

Only with the potency 5mg:

Sunset yellow (E 110) can cause allergic reactions.

4.9Overdose

Symptoms of intoxication:

Miosis, respiratory depression, somnolence up to stupor, decreased tension of the skeletal muscles, bradycardia and drop in blood pressure. In more severe cases, coma, noncardiogenic pulmonary edema, and circulatory failure can occur, which can be fatal.

Therapy of intoxications:

In the event of an overdose, intravenous administration of an opiate antagonist (e.g. 0.4-2 mg naloxone intravenously) may be indicated. This single dose must be repeated at two to three minute intervals as clinically required. Also administration by infusion of 2 mg naloxone in 500 mlIsotonic saline or 5% dextrose solution (equivalent to 0.004 mg naloxone/ml) is possible. The rate of infusion should be tailored to the previously administered bolus dosages and the patient's response.

Gastric lavage may be considered.

Supportive measures (artificial ventilation, oxygenation, administration of vasopressors and infusion therapy) should be used, if necessary, in the management of concomitant circulatory shock. Cardiac arrest or arrhythmias may indicate chest compressions or defibrillation. If necessary, assisted ventilation and maintenance of water and electrolyte balance.

5.PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: natural opium alkaloids

ATC-Code:N02AA05

Oxycodone has affinity for kappa, mu, and delta opiate receptors in the brain, spinal cord, and peripheral organs. Oxycodone acts as an opioid agonist at these receptors without any antagonistic effect. The therapeutic effect is predominantly analgesic and sedating.

Endocrine System

Opioids may affect the hypothalamic-pituitary-adrenal or gonadal axes. Changes that may be observed include an increase in serum prolactin and a decrease in plasma cortisol and testosterone. A manifestation of clinical symptoms due to these hormonal changes may be possible.

Other pharmacological effects

Preclinical studies show different effects of natural opioids on components of the immune system. The clinical significance of these findings is unknown. It is not known whether oxycodone, a semisynthetic opioid, has immune system effects similar to natural opioids.

5.2 Pharmacokinetic properties

Resorption

After ingestion of the capsules, maximum plasma concentrations occur after about 1 to 1.5 hours. In a bioavailability study of another immediate-release oxycodone preparation (solution), the extent of absorption (AUC) after ingestion of a high-fat meal was approximately 20% increased, while the rate of absorption (Cmax) was decreased by about 20% compared to fasting. Clinical consequences are not assumed and specific recommendations are made for taking the OxyNorm^®Capsules not necessary in relation to the timing of meals.

distribution and elimination

The absolute bioavailability of oxycodone is approximately two-thirds relative to parenteral administration. Oxycodone has a volume of distribution of 2.6 L/kg at steady state; a plasma protein binding of 38-45%, an elimination half-life of 4 to 6 hours and a plasma clearance of 0.8 l/min.

Oxycodone is metabolized in the gut and liver via the P450 cytochrome system to noroxycodone and oxymorphone, as well as to several glucuronide conjugates. Invitro- Studies indicate that therapeutic doses of cimetidine are unlikely to significantly affect the formation of noroxycodone. Quinidine reduces the production of oxymorphone in humans, but the pharmacodynamics of oxycodone remain essentially unaffected. The contribution of the metabolites to the overall pharmacodynamic effect is negligible. Oxycodone and its metabolites are excreted in both urine and stool. Oxycodone crosses the placenta and can be detected in breast milk.

5.3 Preclinical safety data

Oxycodone has not been adequately tested for reproductive toxicological properties. There are no studies on fertility and on the postnatal effects of intrauterine exposure. Oxycodone did not induce any malformations in the rat at doses of up to 8 mg/kg body weight/day and in the rabbit at doses of up to 5 mg/kg body weight/day.

Oxycodonzeigte in in vitro-Investigations of a clastogenic potential. Underlive-conditions, however, such findings were not observed even at toxic doses.

Long-term carcinogenicity studies have not been performed.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline cellulose (E 460i), magnesium stearate, sodium dodecyl sulfate, gelatine, titanium dioxide (E171), iron oxide hydrate (E172), indigo carmine (E132), only with a potency of 5 mg additionally: sunset yellow FCF (E110).

6.2Incompatibilities

Not applicable

6.3 Shelf Life

3Jahre.

6.4 Special Storage Precautions

Do not store above 30°C.

6.5 Nature and content of the container

Child-resistant polyvinyl chloride foil blister packs, Pack sizes: 20, 50 and 100 capsules

6.6 Special precautions for disposal

No special requirements.

7. Marketing Authorization Holder

MundipharmaGmbH

MundipharmaStraße 2

65549 Limburg (Lahn)

8.Registration Numbers

58372.00.00

58373.00.00

58374.00.00

9. Date of Granting of Authorization

24.05.2007

10. Stand derInformation

July2007

11. Sales accrual

Prescription only

narcotics