OXYACT

Posology The dose depends on the pain intensity and the patient’s individual susceptibility to the treatment. For doses not realisable/practicable with this strength other strengths of this medicinal product are available.

The following general dose recommendations apply:

Adults and adolescents (≥ 12 years of age) Dose titration and adjustment The initial dose for opioid-naïve patients is usually 5 mg oxycodone hydrochloride given at intervals of every 6 hours. The dose may be increased in steps of 25% to 50% of the respective dose.

The aim is a patient-specific dose which allows for adequate analgesia with tolerable undesirable effects. Therefore, the dosing interval may be shortened to 4 hours if needed. However, Oxyact should not be taken more often than 6 times a day.

Some patients receiving prolonged-release oxycodone medicinal products according to a fixed time schedule may require immediate-release analgesics as rescue medication for the management of breakthrough pain. Oxyact is appropriate for the management of breakthrough pain.

Single doses of the rescue medication should be adjusted based on the patients’ individual requirements. In general, 1/8 to 1/6 of the daily prolonged-release oxycodone dose is appropriate. The requirement of rescue medication more than twice daily may indicate that higher doses of prolonged-release oxycodone are necessary.

The aim is to establish a patient- specific dosage which ensures adequate analgesia with tolerable undesirable effects and as low rescue medication as possible for as long as pain medication is necessary in patients receiving prolonged-release oxycodone treatment twice daily.

Patients already receiving opioids may start treatment with higher doses taking into account their experience with former opioid therapies. 10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the film-coated formulation.

Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with oxycodone hydrochloride after conversion from other opioids, with 50-75% of the calculated oxycodone dose.

In general, patients should be titrated individually until pain relief is achieved, provided that undesirable adverse events can be adequately managed. If long-term pain treatment is required, the patients should be switched to oxycodone hydrochloride prolonged-release tablets.

Method of administration Oral Use Oxyact film-coated tablets should be taken every 4-6 hours based on a fixed schedule at the dosage determined. The film-coated tablets may be taken with or independent of meals with a sufficient amount of liquid.

Oxyact film-coated tablets should not be used with alcoholic beverages. Treatment goals and discontinuation Before initiating treatment with Oxyact film-coated tablets, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.

During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. When a patient no longer requires therapy with oxycodone, it may be advisable to taper the dose gradually to prevent symptoms of withdrawal.

4). DURATION OF TREATMENT Oxycodone hydrochloride should not be taken longer than necessary. Special populations Elderly patients Elderly patients without clinical manifestation of impaired liver and/or kidney function usually do not require dose adjustments.

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 his/her clinical situation.

e. 5 mg, is not suitable as a starting dose. Other patients at risk Patients with low body weight or slow metabolisers who are also opioid naïve, should initially be treated with half the dose usually recommended for adults. e. 5 mg, is not suitable as a starting dose.

Paediatric population Opioids must only be used for appropriate indications and prescribed by a specialist experienced in managing severe pain in children, with careful assessments of the benefits and risks. Children below the age of 12 years The safety and efficacy of oxycodone in children below 12 years of age has not yet been established.

No data are available.

Oxycodone can cause respiratory depression, miosis, bronchial spasms and spasms of the smooth muscles and can suppress the cough reflex. The most frequently reported undesirable effects are nausea (especially at the beginning of treatment) and constipation.

Respiratory depression is the chief hazard of an opioid overdose and occurs predominantly in elderly or debilitated patients. Drug dependence Repeated use of Oxyact can lead to drug dependence, even at therapeutic doses. 4). The adverse reactions considered at least possibly related to treatment are listed below by system organ class and absolute frequency.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. g. g. 4) Not known: aggression Nervous system disorders Very common: somnolence, sedation, dizziness, headache Common: tremor, lethargy Uncommon: amnesia, concentration impaired, convulsions (especially in persons with epileptic disorder or predisposition to convulsions), migraine, hypertonia, hypoaesthesia, involuntary muscle contractions, abnormal coordination, speech disorder, syncope, paraesthesia, dysgeusia Not known: hyperalgesia Eye disorders Uncommon: visual impairment, miosis Ear and labyrinth disorders Uncommon: hearing impaired, vertigo.

g. 6. 1). 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. uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.

g. alcohol), • prostatic hypertrophy, • alcoholism, • known opioid dependence, • drug addiction, substance or alcohol abuse, • delirium tremens, • head injury, increased intracranial pressure, • impaired consciousness of unknown cause, • hypotension, • hypovolaemia, • epileptic disorder or predisposition to convulsions, • pancreatitis, • diseases of the biliary tract, biliary or ureteric colic, • obstructive or inflammatory intestinal diseases, • in patients taking MAO inhibitors.

Paralytic ileus In case of paralytic ileus or suspicion thereof Oxyact should be discontinued straight away. Respiratory depression The major risk of opioid excess is respiratory depression. Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia.

Opioid use increases the risk of CSA in a dose- dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Oxyact 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 Oxyact 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. 5). Adrenal insufficiency 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. MAO-inhibitors Oxycodone should be used with caution in patients administered MAO-inhibitors or who have received MAO-inhibitors during the last two weeks.

Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as oxycodone. Repeated use of Oxyact may lead to Opioid Use Disorder (OUD). A higher dose and longer duration of opioid treatment can increase the risk of developing OUD.

Abuse or intentional misuse of Oxyact may result in overdose and/or death. g. major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD. If these signs occur, patients should be advised to contact their physician.

g. too early requests for refills). This includes the review of concomitant opioids and psycho- active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.

Tolerance , physical dependence and tapering off The patient may develop tolerance to the medicinal product with chronic use and require progressively higher doses to maintain pain control. Oxycodone hydrochloride has a primary dependence potential.

Prolonged use of oxycodone hydrochloride 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 withdrawal symptoms.

Withdrawal symptoms may include yawning, mydriasis, lacrimation, rhinorrhoea, tremor, hyperhidrosis, anxiety, agitation, convulsions,insomnia, and myalgia. 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. Parenteral abuse Abuse of oral dosage forms by parenteral administration can be expected to result in serious adverse events, which may be fatal. Perioperative use, abdominal surgery Oxycodone should be used with caution pre-operatively and within the first 12-24 hours post-operatively.

Depending on the type and extent of surgery, the anaesthetic procedure selected, other co-medication and the individual condition of the patient, the exact timing for initiating post-operative treatment with oxycodone depends on a careful risk-benefit assessment for each individual patient.

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.

Patients with severe hepatic impairment Patients with severe hepatic impairment should be closely monitored. Hepatobiliary disorders Oxycodone may cause dysfunction and spasm of the sphincter of Oddi, thus increasing the risk of biliary tract […]

1. Oxycodone must not be used in any situation where opioids are contraindicated: • severe respiratory depression with hypoxia and/or hypercapnia • severe chronic obstructive pulmonary disease • cor pulmonale • severe bronchial asthma • paralytic ileus • acute abdomen, delayed gastric emptying