Adverse reactions : תופעות לוואי

6 ADVERSE REACTIONS
The following serious adverse reactions are described, or described in greater detail, in other sections:

•   Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] •   Addiction, Abuse, and Misuse [see Warnings and Precautions (5.3)] •   Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] •   Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.5)] •   Myoclonic Activity [see Warnings and Precautions (5.6)]
•   Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.8)] •   Adrenal Insufficiency [see Warnings and Precautions (5.11)]
•   Severe Hypotension [see Warnings and Precautions (5.12)]
•   Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.14)] •   Seizures [see Warnings and Precautions (5.15)]
•    Withdrawal [see Warnings and Precautions (5.16)]
•   Urinary Retention [see Warnings and Precautions (5.18)]
•   Orthostatic Hypotension [see Warnings and Precautions (5.19)]

The following adverse reactions associated with the use of morphine were identified in clinical studies or post marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The most serious adverse reactions encountered during administration of Morphine Injections 1 mg/ml were respiratory depression and/or respiratory arrest.
Cardiovascular System: While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulating catecholamines.
Central Nervous System: myoclonus, seizures, dysphoric reactions, toxic psychosis, dizziness, euphoria, anxiety, confusion, headache. Lumbar puncture-type headache is encountered in a significant minority of cases for several days following intrathecal catheter implantation and generally responds to bed rest and/or other conventional therapy.
Gastrointestinal System: Nausea, vomiting, constipation
Skin: Generalized pruritus, urticaria, wheals, and/or local tissue irritation. Single-dose epidural or intrathecal administration is accompanied by a high incidence of dose-related generalized pruritus.
Urinary System: Urinary retention, oliguria.
Peripheral edema: There are several reports of peripheral edema.
Other: Other adverse reactions reported following morphine therapy include depression of cough reflex, interference with thermal regulation.
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
Anaphylaxis: Anaphylaxis has been reported with ingredients contained in Morphine Injections.
Androgen deficiency: Cases of androgen deficiency have occurred with use of opioids for an extended period of time [seeClinical Pharmacology (12.2)].
Hyperalgesia and Allodynia:
Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions (5.8)].
Hypoglycemia:
Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/