Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The most serious hazard of therapy is respiratory depression (see section 4.9). The commonest side- effects of morphine are:
• Nausea
• Vomiting
• Constipation
• Drowsiness
• Dizziness

Tolerance generally develops with long term use, but not to constipation.
Other side effects include the following:

Psychiatric disorders
• Dependence.
Immune system disorders:
• Anaphylactic reactions following intravenous injection have been reported rarely, anaphylactoid reactions.
Cardiac disorders:
• Bradycardia
• Palpitations
• Tachycardia
• Orthostatic hypotension.

Nervous system disorders:
• Myoclonus
• Mental clouding
• Confusion (with large doses)
• Hallucinations
• Headache
• Vertigo
• Mood changes including dysphoria
• Euphoria
• Allodynia
• Hyperalgesia (see section 4.4)
• Hyperhidrosis

Gastrointestinal disorders:
•   Dry mouth
•   Biliary spasm
•   Pancreatitis
Eye disorders:
• Blurred or double vision or other changes in vision
• Miosis

Reproductive system and breast disorders:
• Long term use may lead to a reversible decrease in libido or potency.
• Central sleep apnoea syndrome

Skin and subcutaneous tissue disorders:
• Pruritus
• Urticaria
• Rash
• Sweating.
• Contact dermatitis has been reported and pain and irritation may occur on injection.
• Facial flushing
• Acute generalised exanthematous pustulosis (AGEP)

Musculoskeletal and connective tissue disorders
• Muscle rigidity

Hepatobiliary disorders
•   Spasm of sphincter of Oddi
Renal and urinary disorders:
• Difficulty with micturition
• Ureteric spasm
• Urinary retention
• Antidiuretic effect.

General disorders and administration site conditions:
• Drug withdrawal (abstinence) syndrome

Tolerance develops to the effects of opioids on the bladder.
The euphoric activity of morphine has led to its abuse and physical and psychological dependence may occur (see section 4.4).

Description of selected adverse reactions
Drug dependence and withdrawal (abstinence) syndrome.

Use of opioid analgesics may be associated with the development of physical and/or psychological dependence or tolerance. An abstinence syndrome may be precipitated when opioid administration is suddenly discontinued, or opioid antagonists administered or can sometimes be experienced between doses. For management, see 4.4.

Repeated use of Morphine Kalceks can lead to drug dependence, even at therapeutic doses. The risk of drug dependence may vary depending on a patient's individual risk factors, dosage, and duration of opioid treatment (see section 4.4) .

Physiological withdrawal symptoms include Body aches, tremors, restless legs syndrome, diarrhoea, abdominal colic, nausea, flu-like symptoms, tachycardia and mydriasis. Psychological 
symptoms include dysphoric mood, anxiety and irritability. In drug dependence, “drug craving” is often involved.

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.
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