Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The following frequencies are the basis for assessing undesirable effects: Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (> 1/10,000 to < 1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available data)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Undesirable effects in the treatment of pain
Immune system disorders
Uncommon:    Hypersensitivity

Metabolism and nutrition disorders
Common:       Decreased appetite up to loss of appetite

Psychiatric disorders
Common:         Insomnia
Uncommon:       Abnormal thinking, anxiety, confusional state, depression, libido decreased, nervousness, restlessness Not known:      Euphoric mood, hallucination, nightmares, aggression, drug dependence (see section 4.4) 
Nervous system disorders
Common:       Dizziness, headache, somnolence
Uncommon:     Convulsions (particularly in persons with epileptic disorder or predisposition to convulsions), disturbance in attention, dysgeusia, speech disorder, syncope, tremor, lethargy
Not known:    Paraesthesia, sedation

Eye disorders
Uncommon:     Visual impairment

Ear and labyrinth disorders
Common:         Vertigo
Cardiac disorders
Uncommon:       Angina pectoris (in particular in patients with history of coronary artery disease), palpitations Rare:           Tachycardia

Vascular disorders
Common:         Hot flush
Uncommon:      Blood pressure decreased, blood pressure increased

Respiratory, thoracic and mediastinal disorders
Uncommon:       Dyspnoea, rhinorrhoea, cough
Rare:           Yawning
Not known:      Respiratory depression, Central sleep apnoea syndrome (see section 4.4) 
Gastrointestinal disorders
Common:          Abdominal pain, constipation, diarrhoea, dry mouth, dyspepsia, vomiting, nausea, flatulence Uncommon:        Abdominal distension
Rare:            Tooth disorder
Not known:       Eructation

Hepatobiliary disorders
Uncommon:       Hepatic enzymes increased, biliary colic

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Skin and subcutaneous tissue disorders
Common:        Pruritus, skin reactions, hyperhidrosis

Musculoskeletal and connective tissue disorders
Uncommon:      Muscle spasms, muscle twitching, myalgia

Renal and urinary disorders
Uncommon:      Micturition urgency
Not known:     Urinary retention
Reproductive system and breast disorders
Not known:     Erectile dysfunction

General disorders and administration site conditions
Common:        Asthenia, fatigue
Uncommon:      Chest pain, chills, malaise, pain, peripheral oedema, thirst Not known:     Drug withdrawal syndrome

Investigations
Uncommon:      Weight decreased
Rare:          Weight increased

Injury, poisoning and procedural complications
Uncommon:        Injuries from accidents


For the active substance oxycodone hydrochloride, the following additional undesirable effects are known: Due to its pharmacological properties, oxycodone hydrochloride may cause respiratory depression, miosis, bronchial spasm and spasms of nonstriated muscles as well as suppress the cough reflex.


Infections and infestations
Rare: Herpes simplex
Immune system disorders
Not known:   Anaphylactic reaction

Metabolism and nutrition disorders
Uncommon:     Dehydration
Rare:         Increased appetite

Psychiatric disorders
Common:         Altered mood and personality change, decreased activity, psychomotor hyperactivity Uncommon:       Agitation, perception disturbances (e.g., derealisation) 
Nervous system disorders
Uncommon:     Concentration impaired, migraine, hypertonia, involuntary muscle contractions, hypoaesthesia, abnormal coordination
Not known:    Hyperalgesia

Ear and labyrinth disorders
Uncommon:       Hearing impaired

Vascular disorders
Uncommon:      Vasodilatation
Respiratory, thoracic and mediastinal disorders
Uncommon:       Dysphonia
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Gastrointestinal disorders
Common:          Hiccups
Uncommon:        Dysphagia, ileus, mouth ulceration, stomatitis
Rare:            Melaena, gingival bleeding,
Not known:       Dental caries

Hepatobiliary disorders
Not known:      Cholestasis, sphincter of Oddi dysfunction

Skin and subcutaneous tissue disorders
Uncommon:      Dry skin
Rare:          Urticaria
Renal and urinary disorders
Common:        Dysuria

Reproductive system and breast disorders
Uncommon:      Hypogonadism
Not known:     Amenorrhoea

General disorders and administration site conditions
Uncommon:      Oedema
Not known:     Drug withdrawal syndrome neonatal, drug tolerance

Drug dependence
The frequencies in the above table regarding drug dependence, drug withdrawal syndrome and drug tolerance reflect that although risk is low with short term and low dose use, it is highly variable.

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

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/