Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse drug reactions identified during clinical trials and post-marketing experience with paracetamol, pseudoephedrine, dextromethorphan, chlorpheniramine or the combination are listed below by System Organ Class (SOC).
The frequencies are defined according to the following convention:
Very common ≥1/10
Common ≥1/100 and < 1/10
Uncommon ≥1/1,000 and <1/100
Rare ≥1/10,000 and <1/1,000
Very rare <1/10,000, including isolated reports
Not known (cannot be estimated from the available data)
ADRs are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available, or 2) when incidence cannot be estimated, frequency category is listed as 'Not known'.



System Organ Class (SOC)         Frequency                      Adverse Drug Reaction (Preferred Term) 


Blood and lymphatic system   Not known       Blood disorders, blood dyscrasias (including agranulocytosis disorders                                    and thrombocytopenia) have been reported following paracetamol use but were not necessarily causally related to the drug haemolytic anaemia, blood dyscrasias



Immune system disorders      Rare
Hypersensitivity (cross-sensitivity may occur with other sympathomimetics)

Unknown:        allergic reaction, angioedema, anaphylactic reactions 


Psychiatric disorders        Common
Insomnia
Nervousness

Not known       Anxiety
Euphoric mood
Excitability
Hallucinations
Irritability
Paranoid delusions
Restlessness
Sleep disorder
Drug dependence (see section 4.4) confusion*, excitation*, irritability*, nightmares*, depression
Nervous system disorders                     Headache
Very common sedation, somnolence

Dizziness
Common disturbance in attention, abnormal coordination, headache

Not known       Cerebrovascular accident
Paraesthesia
Posterior reversible encephalopathy syndrome (PRES)(see section 4.4)/Reversible cerebral vasoconstriction syndrome
(RCVS)(see section 4.4)
Psychomotor hyperactivity
Somnolence
Tremor
 rare            Dizziness, drowsiness, mental confusion



Common:     blurred vision
Eye Disorders
Not known   Ischaemic optic neuropathy
Ear and labyrinth disorders      Unknown:    tinnitus

Cardiac disorders                Not known   Dysrhythmias
Myocardial infarction/myocardial ischaemia
Palpitations
Tachycardia arrhythmias
Hypertension
Vascular disorders               Not known
Hypotension
Gastrointestinal disorders       Common
Dry mouth
Nausea

Not known   Abdominal pain
Diarrhoea
Ischaemic colitis
Vomiting dyspepsia rare        Gastrointestinal upset



Rare        Hepatic necrosis
Hepatobiliary disorders
Unknown:    hepatitis, jaundice

Skin and subcutaneous tissue Rare            Rash disorders
Not known   Angioedema
Fixed eruption
Pruritus
Rash pruritic
Severe skin reactions, including Acute generalised exanthematous pustulosis (AGEP)
Urticaria exfoliative dermatitis, rash, photosensitivity
General disorders and            Common:     fatigue administration site conditions

 unknown     drug withdrawal syndrome chest tightness


Metabolism and nutritional       Unknown:    anorexia disorders


Respiratory, thoracic and        Unknown:    thickening of bronchial secretions mediastinal disorders:



Musculoskeletal and              Unknown:                       muscle twitching, muscle weakness connective tissue disorders


Renal and urinary disorders
Uncommon                       Nephropathy toxic

Not known                      Dysuria
Renal papillary necrosis (after prolonged administration)
Urinary retention (in men whom prostatic enlargement could have been an important predisposing factor)

*Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation(e.g.
increased energy, restlessness, nervousness).
Chronic hepatic necrosis has been reported in a patient who took daily therapeutic dosages of paracetamol for about a year and liver damage has been reported after daily ingestion of excessive amounts for shorter periods. A review of a group of patients with chronic active hepatitis failed to reveal differences in the abnormalities of liver function in those who were long-term users of paracetamol nor was the control of their disease improved after paracetamol withdrawal.
Very rare cases of serious skin reactions have been reported with paracetamol.



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/