Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse drug reactions identified during clinical trials and post-marketing experience with paracetamol, pseudoephedrine, 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

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



Psychiatric disorders        Common
Insomnia
Nervousness

Not known     Anxiety
Euphoric mood
Excitability
Hallucinations
Irritability
Paranoid delusions
Restlessness
Sleep disorder
Drug dependence (see section 4.4)
Nervous system disorders     Very common   Headache

Common        Dizziness

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



Eye Disorders                Not known     Ischaemic optic neuropathy 
Cardiac disorders            Not known     Dysrhythmias
Myocardial infarction/myocardial ischaemia
Palpitations
Tachycardia

Vascular disorders           Not known     Hypertension

Gastrointestinal disorders   Common
Dry mouth
Nausea

Not known     Abdominal pain
Diarrhoea
Ischaemic colitis
Vomiting


rare                         Gastrointestinal upset



Hepatobiliary disorders          Rare                         Hepatic necrosis 
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

General disorders and            Frequency unknown            drug withdrawal syndrome administration site conditions



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)
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/