Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse drug reactions identified during clinical trials and post-marketing experience with paracetamol, pseudoephedrine, chlorpheniramine or the combination are listed below by System Organ Class (SOC).

Acamol Tsinun Liquigel Night SK 03.2024                                                                                           4/8 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 disorders                                                    agranulocytosis 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


Acamol Tsinun Liquigel Night SK 03.2024                                                                                       5/8 Sleep disorder
 confusion*, excitation*, irritability*, nightmares*,
depression
Nervous system disorders            Very common   Headache sedation, somnolence
Common        Dizziness 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



Eye Disorders                       common        blured vision

Not known     Ischaemic optic neuropathy



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

Not known     Abdominal pain
Diarrhoea
Ischaemic colitis
Vomiting
Dyspepsia



Hepatobiliary disorders             Rare          Hepatic necrosis

Unknown       hepatitis, jaundice
Skin and subcutaneous tissue Rare                 Rash


Acamol Tsinun Liquigel Night SK 03.2024                                                                          6/8 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                     chest tightness
Metabolism and nutritional          Unknown                     anorexia disorders
Respiratory, thoracic and                                       Thickening of bronchial secretions Unknown mediastinal disorders


Musculoskeletal and
Unknown                     muscle twitching, muscle weakness connective tissuedisorders

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 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