Adverse reactions : תופעות לוואי

4.8 Undesirable effects
Adverse events are tabulated below by system class. post-marketing experience indicates that adverse reactions to paracetamol are rare and serious reactions are very rare.

Paracetamol
Body System                     Undesirable effect
Blood and lymphatic             Thrombocytopenia system disorders                Agranulocytosis
These were not necessarily causally related to paracetamol.
Immune system disorders         Anaphylaxis
Cutaneous hypersensitivity reactions including skin rashes, angiodema
Very rare cases of serious skin reactions have been reported.
Respiratory, thoracic and      Bronchospasm* mediastinal disorders
Hepatobiliary disorders          Hepatic dysfunction
* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.


Caffeine
Adverse reactions of caffeine are listed below. The frequency of these reactions is unknown.
Body System                      Undesirable effect
Central Nervous system           excitability, dizziness and headache Psychiatric disorders            Nervousness, insomnia, restlessness, anxiety and irritability
Cardiac disorders                Palpitations
Gastrointestinal disorders       Gastrointestinal disturbances

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects.

Phenylephrine
The following adverse events with phenylephrine are listed below.
Body System                   Undesirable effect
Psychiatric disorders         Nervousness
Nervous system disorders      Headache, dizziness, insomnia
Cardiac disorders             Increased blood pressure
Gastrointestinal disorders    Nausea, Vomiting, diarrhoea

The frequency of the following reactions is unknown:
Body System                    Undesirable effect
Immune system disorders        Hypersensitivity, allergic dermatitis, urticaria Eye disorders                  Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma
Cardiac disorders              Tachycardia, palpitations
Skin and subcutaneous          Rash disorders
Renal and urinary disorders    Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.
Chlorpheniramine maleate
Adverse reactions of chlorpheniramine are listed below:

Body System                   Undesirable effect            Frequency Nervous system disorders      Sedation, somnolence          Very common Disturbance in attention,     Common abnormal coordination,
dizziness headache
Eye disorder                  Blurred Vision                Common 
Gastrointestinal disorders    Nausea, dry                    Common Vomiting, abdominal            Unknown pain, diarrhoea,
dyspepsia
Immune system                 Allergic reaction,             Unknown disorders:                    angioedema,
anaphylactic reactions
Metabolism and                Anorexia nutritional disorders                                        Unknown Blood and lymphatic           Haemolytic anaemia,            Unknown system disorders              blood dyscrasias
Musculoskeletal and          Muscle twitching, muscle        Unknown connective tissue             weakness disorders
Psychiatric disorders         Confusion*, excitation*,       Unknown irritability*, nightmares*,
depression
Renal and urinary             Urinary retention              Unknown disorders
Skin and subcutaneous         Exfoliative dermatitis,        Unknown disorders                     rash, urticaria,
photosensitivity
Respiratory, thoracic and     Thickening of bronchial        Unknown mediastinal disorders         secretions
Vascular disorders            Hypotension                    Unknown Hepatobiliary disorders       Hepatitis, including           Unknown jaundice
Ear and labyrinth             Tinnitus                       Unknown Disorders
Cardiac disorders             Palpitations, tachycardia,     Unknown arrythmias
General disorders and         Fatigue                       common administration site           Chest tightness               Unknown conditions
*Children and the elderly are more likely to experience the neurological anticholinergic effects and paradoxical excitation (e.g. increased energy, restlessness, nervousness).

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