Adverse reactions : תופעות לוואי

4.8 Undesirable effects

These adverse reactions have been reported in clinical trials or post-marketing. Frequencies are unknown.

System Organ Class                   Adverse Reaction
Investigations                       Transaminases or alkaline phosphatases increased, Elevated blood pressure.


Cardiac disorders                   Arrhythmia, Tachycardia, Angina Pectoris, Blood and lymphatic system          Thrombocytopenia with thrombocytopenia purpura and disorders                           possibly fatal aplastic anaemia (pancytopenia), leukopenia/neutropenia
Nervous system disorders            Dizziness, Tremor, headache, Paresthesia, Convulsions, Intracranial bleeding, Meningitis aseptic*
Gastrointestinal disorders          Gastrointestinal disorder, Epigastric discomfort, Abdominal distension, Nausea, Vomiting, Bloatness, Diarrhoea,
Constipation, Hypersalivation
Skin and subcutaneous tissue        Pruritus, Erythema, Urticaria, Hot flush, Epidermal necrolysis, disorders                           Stevens-Johnson syndrome, Sweating, Rash Vascular disorders                  Haemorrhage**, Hypotension
Immune system disorders             Anaphylactic reactions, Anaphylactoid reaction, Angioedema, Anaphylactic shock
Hepatobiliary disorders             Cholestasis
Psychiatric disorders               Agitation, Sleep disorder
Respiratory disorders               Bronchospasm, Dyspnoea
Eye disorders                       Visual disturbances, Conjunctivitis, Retinal haemorrhage, Detachment of retina (If retinal haemorrhage occurs during treatment with pentoxifylline, the medicinal product must be discontinued immediately)
General dysorders                   Fever, Peripheral oedema
Description of selected adverse reactions
* Reports of aseptic meningitis were predominantly in patients with autoimmune diseases (SLE, underlying connective tissue disorders)
** A few very rare events of bleeding (e.g. skin, mucosa) have been reported in patients treated with Trental with and without anticoagulants or platelet aggregation inhibitors. The serious cases are predominantly concentrated in the gastrointestinal, genitourinary, multiple site and surgical wound areas and are associated with bleeding risk factors. A causal relationship between Trental therapy and bleeding has not been established.
Thrombocytopenia has occurred in isolated cases.

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
(http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic @moh.gov.il ).