Trental should not be given concomitantly with ketorolac as there is increased risk of bleeding and/or prolongation of prothrombin time.
4.6 Pregnancy and lactation

 Insufficient experience has been gained concerning use in pregnancy. Therefore, it is recommended that Trental is not used during pregnancy .

Pentoxifylline passes into breast milk in minute quantities. Because insufficient experience has been gained, the physician must carefully weigh the possible risks and benefits before administering Trental in breast-feeding women.

4.7 Effects on ability to drive and use machines

 No effects known.

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 increased (Transaminase elevation), Blood pressure decreased (Fall in blood pressure)
 
Cardiac disorders:
 Arrhythmia (Cardiac arrhythmia), Tachycardia, Angina Pectoris
 
Blood and lymphatic system disorders:
 Thrombocytopenia (Thrombopenia
 
Nervous system disorders:
 Dizziness, headache, meningitis aseptic (Aseptic meningitis)
 
Gastrointestinal disorders:
 Gastronitestinal disorder (Gastrointestinal complaints), Epigastric discomfort (Gastric pressure), Abdominal distension (fullness), Nausea, Vomiting, Diarrhoea
 
Skin and subcutaneous tissue disorders:
 Pruritus, Erythema (Reddening of the skin), Urticaria
 
Vascular disorders:
 Hot Flush (Flushes), Haemorrhage (Bleedings)
 
Immune system disorders:
 Anaphylactic reaction, Analphylactoid reaction, Angioedema (Angioneurotic edema), Bronchospasm, Anaphylactic shock (shock)
 
Hepatobiliary disorders:
 Cholestatis (Intrahepatic cholestasis)
 
Psychiatric disorders:
 Agitation, Sleep disorder (Sleep disturbances)

4.9 Overdose

 The treatment of overdosage should be symptomatic with particular attention to supporting the cardiovascular system.

Symptoms of overdose

Initial symptoms of acute overdose with pentoxifylline may be nausea, dizziness, tachycardia or a fall in blood pressure. Furthermore, signs such as fever, agitation, flush, loss of consciousness, areflexia, tonic-clonic convulsions and - as a sign of gastrointestinal bleeding- coffee-ground vomiting may occur.

Treatment of overdose

No specific antidote is known. If ingestion has only just taken place, attempts may be made to prevent further systemic absorption of the active ingredient by primary elimination of the toxin (e.g. gastric lavage) or by delaying its absorption (e.g. activated charcoal).

The treatment of acute overdose and the prevention of complications may necessitate general and specific intensive medical monitoring and therapeutic measures.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

 Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation.

Pentoxifylline increases impaired e