In patients with hypotension or severe coronary artery disease, Trental 400 should be used with caution, as a transient hypotensive effect is possible and, in isolated cases, might result in a reduction in coronary artery perfusion.

Treatment must be started at low-dose levels in hypotensive patients or patients whose circulation is unstable as well as in patients, who would be at particular risk from a reduction in blood pressure (e.g. patients with severe coronary heart disease or relevant stenoses of blood vessels supplying the brain); in such cases, the dose must only be increased gradually, see section 4.2.

Particularly careful monitoring is required in patients with impaired renal function. In patients with impaired renal function (creatinine clearance below 30ml/min),it may be necessary to reduce the daily dose of Trental 400 to one or two tablets to avoid accumulation, see section 4.2. In patients with severely impaired liver function the dosage may need to be reduced, see section 4.2.

Particularly careful monitoring is also required:

• In patients with severe cardiac arrhythmias

• In patients with myocardial infarction

• In hypotensive patients

• In patients with increased bleeding tendency due to e.g. anticoagulant medication or coagulation disorders. Concerning bleeding see also section 4.3.

• In patients treated concomitantly with pentoxifylline and vitamin K antagonists (see also section 4.5)

• In patients treated concomitantly with pentoxifylline and antidiabetic agents (see also section 4.5_

The blood-sugar lowering effect of insulin or oral antidiabetics may be potentiated. Therefore it is recommended that patients under medication for diabetes mellitus be carefully monitored.

Contains 141.88mg of sucrose per tablet. Patients with rare hereditary problems of fructose intolerance glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. This should be taken into account in patients with diabetes mellitus please see section 4.5.

4.5 Interaction with other medicinal products and other forms of interaction

 High doses of Trental injection have been shown, in rare cases, to intensify the hypoglycaemic action of insulin and oral hypoglycaemic agents. However, no effect on insulin release has been observed with Trental following oral administration. . Therefore it is recommended that patients under medication for diabetes mellitus be carefully monitored.

The blood-pressure lowering effect of antihypertensive agents and other drugs with blood-pressure-lowering potential may be increased by Trental. Therefore it is recommended that patients under medication for diabetes mellitus be carefully monitored.

Cases of increased anti-coagulant activity have been reported in patients concomitantly treated with pentoxifylline and vitamin K antagonists. Monitoring of anti-coagulant activity in these patients is recommended when pendoxifylline is introduced or the dose is changed.

Concomitant administration of pentoxifylline and theophylline may increase theophylline levels in some patients. Therefore, there may be an increase in and intensification of adverse reactions from theophylline.

Particularly careful