PENTOXIFYLLINE

Posology Adults The recommended initial dose is 1 tablet (400 mg) three times daily; two tablets daily may prove sufficient in some patients, particularly for maintenance therapy. Elderly No special dosage requirements. Paediatric population Pentoxifylline is not suitable for use in children.

Renal Impairment In patients with impairment of renal function (creatinine clearance below 30ml/min) a dose reduction by approximately 30% to 50% may be necessary guided by individual tolerance. Method of administration Oral administration.

Tablets should be taken with or immediately after meals, and swallowed whole with plenty of water.

These adverse reactions have been reported in clinical trials or post-marketing. Frequencies are unknown. g. skin, mucosa) have been reported in patients treated with Pentoxifylline 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 Pentoxifylline therapy and bleeding has not been established.

Thrombocytopenia has occurred in isolated cases. 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.

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At the first signs of an anaphylactic/anaphylactoid reaction, Pentoxifylline must be discontinued immediately, and a physician must be informed. Particular careful monitoring is required: • In patients with hypotension or severe coronary artery disease, Pentoxifylline 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.

• In patients with impaired renal function. In patients with a creatinine clearance of less than 30 ml/min it may be necessary to reduce the daily dose of Pentoxifylline to one or two tablets to avoid accumulation. In patients with severely impaired liver function the dosage may need to be reduced.

5). 5). 5). 5). Excipient(s) with known effect This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium- free'.

1. Also in patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction and severe cardiac arrhythmias.