Trental

TRENTAL 400.

Pentoxifylline 400MG.

Modified release tablet.

Trental 400 is indicated in the treatment of peripheral vascular disease, including intermittent claudication and rest pain.

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

Special Cases: 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.

Trental 400 is contra-indicated in cases where there is known hypersensitivity to the active constituent, pentoxifylline other methyl xanthines or any of the excipients. Also in patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction and severe cardiac arrhythmias.

At the first signs of an anaphylactic/anaphylactoid reaction, Trental 400 must be discontinued immediately, and a physician must be informed.

Particular careful monitoring is required:

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.

Particularly careful monitoring is required in patients with impaired renal function.).

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No effect known.

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

Description of selected adverse reactions

* Reports of aseptic meningitis were predominantly in patients with 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 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. Healthcare professional are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

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

Leukocyte properties of haemorrheologic importance have been modified in animal and in vitro human studies. Pentoxifylline has been shown to increase leukocyte deformability and to inhibit neutrophil adhesion and activation.

The half life of absorption of Trental 400 is 4-6 hours. Pentoxifylline is extensively metabolised, mainly in the liver. Sixty percent of a single dose of Trental 400 is eliminated via the kidney over 24 hours.

Nothing of clinical relevance.

Hydroxyethyl cellulose, povidone, talc, magnesium stearate, hypromellose, macrogol 8000, erythrosine (E127). titanium dioxide (E171).

None known.

36 months

Do not store above 25°C. Store in the original package.

Amber glass bottle: 100 or 250 tablets.

Plastic (PE) pots: 100 or 250 tablets.

Blister Pack (Alu/PVC): 10 or 90 tablets.

None.

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

Trading as:

Sanofi-aventis or Sanofi

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

PL 04425/0213

15^th April 2002

25 May 2016