Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

1. NAME OF THE MEDICINAL PRODUCT

 Trental 400mg Modified Release Coated Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

 Each tablet contains 400mg of pentoxifylline

Excipients: Sucrose 141.88mg

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

 Modified release, coated tablet

Oblong, pink tablets

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

 Uses: Trental 400 is indicated in the management of peripheral vascular disease

Trental has been shown to increase cerebral blood flow but this may not necessarily be accompanied by an improvement in clinical signs and symptoms.

4.2 Posology and method of administration

 The recommended initial dose is 1 tablet (400mg) three times daily; two tablets daily may prove sufficient in some patients, particularly for maintenance therapy.

Elderly: No special dosage requirements

Children: No experience is available concerning the use of pentoxifylline in children. Consequently Trental 400mg is not currently recommended for use in children.

Special Cases:

In patients with impairment of renal function (creatinine clearance below 30ml/min) a dose reduction by approx. 30% to 50% may be necessary – guided by individual tolerance, see section 4.4.

A dose reduction-guided by individual tolerance- is necessary in patients with severely impaired liver function, see section 4.4.

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 4.4.

4.3 Contraindications

 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 acute myocardial infarction or cerebrovascular accident.

In patients with massive bleeding (risk of increased bleeding).

In patients with extensive retinal bleeding (risk of increased bleeding).

4.4 Special warnings and precautions for use

 At the