Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Pentoxifylline may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for The name of this medicine is Pentoxifylline 400mg Modified Release Tablets (called Pentoxifylline throughout this leaflet). Pentoxifylline contains a medicine called pentoxifylline. This belongs to a group of medicines called peripheral vasodilators. It works by increasing the blood flow to the arms and legs. This medicine can be used to treat:
e Pentoxifylline Do not take this medicine if:
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine. Warnings and precautions Talk to your doctor or pharmacist before taking this medicine if:
Pentoxifylline Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Taking this medicine
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking this medicine and see your doctor or go to a hospital straight away if:
• •
Frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called 'leukopenia' You get more infections than usual. This could be caused by a decrease in the number of white blood cells (neutropenia)
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days. Also tell them if you notice any side effects not listed in this leaflet:
Pentoxifylline Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. Do not use this medicine if you notice your tablets are crumbling, broken or discoloured. Do not store above 25°C. Store in the original package. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What this medicine contains
*commercial film-coating (Opadry 02F24006) can be used instead of single film-coating components What this medicine looks like and contents of the pack The tablets are oblong in shape and coloured pink, with "ATA" stamped on one side. The tablets are available in blister packs of 90 tablets. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Neuraxpharm UK Limited First Floor, Building 1410, Arlington Business Park, Theale, Reading, Berkshire RG7 4SA United Kingdom Manufacturer Neuraxpharm Pharmaceuticals S.L. Avda. de Barcelona 69, Sant Joan Despí, 08970, Barcelona, Spain This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist. This leaflet was last revised in 11/2025.
Pentoxifylline 400 mg Modified-release tablet comes as tablet containing 400mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Pentoxifylline 400 mg Modified-release tablet is pentoxifylline.
Medicines with the same active substance, strength and form include: Trental 400 mg Modified release Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Pentoxifylline 400 mg Modified-release tablet, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Pentoxifylline is indicated in the treatment of peripheral vascular disease, including intermittent claudication and rest pain.
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.
Hypersensitivity to the active substance(s), other methylxanthines or to any of the excipients listed in section 6.1.
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,
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.
• In patients treated concomitantly with pentoxifylline and anti-vitamin K or platelet aggregation inhibitors (see also section 4.5).
• In patients treated concomitantly with pentoxifylline and antidiabetic agents (see also section 4.5).
• In patients treated concomitantly with pentoxifylline and ciprofloxacin (see also section 4.5).
• In patients treated concomitantly with pentoxifylline and theophylline (see also section 4.5).
Excipient(s) with known effect
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium- free'.
High doses of Pentoxifylline 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 Pentoxifylline following oral administration. It is recommended that patients under medication for diabetes mellitus be carefully monitored.
Post-marketing cases of increased anti-coagulant activity have been reported in patients concomitantly treated with pentoxifylline and anti-vitamin K. Monitoring of anti-coagulant activity in these patients is recommended when pentoxifylline is introduced or the dose is changed.
Pentoxifylline may potentiate the effect of anti-hypertensive agents and the dosage of the latter may need to be reduced.
Pentoxifyllineshould not be given concomitantly with ketorolac as there is increased risk of bleeding and/or prolongation of prothrombin time.
Concomitant administration of pentoxifylline and theophylline may increase theophylline levels in some patients. Therefore there may be an increase in and intensification of adverse effects of theophylline.
Concomitant administration with ciprofloxacin may increase the serum concentration of pentoxifylline in some patients. Therefore, there may be an increase in and intensification of adverse reactions associated with co-administration.
Potential additive effect with platelet aggregation inhibitors: Because of the increased risk of bleeding, the concomitant administration of a platelet aggregation inhibitor (such as clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs other than selective COX-2 inhibitors, acetylsalicylates (ASA/LAS), ticlopidine, dipyridamole) with pentoxifylline should be undertaken with caution.
Concomitant administration with cimetidine may increase the plasma concentration of pentoxifylline and the active metabolite, lisofylline.
Pregnancy
There is no information on the use of Pentoxifylline in pregnancy, but no untoward effects have been found in animal studies. Pentoxifylline should not be administered during pregnancy.
Breast-feeding
Pentoxifylline passes into breast milk in minute quantities. Because insufficient experience has been gained, the possible risks and benefits must be weighed before administration of Pentoxifylline to breast feeding mothers.
No effect known.
These adverse reactions have been reported in clinical trials or post-marketing.
Frequencies are unknown.
System Organ Class
Adverse Reaction
Investigations
Transaminases increased
Cardiac disorders
Arrhythmia, Tachycardia, Angina Pectoris
Blood and lymphatic system disorders
Thrombocytopenia, Leukopenia/neutropenia
Nervous system disorders
Dizziness, headache, meningitis aseptic*
Gastrointestinal disorders
Gastrointestinal disorder, Epigastric discomfort, Abdominal distension, Nausea, Vomiting, Diarrhoea, Constipation, Hypersalivation
Skin and subcutaneous tissue disorders
Pruritus, Erythema, Urticaria, Hot flush, Rash
Vascular disorders
Haemorrhage**, Hypotension
Immune system disorders
Anaphylactic reactions, Anaphylactoid reaction, Angioedema
Hepatobiliary disorders
Cholestasis
Psychiatric disorders
Agitation, Sleep disorder
Respiratory disorders
Bronchospasm
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 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. Healthcare professional are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
The treatment of overdosage should be symptomatic with particular attention to supporting the cardiovascular system.
Ask anything about Pentoxifylline 400 mg Modified-release tablet. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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