Oxifyl CR – 400 mg Tablet/pcs

These adverse reactions have been reported in clinical trials or post-marketing-

• Investigations: Transaminases increased (Transaminase elevation), Blood pressure decreased (Fall in blood pressure)
• Cardiac disorders: Arrhythmia (Cardiac arrhythmia), Tachycardia, Angina Pectoris
• Blood and lymphatic system disorders: Thrombocytopenia (Thrombopenia), Leucopenia/neutropenia
• Nervous system disorders: Dizziness, headache, meningitis aseptic (Aseptic meningitis)
• Gastrointestinal disorders: Gastrointestinal disorder (Gastrointestinal complaints), Epigastric discomfort (Gastric pressure), Abdominal distension (Fullness), Nausea, Vomiting, Diarrhoea, Constipation, Hypersalivation
• Skin and subcutaneous tissue disorders: Pruritus, Erythema (Reddening of the skin), Urticaria, Rash
• Vascular disorders: Hot fush (Flushes), Haemorrhage (Bleedings)
• Immune system disorders: Anaphylactic reaction, Anaphylactoid reaction, Angioedema (Angioneurotic edema), Bronchospasm, Anaphylactic shock (shock)
• Hepatobiliary disorders: Cholestasis (Intrahepatic cholestasis)
• Psychiatric disorders: Agitation, Sleep disorder (Sleep disturbances)

Insufficient experience has been gained concerning use in pregnancy. Therefore, it is recommended that Pentoxifylline is not used during pregnancy. Pentoxifylline passes into breast milk in minute quantities. Because insufficient experience has been gained, the physician must carefully weigh the possible risks and benefits before administering Pentoxifylline in breast-feeding women.

At the first signs of an anaphylactic/anaphylactoid reaction, Pentoxifylline must be discontinued or the infusion be halted immediately, and a physician must be informed. Particularly careful monitoring is required:

• in patients with severe cardiac arrhythmias
• in patients with myocardial infarction
• in hypotensive patients
• in patients with impaired renal function (creatinine clearance below 30 ml/min)
• in patients with severely impaired liver function
• in patients with increased bleeding
• in patients treated concomitantly with pentoxifylline and anti-vitamin K or platelet aggregation inhibitors
• in patients treated concomitantly with pentoxifylline and antidiabetic agents
• in patients treated concomitantly with pentoxifylline and ciprofoxacin
• in patients treated concomitantly with pentoxifylline and theophylline

Hepatic impairment: A dose reduction- guided by individual tolerance- is necessary in patients with severely impaired liver function.

Renal impairment: In patients with impairment of renal function (creatinine clearance below 30 mL/min) a dose reduction by approx. 30% to 50% may be necessary guided by individual tolerance.

Other: 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.

Initial symptoms of acute overdose with pentoxifylline may be nausea, dizziness, tachycardia or a fall in blood pressure. Furthermore, signs such as fever, agitation, flush, loss of consciousness, areflexia, tonic -clonic convulsions and as a sign of gastrointestinal bleeding – coffee-ground vomiting may occur. No specific antidote is known. If ingestion has only just taken place, attempts may be made to prevent further systemic absorption of the active ingredient by primary elimination of the toxin (e.g. gastric lavage) or by delaying its absorption (e.g. activated charcoal).

Keep in a cool and dry place, away from light. Do not use later than date of expiry. Keep all medicine out of the reach of children. To be dispensed only on the prescription of a registered physician.