Valsts: Jaunzēlande
Valoda: angļu
Klimata pārmaiņas: Medsafe (Medicines Safety Authority)
Pentoxifylline 400mg; ;
Clinect NZ Pty Limited
Pentoxifylline 400 mg
400 mg
Modified release tablet
Active: Pentoxifylline 400mg Excipient: Erythrosine Hyetellose Hypromellose Macrogol 8000 Magnesium stearate Povidone Purified talc Purified water Titanium dioxide
Blister pack, PVC/Al, 50 tablets
Prescription
Prescription
Sanofi India Limited
The treatment of peripheral occlusive vascular disease and circulatory disorders of arteriosclerotic, diabetic, inflammatory or function origin; trophic disorders (e.g., leg ulcers and gangrene).
Package - Contents - Shelf Life: Blister pack, PVC/Al - 50 tablets - 36 months from date of manufacture stored at or below 25°C
2001-11-16
TRENTAL ® 400 1 TRENTAL ® _Pentoxifylline _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Trental. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TRENTAL IS USED FOR Trental is a type of medicine used to improve the circulation of the blood. Trental is used to treat the symptoms of: • A CONDITION CALLED PERIPHERAL OCCLUSIVE VASCULAR DISEASE. SYMPTOMS OF THIS DISEASE CAN INCLUDE LAMENESS AND PAIN, USUALLY IN THE LEG MUSCLES. • CIRCULATORY DISORDERS CAUSED BY THICKENING OF THE BLOOD VESSEL WALLS, DIABETICS, INFLAMMATION, LEG ULCERS AND GANGRENE. • CIRCULATORY DISORDERS IN THE EYE AND YEAR WHICH HAVE RESULTED IN A DECREASE IN SIGHT AND/OR HEARING FUNCTION. Trental is a slow release tablet, which means that the active ingredient is released slowly over several hours. Your doctor, however, may prescribe Trental for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. This medicine is only available with a doctor's prescription. BEFORE YOU TAKE IT _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE TRENTAL IF YOU HAVE: • had a recent operation • bleeding problems • heart problems, such as having suffered a heart attack • kidney or liver problems • stomach ulcers or a history of stomach ulcers • had an allergic reaction to caffeine, theobromine or theophylline (a medicine used to treat asthma) DO NOT TAKE TRENTAL IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, w Izlasiet visu dokumentu
1 NEW ZEALAND DATA SHEET 1. TRENTAL 400 MG MODIFIED RELEASE TABLETS Trental 400 mg modified release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pentoxifylline 400 mg. Oxpentifylline and Pentoxifylline are interchangeable and refer to the same molecule. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Modified release tablet. Oblong, pink, film-coated tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Trental is indicated in the treatment of peripheral occlusive vascular disease and circulatory disorders of arteriosclerotic, diabetic, inflammatory or function origin; trophic disorders (e.g., leg ulcers and gangrene). Circulatory disorders in the eye and ear associated with degenerative vascular processes resulting in a decrease of visual and auditory function. 4.2 DOSE AND METHOD OF ADMINISTRATION _DOSE _ The usual dosage of Trental in controlled release tablet form is one tablet (400 mg) three times a day with or after meals, to be swallowed whole with some liquid. While the effect of Trental may be seen within 2-4 weeks, it is recommended that treatment be continued for at least 8 weeks. Efficacy has been demonstrated in double blind clinical studies of 6 months duration. Digestive and central nervous system side effects are dose related. If patients develop these side effects it is recommended that dosage be lowered to one tablet twice a day (800mg/day). If side effects persist at this lower dosage the administration of Trental should be discontinued. In patients with low or labile blood pressure, or with renal or hepatic dysfunction, an individual dosage adjustment is required. This also applies to patients with renal dysfunction (creatinine clearance of less than 30 mL/min) where, according to individual tolerance, a dosage adjustment of 30 to 50% may be necessary. PAEDIATRIC POPULATION Trental is not recommended for children. _METHOD OF ADMINISTRATION _ Oral administration. Tablets should be taken with or immediately after meals, and swallowed whole with some liquid. Izlasiet visu dokumentu