OXOPURIN 400

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

PENTOXIFYLLINE

Commercializzato da:

DEXCEL LTD, ISRAEL

Codice ATC:

C04AD03

Forma farmaceutica:

CAPLETS PROLONGED RELEASE

Composizione:

PENTOXIFYLLINE 400 MG

Via di somministrazione:

PER OS

Tipo di ricetta:

Required

Prodotto da:

DEXCEL LTD, ISRAEL

Gruppo terapeutico:

PENTOXIFYLLINE

Area terapeutica:

PENTOXIFYLLINE

Indicazioni terapeutiche:

For the improvement of blood flow in the peripheral blood vessels.

Data dell'autorizzazione:

2020-09-30

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Oxopurin 400
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release caplet contains Pentoxifylline 400mg.
Excipient with known effect:
Each caplet contains approximately 105mg lactose.
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Prolonged release caplet.
Pink, film-coated, caplet, scored on both sides.
The score line is not intended for breaking the caplet.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the improvement of blood flow in the peripheral blood vessels.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
CHRONIC PERIPHERAL ARTERIAL OCCLUSIVE DISEASE AT FONTAINE STAGE IIB
(INTERMITTENT
CLAUDICATION)
Unless otherwise prescribed, 1 Oxopurin 400mg prolonged-release caplet
three times daily
(equivalent to 1,200 mg pentoxifylline per day).
Special dosage instructions may be necessary for patients with low or
fluctuating blood pressure
levels.
In patients with impaired renal function (creatinine clearance less
than 30 ml/min), the dose
should be titrated to 50–70% of the standard dose, depending on
individual tolerability, e.g. by
taking 400 mg pentoxifylline twice daily instead of 400 mg
pentoxifylline three times a day.
In the case of patients with severe hepatic dysfunction, a dose
reduction is required, which should
be decided by the doctor on an individual basis according to the
severity of the illness and
tolerability.
INNER EAR DYSFUNCTION CAUSED BY CIRCULATORY DISORDERS (INCLUDING
HARDNESS OF
HEARING, ‎SUDDEN HEARING LOSS). ‎
Unless otherwise prescribed, 1 Oxopurin 400mg prolonged-release caplet
twice daily or
three ‎times a day (equivalent to 800–1,200 mg pentoxifylline per
day). ‎‎‎
In cases of severe circulatory disturbances, a combination with
parenterally administered
‎Pentoxifylline 100 mg or 300 mg ampoules (IV infusion) can
accelerate the onset of action. ‎
The total daily dose (parenteral + oral) should essentially not exceed
1,200 mg pentoxifylline. ‎
Depending on