Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: Aurogen South Africa (Pty) Ltd, Woodhill Office Park, Building 1, 53 Phillip Engelbrecht Avenue, Meyersdal, Ext. 12, 1448, Johannesburg, South Africa
URODOXA is indicated for the treatment of mild to moderate hypertension.
URODOXA is also indicated for the treatment of the urinary outflow obstruction and symptoms associated with benign prostatic hyperplasia (BPH). URODOXA may be used in BPH patients who are either hypertensive or normotensive.
The initial dosage of URODOXA is 1 mg given once daily. Depending on the individual patient’s urodynamics and BPH symptomatology, dosage may then be increased to 2 mg and thereafter to 4 mg and up to the maximum recommended dose of 8 mg. The recommended titration interval is 1-2 weeks. The usual recommended dose is 2-4 mg once daily. Blood pressure should be evaluated routinely in these patients.
See “SIDE EFFECTS”.
Dialysis is not indicated, since URODOXA is highly protein bound. Treatment is symptomatic and supportive.
URODOXA 1 mg:
1) Tablets are packed in white opaque 250 micron PVC film coated with 60 gsm PVdC and printed 25 micron aluminium foil with 7 gsm heat seal lacquer. Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blister strips of 10 tablets each.
2) Tablets are packed in 40 ml HDPE container of 33 mm neck finish (OFC 51 ml) with 33 mm – 400 RS closure with TEKNIPLEX HS-123 induction sealing wad with rayon coil. The HDPE container is stored in a carton. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
URODOXA 2 mg:
1) Tablets are packed in white opaque 250 micron PVC film coated with 60 gsm PVdC and printed 25 micron aluminium foil with 7 gsm heat seal lacquer. Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blister strips of 10 tablets each.
2) Tablets are packed in 40 ml HDPE container of 33 mm neck finish (OFC 51 ml) with 33 mm – 400 RS closure with TEKNIPLEX HS-123 induction sealing wad with rayon coil. The HDPE container is stored in a carton. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
URODOXA 4 mg:
1) Tablets are packed in white opaque 250 micron PVC film coated with 60 gsm PVdC and printed 25 micron aluminium foil with 7 gsm heat seal lacquer. Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blister strips of 10 tablets each.
2) Tablets are packed in 40 ml HDPE container of 33 mm neck finish (OFC 51 ml) with 33 mm – 400 RS closure with TEKNIPLEX HS-123 induction sealing wad with rayon coil. The HDPE container is stored in a carton. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
URODOXA 8 mg:
1) Tablets are packed in white opaque 250 micron PVC film coated with 60 gsm PVdC and printed 25 micron aluminium foil with 7 gsm heat seal lacquer. Each blister contains 10 tablets.
Pack size: 30’s – Each carton contains 3 blister strips of 10 tablets each.
2) Tablets are packed in 40 ml HDPE container of 33 mm neck finish (OFC 51 ml) with 33 mm – 400 RS closure with TEKNIPLEX HS-123 induction sealing wad with rayon coil. The HDPE container is stored in a carton. Each container contains 30 tablets.
Pack size: 30’s – One HDPE container contains 30 tablets.
Store at or below 25°C. Protect from light. Keep original containers well closed. Do not remove blisters from carton until required for use.
KEEP OUT OF REACH OF CHILDREN.
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