Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amiloride hydrochloride
DE Pharmaceuticals
C03DB01
Amiloride hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020300
8 CUSTOMER PRODUCT NAME ITEM CODE OUR REF DATE PREVIOUS VERSION PHARMACODE NO MATERIAL FLAT SIZE FOLD SIZE VIEW PANEL FOLD DETAIL PACKING DETAILS COLOURS FRONT COLOURS BACK CUSTOMER PRODUCT NAME ITEM CODE OUR REF PROOF NO DATE PREVIOUS VERSION PHARMACODE NO MATERIAL FLAT SIZE FOLD SIZE VIEW PANEL FOLD DETAIL PACKING DETAILS COLOURS FRONT COLOURS BACK Recipharm Ltd AMILORIDE 5MG TABS 11001341 SO45489 One 18/09/2015 n/a Supplied 50gsm Opaque 210 x 148 148 x 26 TITLE TO VIEW PARALLEL Shrinkwrapped in trays BLACK BLACK Sarah Jones Digitally signed by Sarah Jones DN: cn=Sarah Jones, o=Wockhardt, ou, email=sarah.jones@wockhar dt.co.uk, c=US Date: 2015.09.16 09:06:59 +01'00' Vickie Bailey Digitally signed by Vickie Bailey DN: cn=Vickie Bailey, o=Recipharm Ltd, ou=Operational Improvement Technical Support, email=Vickie.bailey@recipharm.com, c=GB Date: 2015.09.16 09:52:26 +01'00' Sarah Jones Digitally signed by Sarah Jones DN: cn=Sarah Jones, o=Wockhardt, ou, email=sarah.jones@wockhar dt.co.uk, c=US Date: 2015.09.16 09:06:59 +01'00' Vickie Bailey Digitally signed by Vickie Bailey DN: cn=Vickie Bailey, o=Recipharm Ltd, ou=Operational Improvement Technical Support, email=Vickie.bailey@recipharm.com, c=GB Date: 2015.09.16 09:52:26 +01'00' SO45489_11001341_P1.indd 1 18/09/2015 10:30 Sarah Jones Digitally signed by Sarah Jones DN: cn=Sarah Jones, o=Wockhardt, ou, email=sarah.jones@wockhardt. co.uk, c=US Date: 2015.09.16 09:07:14 +01'00' Sarah Jones Digitally signed by Sarah Jones DN: cn=Sarah Jones, o=Wockhardt, ou, email=sarah.jones@wockhardt. co.uk, c=US Date: 2015.09.16 09:07:14 +01'00' Sarah Jones Digitally signed by Sarah Jones DN: cn=Sarah Jones, o=Wockhardt, ou, email=sarah.jones@wockhardt. co.uk, c=US Date: 2015.09.16 09:07:14 +01'00' SO45489_11001341_P1.indd 2 18/09/2015 10:30 Soma hati kamili
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amiloride 5 mg Tablets BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5.7mg Amiloride Hydrochloride Dihydrate equivalent to 5.0mg anhydrous Amiloride Hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Off white to creamy white, round, flat, uncoated tablets with beveled edges and debossed with "C" and "G" on either side of breakline and another side is plain. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Potassium- conserving agent;diuretic. Although Amiloride Hydrochloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics in order to conserve potassium during periods of vigorous diuresis and during long-term maintenance therapy. In congestive heart failure, Amiloride Hydrochloride may be effective alone, but its principal indication is for concomitant use in patients receiving thiazides or more potent diuretic agents. In hypertension, it is used as an adjunct to prolonged therapy with thiazides and similar agents to prevent potassium depletion. In hepatic cirrhosis with ascites, Amiloride Hydrochloride usually provides adequate diuresis, with diminished potassium loss and less risk of metabolic alkalosis, when used alone. It may be used with more potent diuretics when a greater diuresis is required while maintaining a more balanced serum electrolyte pattern. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Amiloride Hydrochloride alone.The initial dosage is 10 mg (as a single dose or 5mg twice a day). The total daily dose should not exceed 20mg (4 tablets) per day. After diuresis has been achieved, the dosage may be reduced by 5mg increments to the least amount required. Amiloride Hydrochloride with other diuretic therapy When Amiloride is used with a diuretic which is given on an intermittent basis, it should be given at the same time as the diuretic. HYPERTENSION Usually half ‘Amiloride’ tablet (2.5mg) given once Soma hati kamili