Amiloride 5mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Amiloride hydrochloride

Dostopno od:

DE Pharmaceuticals

Koda artikla:

C03DB01

INN (mednarodno ime):

Amiloride hydrochloride

Odmerek:

5mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02020300

Navodilo za uporabo

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=[e-mail],
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=[e-mail],
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

Lastnosti izdelka

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