Amiloride 5mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Amiloride hydrochloride

Fáanlegur frá:

Actavis UK Ltd

ATC númer:

C03DB01

INN (Alþjóðlegt nafn):

Amiloride hydrochloride

Skammtar:

5mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 02020300; GTIN: 5012617009685

Upplýsingar fylgiseðill

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
Amiloride Tablets
5mg x 28’s (Teva UK)
148x210 (Reel Fed)
50943103
Leaflet for Blisters
2543
R.Wrey
15/11/17
AMILORIDE 5MG TABLETS
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor, pharmacist or nurse.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them even if their signs of
illness are the same as yours.
• If you get any side effects, talk to
your doctor, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1 WHAT AMILORIDE TABLETS ARE AND
WHAT THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE AMILORIDE TABLETS
3 HOW TO TAKE AMILORIDE TABLETS
4 POSSIBLE SIDE EFFECTS
5 HOW TO STORE AMILORIDE TABLETS
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
1 WHAT AMILORIDE TABLETS ARE AND WHAT THEY
ARE USED FOR
Amiloride tablets belong to a group of medicines called
diuretics (water tablets). Amiloride tablets can be used
on their own (monotherapy) or with other drugs such as
thiazide diuretics.
They may be used for:
• high blood pressure
• congestive heart failure
• liver cirrhosis with swelling of the abdomen (ascites).
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
AMILORIDE TABLETS
DO NOT TAKE Amiloride tablets:
• if you are ALLERGIC to amiloride hydrochloride or any of
the other ingredients of this medicine (listed in section
6).
• if you are giving the tablets to a CHILD
• if you are taking any POTASSIUM CONSERVING DRUGS OR
POTASSIUM SUPPLEMENTS
• if you are NOT PRODUCING any urine
• if you are PREGNANT or BREASTFEEDING.
or if YOU HAVE:
• HIGH BLOOD LEVELS of POTASSIUM (hyperkalaemia)
• SEVERE KIDNEY DISEASE or ki

Vara einkenni

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