Amiloride 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiloride hydrochloride

Available from:

Teva UK Ltd

ATC code:

C03DB01

INN (International Name):

Amiloride hydrochloride

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020300; GTIN: 5017007070863

Patient Information leaflet

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
_Continued over page_
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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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amiloride Tablets BP 5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Amiloride Hydrochloride BP equivalent to 5mg
anhydrous amiloride hydrochloride.
Excipients with known effect
Each tablet contains 100.00mg lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Yellow uncoated tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Potassium-conserving agent; diuretic. Although amiloride may be used
alone, its
principal indication is as concurrent therapy with thiazides or more
potent diuretics to
conserve
potassium
during
periods
of
vigorous
diuresis
and
during
long-term
maintenance therapy. It is indicated for use in:
1) Congestive heart failure.
2) Hypertension.
3) Hepatic cirrhosis with ascites.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Monotherapy: _Initially 10mg which may be given as a single or
divided dose.
This may be increased if necessary to a maximum of 20mg daily. When
diuresis has been achieved, the dosage may be reduced by 5mg
increments to
the least amount required.
_ _
_In conjunction 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.
_ _
_Congestive heart failure: _Initially 5-10mg daily, together with the
usual
dosage of the diuretic concurrently employed. Where diuresis is not
achieved
dosage of both agents may be increased if necessary, however, the
maximum
dose for amiloride is 20mg a day. Once diuresis is achieved, reduction
in
dosage of both agents may be attempted for maintenance therapy. The
dosage
of both drugs is determined by diuresis and the level of plasma
potassium.
_ _
_Hypertension: _5-10mg daily, together with the usual antihypertensive
dosage
of the thiazide concurrently employed. It is not usually necessary to
exceed
10mg of amiloride daily; in any event, not more than 20mg a day should
be
given.
_ _
_Hepatic cirrhosis with ascites: _When us