Amiloride 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiloride hydrochloride

Available from:

A A H Pharmaceuticals 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: 5025903002680

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR
THE USER
Amiloride 5 mg Tablets
BP
(Amiloride Hydrochloride)
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 5 mg tablets are and what
are they used for
2. What you need to know before you take
Amiloride 5 mg tablets
3. How to take Amiloride 5 mg tablets
4. Possible side effects
5. How to store Amiloride 5 mg tablets
6. Contents of the pack and other information 1. WHAT AMILORIDE 5 MG TABLETS
ARE AND WHAT ARE THEY USED FOR
Amiloride 5 mg tablets belong to a group of
medicines called diuretics (water tablets).
Amiloride 5 mg 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 5 MG
TABLETS
DO NOT TAKE Amiloride 5 mg 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 kidney FAILURE
• DIABETIC NEUROPATHY (diabetic nerve damage
causing pain, weakness or numbness).
Do not take this medicine if any of the above
apply to you. If you are no

Summary of Product characteristics

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