Amiloride 5mg tablets

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Amiloride hydrochloride

MAH:

Mawdsley-Brooks & Company Ltd

ATC_code:

C03DB01

INN:

Amiloride hydrochloride

dosage:

5mg

pharmaceutical_form:

Oral tablet

administration_route:

Oral

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 02020300

PIL

CHANGE CONTROL : Version changes due to change in:
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Changes in detail:
• Regulatory text amends
PATIENT INFORMATION LEAFLET
AMILORIDE 5MG TABLETS
AMILORIDE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
your pharmacist.
• This medicine has been prescribed only for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of these side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
IN THIS LEAFLET:
1.
What Amiloride Tablets are and what they are used for
2.
Before you take Amiloride Tablets
3.
How to take Amiloride Tablets
4.
Possible side effects
5.
How to store Amiloride Tablets
6.
Further information
1.
WHAT AMILORIDE TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Amiloride 5mg Tablets. It
contains amiloride hydrochloride. This belongs to a group of
medicines called diuretics (water tablets).
Amiloride can be used to stop the build up of extra water in
your body. It does this without loss of potassium from your
body. This extra water can lead to high blood pressure,
heart problems (congestive heart failure) and liver problems
(hepatic cirrhosis).
It works by helping you to pass more water (urine) than you
usually do.
2.
BEFORE YOU TAKE AMILORIDE TABLETS
DO NOT TAKE AMILORIDE TABLETS AND TELL YOUR DOCTOR IF:
• You are allergic (hypersensitive) to amiloride or any other
ingredients in this medicine (listed in Section 6 below).
Signs of an allergic reaction include: a rash, itching or
shortness of breath
• You have kidney problems
• Your doctor has told you that you have high potassium
levels or you are taking other potassium conserving drugs
or potassium supplements
• The person taking the medicine is a child under 18 years old.
Do not take this medicine if any of

SPC

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