Amiloride 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiloride hydrochloride

Available from:

Wockhardt 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: 5012727902289

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• Removed MT details to create UK specific artwork
• Changed text font size from 8pt. to 9pt.
• Updated dimensions from 148 x 210mm to
148 x 275mm to accommodate bigger font size text
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Amiloride 5mg Tablets BP
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Amiloride hydrochloride (anhydrous equivalent) 5.0mg
For excipients see 6.1
3
PHARMACEUTICAL FORM
Tablet for oral use.
Amiloride 5mg Tablets BP are yellow, round tablets marked AML5 with
breakline on
one side and CP on the reverse.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amiloride is a diuretic used alone or as an adjunct to other diuretics
in the treatment
of oedema and hypertension.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Adults: _
Initially 10mg daily or 5mg twice daily, adjusted according to
response. The dosage
may be increased up to a maximum of 20mg daily.
Used as an adjunct to other diuretics for hypertension and congestive
heart failure:
Initially 5mg or 10mg daily.
Cirrhosis with ascites: Initially 5mg daily.
_Elderly: _
_ _
The dosage should be adjusted according to renal function, blood
electrolytes and
diuretic response.
_Children under 18 years: _
_ _
Not indicated.
4.3
CONTRAINDICATIONS
Hyperkalaemia, severe renal impairment, prior sensitivity to
amiloride. Other
potassium-sparing drugs and potassium supplements are contraindicated
during
amiloride therapy. The safety of amiloride hydrochloride for use in
children
under 18 years of age has not been established.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_ _
Amiloride should be given with caution to elderly patients, patients
likely to
develop acidosis, patients with diabetes mellitus and those with
impaired
hepatic or renal function. Patients with impaired renal function
should be
monitored carefully for serum electrolytes and blood urea levels, as
should
seriously ill patients, such as those with hepatic cirrhosis with
ascites and
metabolic alkalosis or those with resistant oedema who are also taking
diuretics. Patients taking amiloride either alone or with other
diuretics or
angiotensin-converting enzyme inhibitors may develop hyperkalaemia.
Serum electrolytes and blood urea should be monitored per