Amiloride 5mg Tablets BP

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

AMILORIDE HYDROCHLORIDE

Disponível em:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

Código ATC:

C03DB01

DCI (Denominação Comum Internacional):

AMILORIDE HYDROCHLORIDE 5 mg

Forma farmacêutica:

TABLET

Composição:

AMILORIDE HYDROCHLORIDE 5 mg

Tipo de prescrição:

POM

Área terapêutica:

DIURETICS

Status de autorização:

Withdrawn

Data de autorização:

2006-08-18

Folheto informativo - Bula

1
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 the above apply to you. If you are
not sure, talk to your doctor
before taking Amiloride Tablets.
TAKE SPECIAL CARE WITH AMILORIDE TABLET

Características técnicas

Page 1 of 6
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.
Page 2 of 6
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