Amoride 5mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Osta kohe

Laadi alla Infovoldik (PIL)
01-07-2015
Laadi alla Toote omadused (SPC)
19-10-2015

Toimeaine:

Amiloride hydrochloride

Saadav alates:

Dr Reddy's Laboratories (UK) Ltd

ATC kood:

C03DB01

INN (Rahvusvaheline Nimetus):

Amiloride hydrochloride

Annus:

5mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02020300

Infovoldik

                                PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AMORIDE 5 MG
TABLETS
1. WHAT AMORIDE IS FOR
2. BEFORE YOU TAKE AMORIDE
3. HOW TO TAKE AMORIDE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE AMORIDE
6. FURTHER INFORMATION
The name of your medicine is Amoride 5mg Tablets
(called Amoride in this leaflet). Amoride Tablets
contain the active ingredient amiloride hydrochloride
which belongs to a group of medicines known as
diuretics (water tablets).
Amoride can be used to stop the build-up of excess
water in your body. It does this by helping you pass
more
than
you
usually
do,
without
the
loss
of
potassium from the body.
Amoride is mainly used together with other medicines
that
increase
urine
flow
in
order
to
conserve
potassium.
Amoride can be used in the treatment of:

heart problems (congestive heart failure)

high blood pressure (hypertension)

fluid retention caused by liver problems (hepatic
cirrhosis)
If you are not sure why you have been prescribed
Amoride, please ask your doctor.
DO NOT TAKE AMORIDE AND TELL YOUR DOCTOR IF YOU:

are allergic (hypersensitive) to amiloride
hydrochloride, or any of the other ingredients of
this medicine (listed in section 6)

have been told that you have high potassium
levels (hyperkalaemia)

are taking any potassium containing medicines or
supplements

are not passing any water (urine)

have severe kidney problems or kidney failure.
This includes those caused by diabetes

have Addison’s disease (a disease of the adrenal
glands), which can cause weakness, tiredness,
weight loss and low blood pressure
Do not take this medicine if any of the above apply to
you. If you are not sure, talk to your doctor before
taking Amoride.
WARNINGS AND PRECAUTIONS
The presence of other medical problems may affect
the use of this medicine. Talk to your doctor before
taking Amoride, if you:

have kidney problems

have liver problems

have diabetes

are elderly

have too much acid in your blood. This can be
caused by diabetes or heart or lung diseases
If you are not s
                                
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Toote omadused

                                SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
AMORIDE/Amiloride 5 mg Tablets BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
tablet
contains
amiloride
hydrochloride
BP
equivalent
to
5mg
anhydrous
amiloride
hydrochloride.
Excipient with known effect:
Also contains 75.0mg lactose per tablet. For the full list of
excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Flat cream coloured tablets, odourless engraved Amoride on one side
and scored on the other
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
While Amiloride may be used independently, its main indication is for
concurrent therapy with
either thiazide diuretics such as hydrochlorothiazide or loop
diuretics such as furosemide in order
to conserve potassium in those at risk from hypokalaemia during
episodes of vigorous diuresis
and during long-term maintenance therapy.
Amiloride is indicated in the treatment of:
(i)
Congestive heart failure
(ii)
Hypertension, as an adjunctive agent
(iii)
Oedema associated with hepatic cirrhosis (including ascites).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
ADULTS:
The initial dosage should be 10 mg either as a single dose or 5 mg
twice a day. This may be
increased if necessary, but must not exceed 20 mg (4 tablets) per day.
After diuresis has been
achieved, the dosage may be reduced to the least amount required (by 5
mg increments).
_AMILORIDE WITH OTHER DIURETIC THERAPY _
Congestive heart failure:
Amiloride may be started at a dosage of 2.5 mg (½ tablet) a day,
together with the usual dosage
of other diuretic agents. If diuresis is not achieved with minimal
dosage of both agents, the
dosage of both may be gradually increased, but that of Amiloride
should not exceed 10 mg (2
tablets) a day. Once diuresis has been achieved, reduction in dosage
of both agents may be
attempted for maintenance therapy. The dosage of both agents should be
determined by the
diuretic response and the plasma potassium level.
Hypertension
Amiloride is given at a dosage of 2.5 mg to 10 mg (½ to 2 tablets
                                
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