Moduret 25 tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiloride hydrochloride; Hydrochlorothiazide

Available from:

Organon Pharma (UK) Ltd

ATC code:

C03EA01

INN (International Name):

Amiloride hydrochloride; Hydrochlorothiazide

Dosage:

2.5mg ; 25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020400; GTIN: 5013945002188

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MODURET
® 25
25 MG/2.5 MG TABLETS
(HYDROCHLOROTHIAZIDE & 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 or pharmacist.
•
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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Moduret 25 is and what it is used for
2.
What you need to know before you take Moduret 25
3.
How to take Moduret 25
4.
Possible side effects
5
How to store Moduret 25
6.
Contents of the pack and other information
1.
WHAT MODURET 25 IS AND WHAT IS IT USED FOR
Moduret 25 contains amiloride and hydrochlorothiazide. They belong to
the group of
medicines known as water tablets (diuretics). They work by increasing
the amount of urine
that passes from your body. This lowers your blood pressure or removes
excess water from
your body.
Moduret 25 is used for:
•
heart failure
•
high blood pressure
•
fluid retention caused by a liver disease called ‘cirrhosis’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MODURET 25
DO NOT TAKE MODURET 25 TABLETS:
•
if you are allergic to hydrochlorothiazide and amiloride hydrochloride
or any of the other
ingredients of this medicine (listed in section 6)
•
if you have diabetes (a high blood sugar level)
•
if you have been told by your doctor you have high levels of urea,
creatinine, potassium or
calcium in your blood
•
if you are allergic to a type of antibiotic called sulfonamides, such
as sulfamethoxazole
•
if you are allergic to acetazolamide which is a diuretic used to
remove fluid from the body
and to treat high pressure in the eye (glaucoma), heart problems and
sometimes

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
MODURET
®
25 mg/2.5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of ‘Moduret 25’ contains amiloride hydrochloride
equivalent to
2.5 mg anhydrous amiloride hydrochloride and 25 mg
hydrochlorothiazide.
Excipient(s) with known effect:
Each tablet contains 35.5 mg lactose hydrous.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Off-white,
diamond-shaped
tablets,
with
a
break-line
and
marked
with
identification number ‘923’
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Potassium-conserving
diuretic
and
anti-hypertensive
for
the
treatment
of
patients with congestive heart failure, hypertension, or hepatic
cirrhosis with
ascites and oedema, in whom potassium depletion might be anticipated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
HYPERTENSION:
Initially one ‘Moduret 25’ tablet given once a day. If necessary
increase to two
‘Moduret 25’ tablets given once a day or in divided doses.
CONGESTIVE HEART FAILURE:
Initially one tablet of ‘Moduret 25’ a day, subsequently adjusted
if required,
but not exceeding four ‘Moduret 25’ tablets a day. Optimal dosage
is
determined by the diuretic response and the plasma potassium level.
Once an
initial diuresis has been achieved, reduction in dosage may be
attempted for
maintenance therapy. Maintenance therapy may be on an intermittent
basis.
PATIENTS WITH HEPATIC CIRRHOSIS WITH ASCITES:
Initiate therapy with a low dose. A single daily dose of two
‘Moduret 25’
tablets may be increased gradually until there is an effective
diuresis. Dosage
should not exceed four ‘Moduret 25’ tablets a day. Maintenance
dosages may
be lower than those required to initiate diuresis; dosage reduction
should
therefore be attempted when the patient’s weight is stabilised. A
gradual
weight reduction is especially desirable in cirrhotic patients to
reduce the
likelihood of untoward reactions associated with diuretic therapy.
PAEDIATRIC POPULATION:
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