Moduretic 5mg/50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Amiloride hydrochloride; Hydrochlorothiazide

Available from:

Merck Sharp & Dohme (UK) Ltd

ATC code:

C03EA01

INN (International Name):

Amiloride hydrochloride; Hydrochlorothiazide

Dosage:

5mg ; 50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020400; GTIN: 5013945002195

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MODURETIC® 50 MG/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 symptoms 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 Moduretic is and what it is used for
2.
What you need to know before you take Moduretic
3.
How to take Moduretic
4.
Possible side effects
5
How to store Moduretic
6.
Contents of the pack and other information
1.
WHAT MODURETIC IS AND WHAT IS IT USED FOR
Moduretic 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.
Moduretic 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 MODURETIC
DO NOT TAKE MODURETIC 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 fits or
epilepsy


Summary of Product characteristics

OBJECT 1
MODURETIC
Summary of Product Characteristics Updated 17-Sep-2015 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
MODURETIC
®
50 mg/5 mg tablets
2. Qualitative and quantitative composition
Each tablet contains amiloride hydrochloride equivalent to 5 mg
anhydrous amiloride hydrochloride and
50 mg hydrochlorothiazide.
Excipient(s) with known effect:
Each tablet contains 71.0 mg lactose hydrous.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablets.
Peach-coloured, half-scored, diamond shaped tablets, marked 'MSD 917'.
4. Clinical particulars
4.1 Therapeutic indications
Potassium-conserving diuretic and antihypertensive.
'Moduretic' is indicated in patients with: hypertension, congestive
heart failure, hepatic cirrhosis with
ascites and oedema. In hypertension, 'Moduretic' may be used alone or
in conjunction with other
antihypertensive agents.
'Moduretic' is intended for the treatment of patients in whom
potassium depletion might be suspected or
anticipated. The presence of amiloride hydrochloride minimises the
likelihood of potassium loss during
vigorous diuresis for long-term maintenance therapy. The combination
is thus indicated especially in
conditions where potassium balance is particularly important.
4.2 Posology and method of administration
_Posology_
_Hypertension_
Initially half a 'Moduretic' tablet given once a day. If necessary,
increase to one 'Moduretic' tablet given
once a day or in divided doses.
_Congestive heart failure_
Initially half a 'Moduretic' tablet a day, subsequently adjusted if
required, but not exceeding two
'Moduretic' 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 one
'Moduretic' tablet may be increased gradually
until there