Milorex 5 mg/50 mg tablets

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

AMILORIDE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE

Mevcut itibaren:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

ATC kodu:

C03EA01

INN (International Adı):

AMILORIDE HYDROCHLORIDE 5 mg HYDROCHLOROTHIAZIDE 50 mg

Farmasötik formu:

TABLET

Kompozisyon:

AMILORIDE HYDROCHLORIDE 5 mg HYDROCHLOROTHIAZIDE 50 mg

Reçete türü:

POM

Terapötik alanı:

DIURETICS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2006-11-08

Bilgilendirme broşürü

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MILOREX 5 MG/50 MG TABLETS
Amiloride hydrochloride/Hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THE
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 Milorex is and what it is used for
2.
What you need to know before you take Milorex
3.
How to take Milorex
4.
Possible side effects
5.
How to store Milorex
6.
Contents of the pack and other information
1.
WHAT MILOREX IS AND WHAT IT IS USED FOR
Milorex
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.
Milorex 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 MILOREX
DO NOT TAKE MILOREX
-
if you are allergic to amiloride hydrochloride and hydrochlorothiazide
or any of the
other ingredients of this medicine (listed in section 6).
-
if you have diabetes (a high blood sugar level).
mt-pl-milorex-tabs-a5
page 2 of 6
-
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 sometim

Ürün özellikleri

mt-spc-milorex-tabs-v05-r00-a0
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Milorex 5 mg/50 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains amiloride hydrochloride equivalent to 5 mg
anhydrous amiloride
hydrochloride and 50 mg hydrochlorothiazide.
Excipients with known effect
Each tablet contains 104.1 mg lactose and 0.3 mg Sunset Yellow E110
FCF.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Peach, diamond-shaped tablets, embossed with Remedica’s logo on one
side and scored
and embossed with 5/50 and MLX on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Potassium-conserving diuretic and antihypertensive.
Milorex is indicated in patients with: hypertension, congestive heart
failure, hepatic
cirrhosis with ascites and oedema. In hypertension, Milorex may be
used alone or in
conjunction with other antihypertensive agents.
Milorex 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 _
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Initially half a Milorex tablet given once a day. If necessary,
increase to one Milorex
tablet given once a day or in divided doses.
_Congestive heart failure _
Initially half a Milorex tablet a day, subsequently adjusted if
required, but not exceeding
two Milorex 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 _