Milorex 5mg+50mg tablets

Страна: Армения

Език: английски

Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активна съставка:

amiloride (amiloride hydrochloride), hydrochlorothiazide

Предлага се от:

Remedica Ltd

АТС код:

C03EA01

INN (Международно Name):

amiloride (amiloride hydrochloride), hydrochlorothiazide

дозиране:

5mg+50mg

Лекарствена форма:

tablets

Броя в опаковка:

(30/3x10/) blisters

Вид предписание :

Prescription

Статус Оторизация:

Registered

Дата Оторизация:

2015-07-03

Листовка

P18/1002 RPILECY1
P18/1002 RPILECY1
PATIENT INFORMATION LEAFLET
Milorex
(AMILORIDE HYDROCHLORIDE + HYDROCHLOROTHIAZIDE)
MILOREX Tablets 5mg Amiloride Hydrochloride + 50mg
Hydrochlorothiazide
PLEASE READ CAREFULLY THIS LEAFLET BEFORE YOU START TAKING THE
MEDICINE.
-
Keep this leaflet in a safe place. You may need to read it
again.
-
If you have any questions ask your doctor or your pharmacist.
-
This medicine was prescribed for you personally and you
should not pass it on to others. It can be harmful, even when
their symptoms are the same as yours.
COMPOSITION:
_Active substances:_ Amiloride Hydrochloride, Hydrochlorothiazide
_Excipients:_ Lactose, Povidone, Maize Starch, Sodium Starch
Glycolate, Microcrystalline Cellulose, Colloidal Silicon Dioxide,
Magnesium Stearate, Talc, Sunset Yellow Lake E110.
MARKETING LICENCE HOLDER & MANUFACTURER:
Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU.
MARKETING LICENCE NUMBER:
Milorex: 10148
1. WHAT IS MILOREX AND WHAT ARE ITS USES
Amiloride
and
hydrochlorothiazide,
the
drastic
substances
of Milorex, belong to the group of medicines that are called
diuretics. They are administered in order to increase the amount
of water excreted by the body. These medicines are used in the
treatment of hypertension (increased arterial pressure).
High arterial pressure burdens the workload of the heart and the
arteries. If not faced timely it may harm the blood vessels of the
brain, of the heart and of the kidneys. As a result, we may have
strokes, cardiac or renal insufficiency.
High arterial pressure may also increase the risk of heart attacks.
When we control arterial pressure there is a smaller probability
of these problems appearing. Diuretics act on the kidneys and
increase the quantity of the excreted water.
The purpose of combining amiloride and hydrochlothiazide is the
boosting of the diuretic action and the protection from potassium
loss caused by diuretics.
INDICATIONS:
Milorex is a potassium-conserving diuretic and antihypertensive
drug indicated for the treatment of

Данни за продукта

MILOREX TABS-SPC-V2-00
Page 1 of 9
Ref: MILOREX TABS-SPC-V2-00
SUMMARY OF PRODUCT CHARACTERISTICS
_1._
_TRADE NAME OF THE MEDICAL PRODUCT _
Milorex Tablets
_2. _
_QUALITATIVE AND QUANTITATIVE COMPOSITION _
Amiloride Hydrochloride BP 5 mg (Anhydrous)
Hydrochlorothiazide BP 50mg
_3. _
_PHARMACEUTICAL FORM _
Tablets
_4. _
_CLINICAL INFORMATION _
_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 _
_Hypertension:_ 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.
_Hepatic cirrhosis with ascites: _ Initiate therapy with a low dose. A
single daily dose of one
'Milorex' tablet may be increased gradually until there is an
effective diuresis. Dosage should
not exceed two 'Milorex' 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
espe