Miron 5mg Tablets

Land: Malaysia

Sprache: Englisch

Quelle: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Wirkstoff:

MIDODRINE HYDROCHLORIDE

Verfügbar ab:

NOVUGEN PHARMA SDN. BHD.

INN (Internationale Bezeichnung):

MIDODRINE HYDROCHLORIDE

Einheiten im Paket:

100 Tablets

Hergestellt von:

NOVUGEN PHARMA SDN. BHD.

Gebrauchsinformation

_Consumer Medication Information Leaflet (RiMUP) _
MIRON TABLETS
Midodrine Hydrochloride
_ _
2.5mg, 5mg, 10mg
1
WHAT IS IN THIS LEAFLET
1.
What Miron is used for
2.
How Miron works
3.
Before you use Miron
4.
How to use Miron
5.
While you are using Miron
6.
Side effects
7.
Storage and Disposal of Miron
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT MIRON IS USED FOR
Miron is a medicine is used to treat
severe forms of low blood pressure in
adults when other treatments have not
worked.
HOW MIRON WORKS
Miron
containing
Midodrine
HCl
which
is
belongs
to
a
group
of
medicines called adrenergic agents.
It
works
by
raising
your
blood
pressure.
BEFORE YOU USE MIRON
−
_When you must not use it _
Do not take this medicine:
•
if you have high blood pressure
•
if you have kidney disease
•
if you have difficulty passing urine
•
if
you
have
hormonal
disorders
caused
by
a
rare
tumour
in
the
adrenal gland, which sits near the
kidney (phaeochromocytoma)
•
if you have an overactive thyroid
gland (thyrotoxicosis)
If any of the above applies to you, tell
your
doctor
or
pharmacist
before
taking Miron.
-
_Before you start to use it _
Talk
to
your
doctor
before
taking
Miron if you have or have been told
you
have
high
blood
pressure
when
you lie down.
If this applies to you then:
Regular
monitoring
of
your
blood
pressure will be required when you are
lying down and standing up as there
may be a risk of your blood pressure
rising when you lie down, for example,
at night. If your blood pressure rises
when you lie down and reducing the
dose
does
not
correct
this
problem,
then treatment with this medicine must
be stopped.
Tell your doctor if you have or have
had
any
of
the
following
medical
conditions:
•
elevated
pressure
in
the
eye
(glaucoma) or poor vision because
of
damage
to
the
eye
caused
by
diabetes
•
slow pulse
Your doctor will perform some tests
such as checking your kidney function
and
blood
pressure
before
you
start
using this medicine.
TELL YOUR DO

Fachinformation

1. NAME OF THE MEDICINAL PRODUCT
Miron 2.5mg Tablets
Miron 5mg Tablets
Miron 10mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
MIRON 2.5MG Tablets: Each tablets contains 2.5mg of Midodrine
Hydrochloride
MIRON 5MG Tablets: Each tablets contains 5mg of Midodrine
Hydrochloride
MIRON 10MG Tablets: Each tablets contains 10mg of Midodrine
Hydrochloride
For the full list of excipients, see section List of excipients.
3. PHARMACEUTICAL FORM
Tablets.
MIRON 2.5MG TABLETS: White to off-white, round, scored tablets
debossed with 2.5
above the score on one side of the tablet and N on the other side
MIRON 5MG TABLETS: White to off-white, round, scored tablets debossed
with 5
above the score on one side of the tablet and N on the other side
MIRON 10MG TABLETS: White to off-white, round, scored tablets debossed
with 10
above the score on one side of the tablet and N on the other side
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Midodrine hydrochloride tablets are indicated for the treatment of
symptomatic
orthostatic hypotension (OH). Because midodrine hydrochloride tablets
can cause
marked elevation of supine blood pressure (BP > 200 mmHg systolic), it
should be
used in patients whose lives are considerably impaired despite
standard clinical
care, including non-pharmacologic treatment (such as support
stockings), fluid
expansion,
and
lifestyle
alterations.
The
indication
is
based
on
midodrine
hydrochloride tablets’ effect on increases in 1-minute standing
systolic blood
pressure, a surrogate marker considered likely to correspond to a
clinical benefit. At
present, however, clinical benefits of midodrine hydrochloride
tablets, principally
improved ability to perform life activities, have not been
established. Further clinical
trials are underway to verify and describe the clinical benefits of
midodrine
hydrochloride tablets.
After initiation of treatment, midodrine hydrochloride tablets should
be continued
only for patients who report significant symptomatic improvement.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION