MIDODRINE HYDROCHLORIDE MORNINGSIDE 2.5 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

MIDODRINE HYDROCHLORIDE

متاح من:

TRUSTPHARM LTD, ISRAEL

ATC رمز:

C01CA17

الشكل الصيدلاني:

TABLETS

تركيب:

MIDODRINE HYDROCHLORIDE 2.5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

APEX LABORATORIES PRIVATE LIMITED

المجال العلاجي:

MIDODRINE

الخصائص العلاجية:

Midodrine hydrochloride 2.5 mg tablets are indicated in adults for the treatment of severe orthostatic hypotension due to autonomic dysfunction when corrective factors have been ruled out and other forms of treatment are inadequate

تاريخ الترخيص:

2022-09-11

نشرة المعلومات

1
-
(PREPARATIONS)
REGULATIONS
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS'
1986
This medicine is dispensed with a doctor’s prescription only
MIDODRINE HYDROCHLORIDE MORNINGSIDE 2.5 MG
TABLETS
ACTIVE INGREDIENT
Each tablet contains 2.5 mg midodrine hydrochloride
Inactive ingredients and allergens: See section 6 "Additional
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Midodrine Hydrochloride
Morningside 2.5 mg is indicated in adults for the treatment
of severe
orthostatic hypotension due to autonomic nervous system dysfunction,
when other
corrective methods have been ruled out and other forms of treatment
are inadequate.
THERAPEUTIC GROUP: adrenergic and dopaminergic agents
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF YOU:
•
are sensitive (allergic) to midodrine hydrochloride or to any of the
other
ingredients in this medicine (listed in section 6)
•
have high blood pressure
•
have a slow pulse
•
have difficulty urinating
•
have certain forms of cardiovascular disease
•
have elevated pressure in the eye (glaucoma) or poor vision as a
result of
diabetes
•
have an overactive thyroid gland
•
have hormonal disorders caused by a tumour in the adrenal medulla
(pheochromocytoma)
•
have a severe kidney disease
•
have an enlarged prostate
•
are breastfeeding
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE TREATMENT WITH MIDODRINE HYDROCHLORIDE
MORNINGSIDE 2.5 MG, TELL YOUR
DOCTOR IF:
2
You have been told that you have high blood pressure when you lie
down. If this
applies to you:
•
Regular monitoring of your blood pressure when you are lying down and
when
you are standing up will be required, as there may

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
4
NAME OF THE MEDICINAL PRODUCT
Midodrine Hydrochloride Morningside 2.5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of midodrine hydrochloride.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, round-shaped, flat tablet with M2 debossed on one side and
score line on the
other side.
The score-line is only to facilitate breaking for ease of swallowing
and not to divide
into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Midodrine Hydrochloride Morningside 2.5 mg tablets are indicated in
adults for the
treatment of severe orthostatic hypotension due to autonomic
dysfunction when
corrective factors have been ruled out and other forms of treatment
are inadequate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Initial dose: 2.5 mg three times a day. Depending on the results of
supine and
standing blood pressure recordings, this dose may be increased weekly
up to a dose of
10 mg three times a day. This is the usual maintenance dosage.
A careful evaluation of the response to treatment and of the overall
balance of the
expected benefits and risks needs to be undertaken before any dose
increase and
advice to continue therapy for long periods.
The last daily dose should be taken at least 4 hours before bedtime in
order to prevent
supine hypertension (see also section 4.4).
Midodrine Hydrochloride Morningside 2.5 mg tablets may be taken with
food (see
section 5.2).
_Paediatric population _
The safety and efficacy of midodrine hydrochloride in children have
not been
established. No data are available.
_Elderly population _
There is limited data on dosing in the elderly and there are no
specific studies which
have focused on a possible dose reduction in the elderly population.
Cautious dose
titration is recommended.
_Patients with renal impairment _
There are no specific studies that have focused on a possible dose
reduction in
patients with renal impairment. Typically, midodrine hydrochloride is
contraindi