Myloc CR

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Metoprolol succinate 23.75mg equivalent to 9.71 mg free drug base;  ;  

متاح من:

Viatris Limited

INN (الاسم الدولي):

Metoprolol succinate 23.75 mg (equivalent to 9.71 mg free drug base)

جرعة:

23.75 mg

الشكل الصيدلاني:

Modified release tablet

تركيب:

Active: Metoprolol succinate 23.75mg equivalent to 9.71 mg free drug base     Excipient: Colloidal silicon dioxide Hypromellose Macrogol 6000   Magnesium stearate Microcrystalline cellulose Polyacrylate dispersion 30% Povidone Purified talc   Sugar spheres Titanium dioxide

الوحدات في الحزمة:

Blister pack, Alu/Alu blister, 30 tablets

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Benechim S.P.R.L

الخصائص العلاجية:

Hypertension. To reduce blood pressure and to reduce the risk of cardiovascular and coronary mortality (including sudden death), and morbidity. Paediatric hypertension

ملخص المنتج:

Package - Contents - Shelf Life: Blister pack, Alu/Alu blister - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu blister - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Alu/Alu blister - 100 tablets - 24 months from date of manufacture stored at or below 25°C

تاريخ الترخيص:

2009-05-22

نشرة المعلومات

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
MYLOC CR
_METOPROLOL SUCCINATE CONTROLLED-RELEASE TABLETS_
_23.75 MG, 47.5 MG, 95 MG AND 190 MG _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Myloc CR.
This leaflet answers some common
questions about Myloc CR.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Myloc CR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT MYLOC CR IS
USED FOR
Myloc CR is used to treat:

high blood pressure

angina (a feeling of tightness,
pressure or heaviness in the
chest, usually bought on by
stress or exercise)

heart failure

abnormal or irregular heart rate

overactive thyroid gland.
Myloc
CR
is
also
used
to
help
prevent migraines.
Myloc CR contains the active
ingredient metoprolol succinate. It
belongs to a group of medicines
called beta-blockers.
It works by affecting the body's
response to some nerve impulses,
especially in the heart. As a result, it
decreases the heart's need for
blood and oxygen and therefore
reduces the amount of work the
heart has to do. It also widens the
blood vessels in the body, causing
blood pressure to fall, and helps the
heart to beat more regularly.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
MYLOC CR
_WHEN YOU MUST NOT TAKE _
_IT:_
DO NOT TAKE MYLOC CR IF YOU HAVE
AN ALLERGY TO:

any medicine containing
metoprolol or to other beta-
blockers

any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
di

خصائص المنتج

Page 1 of 11
NEW ZEALAND DATA SHEET
MYLOC CR
1. PRODUCT NAME
Myloc CR, 23.75 mg, 47.5 mg, 95 mg and 190 mg, modified-release
tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each modified-release tablet contains 23.75 mg, 47.5 mg, 95 mg or 190
mg of metoprolol succinate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Modified-release tablets of metoprolol succinate will be referred to
as controlled release tablets in
the following text.
Myloc CR tablets are a controlled delivery, prolonged release tablet
formulation, containing
membrane coated drug pellets embedded in a rapidly-disintegrating
tablet.
Myloc CR 23.75 mg tablets: white to off-white, oblong, biconvex,
film-coated tablets with break
scores on both sides. The tablet can be divided into equal doses. Each
tablet contains 23.75 mg of
the active substance metoprolol succinate (corresponding to 9.71 mg of
free drug base).
Myloc CR 47.5 mg tablets: white to off-white, oblong, biconvex,
film-coated tablets with break scores
on both sides. The tablet can be divided into equal doses. Each tablet
contains 47.5 mg of the active
substance metoprolol succinate (corresponding to 19.42 mg of free drug
base).
Myloc CR 95 mg tablets: white to off-white, oblong, biconvex,
film-coated tablets with break scores
on both sides. The tablet can be divided into equal doses. Each tablet
contains 95 mg of the active
substance metoprolol succinate (corresponding to 38.84 mg of free drug
base).
Myloc CR 190 mg tablets: white to off-white, oblong, biconvex,
film-coated tablets with break scores
on both sides. The tablet can be divided into equal doses. Each tablet
contains 190 mg of the active
substance metoprolol succinate (corresponding to 77.69 mg of free drug
base).
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_

Hypertension. To reduce blood pressure and to reduce the risk of
cardiovascular and
coronary mortality (including sudden death), and morbidity

Angina pectoris

Symptomatic mild to severe chronic heart failure as an adju