MINAX XL metoprolol succinate 23.75 mg modified release tablet blister pack

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

metoprolol succinate, Quantity: 23.75 mg

Disponibil de la:

Alphapharm Pty Ltd

INN (nume internaţional):

Metoprolol succinate

Forma farmaceutică:

Tablet, modified release

Compoziție:

Excipient Ingredients: hypromellose; microcrystalline cellulose; macrogol 400; ethylcellulose; sodium stearylfumarate; macrogol 6000; colloidal anhydrous silica; titanium dioxide; lactose monohydrate; triacetin

Calea de administrare:

Oral

Unități în pachet:

15 tablets, 30 tablets

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Stable, chronic heart failure as an adjunct to other heart failure therapy.

Rezumat produs:

Visual Identification: White to off white, round shaped, biconvex film coated tablets debossed with 'M' on one side of break line on one side of the tablet and 'MT1' on other side of the tablet.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2014-04-09

Prospect

MINAX XL
_metoprolol succinate modified release tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about MINAX XL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking MINAX XL
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT MINAX XL IS
USED FOR
MINAX XL 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 helps the heart to beat more
regularly.
MINAX XL is used to treat heart
failure - increase survival, reduce
hospitalisation and improve
symptoms. It is used in combination
with other medicines to treat your
condition.
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.
BEFORE YOU TAKE
MINAX XL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE MINAX XL IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
metoprolol succinate
•
any of the ingredients listed at the
end of this leaflet
•
any other beta-blockers.
Some of the symptoms of an allergic
reaction may include
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
HAVE OR HAVE HAD ASTHMA
(DIFFICULTY IN BREATHING, WHEEZING
AND COUGHING), BRONCHITIS OR OTHER
LUNG PROBLEMS IN THE PAST.
DO NOT TAKE MINAX XL IF YOU
HAVE THE FOLLOWING CONDITIONS:
•
a history of allergic problems,
including hayfever
•
a very slow heart beat (less than
45-50 beats/minu

Caracteristicilor produsului

AUSTRALIAN PRODUCT INFORMATION
MINAX XL
_Metoprolol succinate modified release tablet _
1
NAME OF THE MEDICINE
Metoprolol succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each MINAX XL modified release tablet contains, 23.75 mg, 47.5 mg, 95
mg, 190 mg metoprolol succinate as
the active ingredient.
Excipient with known effects: Lactose
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
MINAX
XL
23.75
TABLETS
(23.75 mg)
:
White to off-white, round shaped, biconvex film coated tablets
debossed with
“M” on one side of break line on one side of the tablet and
“MT1” on other side
of the tablet.
MINAX
XL
47.5
TABLETS
(47.5 mg)
:
White to off-white, oval shaped, biconvex film coated tablet debossed
with “M”
on one side of break line on one side of the tablet and “MT2” on
other side of
the tablet.
MINAX
XL
95
TABLETS
(95 mg)
:
White to off-white, oval shaped, biconvex film coated tablet debossed
with “M”
on one side of break line on one side of the tablet and “MT3” on
other side of
the tablet.
MINAX
XL
190
TABLETS
(190 mg)
:
White to off-white, oval shaped, biconvex film coated tablet debossed
with “M”
on one side of break line on one side of the tablet and “MT4” on
other side of
the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Stable, chronic heart failure as an adjunct to other heart failure
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
MINAX XL has not been established to be clinically equivalent to
immediate release forms of metoprolol, and
should not be used for treatment of conditions other than stable,
chronic heart failure.
MINAX XL is recommended for once daily treatment and is preferably
taken together with the morning meal.
The tablets may be broken in half. MINAX XL tablets should be
swallowed with liquid and should not be
chewed or crushed.
The dose of MINAX XL should be individually adjusted in patients with
chronic heart failure stabilised on
other heart failure treatment.
It is recommended that patients be titrated