METROL-XL 23.75 metoprolol succinate 23.75 mg modified release tablet blister pack

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

metoprolol succinate, Quantity: 23.75 mg

Beszerezhető a:

Arrotex Pharmaceuticals Pty Ltd

INN (nemzetközi neve):

Metoprolol succinate

Gyógyszerészeti forma:

Tablet, modified release

Összetétel:

Excipient Ingredients: titanium dioxide; glycerol; magnesium stearate; microcrystalline cellulose; stearic acid; ethylcellulose; maize starch; hypromellose; methylcellulose

Az alkalmazás módja:

Oral

db csomag:

15 tablets

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

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

Termék összefoglaló:

Visual Identification: White, oval film coated tablet, 9 x 5 mm, scored on both sides; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2011-10-18

Betegtájékoztató

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METROL-XL
metoprolol succinate
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about METROL-XL.
It does not contain all of 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 METROL-XL
against the
benefits they expect it
will have 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 METROL-XL IS
USED
FOR
METROL-XL is used to treat heart
failure. It helps to increase
survival,
reduce hospitalisation and
improve
symptoms. It is used in
combination
with other medicines to
treat your
condition.
METROL-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.
Your doctor may have prescribed
METROL-XL for another reason.
Ask
your doctor if you have any
questions
about why METROL-XL
has been
prescribed for you.
METROL-XL is not recommended for
use in children, as there have
been no
studies of its effects in
children
METROL-XL is available only with a
doctor's prescription.
There is no evidence that METROL -
XL is addictive.
BEFORE YOU TAKE
METROL-
XL
WHEN YOU MUST NOT TAKE IT
DO NOT TAKE METROL-XL IF:
•
YOU
ARE ALLERGIC TO MEDICINES
CONTAINING METOPROLOL OR 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 difficulty
breathing; swelling of the face, lips,
tongue or other parts of the body;
rash, itching or hives on the skin or
you may feel faint.
•
YOU HAVE OR HAVE HAD ASTHMA
DIFFICULTY IN BREATHING, WHEEZING,
BRONCHITIS OR OTHER LUNG PROBLEMS
IN THE P

Termékjellemzők

1
AUSTRALIAN PRODUCT INFORMATION - METROL – XL (METOPROLOL
SUCCINATE) TABLETS
1
NAME OF THE MEDICINE
Metoprolol succinate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metrol – XL modified release tablets come in four strengths and
contain 23.75 mg, 47.5 mg, 95 mg or
190 mg of metoprolol succinate.
Each Metrol – XL 23.75 modified release tablet contains 23.75mg
metoprolol succinate.
Each Metrol – XL 47.5 modified release tablet contains 47.5mg
metoprolol succinate.
Each Metrol – XL 95 modified release tablet contains 95mg metoprolol
succinate.
Each Metrol – XL 190 modified release tablet contains 190mg
metoprolol succinate.
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Metrol – XL 23.75
White, oval, biconvex tablet, 9 x 5 mm, scored on both sides.
Metrol – XL 47.5
White, oval, biconvex tablet, 11 x 6 mm, scored on both sides, marked
‘A’ on
one side.
Metrol – XL 95
White, oval, biconvex tablet, 16 x 8 mm, scored on both sides, marked
‘B’ on
one side.
Metrol – XL 190
White, oval, biconvex tablet, 19 x 10 mm, scored on both sides, marked
‘C’
on one side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Stable, chronic heart failure as an adjunct to other heart failure
therapy.
2
4.2
D
OSE AND METHOD OF ADMINISTRATION
Metoprolol succinate modified release tablets have 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.
Metoprolol succinate modified release tablets is recommended for once
daily treatment and is
preferably taken together with the morning meal. The tablets may be
broken in half. Metoprolol
succinate modified release tablets should be swallowed with liquid and
should not be chewed or
crushed.
The dose of Metoprolol succinate modified release tablets should be
individually adjusted in patients
with chronic heart failure stabilised on other heart failure
treatment. It is recommended that
patients be t