TOPROL-XL metoprolol succinate 23.75mg controlled release tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

metoprolol succinate, Quantity: 23.75 mg

Beschikbaar vanaf:

AstraZeneca Pty Ltd

farmaceutische vorm:

Tablet, modified release

Samenstelling:

Excipient Ingredients: silicon dioxide; ethylcellulose; hyprolose; microcrystalline cellulose; sodium stearylfumarate; synthetic paraffin; macrogol 6000; hypromellose; titanium dioxide

Toedieningsweg:

Oral

Eenheden in pakket:

15 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

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

Product samenvatting:

Visual Identification: White to off-white, oval, biconvex, film-coated tablet scored on both sides and engraved "A/B" on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Licence status A

Autorisatie datum:

2003-10-28

Bijsluiter

TOPROL-XL™
_23.75, 47.5, 95, 190 TABLETS_
_Metoprolol succinate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions people ask about
TOPROL-XL tablets. It does not
contain all the information that is
known about TOPROL-XL.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking
TOPROL-XL 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 TOPROL-XL IS
USED FOR
TOPROL-XL belongs to a group of
medicines called beta-blockers.
TOPROL-XL tablets are used to treat
heart failure. It is used in
combination with other medicines to
treat your condition.
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.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TOPROL-XL
HAS BEEN PRESCRIBED FOR YOU.
Your doctor will have explained why
you are being treated with TOPROL-
XL and told you what dose to take.
Your doctor may have prescribed this
medicine for another reason.
FOLLOW ALL DIRECTIONS GIVEN TO YOU
BY YOUR DOCTOR CAREFULLY.
They may differ from the
information contained in this leaflet.
TOPROL-XL is not addictive.
BEFORE YOU TAKE
TOPROL-XL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TOPROL-XL TABLETS
IF:
•
YOU HAVE ANY ALLERGIES TO
METOPROLOL SUCCINATE, THE ACTIVE
INGREDIENT IN TOPROL-XL
TABLETS, OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET, OR ANY OTHER BETA-
BLOCKER MEDICINE.
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 yo

Productkenmerken

1 of 17
AUSTRALIAN PRODUCT INFORMATION
TOPROL-XL ™
METOPROLOL SUCCINATE TABLETS
1
NAME OF THE MEDICINE
Metoprolol succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TOPROL-XL tablets contain 23.75mg, 47.5mg, 95mg or 190mg metoprolol
succinate drug
substances and the following inactive ingredients: ethylcellulose,
hyprolose, hypromellose,
microcrystalline cellulose, synthetic paraffin, macrogol 6000, silicon
dioxide, sodium
stearylfumarate and titanium dioxide
3
PHARMACEUTICAL FORM
All TOPROL-XL tablets are white to off white in colour and have the
following appearance:
TOPROL-XL 23.75 tablets (23.75 mg ) are oval with a size of 5.5 mm x
10.5 mm, one side
marked with “A/β” and scored on both sides. The tablet can be
divided into equal doses.
TOPROL-XL 47.5 tablets (47.5 mg) are circular with a diameter of 9 mm,
one side marked with
“A/mO” and scored on the other side. The score line is only to
facilitate breaking for ease of
swallowing and not to divide into equal doses.
TOPROL-XL 95 tablets (95 mg) are circular with a diameter of 10 mm,
one side marked with
“A/mS” and scored on the other side. The score line is only to
facilitate breaking for ease of
swallowing and not to divide into equal doses.
TOPROL-XL 190 tablets (190 mg) are oval with a size of 8.5 mm x 17 mm,
one side marked with
“A/mY” and scored on the same 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
Stable, chronic heart failure as an adjunct to other heart failure
therapy.
4.2
DOSE AND METHOD OF ADMINISTRATION
TOPROL-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.
2 of 17
TOPROL-XL is recommended for once daily treatment and is preferably
taken together with the
morning meal. TOPROL-XL tablets should be swallowed with liquid and
should not be chewed or
crushed.
The dose of TO