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

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

metoprolol succinate, Quantity: 23.75 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, modified release

Composition:

Excipient Ingredients: purified talc; macrogol 6000; microcrystalline cellulose; povidone; silicon dioxide; triethyl citrate; sodium stearylfumarate; croscarmellose sodium; silicified microcrystalline cellulose; methacrylic acid copolymer; ethylcellulose; titanium dioxide; hypromellose; PEG-150 distearate; lauromacrogol 400

Administration route:

Oral

Units in package:

15 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: White to off white, oval shape, biconvex FCT with breakline on one side and debossed with A and 3 on each side of breakline on other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-03-04

Patient Information leaflet

_TOBETA-XL_
_ _
_ 1 _
TOBETA-XL
METOPROLOL SUCCINATE
_ _
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or
pharmacist
.
1.
WHY AM I USING TOBETA-XL?
TOBETA-XL contains the active ingredient metoprolol succinate. It
belongs to a group of medicines called
beta-blockers, which used to treat heart failure.
For more information, see Section 1. Why am I using TOBETA-XL? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TOBETA-XL?
Do not use if you have ever had an allergic reaction to TOBETA-XL or
any of the ingredients listed at the end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT
OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING
.
For more information, see Section 2. What should I know before I use
TOBETA-XL?
in the full CMI
.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TOBETA-XL and affect how it works.
A list of these medicines is in section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE TOBETA-XL?
TAKE TOBETA-XL EXACTLY AS YOUR DOCTOR HAS PRESCRIBED.
Your doctor will tell you how much TOBETA-
XL tablets to take each day.
More instructions can be found in Section 4. How do I use TOBETA-XL?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TOBETA-XL?
THINGS YOU SHOULD
DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
TOBETA-XL
•
If
you
are
about to
be started
on
any
new
medicine, remind
your
doctor
and
pharmacist that you are taking TOBETA-XL
•
Stop
taking
TOBETA-XL
and
contact
your
doctor
immediately
if
you
become
pregnant while you are taking TOBETA-XL
THINGS YOU SHOULD
NOT DO
•
Do not give this medicine to anyone else, even if their condition
seems similar to
yours.
•
Do not use it to treat any other complaints unless your doctor tells
you to
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know

Summary of Product characteristics

TOBETA-XL
1
AUSTRALIAN PRODUCT INFORMATION
TOBETA-XL (METOPROLOL SUCCINATE) MODIFIED RELEASE TABLETS
1 NAME OF THE MEDICINE
Metoprolol succinate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TOBETA-XL 23.75 mg: Each modified release tablet contains 23.75 mg
metoprolol succinate.
TOBETA-XL 47.5 mg: Each modified release tablet contains 47.5 mg
metoprolol succinate.
TOBETA-XL 95 mg: Each modified release tablet contains 95 mg
metoprolol succinate.
TOBETA-XL 190 mg: Each modified release tablet contains 190 mg
metoprolol succinate.
Excipient with known effect: None
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
TOBETA-XL
23.75 MG:
White to off white, oval shape, biconvex film coated tablet with
breakline on one side and debossed with ‘A’ and ‘3’ on each
side of breakline on other side.
TOBETA-XL
47.5 MG:
White to off white, round shape, biconvex film coated tablet with
breakline on one side and debossed with ‘A50’ on other side.
TOBETA-XL
95 MG:
White to off white, round shape, biconvex film coated tablet with
breakline on one side and debossed with ‘A100’ on other side.
TOBETA-XL
190 MG:
White to off white, oval shape, biconvex film coated tablet with
breakline on one side and debossed with ‘A200’ on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Stable, chronic heart failure as an adjunct to other heart failure
therapy.
TOBETA-XL
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
TOBETA-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.
TOBETA-XL is recommended for once daily treatment and is preferably
taken together with the
morning meal. TOBETA-XL tablets should be swallowed with liquid and
should not be chewed
or crushed.
The dose of TOBETA-XL should be individually adjusted in patients with
chronic heart failure
stabilised on other heart failure treatment.
It is recommended that patients be titrated