Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
metoprolol succinate, Quantity: 23.75 mg
Pharmacor Pty Ltd
Tablet, modified release
Excipient Ingredients: microcrystalline cellulose; ethylcellulose; triethyl citrate; silicified microcrystalline cellulose; methacrylic acid copolymer; sodium stearylfumarate; macrogol 6000; povidone; purified talc; croscarmellose sodium; silicon dioxide; titanium dioxide; hypromellose; PEG-150 distearate; lauromacrogol 400
Oral
15 tablets, 30 tablets, 90 tablets
(S4) Prescription Only Medicine
Stable, chronic heart failure as an adjunct to other heart failure therapy.
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: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2022-03-04
_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 Przeczytaj cały dokument
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 Przeczytaj cały dokument