Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
sotalol hydrochloride, Quantity: 80 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet, uncoated
Excipient Ingredients: colloidal anhydrous silica; methylcellulose; dextrates; magnesium stearate; indigo carmine aluminium lake
Oral
60 tablets
(S4) Prescription Only Medicine
Prevention and treatment of supraventricular and ventricular arrhythmias.
Visual Identification: Blue, capsule-shaped, biconvex tablet, engraved APO-80 on one side, other side scored.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2002-10-24
APO-SOTALOL _Sotalol hydrochloride_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about sotalol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine 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 want to read it again. WHAT THIS MEDICINE IS USED FOR Sotalol is used to prevent and treat an irregular heart rhythm or heartbeat, also known as an 'arrhythmia'. Sotalol belongs to a group of medicines called beta-blockers. _HOW IT WORKS_ Sotalol works by changing the body's response to some nervous impulses, especially in the heart. By doing so, sotalol helps the heart to beat more regularly and reduce the effort to which the heart has to pump blood. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine in children. BEFORE YOU TAKE THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • sotalol • 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, throat or other parts of the body • rash, itching or hives on the skin. DO NOT TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • bronchospasm (e.g. bronchial asthma or chronic obstructive airway disease) • allergic disorders, such as allergic rhinitis • severe Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION APO-SOTALOL (SOTALOL HYDROCHLORIDE) TABLETS 1 NAME OF THE MEDICINE Sotalol hydrochloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sotalol hydrochloride as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM 80MG TABLETS Blue capsule shaped, biconvex tablets, engraved APO-80 on one side and scored on the other. 160MG TABLETS Blue, capsule-shaped, biconvex tablets, engraved APO-160 on one side and scored on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention and treatment of supraventricular and ventricular arrhythmias. 4.2 DOSE AND METHOD OF ADMINISTRATION APO-Sotalol tablets are intended for oral administration. DOSAGE Sotalol is administered orally for the prevention and treatment of arrhythmias. As with other antiarrhythmic agents, sotalol should be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm. The dosage must be individualised for each patient on the basis of therapeutic response and tolerance. Proarrhythmic events can occur not only at commencement of therapy, but also with each upward dosage adjustment. Sotalol should be taken preferably 1 to 2 hours before meals. Oral dosage of sotalol should be adjusted gradually allowing 2 to 3 days between dosing increments in order to attain steady-state and to allow monitoring of QT intervals. Graded dose adjustment will help prevent the use of doses which are higher than necessary to control the arrhythmia. The recommended initial oral dosing schedule is 160 mg/day, given in two divided doses at approximately 12 hour intervals. This dose may be increased, if necessary, after appropriate evaluation to 240 or 320 mg/day. In most patients, a therapeutic response is obtained at a total daily dose of 160 to 320 mg/day, given in 2 divided doses. Some patients with life- threatening refractory ventricular arrhythmias may require doses as high as 480 to 640 mg/day; however, these doses should Прочетете целия документ