Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
sotalol hydrochloride, Quantity: 80 mg
Sandoz Pty Ltd
Sotalol hydrochloride
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; maize starch; sodium starch glycollate; hyprolose; magnesium stearate; colloidal anhydrous silica
Oral
60 tablets
(S4) Prescription Only Medicine
Prevention and treatment of supraventricular and ventricular arrhythmias.
Visual Identification: White, round tablets, scored on one side, convex with "SOT" embossed on the other.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-12-14
CARDOL _contains the active ingredient sotalol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cardol. 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 taking Cardol against the benefits it is expected to 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 CARDOL IS USED FOR The name of your medicine is Cardol. It contains the active ingredient sotalol. Cardol is used for the prevention and treatment of supraventricular and ventricular arrhythmias (irregular heartbeats). ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY CARDOL WAS PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. _HOW CARDOL WORKS_ Cardol belongs to a group of medicines called beta-blockers. It works by changing the body's response to some nerve impulses, especially in the heart. It decreases the heart's need for blood and oxygen and therefore reduces the amount of work the heart has to do. As a result, it helps the heart to beat more regularly. This medicine is not addictive. Cardol is available only with a doctor's prescription. BEFORE YOU TAKE CARDOL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF: • you are allergic to the active ingredient or any of the inactive ingredients mentioned at the end of this leaflet under Product Description Some of the symptoms of an allergic reaction may include skin rash, itching or hives; swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing; wheezing or shortness of breath. • you are pregnant or breastfeeding, or if you intend to breast feed • you have a condition that causes narrowing of the airways, ie bronchial asthma or chronic obstructive airway disease • you have allergic disorders (including hay fever) w Lees het volledige document
AUSTRALIAN PRODUCT INFORMATION CARDOL 80 MG TABLETS _Sotalol hydrochloride tablets _ 1 NAME OF THE MEDICINE Sotalol hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg of sotalol as the active ingredient. Excipients with known effect: lactose monohydrate For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM CARDOL 80mg tablet: White, round tablets, scored on one side, convex with “SOT” embossed 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 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 initiation of therapy, but also with each upward dosage adjustment. Cardol tablets should be taken preferably one to two hours before meals. Oral dosage of sotalol should be adjusted gradually allowing two to three 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 daily, given in two divided doses at approximately twelve 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 two 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 only be prescribed when the potential benefit outweighs the increased risk of adverse event Lees het volledige document