Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
sulthiame, Quantity: 50 mg
Phebra Pty Ltd
Tablet, film coated
Excipient Ingredients: hypromellose; titanium dioxide; macrogol 4000; purified talc; Gelatin; lactose monohydrate; magnesium stearate; maize starch; colloidal anhydrous silica
Oral
200 tablets
(S4) Prescription Only Medicine
INDICATIONS AS AT 01 JANUARY 1991 : Behavioural disorders associated with epilepsy; hyperkinetic behaviour; temporal lobe epilepsy; myoclonic seizures; grand mal attacks; Jacksonian seizures.
Visual Identification: White filmcoated round tablets debossed "50" on one side and plain on the reverse side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1991-10-08
Ospolot ® Page 1 of 4 _Version 07 _ OSPOLOT ® _Sulthiame _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ospolot. 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 Ospolot 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 OSPOLOT IS USED FOR Ospolot is used to control epilepsy. Epilepsy is a condition where you have repeated seizures or fits. There are many different types of seizures, ranging from mild to severe. _ _ This medicine belongs to a group of medicines called sulphonamides. These medicines are thought to work by controlling brain chemicals that send signals to nerves so that seizures do not happen. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE OSPOLOT _WHEN YOU MUST NOT TAKE IT_ _ _ DO NOT TAKE OSPOLOT IF YOU HAVE AN ALLERGY TO: • any medicine containing sulthiame • any of the ingredients listed at the end of this leaflet • any other similar medicines such as sulphonamides 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. DO NOT DRINK ALCOHOL WHILE YOU ARE BEING TREATED WITH OSPOLOT. YOU SHOULD NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK, OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING THIS MEDICINE, TALK TO YOUR DOCTOR . _BEFORE YOU START TO TAKE IT _ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO Přečtěte si celý dokument
PRODUCT INFORMATION Australian Product Information – Ospolot ® 50 mg and 200 mg Tablets Page 1 of 9 Version 10 OSPOLOT ® (SULTHIAME) TABLETS 1 NAME OF THE MEDICINE Sulthiame 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Ospolot film-coated tablets contain 50 mg or 200 mg of sulthiame. Excipients of known effect: sugars as lactose. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Ospolot 50 mg tablets are white film-coated round tablets, debossed "50" on one side and plain on the reverse side. Ospolot 200 mg tablets are white film-coated round tablets debossed "200" on one side and scored on the reverse side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Ospolot is indicated as an anticonvulsant for behavioural disorders associated with epilepsy; hyperkinetic behaviour; temporal lobe epilepsy; myoclonic seizures; grand mal attacks; Jacksonian seizures. 4.2 D OSE AND METHOD OF ADMINISTRATION Caution should be used when establishing dosage in the presence of renal or hepatic impairment. Treatment should start with a low dosage which is gradually increased until clinical response is satisfactory. This may require four weeks. Ospolot tablets should preferably be swallowed whole with a little fluid after meals. ADULTS Initially 100 mg twice daily or 50 mg three times daily (optimum: 200 mg three times daily). CHILDREN Initially 3-5 mg/kg daily in equal divided doses (optimum: 10-15 mg/kg daily in equal divided doses). PRODUCT INFORMATION OSPOLOT ® Australian Product Information – Ospolot ® 50 mg and 200 mg Tablets Page 2 of 9 Version 10 4.3 C ONTRAINDICATIONS Ospolot may not be used in cases of • known hypersensitivity to sulthiame, other sulfonamides or to any of the excipients listed in Section 6.1 List of Excipients. Sulthiame should not be used in patients with • known acute porphyria • hyperthyroidism or arterial hypertension. 4.4 S PECIAL WARNINGS AND PRECAUTIONS FOR USE Ospolot should be administered to patients with a history of psychiatric disorders or Přečtěte si celý dokument