Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
trandolapril, Quantity: 0.5 mg
Viatris Pty Ltd
Capsule, hard
Excipient Ingredients: titanium dioxide; povidone; erythrosine; Gelatin; sodium stearylfumarate; sodium lauryl sulfate; maize starch; lactose monohydrate; iron oxide yellow
Oral
7, 10, 14, 15, 28 & 30 capsules
(S4) Prescription Only Medicine
GOPTEN is indicated for the treatment of hypertension. Data to support the usage of GOPTEN in severe hypertension or renovascular hypertension is, at present, not available. GOPTEN is also indicated for patients with left ventricular dysfunction post myocardial infarction [ejection fraction less than or equal to 35%) or Wall Motion Index (WMI) less than or equal to 1.2],GOPTEN is indicated for the treatment of hypertension. Data to support the usage of GOPTEN in renovascular hypertension is, at present, not available. GOPTEN is also indicated for patients with left ventricular dysfunction post myocardial infarction [ejection fraction less than or equal to 35%) or WMI (Wall Motion Index) less than or equal to 1.2]
Visual Identification: White to off white granules filled in Size 4 hard gelatin capsules with yellow opaque cap and red opaque body.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
1994-01-27
GOPTEN ® G O P T E N 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 GOPTEN? GOPTEN contains the active ingredient trandolapril. GOPTEN is used to treat high blood pressure (hypertension) and also to treat some heart conditions. For more information, see Section 1. Why am I using GOPTEN? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE GOPTEN? Do not use if you have ever had an allergic reaction to trandolapril 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 GOPTEN? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with GOPTEN 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 GOPTEN? • The usual dosage is one or two capsules taken once daily, up to a maximum of 4mg (two 2mg capsules) once daily. More instructions can be found in Section 4. How do I use GOPTEN? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING GOPTEN? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using trandolapril. • Have your blood pressure checked when your doctor says, to make sure GOPTEN is working. • If you become pregnant while taking GOPTEN tell your doctor immediately. • If you feel light-headed or dizzy after taking your first dose of GOPTEN, or when your dose is increased, tell your doctor immediately. • Tell your doctor if you have excessive vomiting and/or diarrhoea while taking GOPTEN. THINGS YOU SHOULD NOT DO • Do not give GOPTEN to anyone else, even if they have the same condition as you. • Do not take GOPTEN to treat any other complaints unless your doctor tells you to. • Do not Read the complete document
AUSTRALIAN PRODUCT INFORMATION GOPTEN ® _Trandolapril Capsules _ 1 NAME OF THE MEDICINE Trandolapril 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each GOPTEN capsule contains 0.5 mg, 1 mg, 2 mg or 4 mg of trandolapril as active ingredient. Excipients with known effect: Contains sugars as lactose and sulfites. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM GOPTEN 0.5 mg White to off white granules filled in Size 4 hard gelatin capsules with yellow opaque cap and red opaque body. GOPTEN 1 mg White to off white granules filled in Size 4 hard gelatin capsules with orange opaque cap and red opaque body. GOPTEN 2 mg White to off white granules filled in Size 4 hard gelatin capsules with red opaque cap and red opaque body. GOPTEN 4 mg White to off white granules filled in Size 2 hard gelatin capsules with maroon opaque cap and red opaque body. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GOPTEN is indicated for the treatment of hypertension. Data to support the usage of GOPTEN in renovascular hypertension is, at present, not available. GOPTEN is also indicated for patients with left ventricular dysfunction post myocardial infarction [ejection fraction 35% or WMI (Wall Motion Index) 1.2]. 4.2 DOSE AND METHOD OF ADMINISTRATION GOPTEN has a duration of action of greater than 24 hours and should not be administered at intervals of less than 24 hours. Monitoring of trough BP should be done initially to ensure control lasts over the dosing period. Should daily doses of more than one capsule be required, they should be administered together as a single daily dose. Since there is no clinically significant effect of food on the absorption of GOPTEN, the capsules may be taken before, during, or after a meal. HYPERTENSION The usual starting dose is one 1 mg capsule once daily. Maximum response is usually achieved within 2 - 4 weeks. Some patients not responding to 1 mg once daily may respond to 2 mg once daily. An alternative to increasing the dose is to add a calcium chann Read the complete document