מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
trandolapril, Quantity: 1 mg
Arrotex Pharmaceuticals Pty Ltd
Trandolapril
Capsule
Excipient Ingredients: titanium dioxide; croscarmellose sodium; Gelatin; erythrosine; povidone; sunset yellow FCF; lactose monohydrate; sodium stearylfumarate; maize starch; brilliant blue FCF; allura red AC; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
28 capsules
(S4) Prescription Only Medicine
Treatment of hypertension. Data to support the usage of trandolapril in renovascular hypertension are, at present, not available. Trandolapril is also indicated for patients with left ventricular dysfuntion 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: A hard gelatin, peach/scarlet opaque capsule with "TN" over "1" on the cap and no markings on the body.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2007-07-10
DOLAPRIL- Consumer Medicine Information Page 1 of 5 DOLAPRIL trandolapril CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about DOLAPRIL. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking DOLAPRIL against the benefits they expect it will have for you. TALK TO YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE. Keep this leaflet with your medicine. You may need to read it again. WHAT DOLAPRIL IS USED FOR DOLAPRIL is used to treat: • high blood pressure (hypertension) • some heart conditions. There are usually no symptoms of hypertension. The only way of knowing that you have hypertension is to have your blood pressure checked on a regular basis. If high blood pressure is not treated it can lead to serious health problems. You may feel fine and have no symptoms, but eventually hypertension can lead to serious health problems, including stroke, heart disease and kidney failure. DOLAPRIL helps to lower your blood pressure. DOLAPIRL belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. It works by relaxing your blood vessels, making it easier for blood to move around your body. This helps lower blood pressure and increase the supply of blood and oxygen to the heart. Your doctor may have prescribed DOLAPRIL for another reason. Ask your doctor if you have any questions about why DOLAPRIL has been prescribed for you. DOLAPRIL is not addictive. This medicine is available only with a doctor's prescription. DOLAPRIL is not recommended for use in children as there have been no studies of its effects in children. BEFORE YOU TAKE DOLAPRIL WHEN YOU MUST NOT TAKE IT DO NOT TAKE DOLAPRIL IF YOU: • Are allergic (sensitive) to trandolapril or any of the ingredients in DOLAPRIL capsules listed at the end of this leaflet Symptoms of an allergic reaction may i קרא את המסמך השלם
1 AUSTRALIAN PI – DOLAPRIL (TRANDOLAPRIL) 1 NAME OF THE MEDICINE Trandolapril. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION DOLAPRIL 0.5 capsules contain 0.5 mg of trandolapril. DOLAPRIL 1 capsules contain 1 mg of trandolapril. DOLAPRIL 2 capsules contain 2 mg of trandolapril. DOLAPRIL 4 capsules contain 4 mg of trandolapril. EXCIPIENTS WITH KNOWN EFFECT: The capsules contain sugars as lactose. For the full list of excipients, see _SECTION 6.1 LIST OF _ _EXCIPIENTS_. 3 PHARMACEUTICAL FORM DOLAPRIL 0.5 capsules: White opaque capsule with ‘TN’ over ‘5’ on the cap. DOLAPRIL 1 capsules: Peach and scarlet opaque capsule with ‘TN’ over ‘1’ on the cap. DOLAPRIL 2 capsules: Scarlet opaque capsule with ‘TN’ over ‘2’ on the cap DOLAPRIL 4 capsules: White opaque capsule with ‘TN’ over ‘4’ on the cap. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Treatment of hypertension. Data to support the usage of DOLAPRIL in renovascular hypertension are, at present, not available. DOLAPRIL 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). 2 4.2 D OSE AND METHOD OF ADMINISTRATION DOLAPRIL has a duration of action greater than 24 hours and should not be administered at intervals of less than 24 hours. Monitoring of trough blood pressure should be done initially to ensure that 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 trandolapril, 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 two to four 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 channel blocker or di קרא את המסמך השלם