Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
trandolapril, Quantity: 2 mg; verapamil hydrochloride, Quantity: 180 mg
Viatris Pty Ltd
Trandolapril,Verapamil hydrochloride
Tablet, film coated
Excipient Ingredients: maize starch; lactose monohydrate; povidone; hypromellose; sodium stearylfumarate; microcrystalline cellulose; sodium alginate; magnesium stearate; hyprolose; macrogol 400; macrogol 6000; purified talc; colloidal anhydrous silica; titanium dioxide; iron oxide red; iron oxide yellow; iron oxide black; docusate sodium
Oral
56 tablets, 7 tablet sample pack, 28 tablets, 50 tablets, 14 tablets, 98 tablets, 280 tablets, 30 tablets
(S4) Prescription Only Medicine
TARKA is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.
Visual Identification: Pink, oval, film coated tablet embossed with '182' on one face. Other face has no embossing.; 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
2005-10-24
TARKA ® T A R K A ® 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 TARKA TARKA contains the active ingredients trandolapril and verapamil hydrochloride. TARKA is used to treat hypertension (high blood pressure). For more information, see Section 1. Why am I using TARKA in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TARKA Do not use if you have ever had an allergic reaction to any medicine containing trandolapril (or any other ACE inhibitor), any medicine containing verapamil 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 TARKA in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with TARKA 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 TARKA • The usual dosage for TARKA is one tablet daily. The maximum dose of TARKA is one 4/240 mg tablet once daily. More instructions can be found in Section 4. How do I use TARKA in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TARKA THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using TARKA. • Have your blood pressure checked when your doctor says, to make sure TARKA is working for you • If you feel light-headed or dizzy after taking your first dose of TARKA, or when your dose is increased, tell your doctor immediately. • Tell your doctor if you have excessive vomiting and/or diarrhoea while taking TARKA. THINGS YOU SHOULD NOT DO • Do not take eat grapefruit or drink grapefruit juice whilst taking TARKA. • Do not use TARKA to treat any other complaints unless your doctor or pharmacist tells you to. • Do not give this medicin Read the complete document
AUSTRALIAN PRODUCT INFORMATION TARKA ® 2/180 TARKA ® 4/240 _Trandolapril/verapamil hydrochloride _ 1 NAME OF THE MEDICINE Trandolapril/verapamil hydrochloride _ _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TARKA 2/180 contains trandolapril 2 mg and verapamil 180 mg modified release as the active ingredients in pink, oval, film coated tablets. TARKA 2/180 also contain 107.00 mg lactose monohydrate. TARKA 4/240 contains trandolapril 4 mg and verapamil 240 mg modified release as the active ingredients in red-brown, oval, film coated tablets. TARKA 4/240 also contain 110.37 mg lactose monohydrate. Excipients with known effect: Contains sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TARKA 2/180 are pink, oval, film coated tablets embossed with ‘182’ on one face. TARKA 4/240 are red-brown, oval, film coated tablets embossed with ‘244’ on one face. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TARKA is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination. _ _ 4.2 DOSE AND METHOD OF ADMINISTRATION The product should be swallowed whole with water ideally in the morning with or after food. ADULTS The usual dosage is one tablet daily. The maximum dose of TARKA is 4/240 mg once daily. ELDERLY TARKA has been studied in a limited number of elderly hypertensive patients only. Pharmacokinetic data show that the systemic availability of TARKA is higher in elderly compared to younger hypertensives. Some elderly patients might experience a more pronounced blood pressure lowering effect than others. CHILDREN TARKA has not been studied in children and adolescents, therefore use in this age group is not recommended. ANGINA The safety and efficacy of TARKA has not been evaluated in the treatment of angina. TARKA ® – PRODUCT INFORMATION 2 4.3 CONTRAINDICATIONS TARKA is contraindicated in: • Patients who are hypersensitive to trandolapril or any other ACE inhibitor or to verapamil hydrochloride or Read the complete document