Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
amlodipine besilate, Quantity: 6.935 mg (Equivalent: amlodipine, Qty 5 mg)
Ipca Pharma (Australia) Pty Ltd
amlodipine besilate
Tablet, uncoated
Excipient Ingredients: calcium hydrogen phosphate dihydrate; microcrystalline cellulose; colloidal anhydrous silica; sodium starch glycollate type A; magnesium stearate
Oral
56, 84, 28, 30, 50, 10, 14
(S4) Prescription Only Medicine
1. Hypertension Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor.,2. Angina Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs.
Visual Identification: White to off-white, circular, biconvex, uncoated tablets debossed with 'E 21' on one side and score line on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2017-04-13
1 GTA‐AMLODIPINE TABLETS 5 MG, 10 MG GTA-AMLODIPINE TABLETS 5 MG, 10 MG CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Amlodipine besylate. 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 Amlodipine besylate 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 need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine GTA- AMLODIPINE tablets. It contains the active ingredient amlodipine besylate. _WHAT IT DOES_ This is used to: • lower high blood pressure (hypertension). There are usually no symptoms of This medicine is not for the relief of a sudden attack of angina. Your doctor will give you other medication to treat this. _HOW IT WORKS_ This medicine belongs to a group of medicines called calcium channel blockers or calcium ion antagonists. They work by widening your blood vessels, making it easier for your heart to pump blood around the body and help increase the supply of blood and oxygen to your heart. Calcium channel blockers do not change the amount of calcium in your blood or bones. 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. This medicine is available only with a doctor's prescription. _USE IN CHILDREN_ There is not enough information to recommend the use of this medicine in children. ingredient felodipine, nifedipine or lercanidipine. Check with your doctor or pharmacist if you are unsure. • any of the ingredients listed at the end of this leaflet. Some of the 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 • r Read the complete document
Page 1 Product Information GTA-AMLODIPINE TABLETS 5 MG AND 10 MG GTA-AMLODIPINE TABLETS 5 MG, 10 MG NAME OF THE MEDICINE Amlodipine Tablets 5 mg and 10 mg. Amlodipine Tablets contains the active ingredient amlodipine besilate. Amlodipine besylate is a dihydropyridine derivative and has the following structural formula: SO 3 H H 3 CO 2 C H 3 C N H Cl CO 2 CH 2 CH 3 CH 2 OCH 2 CH 2 NH 2 Chemical name: 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4- dihydro-6-methyl-3,5-pyridinedicarboxylate benzene sulphonate Molecular formula: C 20 H 25 ClN 2 O 5. C 6 H 6 O 3 S Molecular weight: 567.1 (free base 408.9) CAS registry numbers: amlodipine 88150-42-9; amlodipine besylate 111470-99-6. DESCRIPTION Amlodipine besylate is a white crystalline powder, and is slightly soluble in water and sparingly soluble in ethanol. In addition to amlodipine besylate, each Amlodipine Tablets contains the following inactive ingredients: microcrystalline cellulose; calcium hydrogen phosphate; sodium starch glycollate; Silica-colloidal anhydrous, magnesium stearate. PHARMACOLOGY PHARMACODYNAMICS Amlodipine is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. Experimental data suggest that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these Page 2 Product Information GTA-AMLODIPINE TABLETS 5 MG AND 10 MG cells through specific ion channels. Amlodipine inhibits calcium ion influx across cell membranes selectively, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Negative inotropic effects can be detected _in vitro _ but such effects have not been seen in intact animals at therapeutic doses. Serum calcium concentration is not affected by amlodipine. Within the physiologic pH range, amlodipine is an ionise Read the complete document