Land: Australië
Taal: Engels
Bron: Department of Health (Therapeutic Goods Administration)
Diltiazem hydrochloride
Sandoz Pty Ltd
Medicine Registered
Diltiazem Sandoz ® 1 DILTIAZEM SANDOZ ® _ _ DILTIAZEM HYDROCHLORIDE TABLETS CONSUMER MEDICINE INFORMATION _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Diltiazem Sandoz. 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 this medicine 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 DILTIAZEM SANDOZ IS USED FOR This medicine is used to prevent angina. Angina is a pain or uncomfortable feeling in the chest, often spreading to the arms and neck, and sometimes the shoulders and back. This may be caused by too little blood and oxygen getting to the heart. Angina is usually brought on by exercise or stress. It contains the active ingredient diltiazem hydrochloride. _ _ Diltiazem belongs to a group of medicines called calcium channel blockers. _ _ It works by opening up blood vessels, thereby increasing the blood flow and allowing more blood (and oxygen) to reach the heart. _ _ _ _ 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 not addictive. This medicine is available only with a doctor’s prescription. _ _ BEFORE YOU TAKE DILTIAZEM SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO: • diltiazem hydrochloride, the active ingredient, or to any of the other ingredients listed at the end of this leaflet under Product Description. Some of the symptoms of an allergic reaction may include: • shortness of breath Diltiazem Sandoz ® 2 • wheezing or Lees het volledige document
1 PRODUCT INFORMATION DILTIAZEM SANDOZ ® 60MG FILM-COATED TABLETS NAME OF THE MEDICINE Chemical name: (2_S_,3_S_)-5-(2-dimethylaminoethyl)-2,3,4,5-tetrahydro-2-(4-methoxyphenyl)- 4-oxo-1,5-benzothiazepin-3-yl acetate hydrochloride. Generic name: diltiazem hydrochloride. CAS 33286-22-5 MW: 450.98 DESCRIPTION Diltiazem hydrochloride is a white to off white crystalline powder with a bitter taste, soluble in water, methanol and chloroform. Composition Each tablet contains: _Active ingredient: _ Diltiazem Hydrochloride 60.00mg _Inactive excipients: _ Hydrogenated Castor Oil, Lactose, Povidone 25, Macrogol 6000, Microcrystalline Cellulose, Sodium Starch Glycollate, Colloidal Anhydrous Silica, Magnesium Stearate, Hypromellose, Stearic Acid, Titanium Dioxide. PHARMACOLOGY Diltiazem is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). The therapeutic benefits achieved with Diltiazem are believed to be related to its ability to inhibit the influx of calcium ions during membrane depolarisation of cardiac and vascular smooth muscle. Me 2 N O N S OAc H H OMe HCL 2 _Mechanism of Action._ Although the precise mechanisms of its antianginal actions are still being delineated, Diltiazem is believed to act in the following ways: 1. Vasospastic angina. Diltiazem has been shown to be a potent dilator of coronary arteries both epicardial and subendocardial. Spontaneous and ergometrine induced coronary artery spasm are inhibited by Diltiazem. 2. Exertional angina. Diltiazem has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand and increase oxygen supply. This is accomplished via reductions in heart rate and systemic blood pressure a Lees het volledige document