Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
diltiazem hydrochloride, Quantity: 360 mg
Sanofi-Aventis Australia Pty Ltd
diltiazem hydrochloride
Capsule, modified release
Excipient Ingredients: purified talc; sodium lauryl sulfate; methacrylic acid copolymer; povidone; simethicone; diethyl phthalate; tributyl acetylcitrate; maize starch; sucrose; titanium dioxide; brilliant blue FCF; potable water; Gelatin; silicon dioxide
Oral
30 capsules, 10 capsules, 7 capsules, 28 capsules
(S4) Prescription Only Medicine
DILTIAZEM SANDOZ CD is indicated for the treatment of hypertension. DILTIAZEM SANDOZ CD is also indicated for the management of chronic stable angina (effort-associated angina) where there is no evidence of vasospastic or unstable angina. Since the safety and efficacy of CD capsules in the management of unstable or vasospastic angina has not been substantiated, use of this formulation for these indications is not recommended.
Visual Identification: Size 00, light blue opaque cap and white opaque body; locking, hard gelatin capsule containing white to off white beads.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2007-02-26
DILTIAZEM SANDOZ CD ® D i l t i a z e m S a n d o z C D ® 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 DILTIAZEM SANDOZ CD? Diltiazem Sandoz CD capsules contains the active ingredient diltiazem hydrochloride. Diltiazem Sandoz CD is used to prevent angina or to treat hypertension (high blood pressure). For more information, see Section 1. Why am I using Diltiazem Sandoz CD? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE DILTIAZEM SANDOZ CD? Do not use if you have ever had an allergic reaction to Diltiazem Sandoz CD capsules 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 Diltiazem Sandoz CD? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Diltiazem Sandoz CD 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 DILTIAZEM SANDOZ CD? • Diltiazem Sandoz CD capsules can be taken once a day, preferably at the same time every day. • Swallow the capsules or the tablets with a glass of water. Do not chew them. • Your doctor will tell you how often and how many Diltiazem Sandoz CD capsules to take. More instructions can be found in Section 4. How do I use Diltiazem Sandoz CD? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING DILTIAZEM SANDOZ CD? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Diltiazem Sandoz CD. • If you are taking these medicines for angina, tell your doctor if you continue to have angina attacks or if they become more frequent. • Take these medicines exactly as your doctor has prescribed. THINGS YOU SHOULD NOT DO • Do not use these medicines t Đọc toàn bộ tài liệu
diltiazem-sandoz-cd-ccdsv13-piv16-11mar20 Page 1 of 20 AUSTRALIAN PRODUCT INFORMATION DILTIAZEM SANDOZ ® CD (DILTIAZEM HYDROCHLORIDE) 1 NAME OF THE MEDICINE Diltiazem hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diltiazem Sandoz CD capsules contain a blend of beads with controlled dissolution characteristics for once-a-day administration. The capsules are available as either 180 mg, 240 mg or 360 mg diltiazem hydrochloride in sustained release form. Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is freely soluble in water, methanol, and chloroform. For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM Modified release capsule Diltiazem Sandoz CD is registered in 3 strengths: 180 mg: Light turquoise blue/blue capsule 240 mg: Blue/blue capsule 360 mg: Light blue/white capsule 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Diltiazem Sandoz CD is indicated for the treatment of hypertension. Diltiazem Sandoz CD is also indicated for the management of chronic stable angina (effort-associated angina) where there is no evidence of vasospastic or unstable angina. Since the safety and efficacy of CD capsules in the management of unstable or vasospastic angina has not been substantiated, use of this formulation for these indications is not recommended. diltiazem-sandoz-cd-ccdsv13-piv16-11mar20 Page 2 of 20 4.2 DOSE AND METHOD OF ADMINISTRATION For oral administration. Patients controlled on diltiazem alone or in combination with other medications may be safely switched to Diltiazem Sandoz CD at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may be necessary and should be initiated as clinically warranted. There is limited clinical experience with doses above 360 mg. Therefore, treatment with doses exceeding 360 mg/day is not recommended. HYPERTENSION Dosage needs to be adjusted by titration to individual patient needs. Monitoring of trough BP should be done initially to ensure BP control Đọc toàn bộ tài liệu