Kraj: Nowa Zelandia
Język: angielski
Źródło: Medsafe (Medicines Safety Authority)
Diltiazem hydrochloride 360mg (30-35 mesh nonpareil seed);
sanofi-aventis new zealand limited
Diltiazem hydrochloride 360 mg (30-35 mesh nonpareil seed)
360 mg
Modified release capsule
Active: Diltiazem hydrochloride 360mg (30-35 mesh nonpareil seed) Excipient: Acetyl tributyl citrate Brilliant blue FCF Diethyl phthalate Ethanol Gelatin Methacrylic acid copolymer Povidone Purified talc Purified water Simeticone Sodium laurilsulfate Sugar spheres Titanium dioxide
Blister pack, PVD/PE/PVDC Alu sample pack, 7 capsules
Prescription
Prescription
Finorga SA
CARDIZEM CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications such as diuretics.
Package - Contents - Shelf Life: Blister pack, PVD/PE/PVDC Alu sample pack - 7 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Blister pack, PVD/PE/PVDC Alu - 10 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE sample pack - 7 capsules - 36 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE - 10 capsules - - Bottle, plastic, HDPE - 28 capsules - - Bottle, plastic, HDPE - 30 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE - 100 capsules - - Calendar pack, PVD/PE/PVDC Alu - 28 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Calendar pack, PVD/PE/PVDC Alu - 30 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Calendar pack, PVD/PE/PVDC Alu - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture
1999-06-23
Cardizem® CD capsules and Cardizem® tablets _1_ CARDIZEM® CD CAPSULES AND CARDIZEM® TABLETS 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 CARDIZEM? Cardizem CD capsules or Cardizem tablets both contain an active ingredient diltiazem hydrochloride. Cardizem tablets are used to prevent angina. Cardizem CD capsules are used to prevent angina or to treat hypertension (high blood pressure). For more information, see Section 1. Why am I using Cardizem? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE CARDIZEM? Do not use if you have ever had an allergic reaction to Cardizem CD capsules or Cardizem tablets 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 Cardizem? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Cardizem 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 CARDIZEM? • Cardizem CD capsules can be taken once a day, preferably at the same time every day. • Cardizem tablets can be taken three or four times a 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 much Cardizem CD or Cardizem tablets to take. More instructions can be found in Section 4. How do I use Cardizem? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING CARDIZEM? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using Cardizem CD or Cardizem tablets. • 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 exactl Przeczytaj cały dokument
cardizem-cd-ccdsv15-dsv20-24aug23 Page 1 NEW ZEALAND DATA SHEET 1 PRODUCT NAME Cardizem CD 180 mg modified release capsules Cardizem CD 240 mg modified release capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Diltiazem hydrochloride 180 mg or 240 mg in sustained release form. Chemically diltiazem hydrochloride is the hydrochloride salt of (2S, 3S)-5-(2- Dimethylaminoethyl)-2, 3, 4, 5-tetrahydro-2-(4-methoxyphenyl)-4-oxo-1, 5-benzothiazepin-3-yl acetate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Modified release capsule Cardizem CD is registered in 2 strengths: 180 mg: Light turquoise blue/blue capsule 240 mg: Blue/blue capsule Cardizem CD contains a white to off-white crystalline powder with a bitter taste. It is freely soluble in water, methanol, and chloroform. Cardizem CD capsules contain a blend of beads with controlled dissolution characteristics for once-a-day administration. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cardizem CD is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications such as diuretics. cardizem-cd-ccdsv15-dsv20-24aug23 Page 2 Cardizem CD is also indicated for the management of chronic stable angina and angina due to coronary artery spasm. 4.2 DOSE AND METHOD OF ADMINISTRATION Patients controlled on diltiazem alone or in combination with other medications may be safely switched to Cardizem 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. ADULTS _HYPERTENSION _ Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, reasonable starting doses are 180 to 240 mg once daily, although some patients may respond to lower doses. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; Przeczytaj cały dokument