Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Diltiazem hydrochloride 60mg; ; ; ;
Douglas Pharmaceuticals Limited
Diltiazem hydrochloride 60 mg
60 mg
Film coated tablet
Active: Diltiazem hydrochloride 60mg Excipient: Aluminium hydroxide gel Hydrogenated castor oil Lactose monohydrate Magnesium stearate Methacrylic acid copolymer Opadry white Y-1R-7000B Purified talc
Blister pack, 1x30, 30 tablets
Prescription
Prescription
Teva API India Ltd
Package - Contents - Shelf Life: Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 100 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 500 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, - 1000 tablets - 36 months from date of manufacture stored at or below 25°C
1986-11-27
CONSUMER MEDICINE INFORMATION 1 DILZEM® _diltiazem hydrochloride _ 30 mg and 60 mg tablets WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING DILZEM. This leaflet answers some common questions about DILZEM. 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 DILZEM 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 DILZEM IS USED FOR DILZEM belong to a group of medicines called calcium channel blockers. DILZEM is used to treat (long term) and prevent angina pectoris. Diltiazem acts by relaxing the muscles around the blood vessels and so relaxes and widens the blood vessels. This makes it easier for the heart to do its work and allows more blood to flow to the heart, relieving angina (chest pain due to an inadequate blood supply to the heart). DILZEM also has an effect on the heart muscle itself, helping the heart to slow down and reduce the amount of work it is doing. Your doctor may have prescribed DILZEM for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY DILZEM HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE DILZEM _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE DILZEM IF YOU HAVE AN ALLERGY TO: • any medicine containing diltiazem hydrochloride or a class of medicines called calcium channel blockers. • any of the ingredients listed at the end of this leaflet. DILZEM tablets contain lactose, if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Some of the symptoms of an allergic reaction may include: • difficulty in breathing or wheezing. • shortness of breath. • swelling of the face, tongue, lips, or other parts Soma hati kamili
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME Dilzem® 30 mg film coated tablets Dilzem® 60 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Diltiazem hydrochloride 30 mg Diltiazem hydrochloride 60 mg EXCIPIENT(S) WITH KNOWN EFFECT: Dilzem tablets contain lactose. For the full list of excipients, _see section 6.1_. 3. PHARMACEUTICAL FORM Dilzem 30 mg tablet: a white, circular, film-coated, biconvex tablet of approximately 6mm diameter embossed "D" one side. Dilzem 60 mg tablet: a white capsule shaped, film-coated tablet, 10mm in length and 5mm wide; with a breakline and ‘DL60’ engraved on one face. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Angina pectoris due to coronary artery spasm and chronic stable angina. 4.2. DOSE AND METHOD OF ADMINISTRATION DOSE _ADULTS _ Initially 30 mg three to four times daily increasing to 240 mg daily in divided doses. The maximum recommended dose is 360 mg daily. _SPECIAL POPULATIONS _ Elderly population Pharmacokinetics of diltiazem in elderly patients has not been fully elucidated. Preliminary results in elderly patients (over 65 years old) suggest that a lower dosage might be required in this age group, _see Section 4.4_. 2 | P a g e Hepatic and renal impairment Dilzem should be used with caution in patients with hepatic or renal impairment. If diltiazem must be used in these patients, the dosage should be carefully and gradually adjusted depending on patient tolerability and responses,_ see Section 4.4_. Concomitant use with other cardiovascular agents SUBLINGUAL GLYCERYL TRINITRATE may be taken as required to abort acute anginal attacks during Dilzem therapy. Diltiazem may be safely co-administered with short- and long-acting nitrates but there have been no controlled studies to evaluate the antianginal effectiveness of this combination. BETA-BLOCKERS- _see Section 4.4._ ANTIHYPERTENSIVES- Diltiazem has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem or the concomitant an Soma hati kamili