Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
moxonidine, Quantity: 400 microgram
Viatris Pty Ltd
Tablet, film coated
Excipient Ingredients: crospovidone; lactose monohydrate; ethylcellulose; titanium dioxide; povidone; macrogol 6000; hypromellose; purified talc; magnesium stearate; iron oxide red
Oral
30 tablets
(S4) Prescription Only Medicine
For the treatment of hypertension.
Visual Identification: Dull red, round, biconvex, film-coated tablet, imprinted with 0.4 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2018-01-25
MOXONIDINE GX M O X O N I D I N E G X CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about taking this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING MOXONIDINE GX? MOXONIDINE GX contains the active ingredient moxonidine. MOXONIDINE GX is used to lower high blood pressure. For more information, see Section 1. Why am I taking MOXONIDINE GX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE MOXONIDINE GX? Do not use if you have ever had an allergic reaction to moxonidine or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE OTHER MEDICAL CONDITIONS, TAKE 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 take MOXONIDINE GX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with MOXONIDINE GX and affect how it works or may be affected by MOXONIDINE GX. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE MOXONIDINE GX? • The usual starting dose is one 200 micrograms tablet once per day. Depending on how your blood pressure responds, your dosage may be increased by your doctor. • Swallow the tablets whole with a full glass of water or another liquid. Do not chew the tablets. More instructions can be found in Section 4. How do I take MOXONIDINE GX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING MOXONIDINE GX? THINGS YOU SHOULD DO • Remind any doctor, surgeon, dentist or pharmacist you visit that you are taking this medicine. • Drink enough water during exercise and hot weather when you are taking this medicine. • TELL YOUR DOCTOR IF: you become pregnant, you are about to have any blood tests or you have excessive vomiting and/or diarrhoea while taking this medicine. THINGS YOU SHOULD NOT DO • Do not use MOXONIDINE GX to treat any other complaints unless your doctor or pharmacist tells you to. Do Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION MOXONIDINE GX _moxonidine film-coated tablet _ 1 NAME OF THE MEDICINE Moxonidine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MOXONIDINE GX tablets are immediate release film-coated tablets for oral use containing 200 micrograms or 400 micrograms moxonidine. Excipients with known effect: sugars as lactose For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM MOXONIDINE GX 200 micrograms tablets: Pale pink, round, biconvex, film-coated tablet, imprinted 0.2 on one side. MOXONIDINE GX 400 micrograms tablets: Dull red, round, biconvex, film-coated tablet, imprinted 0.4 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MOXONIDINE GX is indicated for the treatment of hypertension. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should be started with 200 micrograms MOXONIDINE GX in the morning. The dose may be titrated after two weeks to 400 micrograms given as one dose or as divided doses (morning and evening) until a satisfactory response is achieved. If the response is still unsatisfactory after a further 2 weeks treatment, the dosage can be increased up to a maximum of 600 micrograms in divided doses (morning and evening). A single daily dose of 400 micrograms and a divided daily dose of 600 micrograms of MOXONIDINE GX should not be exceeded. MOXONIDINE GX may be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients (see Section 6.1 List of excipients). Heart failure (NYHA Class I – IV). Patients aged 75 years or older (see Section 5.2 Pharmacokinetic properties - Pharmacokinetics in the elderly). Bradycardia (HR < 50 beats/minute) or severe bradyarrhythmia, including sick sinus syndrome, or second or third degree atrioventricular (AV) block. Malignant arrhythmias. Severe renal impairment (GFR < 30 mL/min, serum creatinine concentration >160 mol/L). MOXONIDINE GX – PRODUCT INFORMATION 2 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE CESSATION OF COMBINATION THERAPY WITH BETA-BLOCKERS Abrupt Прочетете целия документ