Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
moxonidine, Quantity: 0.2 mg
Viatris Pty Ltd
Moxonidine
Tablet, film coated
Excipient Ingredients: magnesium stearate; macrogol 6000; povidone; ethylcellulose; crospovidone; purified talc; iron oxide red; titanium dioxide; hypromellose; lactose monohydrate
Oral
30, 84 tablets, 28 tablets, 10, 7 tablets sample pack, 56 tablets, 14 tablets, 98 tablets
(S4) Prescription Only Medicine
For the treatment of hypertension.
Visual Identification: Pale pink, round, biconvex, film-coated tablet, imprinted with 0.2 on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2004-11-10
PHYSIOTENS ® P H Y S I O T E N S ® 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 PHYSIOTENS? PHYSIOTENS contains the active ingredient moxonidine. PHYSIOTENS is used to lower high blood pressure. For more information, see Section 1. Why am I taking PHYSIOTENS? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE PHYSIOTENS? 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 PHYSIOTENS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with PHYSIOTENS and affect how it works or may be affected by PHYSIOTENS. 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 PHYSIOTENS? • 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 PHYSIOTENS? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING PHYSIOTENS? THINGS YOU SHOULD DO • Remind any doctor, surgeon, dentist or pharmacist you visit that you are taking PHYSIOTENS. • Drink enough water during exercise and hot weather when you are taking PHYSIOTENS. • 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 PHYSIOTENS. THINGS YOU SHOULD NOT DO • Do not use PHYSIOTENS to treat any other complaints unless your doctor or pharmacist tells you to. • Do not give PHYSIOTENS to anyone else, even Read the complete document
AUSTRALIAN PRODUCT INFORMATION PHYSIOTENS ® _moxonidine film-coated tablet _ 1 NAME OF THE MEDICINE Moxonidine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PHYSIOTENS tablets are immediate release film-coated tablets for oral use containing 200 micrograms, 300 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 PHYSIOTENS 200 micrograms tablets: Pale pink, round, biconvex, film-coated tablet, imprinted 0.2 on one side. PHYSIOTENS 300 micrograms tablets: Pink, round, biconvex, film-coated tablet, imprinted with 0.3 on one side. PHYSIOTENS 400 micrograms tablets: Dull red, round, biconvex, film-coated tablet, imprinted 0.4 on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PHYSIOTENS is indicated for the treatment of hypertension. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should be started with 200 micrograms PHYSIOTENS 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 PHYSIOTENS should not be exceeded. PHYSIOTENS 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). PHYSIOTENS ® – PRODUCT INFORMATION 2 Read the complete document