Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
moxonidine, Quantity: 200 microgram
Arrotex Pharmaceuticals Pty Ltd
Tablet, film coated
Excipient Ingredients: povidone; lactose monohydrate; magnesium stearate; crospovidone; titanium dioxide; hypromellose; purified talc; macrogol 6000; iron oxide red
Oral
84 tablets, 56 tablets, 98 tablets, 10 tablets, 28 tablets, 30 tablets, 7 tablets (sample), 14 tablets
(S4) Prescription Only Medicine
MOXOTENS is indicated for the treatment of hypertension.
Visual Identification: Pale pink coloured round shaped tablet debossed with MX2 on one side and plain on another side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2019-07-02
1 MOXOTENS ® TABLETS _moxonidine_ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Moxotens. 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 ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Moxotens for another use. This medicine is only available with a doctor's prescription. This medicine is not addictive. • HAVE HEART PROBLEMS SUCH AS HEART FAILURE OR ABNORMAL RHYTHM • HAVE SEVERE KIDNEY DISEASE DO NOT TAKE IT AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged return it to your pharmacist for disposal. the risks of you taking Moxotens IF YOU ARE NOT SURE WHETHER YOU 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 MEDICATION. You may want to read it again. WHAT MOXOTENS IS USED FOR Moxotens lowers high blood pressure, which is sometimes called hypertension. Everyone has blood pressure. This pressure helps to move your blood around your body. Your blood pressure may change at different times of the day. You have hypertension when your blood pressure stays higher than normal, even when you are calm or relaxed. There are usually no symptoms of hypertension. The only way of knowing if you have hypertension is to have your blood pressure checked regularly. If high blood pressure is not treated it can lead to serious health problems, including stroke, heart disease and kidney failure. BEFORE YOU TAKE MOXOTENS _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE MOXOTENS IF YOU HAVE AN ALLERGY TO: • ANY MEDICINE CONTAINING MOXONIDINE • ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET Some symptoms of an allergic reaction include skin rash, itching, short Read the complete document
Page 1 of 9 AUSTRALIAN PRODUCT INFORMATION MOXOTENS (MOXONIDINE) 1 NAME OF THE MEDICINE Moxonidine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Moxonidine is a white to almost white powder with a melting point of 197 – 205 ◦ C. Moxonidine is very slightly soluble in water, sparingly soluble in methanol. 200 microgram: Each tablet contains 200 microgram moxonidine. 400 microgram: Each tablet contains 400 microgram moxonidine. List of excipients with known effect: Contains sugars as lactose. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet, film coated. MOXOTENS 200 μg tablets: Pale pink, coloured round shaped tablet debossed with MX2 on one side and plain on another side. MOXOTENS 400 μg tablets: Dull brick red coloured round shaped tablets debossed with MX4 on one side and plan on another side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MOXOTENS is indicated for the treatment of hypertension. 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should be started with 200 μg MOXOTENS in the morning. The dose may be titrated after two weeks to 400 μg 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 μg in divided doses (morning and evening). A single daily dose of 400 μg and a divided daily dose of 600 μg of MOXOTENS should not be exceeded. MOXOTENS may be taken with or without food. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients of this product. Heart failure (NYHA Class I – IV). Patients aged 75 years or older. 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 µ mol/L). Page 2 of 9 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE RENAL IMPAIRMENT In patients with m Read the complete document