Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Metolazone
Renascience Pharma Ltd
C03BA08
Metolazone
5mg
Oral tablet
Oral
No Controlled Drug Status
Caution - AMP level prescribing advised
BNF: 02020100; GTIN: 5060512180053
200MM 320MM Code reading direction Code reading direction READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Xaqua is and what it is used for 2. What you need to know before you take Xaqua 3. How to take Xaqua 4. Possible side effects 5. How to store Xaqua 6. Contents of the pack and other information 1. WHAT IS XAQUA AND WHAT IS IT USED FOR Xaqua is a diuretic drug containing the active substance metolazone. It is used for the treatment of: • fluid retention (oedema) related to the heart and kidneys by increasing the flow of urine. • high blood pressure, taken alone or with other medication. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XAQUA DO NOT TAKE XAQUA • if you are allergic (hypersensitive) to Metolazone, to thiazides, to sulfonamides or any of the other ingredients of this medicine (listed in section 6). • if you are no longer able to urinate • in case of coma or comatose conditions which is caused by liver cirrhosis • in case of severe disturbances to the balance of salts or chemicals in the blood WARNING AND PRECAUTIONS Talk to your doctor or pharmacist before taking Xaqua: • If you have severe kidney or liver disease. • If you are elderly, your doctor may want to monitor you more closely. • If you have a fluid or electrolyte imbalance in your blood (e.g. sodium, calcium or potassium), your doctor may want to monitor you more closely. Symptoms can include thirst, nausea, vomiting, disorientation, drowsiness, muscle cramps, low blood pressure and irregular heart rate. • Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Xaqua 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg metolazone. Excipients with known effect: Each tablet contains 53 mg lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Round, biplanar, white to off-white tablets with bevelled edges and single score-line, diameter: 7.0 mm The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xaqua is indicated for the treatment of • oedema related to kidney diseases, including the nephrotic syndrome and states of impaired renal function • oedema related to congestive heart failure Xaqua is also indicated for the treatment of mild and moderate hypertension, alone or in combination with other antihypertensive medicines of a different class. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _IMPORTANT NOTE:_ Xaqua tablets bioavailability may be different from other metolazone preparations (see section 5.2). Therefore, the recommended doses (expressed in mg) can differ from other metolazone products. A dose adjustment may be necessary and individualised titration based on patient’s response and tolerability is advised if switching from Xaqua tablets to another metolazone product, or vice versa. Posology _Adults _ _Treatment of Oedema _ Metolazone should generally be administered once daily The tablet should always be taken at the same time in relation to food. The following dosages should serve as guidelines: Oedema related to congestive heart failure and kidney disease: 2.5-5 mg/day. The therapy should be initiated with a dose of 2.5 mg/day and the dose must be adjusted according to the individual reaction of the patient. Once the desired therapeutic effect has been achieved, it may be advisable to reduce the maintenance dose if possible _Hypertension _ Mild and moderate hypertension: 2.5mg-5mg/day The recommended initial dose in mild and moderate hypertension is 2.5 mg/day, and the dose must be adj Læs hele dokumentet