Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amiloride hydrochloride
Mawdsley-Brooks & Company Ltd
C03DB01
Amiloride hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020300
CHANGE CONTROL : Version changes due to change in: Size/Layout Regulatory Non-Regulatory Changes in detail: • Regulatory text amends PATIENT INFORMATION LEAFLET AMILORIDE 5MG TABLETS AMILORIDE HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or your pharmacist. • This medicine has been prescribed only for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. • If any of these side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Amiloride Tablets are and what they are used for 2. Before you take Amiloride Tablets 3. How to take Amiloride Tablets 4. Possible side effects 5. How to store Amiloride Tablets 6. Further information 1. WHAT AMILORIDE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Amiloride 5mg Tablets. It contains amiloride hydrochloride. This belongs to a group of medicines called diuretics (water tablets). Amiloride can be used to stop the build up of extra water in your body. It does this without loss of potassium from your body. This extra water can lead to high blood pressure, heart problems (congestive heart failure) and liver problems (hepatic cirrhosis). It works by helping you to pass more water (urine) than you usually do. 2. BEFORE YOU TAKE AMILORIDE TABLETS DO NOT TAKE AMILORIDE TABLETS AND TELL YOUR DOCTOR IF: • You are allergic (hypersensitive) to amiloride or any other ingredients in this medicine (listed in Section 6 below). Signs of an allergic reaction include: a rash, itching or shortness of breath • You have kidney problems • Your doctor has told you that you have high potassium levels or you are taking other potassium conserving drugs or potassium supplements • The person taking the medicine is a child under 18 years old. Do not take this medicine if any of Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amiloride 5 mg Tablets BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5.7mg Amiloride Hydrochloride Dihydrate equivalent to 5.0mg anhydrous Amiloride Hydrochloride. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Off white to creamy white, round, flat, uncoated tablets with beveled edges and debossed with "C" and "G" on either side of breakline and another side is plain. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Potassium- conserving agent;diuretic. Although Amiloride Hydrochloride may be used alone, its principal indication is as concurrent therapy with thiazides or more potent diuretics in order to conserve potassium during periods of vigorous diuresis and during long-term maintenance therapy. In congestive heart failure, Amiloride Hydrochloride may be effective alone, but its principal indication is for concomitant use in patients receiving thiazides or more potent diuretic agents. In hypertension, it is used as an adjunct to prolonged therapy with thiazides and similar agents to prevent potassium depletion. In hepatic cirrhosis with ascites, Amiloride Hydrochloride usually provides adequate diuresis, with diminished potassium loss and less risk of metabolic alkalosis, when used alone. It may be used with more potent diuretics when a greater diuresis is required while maintaining a more balanced serum electrolyte pattern. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults Amiloride Hydrochloride alone.The initial dosage is 10 mg (as a single dose or 5mg twice a day). The total daily dose should not exceed 20mg (4 tablets) per day. After diuresis has been achieved, the dosage may be reduced by 5mg increments to the least amount required. Amiloride Hydrochloride with other diuretic therapy When Amiloride is used with a diuretic which is given on an intermittent basis, it should be given at the same time as the diuretic. HYPERTENSION Usually half ‘Amiloride’ tablet (2.5mg) given once Läs hela dokumentet