Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amiloride hydrochloride
Sigma Pharmaceuticals Plc
C03DB01
Amiloride hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02020300
PACKAGE LEAFLET: INFORMATION FOR THE USER Amiloride 5 mg Tablets BP (Amiloride Hydrochloride) 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, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Amiloride 5 mg tablets are and what are they used for 2. What you need to know before you take Amiloride 5 mg tablets 3. How to take Amiloride 5 mg tablets 4. Possible side effects 5. How to store Amiloride 5 mg tablets 6. Contents of the pack and other information 1. WHAT AMILORIDE 5 MG TABLETS ARE AND WHAT ARE THEY USED FOR Amiloride 5 mg tablets belong to a group of medicines called diuretics (water tablets). Amiloride 5 mg tablets can be used on their own (monotherapy) or with other drugs such as thiazide diuretics. They may be used for: • high blood pressure • congestive heart failure • liver cirrhosis with swelling of the abdomen (ascites). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AMILORIDE 5 MG TABLETS DO NOT TAKE Amiloride 5 mg tablets: • if you are allergic to amiloride hydrochloride or any of the other ingredients of this medicine (listed in section 6). • if you are giving the tablets to a CHILD • if you are taking any POTASSIUM CONSERVING DRUGS OR POTASSIUM SUPPLEMENTS • if you are NOT PRODUCING any urine • if you are PREGNANT or BREASTFEEDING or if YOU HAVE: • HIGH BLOOD LEVELS of POTASSIUM (hyperkalaemia) • SEVERE KIDNEY DISEASE or kidney FAILURE • DIABETIC NEUROPATHY (diabetic nerve damage causing pain, weakness or numbness). Do not take this medicine if any of the above apply to you. If you are no Citiți documentul complet
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 Citiți documentul complet