Valsts: Malta
Valoda: angļu
Klimata pārmaiņas: Malta Medicines Authority
AMILORIDE HYDROCHLORIDE
Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom
C03DB01
AMILORIDE HYDROCHLORIDE 5 mg
TABLET
AMILORIDE HYDROCHLORIDE 5 mg
POM
DIURETICS
Withdrawn
2006-08-18
1 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 the above apply to you. If you are not sure, talk to your doctor before taking Amiloride Tablets. TAKE SPECIAL CARE WITH AMILORIDE TABLET Izlasiet visu dokumentu
Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amiloride 5mg Tablets BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Amiloride hydrochloride (anhydrous equivalent) 5.0mg For excipients, see 6.1 3 PHARMACEUTICAL FORM Tablet for oral use Amiloride 5mg Tablets BP are yellow, round tablets marked AML5 with breakline on one side and CP on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amiloride is a diuretic used alone or as an adjunct to other diuretics in the treatment of oedema and hypertension. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Adults:_ Initially 10mg daily or 5mg twice daily, adjusted according to response. The dosage may be increased up to a maximum of 20mg daily. Used as an adjunct to other diuretics for hypertension and congestive heart failure: Initially 5mg or 10mg daily. Cirrhosis with ascites: Initially 5mg daily. _ _ _Elderly:_ The dosage should be adjusted according to renal function, blood electrolytes and diuretic response. _ _ _Children under 18 years :_ Not indicated. Page 2 of 6 4.3 CONTRAINDICATIONS Hyperkalaemia, severe renal impairment, prior sensitivity to amiloride. Other potassium- sparing drugs and potassium supplements are contraindicated during amiloride therapy. The safety of amiloride hydrochloride for use in children under 18 years of age has not been established. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Amiloride should be given with caution to elderly patients, patients likely to develop acidosis, patients with diabetes mellitus and those with impaired hepatic or renal function. Patients with impaired renal function should be monitored carefully for serum electrolytes and blood urea levels, as should seriously ill patients, such as those with hepatic cirrhosis with ascites and metabolic alkalosis or those with resistant oedema who are also taking diuretics. Patients taking amiloride either alone or with other diuretics or angiotensin-converting enzyme inhibitors may develop hyperkalaemia. Serum electrolytes and blood urea Izlasiet visu dokumentu