Land: Malta
Tungumál: enska
Heimild: Malta Medicines Authority
FINASTERIDE
Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta
G04CB01
FINASTERIDE 5 mg
FILM-COATED TABLET
FINASTERIDE 5 mg
POM
UROLOGICALS
Authorised
2016-09-14
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER FINASTERIDE AUROBINDO 5 MG FILM-COATED TABLETS finasteride 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 signs of illness are the same as yours. - If you get any 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 Finasteride Aurobindo is and what it is used for 2. What you need to know before you take Finasteride Aurobindo 3. How to take Finasteride Aurobindo 4. Possible side effects 5. How to store Finasteride Aurobindo 6. Contents of the pack and other information 1. WHAT FINASTERIDE AUROBINDO IS AND WHAT IT IS USED FOR Finasteride Aurobindo belongs to the group of medicines, called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men. The prostate gland is found underneath the bladder (but only in men). It produces the fluid found in semen. A swollen prostate gland can lead to a condition called ‘benign prostatic hyperplasia’ or BPH. WHAT IS BPH? If you have BPH it means that your prostate gland is swollen. It can press on the tube that urine passes through, on its way out of your body. This can lead to problems such as: • feeling like you need to pass urine more often, especially at night, • feeling that you must pass urine right away, • finding it difficult to start passing urine, • when you pass urine the flow of urine is weak, • when you pass urine the flow stops and starts, • feeling that you cannot empty your bladder completely. In some men, BPH can lead to more serious problems, such as: • urinary tract infections, • a sudden inability to pass urine (acute urinary retention), • t Lestu allt skjalið
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Finasteride Aurobindo 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg finasteride. Excipient with known effect: contains 97.5 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Blue coloured, circular (diameter is 7.6 mm), biconvex, beveled edged film-coated tablets debossed with ‘E’ on one side and ‘61’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Finasteride Aurobindo 5 mg is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in adult patients with enlarged prostate to: - cause regression of the enlarged prostate, improve urinary flow and improve the symptoms associated with BPH, - reduce the incidence of acute urinary retention and reduce need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology DOSAGE IN ADULTS The recommended dosage is one 5 mg tablet daily with or without food. Even though improvement can be seen within a short time, treatment for at least 6 months may be necessary in order to determine objectively whether a satisfactory response to treatment has been achieved. Special population: DOSAGE IN THE ELDERLY Dosage adjustments are not necessary although pharmacokinetic studies have shown that the elimination rate of finasteride is slightly decreased in patients over the age of 70. Page 2 of 12 DOSAGE IN HEPATIC INSUFFICIENCY There is no data available in patients with hepatic insufficiency (see section 4.4). DOSAGE IN RENAL INSUFFICIENCY Dosage adjustments are not necessary in patients with varying degrees of renal insufficiency (starting from creatinine clearance as low as 9 ml/min) as in pharmacokinetic studies renal insufficiency was not found to affect the elimination of finasteride. Finasteride has not been studied in patients on haemodialysis. Lestu allt skjalið