Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Finasteride
Arrow Generics Ltd
G04CB01
Finasteride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040200; GTIN: 5060034833598
PACKAGE LEAFLET: INFORMATION FOR THE USER FINASTERIDE 5 MG FILM-COATED TABLETS Finasteride P1521660 Black 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 is and what it is used for 2. What you need to know before you take Finasteride 3. How to take Finasteride 4. Possible side effects 5. How to store Finasteride 6. Contents of the pack and other information 1. WHAT FINASTERIDE IS AND WHAT IT IS USED FOR Finasteride belongs to the group of medicines, called 5-alpha reductase inhibitors. They act by reducing the size of the prostate gland in men. Finasteride is used in the treatment and control of benign enlargement of the prostate (benign prostatic hyperplasia - BPH). It causes regression of the enlarged prostate, improves urinary flow and symptoms caused by BPH, and reduces the risk of acute urinary retention and the need for surgery. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FINASTERIDE DO NOT TAKE FINASTERIDE - if you are allergic to finasteride or any of the other ingredients of this medicine (listed in section 6) - if you are a woman (because this medicine is for men) - if you are a child. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking Finasteride. − if you have a large amount of residual urine and/or severely reduced urinary flow. If this is the case, you should be closely monitored for narrowing of the urinary tract. − if you have a PSA test (test used to detect prostate cancer). Tell your doctor that you are taking finasteride. Finasteride can affec Preberite celoten dokument
OBJECT 1 FINASTERIDE 5MG TABLETS Summary of Product Characteristics Updated 17-Dec-2018 | Aurobindo Pharma - Milpharm Ltd. • 1. Name of the medicinal product • 2. Qualitative and quantitative composition • 3. Pharmaceutical form • 4. Clinical particulars • 4.1 Therapeutic indications • 4.2 Posology and method of administration • 4.3 Contraindications • 4.4 Special warnings and precautions for use • 4.5 Interaction with other medicinal products and other forms of interaction • 4.6 Fertility, pregnancy and lactation • 4.7 Effects on ability to drive and use machines • 4.8 Undesirable effects • 4.9 Overdose • 5. Pharmacological properties • 5.1 Pharmacodynamic properties • 5.2 Pharmacokinetic properties • 5.3 Preclinical safety data • 6. Pharmaceutical particulars • 6.1 List of excipients • 6.2 Incompatibilities • 6.3 Shelf life • 6.4 Special precautions for storage • 6.5 Nature and contents of container • 6.6 Special precautions for disposal and other handling • 7. Marketing authorisation holder • 8. Marketing authorisation number(s) • 9. Date of first authorisation/renewal of the authorisation • 10. Date of revision of the text 1. Name of the medicinal product Finasteride 5mg film-coated tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 5mg finasteride Excipient with known effect: lactose monohydrate (97.5mg) For the full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated tablet Blue coloured, circular, 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 5mg is indicated for the treatment and control of benign prostatic hyperplasia (BPH) 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 prosta Preberite celoten dokument