Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Finasteride
Accord-UK Ltd
G04CB01
Finasteride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040200; GTIN: 5060149312377
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND UK-Eire-Artwork-Support@Actavis.com Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item no: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. FINASTERIDE 5MG TABLETS PIL - UK Black Code Area BBBA1092 S.Anson 31.07.17 140 x 210 7.5pt Intas 31.07.17 31.07.17 1 FINASTERIDE 5MG TABLETS 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 pharmacist. – This medicine has been prescribed 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 the 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 FINASTERIDE TABLETS ARE AND WHAT THEY ARE USED FOR 2. BEFORE YOU TAKE FINASTERIDE TABLETS 3. HOW TO TAKE FINASTERIDE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE FINASTERIDE TABLETS 6. FURTHER INFORMATION 1. WHAT FINASTERIDE TABLETS ARE AND WHAT THEY ARE USED FOR Finasteride belongs to a 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 (not cancerous) enlargement of the prostate. 2. BEFORE YOU TAKE FINASTERIDE TABLETS DO NOT TAKE FINASTERIDE TABLETS IF YOU – are ALLERGIC (hypersensitive) to finasteride or any other ingredients in Finasteride tablets (see section 6) – are a WOMAN who is pregnant, or who may potentially be pregnant CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING FINASTERIDE TABLETS IF YOU – have DIFFICULTY EMPTYING YOUR BLADDER COMPLETELY or a greatly REDUCED FLO Read the complete document
OBJECT 1 FINASTERIDE 5 MG TABLETS Summary of Product Characteristics Updated 28-Nov-2017 | Accord-UK 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 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 • Administrative data • 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 5 mg Tablets 2. Qualitative and quantitative composition Each tablet contains 5 mg of finasteride Excipients: Each tablet contains 90.95 mg of lactose monohydrate For a full list of excipients, see section 6.1 3. Pharmaceutical form Film-coated tablets Film-coated, Blue, round biconvex tablets. Diameter 7mm. Marked “F5” on one side. 4. Clinical particulars 4.1 Therapeutic indications Finasteride is indicated for the treatment and control of benign prostatic hyperplasia (BPH) in patients with an 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 the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. 4.2 Posology an Read the complete document