Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Finasteride
Waymade Healthcare Plc
G04CB01
Finasteride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 06040200
PHARMA CODE NO: 8770 > GBR 726-7073-APIL Patient Information Leaflet Finasteride 5 MG 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. SPECIAL PRECAUTIONS 4. HOW TO TAKE FINASTERIDE TABLETS 5. POSSIBLE SIDE EFFECTS 6. HOW TO STORE FINASTERIDE TABLETS 7. 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 of the other ingredients in Finasteride Tablets (see section 7); • are a woman; • are a child as finasteride tablets are not recommended for children. CHECK WITH YOUR DOCTOR OR PHARMACIST BEFORE TAKING FINASTERIDE TABLETS IF YOU • have difficulty emptying your bladder completely or a greatly reduced flow of urine. Your doctor should examine you before you start taking Finasteride Tablets to exclude other obstructions in the urinary tract; • have liver problems. Finasteride Tablets can normally be taken with other medicines. However, please ask your doctor or pharmacist before you take other medicines at the same time or if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 3. SPECIAL PRECAUT Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Finasteride 5 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated 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. Blue, round biconvex 7 mm film-coated tablet with “F5” marking 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. Finasteride 5 mg tablets should be administered in patients with an enlarged prostate (prostate volume above ca. 40 ml). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Dosage in Adults_ _: _The recommended dosage is one 5 mg tablet daily with or without food. The tablet should be swallowed whole and must not be divided or crushed (see section 6.6). Even though improvement can be seen within a short time, treatment for at least six months may be necessary in order to determine objectively whether a satisfactory response to the treatment has been achieved. _Dosage in Children:_ Finasteride is contraindicated in children (see section 4.3). _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. _Dosage in hepatic insufficiency: _There are 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 stud Izlasiet visu dokumentu