Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terazosin hydrochloride
Viatris UK Healthcare Ltd
G04CA03
Terazosin hydrochloride
5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050400
Colours Non-Print Colours Date: Time: Equate CMYK with Dimensions Main Font Body Text Size Min Text Size used Page Count No. of colours Pharma Code SAP No. Vendor Job No. Trackwise Proof No. Client Market Keyline/Drawing No. Barcode Info Description Component Type Affiliate Item Code Superceded Affiliate Item Code TrackWise PR No. MA No. Packing Site/Printer Supplier Code Sign-offs v2/Oct 2016 1/2 1 Myriad Pro 15 Sep 2017 17:42 10 pt 10 pt 170 x 480 mm Terazosin Hydrochloride 5 mg,10 mg,2 mg,1 mg 28,30,84,50,20,7,14,98,100,10 Leaflet 1206831 618304 1206831 N/A N/A LT1858AB 202 N/A 313718 5 United Kingdom N/A N/A Black PACKAGE LEAFLET: INFORMATION FOR THE PATIENT BENPH 1 MG, 2 MG, 5 MG AND 10 MG TABLETS terazosin 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 Benph is and what it is used for 2. What you need to know before you take Benph 3. How to take Benph 4. Possible side effects 5. How to store Benph 6. Contents of the pack and other information 1. WHAT BENPH IS AND WHAT IT IS USED FOR Your medicine contains terazosin, which belongs to a group of medicines called alpha-blockers. Benph is given to adult men suffering from an enlarged prostate gland (part of the male sexual organs found just below the bladder, which can place pressure on the bladder, causing problems, when passing water (urine)), as it can relax the muscles allowing urine to be passed more easily. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENPH DO NOT TAKE BENPH: • if you are allergic to terazosin or any of the other Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Benph 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1MG: Each tablet contains 1mg of terazosin (in the form of terazosin hydrochloride dihydrate). _ _ Excipient with known effect: 55mg lactose monohydrate For the full list of excipients, see section 6.1. 2MG: Each tablet contains 2mg of terazosin (in the form of terazosin hydrochloride dihydrate). _ _ Excipient with known effect: 110mg lactose monohydrate For the full list of excipients, see section 6.1. 5MG: Each tablet contains 5mg of terazosin (in the form of terazosin hydrochloride dihydrate). _ _ Excipients with known effect: 110mg lactose monohydrate 0.01mg Sunset Yellow (E110) For the full list of excipients, see section 6.1. 10MG: Each tablet contains 10mg of terazosin (in the form of terazosin hydrochloride dihydrate). _ _ Excipients with known effect: 110mg lactose monohydrate 0.1mg Sunset Yellow (E110) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM 5mg: Tablet Light orange, round, flat, bevel edged, tablet imprinted “E” and “453” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benph tablets are indicated in adults for: - symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults only: The dose of terazosin should be managed according to each patient’s response. The following is a guide to administration. Initial dose An initial dose of 1.0mg daily should be given before bedtime. Strict compliance with this recommendation should be observed to minimise acute first-dose hypotensive episodes. Subsequent dose The dose may be increased by approximately doubling the dose at weekly or bi-weekly intervals to achieve the desired reduction in symptoms. The maintenance dose is usually 5 to 10mg once daily. Improvements in symptoms have been detected as early as two weeks after starting treatment with terazosin. At present there are insufficient data Baca dokumen lengkapnya