Država: Velika Britanija
Jezik: angleščina
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Terazosin hydrochloride
Focus Pharmaceuticals Ltd
G04CA03
Terazosin hydrochloride
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050400
BLACK PANTONE® GREEN C ZINC Ref: EAS3577B LEA TERAZOSIN 2MG 5MG 10MG TAB TUK 28 MAY 2020 Version: 3 Colours Used: Length: Width: Depth: 323 MM 160 MM - TEMPLATE UK & Ireland Artwork Department TERAZOSIN 2 MG, 5 MG AND 10 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 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. 1. WHAT TERAZOSIN IS AND WHAT IT IS USED FOR 2. BEFORE YOU TAKE TERAZOSIN 3. HOW TO TAKE TERAZOSIN 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TERAZOSIN 6. FURTHER INFORMATION WHAT TERAZOSIN IS AND WHAT IT IS USED FOR Terazosin belongs to a group of medicines called alpha-blockers. Terazosin is used to treat: • high blood pressure • blocked urine flow caused by benign prostatic hyperplasia (BPH), which is common in older men BPH is caused by the prostate gland growing too big and obstructing the flow of urine from the bladder. This leads to some unpleasant symptoms such as weak or interrupted urine flow, a need to pass water more frequently and/or a sudden need to pass water. Terazosin can relax the muscle of the prostate gland and bladder exit to help relieve these symptoms. BEFORE YOU TAKE TERAZOSIN DO NOT TAKE TERAZOSIN IF YOU: • are allergic (hypersensitive) to terazosin or any of the other ingredients of this medicine • are allergic (hypersensitive) to other similar medicines such as prazosin or doxazosin • have ever fainted when urinating • have the rare hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. TAKE SPECIAL CARE WITH TERAZOSIN TALK TO YOUR DOCTOR BEFORE YOU START TO TAKE THIS MEDICINE IF YOU: • have any liver problems • ha Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Terazosin Teva 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 11.87mg of terazosin hydrochloride dihydrate equivalent to 10 mg of terazosin. Excipient with known effect: Each 10 mg tablet contains 109.03 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Mottled blue, round, flat tablet with bevelled edges embossed with “93” on one-side and “763” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Terazosin Teva Tablets are indicated for: The treatment of mild to moderate hypertension. The symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use. For the different dosage regimens suitable strengths are available. The dose of terazosin should be adjusted according to the patient's response. The following is a guide to administration: INITIAL DOSE The lowest single dose of 1 mg before bedtime for all patients which should not be exceeded. Strict compliance with this recommendation should be observed to minimise potential acute first-dose hypotensive episodes. SUBSEQUENT DOSES Treatment of mild to moderate hypertension. The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired blood pressure response. The maintenance dose needs to be adjusted to the patient’s response. 2 mg/day may be sufficient with increases up to 10 mg if necessary (clinical studies support the use of 2 – 10 mg as maintenance dose). The maximum dose is 20 mg of terazosin per day and should not be exceeded. Use with thiazide diuretics and other antihypertensive agents in the treatment of hypertension When adding a thiazide diuretic or another antihypertensive agent to a patient's regimen the dose of terazosin should be reduced or discontinued and retitration carried out if necessary. Caution should be observed when terazo Preberite celoten dokument