البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
TERAZOSIN AS MONOHYDRACHLORIDE DIHYDRATE
BIOTIS LTD
G04CA03
TABLETS
TERAZOSIN AS MONOHYDRACHLORIDE DIHYDRATE 5 MG
PER OS
Required
AMDIPHARM SALES & MARKETING LTD., UK
TERAZOSIN
TERAZOSIN
For symptomatic treatment of urinary obstruction caused by benign prostatic hypertrophy (BPH). For mild to moderate hypertension.
2021-12-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor’s prescription only HYTRIN 5 MG TABLETS HYTRIN 10 MG TABLETS Tablets Each tablet contains: Hytrin 5 mg Tablets: Terazosin (as monohydrochloride dihydrate) 5 mg Hytrin 10 mg Tablets: Terazosin (as monohydrochloride dihydrate) 10 mg Inactive and allergenic ingredients: see section 6 “Further Information” and in section 2 “Important information about some of the ingredients of the medicine”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1) WHAT IS THE MEDICINE INTENDED FOR? Hytrin Tablets is used for the symptomatic treatment of urinary tract obstruction caused by benign enlargement of the prostate gland (benign prostatic hyperplasia - BPH) and for the treatment of mild to moderate hypertension. Therapeutic group: Selective apha-1 andrenergic receptor blocker. 2) BEFORE USING THE MEDICINE Do not use the medicine if: You are sensitive (allergic) to terazosin or to any of the additional ingredients contained in the medicine. For the list of inactive ingredients, see section 6 “Further Information”. (Allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing). You are sensitive to any of the following medicines: alfuzosin, indoramin, prazosin, tamsulosin, doxazosin. You have ever fallen or fainted while passing water. Special warnings regarding use of the medicine Before taking the medicine, tell your doctor if you: Are taking other medicines for high blood pressure. If you start taking a medicine for اقرأ الوثيقة كاملة
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Hytrin 5 mg Tablets Hytrin 10 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Hytrin 5 mg tablets contain 5 mg of terazosin as monohydrochloride dihydrate. Hytrin 10 mg tablets contain 10 mg of terazosin as monohydrochloride dihydrate. Excipients with known effect: Hytrin 5 mg tablets: Lactose (123.07 mg). Hytrin 10 mg tablets: Lactose (117.68 mg) For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hytrin 5 mg tablets are: Tan, round, flat, bevelled edge tablets embossed with corporate logo and triangular facets on one face, plain on the other. Hytrin 10 mg tablets are: Blue, round, flat, bevelled edge tablets embossed with corporate logo and triangular facets on one face, plain on the other. 4. CLINICAL PARTICULARS 4.1. Therapeutic indications For symptomatic treatment of urinary obstruction caused by benign prostatic hypertrophy (BPH). For mild to moderate hypertension. 4.2. Posology and method of administration Posology Hypertension Adults Initial dose Do not start treatment with a new patient if it is not possible to reach a dose of 1 mg and 2 mg. 1 mg before bedtime is the starting dose for all patients and should not be exceeded. Compliance with this initial dosage recommendation should be strictly observed to minimise potential for acute first-dose hypotensive episodes. Subsequent doses The single daily dosage may be increased by approximately doubling the dosage at weekly intervals to achieve the desired blood pressure response. The usual maintenance dose is 2 mg to 10 mg once daily. Doses over 20 mg rarely improve efficacy and doses over 40 mg have not been studied. If 1 or 2 mg dose is not optional, the physician should consider alternative therapies for these patients. BPH Adults The dose of terazosin should be adjusted according to the patient’s response. The following is a guide to administration: Initial dose Do not start treatment with a new patient if it is not possible to reach a dose of 1 mg and 2 m اقرأ الوثيقة كاملة