Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Terazosin
Amdipharm Limited
G04CA; G04CA03
Terazosin
5 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Alpha-adrenoreceptor antagonists; terazosin
Marketed
1989-05-25
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT HYTRIN® 1 MG AND 2 MG TABLETS (STARTER PACK) HYTRIN® 2 MG TABLETS HYTRIN® 5 MG TABLETS HYTRIN® 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 Hytrin Tablets are and what they are used for 2. What you need to know before you take Hytrin Tablets 3. How to take Hytrin Tablets 4. Possible side effects 5. How to store Hytrin Tablets 6. Contents of the pack and other Information 1. WHAT HYTRIN TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Hytrin Tablets. Hytrin Tablets contains the active ingredient terazosin. Terazosin belongs to a group of medicines called alpha blockers. Hytrin Tablets are used to treat high blood pressure, either on its own or in combination with other medicines used to treat high blood pressure. Hytrin Tablets is also used for the treatment of a condition called benign prostatic hyperplasia (BPH) which affects the prostate and is common in older men. This condition stops the flow of urine from the bladder and can lead to symptoms such as a weak or interrupted urine flow, a need to pass water more frequently and/or a sudden need to pass water. Hytrin Tablets can relax the muscle of the prostate gland and bladder exit to help relieve these symptoms. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE HYTRIN TABLETS DO NOT TAKE HYTRIN TABLETS: - if you are allergic to terazosin or any of the other ingredients of this medicine (listed in section 6) - if you have a history of syncope (fainting) duri Izlasiet visu dokumentu
Health Products Regulatory Authority 16 March 2023 CRN00DC0C Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hytrin 5mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5mg terazosin (as terazosin hydrochloride dihydrate). Excipient with known effect Contains lactose monohydrate 123.07 mg per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet A tan round flat, bevel edged tablet embossed with company logo ' ' and triangular facets on one face and plain on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hytrin is a selective blocker of post-junctional alpha-1-adrenoreceptors. Hytrin is indicated as: A peripheral vasodilator for use in the management of hypertension either alone or in conjunction with other anti-hypertensive agents such as thiazide diuretics or beta-adrenoreceptor blockers. An alpha-1-adrenoreceptor blocker for use in the symptomatic treatment of benign prostatic hyperplasia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HYPERTENSION _Adults_ An initial dose of 1.0 mg should be given in the evening, one to two hours before retiring. If no untoward effect has occurred a dose of 2.0 mg daily may be given after 7 to 14 days. Subsequent increments should be tailored to the individual patient's response and requirements, bearing in mind the delay in complete response. The usual procedure thereafter is to increase the dose by gradual increments to the level of optimum response usually 5 - 10 mg daily. Doses over 20 mg rarely improve efficacy and doses over 40 mg have not been studied. If additional anti-hypertensive therapy is to be introduced, the dose of terazosin should be reduced and re-titration carried out if necessary. _Elderly_ In the elderly dosage should be kept as low as possible and increments made under close supervision. Health Products Regulatory Authority 16 March 2023 CRN00DC0C Page 2 of 7 BENIGN PROSTATIC HYPERPLASIA _Adults_ An initial dose of 1.0 mg daily should be give Izlasiet visu dokumentu