País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PRAZOSIN HYDROCHLORIDE
PFIZER (MALAYSIA) SDN. BHD.
PRAZOSIN HYDROCHLORIDE
100Tablet Tablets
PFIZER AUSTRALIA PTY. LTD.
Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ MINIPRESS ® TABLET Prazosin Hydrochloride (1 mg, 2 mg & 5 mg) 1 PLD TITLE: MINIPRESS PLD DATE: 04 April 2019 COUNTRY: Malaysia REFERENCE DOCUMENT: Malaysia LPD dated 13 April 2018 REASON FOR CHANGE : To align as per new template and the HA approved LPD To update PIL as per HA Request dated 18-Dec-2018 To align as per MINIPRESS PMB PIL To update PRH address Pfizer Confidential _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ MINIPRESS ® TABLET Prazosin Hydrochloride (1 mg, 2 mg & 5 mg) 2 WHAT IS IN THIS LEAFLET 1. What MINIPRESS is used for 2. How MINIPRESS works 3. Before you use MINIPRESS 4. How to use MINIPRESS 5. While you are using it 6. Side effects 7. Storage and Disposal of MINIPRESS 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT MINIPRESS IS USED FOR MINIPRESS is one of a group of medicines called alpha-blockers. It is usually used to treat high blood pressure (hypertension). It may also be used to treat heart failure (left ventricle- related), painful cold fingers (Raynaud’s Disease) or mild enlargement of the prostate gland (Benign prostatic hyperplasia) in men. HOW MINIPRESS WORKS In patients with high blood pressure (hypertension) MINIPRESS works by relaxing blood vessels (more on peripheral vessels) so that blood passes through them more easily. It can be used alone or in combination with other drugs used to treat hypertension. In patients with heart failure, MINIPRESS works by relaxing the main blood vessels of the heart, allowing the heart to pump blood more easily. MINIPRESS is usually used in heart failure when other drugs are either no longer working or have not worked at all. In patients with Raynaud’s Disease the treatment relaxes blood vessels in the hands, so blood can reach the fingers more easily. This helps to prevent coldness and stiffness. In patients with Benign Prostatic Hyperplasia, enlargement of the prostate gland, the medicine is taken to Leer el documento completo
Pfizer Confidential LPD Title : MINIPRESS LPD Date : 13 April 2018 Country : Malaysia References : CDS v4 dated 11 November 2014 Reason : To include product description information as per BoH directive 1. NAME OF THE MEDICINAL PRODUCT MINIPRESS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each prazosin hydrochloride tablet contains the equivalent of 1 mg, 2 mg or 5 mg of prazosin-free base. 3. PHARMACEUTICAL FORM Tablets Minipress 1 mg: An orange capsule shaped tablet with 'MNP 1' on one side and score line on the other. Minipress 2 mg: A round white tablet with 'MNP score line 2' on one side and plain on the other. Minipress 5 mg: A white diamond shaped tablet with 'MNP score line 5' debossing on one side and score line on the other. 4. CLINICAL PARTICULARS 4.1 Therapeutic Indications Hypertension Prazosin hydrochloride is indicated in the treatment of all grades of essential (primary) hypertension and all grades of secondary hypertension of varied etiology. It can be used as the initial and sole agent or it may be employed in a treatment program in conjunction with a diuretic and/or other antihypertensive drugs, as needed, for proper patient response. Left Ventricular Failure Prazosin hy drochloride is indicated in the treatment of left ventricular failure. Prazosin hydrochloride may be added to the therapeutic regimen in patients who have not shown a satisfactory response or who have become refractory to conventional therapy with diuretic s, with or without cardiac glycosides. Leer el documento completo