देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PRAZOSIN HYDROCHLORIDE
PFIZER (MALAYSIA) SDN. BHD.
PRAZOSIN HYDROCHLORIDE
100 Tablet Tablets
PHARMANIAGA MANUFACTURING BERHAD
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 treat the poor and/or frequent passing of urine. This is common in patients with enlargement of the prostate gland. The treatment works by relaxing muscle around the bladder and prostate gland so urine can pass through easily. You should ask your doctor if you are unsure why you have been given MINIPRESS. BEFORE YOU USE MINIPRESS - _ When you must not use it _ Do not take MINIPRESS if you: • are allergic (hypersensitive) पूरा दस्तावेज़ पढ़ें
1 Pfizer Confidential Pharmaniaga LPD Title : MINIPRESS LPD Date : 6 January 201 5 Country : Malaysia References : CDS version 4 dated 11 November 20 14 Reason : Per RMC of Sep 8, priapism is being added to section 4.4 of the Prazosin tablets/capsules CDS. Note t hat priapism is a listed event in section 4.8 of the CDS and currently is not included in section 4.4 of the CDS. Additionally, format/editorial changes per recent QC review are being made. For details about the impact of the CDS -driven changes into the US PI refer to the GLDD prepared for the USPI in the widget related documents tab in the GDMS homepage of the newly revised USPI. PFIZER MINIPRESS* Prazosin Hydrochloride 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 Tablet : Orange, round, biconvex tablet with ‘K’ brea kline ‘K’ on one side and Pfizer logo on the other. Minipress 2 mg Tablet : White, round, biconvex tablet with ‘K’ breakline ‘K’ on one side and Pfizer logo on the other. Minipress 5 mg Tablet: White, diamond shaped tablet with ‘K’ breakline ‘K’ on one si de and ‘MNP’ breakline ‘5’ on the other. पूरा दस्तावेज़ पढ़ें