Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Prazosin hydrochloride
Pfizer Ltd
C02CA01
Prazosin hydrochloride
500microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02050400; GTIN: 5013457019681
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER HYPOVASE ® 0.5 MG AND 1 MG TABLETS (prazosin hydrochloride) 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 Hypovase is and what it is used for 2. What you need to know before you take Hypovase 3. How to take Hypovase 4. Possible side effects 5. How to store Hypovase 6. Contents of the pack and other information 1. WHAT HYPOVASE IS AND WHAT IT IS USED FOR Hypovase contains the active substance prazosin hydrochloride, which 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, painful cold fingers (Raynaud’s Disease) or mild enlargement of the prostate gland (prostatic hyperplasia) in men. In patients with high blood pressure (hypertension) Hypovase works by relaxing blood 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, Hypovase works by relaxing the main blood vessels of the heart, allowing the heart to pump blood more easily. Hypovase 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 enlargement of the prostate gland the treatment is taken to treat poor and/o Read the complete document
OBJECT 1 HYPOVASE TABLETS 0.5MG Summary of Product Characteristics Updated 12-Jun-2017 | Pfizer Limited 1. Name of the medicinal product Hypovase 0.5 mg tablets 2. Qualitative and quantitative composition Prazosin hydrochloride equivalent to 500 micrograms prazosin base, based on potency of 93.1 % base activity. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Tablets. White and round marked "Pfizer" on one side. 4. Clinical particulars 4.1 Therapeutic indications _Hypertension: _Hypovase is indicated in the treatment of all grades of essential (primary) hypertension and all grades of secondary hypertension of varied aetiology. It can be used as the initial and sole agent or it may be employed in a treatment regimen in conjunction with a diuretic and/or other antihypertensive drug as needed for proper patient response. _Congestive heart failure: _Hypovase may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides. _Raynaud's phenomenon and Raynaud's disease: _Hypovase is indicated for the symptomatic treatment of patients with Raynaud's phenomenon and Raynaud's disease. _Benign prostatic hyperplasia: _Hypovase is indicated as an adjunct in the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia (BPH). It may therefore be of value in patients awaiting prostatic surgery. 4.2 Posology and method of administration Posology _Hypertension:_ The dosage range is from 500 micrograms – 20 mg daily. It is recommended that therapy be initiated at the lowest dose, 500 micrograms, twice or three times daily for three to seven days, with the starting dose administered in the evening. This dose should be increased to 1 mg twice or three times daily for a further three to seven days. Thereafter, the daily dose should be increased gradually as determined by the patient's response to the blood pressure lowering effect. Most patients are Read the complete document