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PATIENT INFORMATION LEAFLET DOXAZOSIN 1mg, 2mg and 4mg TABLETS

(doxazosin mesilate)

Read all of this leaflet carefully before you start taking this medicine.

•    Keep this leaflet. You may need to read it again.

•    If you have further questions, please ask your doctor or your pharmacist.

•    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Doxazosin is one of a group of medicines called alpha blockers. Doxazosin Tablets are used for the treatment of a condition called benign prostatic hyperplasia (BPH) which is common in older men.

BPH is caused by the prostate gland growing too big and obstructing the flow of urine from the bladder. This leads to some unpleasant symptoms such as weak or interrupted urine flow, a need to pass water more frequently and/or a sudden need to pass water. Doxazosin can relax the muscle of the prostate gland and bladder exit to help relieve these symptoms.

Doxazosin is also used to treat hypertension (high blood pressure) by relaxing blood vessels so that blood passes through them more easily. This has the effect of helping to reduce the blood pressure.

2. BEFORE YOU TAKE DOXAZOSIN TABLETS

Do not take Doxazosin Tablets if you:

•    are allergic (hypersensitive) to doxazosin, other alpha-blockers (e.g. prazosin or terazosin) or any of the other ingredients in the tablets (these are listed in Section 6, Further Information)

•    are breast-feeding and are taking Doxazosin Tablets for high blood pressure

•    have low blood pressure and are taking Doxazosin Tablets for benign prostatic hyperplasia

•    have a history of a condition known as 'orthostatic hypotension' which is a form of low blood pressure that causes you to feel dizzy or light-headed when you stand up from sitting or lying down

•    have an enlarged prostate gland with any one of the following: any kind of congestion or blockage in your urinary tract; a long standing infection of the urinary tract; bladder stones

•    have overflow incontinence (you do not feel the urge to urinate), or anuria (your body is not producing any urine) with or without kidney problems.

If any of the above apply to you talk to your doctor who will decide what to do.

Take special care with Doxazosin Tablets:

Before you take Doxazosin Tablets you should tell your doctor if you:

•    have liver disease

•    have heart disease

If you are undergoing eye surgery because of a cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used doxazosin. This is because doxazosin may cause complications during the surgery which can be managed if your specialist is prepared in advance.

Doxazosin treatment might cause you to feel faint or dizzy, particularly when you stand up quickly, so you should avoid situations when this might cause you to fall over or collapse. This is more likely to happen when you are starting treatment or are increasing the dose.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Certain medicines can interfere with the effectiveness of each other. It is particularly important to tell your doctor or pharmacist before taking this medicine if you are also on:

•    medicines to treat high blood pressure

•    phosphodiesterase inhibitors, such as sildenafil (Viagra), tadalafil and vardenafil for erectile dysfunction

Some patients, who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement, may experience dizziness or light-headedness, which may be caused by low blood pressure upon sitting or standing up quickly. Certain patients have experienced these symptoms when taking drugs for erectile dysfunction (impotence) with alpha-blockers.

In order to reduce the likelihood that these symptoms occur, you should be on a regular daily dose of your alpha-blocker before you start drugs for erectile dysfunction.

It may still be alright for you to take Doxazosin Tablets and your doctor will be able to decide what is suitable for you.

Taking your medicine with food and drink

These tablets are for oral use. Take the tablets with a glass of water. You can take your tablets before or after food.

Pregnancy and breast-feeding

The safety of using Doxazosin Tablets during pregnancy has not been established. If you are pregnant, likely to become pregnant or suspect you are pregnant you must tell your doctor before taking this medicine.

Do not take Doxazosin Tablets if you are breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Doxazosin may affect your ability to drive or operate machinery safely, particularly at the beginning of treatment. Doxazosin may make you feel faint or dizzy. If affected do not drive or operate machinery.

Important information about some of the ingredients of Doxazosin Tablets

These tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Method of Administration

The tablets should be swallowed whole with plenty of water before or after a meal each day. Take your tablets at the same time each day.

Dosage

Always take Doxazosin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The label on the carton will tell you how to take your medicine.

The usual doses for Doxazosin are as follows:

Adults and the elderly: your dose of Doxazosin is to be taken only once daily.

If you have been prescribed Doxazosin Tablets for the first time the normal dose is 1mg daily. After this, your doctor may increase your dose to 2mg or 4mg daily. In certain cases, your dose may be further increased to a maximum of 8mg daily if you are being treated for prostate enlargement or 16mg daily if you are being treated for high blood pressure.

Doxazosin Tablets are not recommended for children.

If you take more Doxazosin Tablets than you should

If you have accidentally taken more than your prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you.

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