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Active substance(s): DOXAZOSIN MESILATE

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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.
In this leaflet:
1. What Doxazosin Tablets are and what they are used for.
2. Before you take Doxazosin Tablets.
3. How to take Doxazosin Tablets.
4. Possible side effects.
5. How to store Doxazosin Tablets.
6. Further information.
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
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
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
• 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
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.
3. how to take doxazosin tablets
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.
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
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.
If you forget to take your dose of Doxazosin Tablets
It is important that you take your medicine every day. However, if you forget to take one or more
doses, wait until the next dose is due and then go on as prescribed. Do not take a double dose to
make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects

Like with all medicines Doxazosin Tablets can cause side effects although not everybody gets
If you get any of the following symptoms after taking these tablets, you should stop taking
the tablets and contact your doctor immediately:
• heart attack
• weakness of the arms or legs or problems speaking which may be signs of a stroke
• swelling of the face, tongue or throat which may be a result of an allergic reaction to this
Doxazosin Tablets may also cause other serious side effects needing urgent medical attention. If
you experience any of the following you should tell your doctor as soon as possible.
• chest pain; angina
• shortness of breath or difficulty breathing
• an increased, decreased or irregular heartbeat
• feeling your heartbeat (palpitations)
• fainting
• yellowing of the skin or the eyes (symptoms of jaundice)
• low number of white blood cells or blood platelets, which may result in bruising or easy
Very Common side effects (affecting up to 1 in 10 people) include:
• dizziness
• headache
Common side effects (affecting up to 1 in 100 people) include:
• flu-like symptoms
• bronchitis; coughing; respiratory tract infection (nose, throat, lungs); blocked or runny nose
caused by inflammation of the lining of the nose (rhinitis)
• low blood pressure
• dizziness on standing; feeling of spinning (vertigo)
• anxiety; nervousness; insomnia (difficulty sleeping)
• feeling sick; stomach pains; diarrhoea
• dry mouth; indigestion; heartburn
• urinary tract infection; urinary incontinence (inability to control passing urine)
• feelings of weakness, tiredness and sleepiness
• swelling of the feet, ankles or fingers
• general feeling of being unwell (malaise)
• back pain; painful muscles
• numbness or tingling of the skin (paraesthesia)
Uncommon side effects (affecting up to 1 in 1,000 people) include:
• agitation; depression
• faintness and dizziness, especially on getting up from a sitting or lying position
• tremor (shaking)
• increased appetite; weight increase

• reduced sense of touch or sensation of the hands and feet
• ringing or noise in the ears (tinnitus)
• hot flushes
• nose bleeds
• increased urinary frequency; painful urination; blood in the urine
• constipation; flatulence (wind); being sick; inflammation of the stomach and intestines
(gastroenteritis) which can cause diarrhoea and vomiting
• alopecia (hair loss); red or purple patches on the skin; bleeding under the skin
• cough
• joint pain; inflammation of the joints (gout); muscle weakness; muscle cramps; general pain
• failure or inability to achieve an erection (impotence)
• liver enzyme increases which may have an effect on some medical tests
Very rare side effects (affecting up to 1 in 10,000 people) include:
• aggravated wheezing
• blurred vision
• a very slow heart rate
• hepatitis (liver inflammation); bile disorder
• gynaecomastia (swelling of the breast tissue in men)
• urticaria (hives)
• disorder in passing urine; needing to pass urine at night; increased volume of urine passed
• painful persistent erection of the penis
Other side effects (the frequency of these side effects is unknown)
• little or no semen ejaculated at sexual climax; cloudy urine following ejaculation
• eye problems may occur during eye surgery for cataract (cloudiness of the lens of the eye). See
section “Take special care with Doxazosin Tablets.
• taste disturbances
If any of these side effects become serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
5. how to store doxazosin tablets
Store the tablets in the pack in which they are supplied. There are no special storage
instructions. Do not use the tablets after the expiry date which is stated on the carton after
EXP. The expiry date refers to the last day of that month.
Keep all medicines out of the reach and sight of children.
Medicines should not be disposed of via wastewater or household waste. If you have any
Doxazosin Tablets left after completing your course of treatment, please return them to
your pharmacist who will dispose of them safely. These measures will help to protect the
What Doxazosin Tablets contain: The active substance is doxazosin mesilate.

Doxazosin 1mg Tablets: Each tablet contains 1.21mg doxazosin mesilate equivalent to 1mg
Doxazosin 2mg Tablets: Each tablet contains 2.42mg doxazosin mesilate equivalent to 2mg
Doxazosin 4mg Tablets: Each tablet contains 4.85mg doxazosin mesilate equivalent to 4mg
The other ingredients are lactose, magnesium stearate, microcrystalline cellulose, sodium lauryl
sulphate and sodium starch glycolate.
What Doxazosin Tablets look like and the contents of the pack:
Doxazosin 1mg Tablets are white coloured, round and biconvex.
Doxazosin 2mg Tablets are white coloured, and capsule shaped with a break line on one side.
Doxazosin 4mg Tablets are white coloured, capsule shaped biconvex and plain on both sides.
The tablets are supplied in blister packs of 28 and 30 tablets. Not all pack sizes may be marketed.
Your pharmacist will provide you with the required number of tablets as prescribed by your
Marketing Authorisation Holder and Manufacturer:
The Product Licence holder is Cipla (EU) Ltd, Hillbrow House, Hillbrow Road, Esher, Surrey,
KT10 9NW.
The manufacturer responsible for batch release is
Cipla (EU) Limited, 20 Balderton Street, London W1K 6TL, United Kingdom
Cipla Europe NV, Uitbreidingstraat 80, 2600 Antwerp, Belgium.
This leaflet was last revised in 01/2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.