Patient leaflet - Doxazosin 8 mg tablets
1. What Doxazosin is and what it is used for
Doxazosin is one of a group of medicines called alpha-blockers. It is used to treat high blood pressure, or the symptoms caused by enlargement of the prostate gland in men.
Doxazosin can be used to treat high blood pressure (hypertension), by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.
In patients with an enlarged prostate gland, doxazosin is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. Doxazosin works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.
2. What you need to know before you take Doxazosin
Do not take Doxazosin
if you are allergic to doxazosin, other types of quinazolines (such as prazosin and terazosin) or any of the other ingredients
of this medicine (listed in section 6). This may have been itching, reddening of the skin or difficulty in breathing.
if you have an enlarged prostate gland (benign prostatic
hyperplasia) and have low blood pressure.
If you 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.
If you have an enlarged prostate gland with one of the following:
any kind of congestion or blockage in your urinary tract, a longstanding infection of the urinary tract or you have bladder stones.
if you 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Doxazosin if:
- you are pregnant or trying to become pregnant
- you have liver disease
- you are also taking other medicines
- you have heart disease
If you are undergoing eye surgery because of 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. Before starting treatment with Doxazosin your doctor may perform tests to rule out other conditions such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia (enlargement of the prostate gland).
Persistent painful erections may occur very rarely. If this happens you should contact a doctor immediately.
When you start to take Doxazosin you may experience faintness or dizziness caused by low blood pressure, when getting up from sitting or lying down. If you feel faint or dizzy, you should sit or lie down until you feel better and avoid situations where you might fall or hurt yourself. Your doctor may want to measure your blood pressure regularly at the start of therapy to reduce the possibility of these effects happening.
Children and adolescents
Doxazosin is not recommended for use in children or adolescents below 18 years as safety and efficacy have not yet been established. Benign prostate hyperplasia is not relevant in children.
Other medicines and Doxazosin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. There are some medicines that may interact with Doxazosin. Ask your doctor or pharmacist before use if you are taking any of these medicines as they may change the effect of Doxazosin.
- 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 medicines called PDE 5 inhibitors for the treatment of erectile dysfunction (impotence) with alpha-blockers e.g. sildenafil, tadalafil, vardenafil (please see Section “Warnings and precautions”). 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.
- Doxazosin may lower your blood pressure even more if you are already taking other medicines to treat high blood pressure.
Medicines to treat bacterial or fungal infections, e.g.
clarithromycin, itraconazole, ketoconazole, telithromycin, voriconazole
- Medicines used in the treatment of HIV e.g. indinavir, nelfinavir, ritonavir, saquinavir.
- Nefazodone, a medicine used to treat depression.
Doxazosin with food and drink
Please refer to section 3.
Pregnancy, breast-feeding and fertility
Breast-feeding
Small amounts of doxazosin can get into your breast milk. You should not use doxazosin during breast-feeding unless your doctor advises you to do so.
Pregnancy
The safety of using doxazosin during pregnancy has not been established. If you are pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Take care if you drive or operate machinery. Your tablets may affect your ability to drive or operate machinery safely, particularly when you first start to take them. They may make you feel weak or dizzy. If you are affected, do not drive or operate machinery and contact your doctor immediately.
Doxazosin contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Doxazosin tablet contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’
3. How to take Doxazosin
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist or nurse if you are not sure.
- The recommended dose of Doxazosin is one tablet taken once a day.
- If you are taking Doxazosin for the first time the normal dose is 1mg daily. Your doctor may increase this after a couple of weeks to the usual dose of 2mg or 4mg daily. In some circumstances this may be increased to a maximum of 8mg daily if you are being treated for prostate enlargement, or to a maximum of 16mg if you are being treated for high blood pressure.
- Doxazosin may be taken in the morning or the evening.
- It is best to take your tablets at about the same time each day with a drink of water.
- Doxazosin can be taken with or without food.
- Take your tablet as your doctor told you or by following the days and arrows on the blister foil.
- It is important to keep taking your tablets. They help to control your blood pressure.
- Do not change the dose or stop taking the tablets without first checking with your doctor.
- Do not wait until your tablets are finished before seeing your doctor.
Use in children
The safety and efficacy of Doxazosin in children have not been established.
If you take more Doxazosin than you should
Too many tablets at once may make you unwell. If several tablets are taken it may be dangerous. Tell your doctor immediately or go to your nearest hospital casualty department.
If you forget to take Doxazosin
Do not worry. If you forget to take a tablet, leave that dose out completely. Then go on as before. Do not take a double dose to make up for a forgotten tablet.
Sign / Date Product Name
2D Code
210 x 420 mm
40348
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Doxazosin and call an ambulance immediately if you experience any of the following:
- Heart attack
Weakness of arms, legs or problems speaking which may be
symptoms of a stroke
Swelling of the face, tongue or throat which may be the result of
an allergic reaction to this medicine
Tell your doctor immediately if you experience any of the following symptoms after taking Doxazosin:
Shortness of breath, difficulty breathing (common: may affect up
to 1 in 10 people)
Increased or decreased heartbeat (common: may affect up to 1
in 10 people)
Feeling your heartbeat (palpitations) (common: may affect up to
1 in 10 people)
Chest pain, angina (uncommon: may affect up to 1 in 100
people)
Irregular heartbeat (very rare: may affect up to 1 in 10,000
people)
Yellowing of the skin or the eyes (jaundice) (very rare: may affect
up to 1 in 10,000 people)
Low numbers of white blood cells or blood platelets, which may
result in bruising or easy bleeding (very rare: may affect up to 1 in 10,000 people)
Persistent painful erection of the penis. Seek urgent medical
advice (very rare: may affect up to 1 in 10,000 people)
The following events have been reported in patients being treated with Doxazosin. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor
Common: may affect up to 1 in 10 people
Dizziness, feeling of spinning or rotation of surroundings
(vertigo), headache
- Low blood pressure
- Swelling of feet, ankles or fingers
Chest cold, coughing, respiratory tract (nose, throat, lungs)
infection
Nasal stuffiness, sneezing and/or runny nose caused by
inflammation of the lining of the nose (rhinitis)
- Stomach/abdominal pains, feeling/being sick
Urinary tract infection, urinary incontinence (inability to control
passing urine), inflammation of bladder (cystitis)
- Sleepiness, general weakness
- Indigestion, heartburn, dry mouth
- Itching
- Back pain, painful muscles
- Flu-like symptoms
Uncommon: may affect up to 1 in 100 people
Constipation, wind, inflammation of the stomach and intestines
(gastroenteritis) which can cause diarrhoea and vomiting
Pain or discomfort on passing urine, increased frequency in
passing urine, blood in urine
- Inflammation of the joints (gout), painful joints, general pain
- Swelling of the face
- Sleeplessness, agitation, anxiety, depression or nervousness,
Reduced or altered sense of touch or sensation of the hands
and feet
- Increased appetite or loss of appetite, weight gain
- Nose bleeds
- Skin rash
- Ringing or noise in the ears, tremor
- Failure / inability to achieve penile erection
Liver enzyme increases which may have an effect on some
medical tests
- Stroke
Rare: may affect up to 1 in 1,000 people
- Increased number of times of passing urine
- Muscle cramps, muscle weakness
Very Rare: may affect up to 1 in 10,000 people
Faintness or dizziness caused by low blood pressure when
getting up from a sitting or lying position
- Hepatitis (liver inflammation) or bile disorder
Hives, hair loss, red or purple patches on the skin, bleeding
under the skin
- Tingling or numbness of the hands and feet
- Tiredness, generally feeling unwell
- Aggravated wheezing
- Blurred vision
- Hot flushes
Disorder in passing urine, needing to pass urine at night,
increased volume of urine passed
Discomfort or enlargement of the breasts in men
Not known :frequency cannot be estimated from available data
- Little or no semen ejaculated at sexual climax, cloudy urine following sexual climax
Eye problems may occur during eye surgery for cataract
(cloudiness of the lens of the eye). See section “Warnings and precautions”.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Doxazosin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, label, bottle and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage condition.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
6. Contents of the pack and other information
What Doxazosin contains
- The active substance is doxazosin. Each tablet contains 1/2/4/8 mg doxazosin (as doxazosin mesilate).
- The other ingredients are: Cellulose microcrystalline, lactose, sodium starch glycollate, magnesium stearate
What Doxazosin looks like and contents of the pack
Doxazosin 1mg tablets:
White to off-white coloured, circular biconvex shaped uncoated tablet debossed with ‘D O’ on one side and ‘1’ on other side
Doxazosin 2mg tablets:
White to off-white coloured, caplet shaped uncoated tablet debossed with ‘D O’ on one side separated by break line and ‘2’ on other side.
The tablet can be divided into equal halves.
Doxazosin 4mg tablets:
White to off-white coloured, diamond shaped uncoated tablet debossed with ‘D O’ on one side separated by break line and ‘4’ on other side.
The tablet can be divided into equal halves.
Doxazosin 8mg tablets:
White to off-white coloured, caplet shaped uncoated tablet debossed with ‘D O’ on one side separated by break line and ‘8’ on other side.
The tablet can be divided into equal halves.
PVC-PVDC Aluminium blisters:
Pack size: 10, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98, 100 and 140 tablets
HDPE bottle:
Pack size: 100 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
1 Roundwood Avenue
Stockley Park, Uxbridge
UB11 1AF
United Kingdom
Manufacturer
Milpharm Limited
1 Roundwood Avenue
Stockley Park, Uxbridge
UB11 1AF
United Kingdom
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
This leaflet was last revised in 10/2025