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DOXAZOSIN 4 MG TABLETS

Active substance(s): DOXAZOSIN MESILATE / DOXAZOSIN MESILATE / DOXAZOSIN MESILATE

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Package leaflet: Information for the user
Doxazosin 1 mg tablets
Doxazosin 2 mg tablets
Doxazosin 4 mg tablets
(doxazosin mesilate)
Important things that you SHOULD know about your medicine:
 Doxazosin tablets are a treatment for high blood pressure, or the symptoms caused by
enlargement of the prostate gland in men.
 This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
 You should take Doxazosin tablets regularly to get the maximum benefit, even if you are
feeling well.
 Most people do not have serious problems when taking Doxazosin tablets but side effects can
occur – see section 4 for details. If you experience swelling of the face, tongue or windpipe,
see your doctor immediately. If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
 Taking other medicines may sometimes cause problems. Check with your doctor or
pharmacist before taking this or any other medicines.
 If you are, or are trying to become pregnant, do not take Doxazosin tablets and tell your
doctor.
Please read the rest of this leaflet. It includes other important information on the safe and
effective use of this medicine that might be especially important to you. If you have any further
questions, ask your doctor or pharmacist.

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 further questions, please 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 Doxazosin Tablet is and what it is used for
2. What you need to know before you take Doxazosin Tablets.
3. How to take Doxazosin Tablets.
4. Possible side effects.

5. How to store Doxazosin Tablets.
6. Contents of the pack and other information
1. What Doxazosin Tablet is and what it is used for
Doxazosin Tablet contains the active substance doxazosin which belongs to a group of medicines
called alpha-blockers. Doxazosin Tablets are used to treat high blood pressure or the symptoms
caused by enlargement of the prostate gland in men.
Doxazosin Tablets 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 Tablets is taken to treat poor and/or
frequent passing of urine. This is common in patients with an enlarged prostate gland. Doxazosin
Tablets 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 Tablets
Do not take Doxazosin Tablets if you:
• are allergic to doxazosin, other type of quinazolines (such as prazosin or terazosin) or any
of the other ingredients of this medicine (listed in section 6).
• are breast-feeding
• If you are under 18 years of age
• have an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure
• 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; or you have
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.
Warnings and precautions:
Talk to your doctor or pharmacist before taking Doxazosin Tablets if you:
• have liver disease
• are also taking other medicines
• 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).
If any of these apply to you speak to your doctor before taking this medicine.
When you start to take Doxazosin Tablets 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 Tablet is not recommended for use in children or adolescents below 18 years as safety
and efficacy have not yet been established.
Other medicines and Doxazosin Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
 Doxazosin tablets may lower your blood pressure even more if you are already taking other
medicines to treat your high blood pressure such as terazosin and prazosin.
• phosphodiesterase inhibitors, such as sildenafil, 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.
Doxazosin tablets with food and drink
These tablets are for oral use. Take the tablets with a glass of water. You can take your tablets
with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before taking this medicine.

The safety of using Doxazosin Tablets during pregnancy has not been established.
Do not take Doxazosin Tablets if you are breast-feeding
Driving and using machines
Take care if you drive or operate machinery. This medicine may affect your ability to drive or
operate machinery safely, particularly when you first start to take them. Doxazosin may make
you feel weak or dizzy. If affected do not drive or operate machinery and contact your doctor
immediately.
Doxazosin Tablets contains 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
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist.
The usual doses for Doxazosin are as follows:
Adults and the elderly: The recommended dose of Doxazosin Tablets is one tablet taken as a
single daily dose each day.
Doxazosin Tablets may be taken in the morning or the evening.
You can take your tablets with or without food.
You should take your tablets at the same time each day with a small amount of water.
If you are taking Doxazosin Tablets 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 daily if you are being treated for high blood
pressure.
If you are still not sure, ask your doctor or pharmacist.
It is important to keep taking your tablets. They help to control your blood pressure.
Don’t change the dose or stop taking the tablets without first checking with your doctor.
Don't wait until your tablets are finished before seeing your doctor.
Use in children and adolescents:

Doxazosin Tablet is not recommended for use in children or adolescents below 18 years as safety
and efficacy have not yet been established.
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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you get any of the following symptoms after taking these tablets, you should stop taking
the tablets and contact your doctor immediately:
Common (may affect up to 1 in 10 people):
• shortness of breath or difficulty breathing
• increased heartbeat
• feeling your heartbeat (palpitations)
• fainting
Uncommon (may affect up to 1 in 100 people):
• signs of a 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
medicine
• chest pain; angina
Very rare may affect up to 1 in 10,000 people):
• decreased or irregular heartbeatyellowing 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
bleeding
Frequency (Very rare may affect up to 1 in 10,000 people):
• sign of inflammation of the liver or changes in the way your liver is working (hepatitis)
• persistent painful erection of the penis
Other side effects include:
Common side effects (may affect up to 1 in 10 people):














flu-like symptoms
bronchitis; coughing; respiratory tract infection (nose, throat, lungs);
nasal stuffiness, sneezing and/or runny nose caused by inflammation of the lining of the nose
(rhinitis)
low blood pressure
dizziness on standing; feeling of spinning or rotating of surroundings (vertigo); headache
feeling sick; stomach/ abdominal pains;
dry mouth; indigestion; heartburn
urinary tract infection; urinary incontinence (inability to control passing urine) ;
inflammation of bladder (cystitis)
feelings of weakness, sleepiness
swelling of the feet, ankles or fingers
back pain; painful muscles
itching

Uncommon side effects (may affect up to 1 in 100 people):
• agitation; depression or nervousness; sleeplessness; anxiety
• tremor (shaking)
• increased appetite or loss of appetite; weight increase
• reduced or altered sense of touch or sensation of the hands and feet
• ringing or noise in the ears (tinnitus)
• nose bleeds
• pain or discomfort on passing urine; increased frequency in passing urine; blood in the urine
• constipation; flatulence (wind); inflammation of the stomach and intestines (gastroenteritis)
which can cause diarrhoea and vomiting
• joint pain; inflammation of the joints (gout); general pain
• failure or inability to achieve an erection (impotence)
• liver enzyme increases which may have an effect on some medical tests
• skin rash
• swelling of the face
Rare side effects (may affect up to 1 in 1000 people):



increased number of times of passing urine
muscle cramps, muscle weakness

Very rare side effects (may affect up to 1 in 10000 people):
• aggravated wheezing
• blurred vision
• gynaecomastia (swelling of the breast tissue in men)
• urticaria (hives), hair loss, red or purple patches on the skin, bleeding under the skin
• disorder in passing urine; needing to pass urine at night; increased volume of urine passed
• hot flushes
• faintness or dizziness caused by low blood pressure when getting up from a sitting or lying
position
• tingling or numbness of the hands and feet



tiredness, generally feeling unwell

Not known (frequency cannot be estimated from the available data)
• 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 “Warnings and precautions”.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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. By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Doxazosin Tablets
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 carton after EXP. The expiry
date refers to the last day of that month.
This medicinal product does not require any special storage conditions
Do not throw 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 Tablets contain:


The active substance is doxazosin.

o Doxazosin 1mg Tablets: Each tablet contains 1 mg doxazosin (as mesilate)
o Doxazosin 2mg Tablets: Each tablet contains 2 mg doxazosin (as mesilate)
o Doxazosin 4mg Tablets: Each tablet contains 4 mg doxazosin (as mesilate)


The other ingredients are lactose monohydrate, 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, round, biconvex tablets.
Doxazosin 2mg tablets are whitecapsule shaped tablets with a break line on one side.
Doxazosin 4mg tablets are white, capsule shaped, biconvex tablets plain on both sides.
The tablets are supplied in PVC/aluminium blister packs containing 28 or 30 tablets.

Not all pack sizes may be marketed.

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 December 2016.

Expand Transcript

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.

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