Doxazosin 2mg Tablets
PATIENT INFORMATION LEAFLET
DOXAZOSIN 1 MG TABLETS DOXAZOSIN 2 MG TABLETS DOXAZOSIN 4 MG TABLETS
(as 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 onto others. It may harm them, even if their symptoms are the same as yours.
• 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.
In this leaflet:
1. What DOXAZOSIN is and what it is used for
2. Before you take DOXAZOSIN
3. How to take DOXAZOSIN
4. Possible side effects
5. Storing DOXAZOSIN
6. Further information
The name of your medicine is DOXAZOSIN 1 mg Tablets, DOXAZOSIN 2 mg Tablets, DOXAZOSIN 4 mg Tablets (referred to as DOXAZOSIN throughout this leaflet).
1. WHAT DOXAZOSIN IS AND WHAT IT IS USED FOR Doxazosin is one of a group of medicines called alpha-blockers.
DOXAZOSIN tablets are used to treat high blood pressure (hypertension) or the symptoms caused by enlargement of the prostate gland in men.
In patients taking DOXAZOSIN to treat high blood pressure (hypertension) DOXAZOSIN works by relaxing blood vessels so that blood passes through them more easily. This helps to lower blood pressure.
In patients with enlargement of the prostate gland, DOXAZOSIN is taken to treat frequent and/or poor passing of urine. This is common in patients with enlargement of the prostate gland. DOXAZOSIN works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.
2. BEFORE YOU TAKE DOXAZOSIN Do not take DOXAZOSIN if you:
• have ever had an allergic reaction (hypersensitivity) to doxazosin, other types of quinazolines (such as prazosin or terazosin) or any of the other ingredients of DOXAZOSIN tablets listed in section 6. This may have been itching, reddening of the skin or difficulty in breathing.
• are breastfeeding
• are aged under 16 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 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
• 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
Take special care with DOXAZOSIN:
The following are reasons why DOXAZOSIN may not be suitable for you:
• If you have liver disease
• If you are pregnant or trying to become pregnant
• If you are also taking other medicines
• If 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.
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.
Taking other medicines:
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.
DOXAZOSIN may lower your blood pressure even more if you are already taking other medicines to treat your blood pressure such as terazosin or prazosin.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Taking DOXAZOSIN with food and drink DOXAZOSIN can be taken with or without food.
Pregnancy:
The safety of using DOXAZOSIN during pregnancy has not been established. If you are pregnant or trying to become pregnant speak to your doctor and he/she will decide if DOXAZOSIN is suitable for you.
Breastfeeding:
Do not take DOXAZOSIN if you are breast-feeding.
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 affected, do not drive or operate machinery and contact your doctor immediately.
Important information about some of the ingredients of DOXAZOSIN: This medicine 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
Adults and Elderly:
Always take DOXAZOSIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.
DOXAZOSIN is usually taken once daily. DOXAZOSIN may be taken in the morning or the evening.
You can take your tablets before or after food.
You should take your tablets at the same time each day with a small amount of water.
The initial dose of DOXAZOSIN is 1mg once daily. Thereafter the dose may be gradually increased (within 1-2 weeks interval) to the usual dose (2mg or 4mg daily).
In some circumstances the dose 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.
Children:
This medicine is not recommended for children.
You have been given a calendar pack that will help you remember to take your tablets. If you are taking more than one tablet a day, you must ignore the marking for the day, printed on the back of the blister.
Because high blood pressure is treated in order to prevent problems from arising, you may have no symptoms at all while taking DOXAZOSIN. Even if this is so and you feel well, you should not stop taking your blood pressure medication unless instructed to by your doctor.
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.
If you have impression that the effect of DOXAZOSIN is too strong or too weak, talk to your doctor or pharmacist.
If you forget to take DOXAZOSIN: If you miss a dose just carry on with the next one as normal. Do not take a double dose to make up for the missed one.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, DOXAZOSIN can have side effects but 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:
• Chest pain, angina
• Shortness of breath, difficulty breathing
• Increased, decreased or irregular heartbeat
• Feeling your heartbeat (palpitations)
• Fainting
• Yellowing of the skin or the eyes (jaundice)
• Low numbers of white blood cells or blood platelets, which may result in increasing frequency of infection, bruising or easy bleeding
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 side effects
These can affect between 1 in 10 and 1 in 100 patients:
• Dizziness, feeling of spinning or rotation of surroundings (vertigo), headache
• Low blood pressure
• Swelling of feet, ankles or fingers
• Bronchitis, 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)
• Sleepiness, general weakness
• Indigestion, heartburn, dry mouth
• Itching
• Back pain, painful muscles
• Flu-like symptoms
Uncommon side effects:
These can affect between 1 in 100 and 1 in 1,000 patients:
• 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
• 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 Rare side effects
These can affect between 1 in 1,000 and 1 in 10,000 patients
• Increased number of times of passing urine
• Muscle cramps, muscle weakness
Very Rare side effects
These can affect less than 1 in 10,000 patients:
• 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
• 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 sexual climax
• Eye problems may occur during eye surgery for cataract (cloudiness of the lens of the eye). See section “Take special care with DOXAZOSIN”.
If any of the side-effects become serious, or you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. STORING DOXAZOSIN
There are no special precautions for storage. Keep out of the reach and sight of children.
Check the expiry date on the label. Do not use the tablets if the expiry date has passed.
6. FURTHER INFORMATION
What DOXAZOSIN contains
The active substance is: doxazosin. Each tablet contains 1mg, 2mg, or 4mg of doxazosin (as mesilate).
The other ingredients are: Lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, sodium starch glycolate (type A) and colloidal anhydrous silica.
What DOXAZOSIN looks like and contents of the pack
DOXAZOSIN comes in three different strengths:
Doxazosin 1 mg tablet is a round white to off-white tablet scored on one side.
Doxazosin 2 mg tablet is a white to off-white capsule shaped tablet scored on one side.
Doxazosin 4 mg tablet is a white to off-white capsule shaped tablet, scored on both sides, with embossement “D4” on one side.
Doxazosin 1 mg, 2 mg and 4 mg tablets are available in calendar packs of 28 tablets in foil blister strips.
The manufacturer / holder of the marketing authorization is:
Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8PB, UK