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Cardura 2mg Tablets

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143 LEAFLET Cardura 20150616

PATIENT INFORMATION LEAFLET CARDURA 2mg TABLETS DOXAZOSIN TABLETS 2mg (doxazosin mesilate)

Your medicine is known by the above names but will be referred to as Cardura throughout the following leaflet.

Information for other strength of Cardura tablets (1mg) also may be present in this leaflet.

Important things that you SHOULD know about your medicine:

•    Cardura is 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 Cardura regularly to get the maximum benefit, even if you are feeling well.

•    Most people do not have serious problems when taking Cardura 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 Cardura 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.

In this leaflet:

1.    What Cardura is and what it is used for

2.    Before you take Cardura

3.    How to take Cardura

4.    Possible side effects

5.    storing Cardura

6.    Further information

1. WHAT CARDURA IS AND WHAT IT IS USED FOR

Cardura 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.

Cardura 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, Cardura is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. Cardura works by relaxing muscle around the bladder exit and prostate gland so urine is passed more easily.

Take special care with Cardura:

The following are reasons why Cardura may not be suitable for you:

-    If you are pregnant or trying to become pregnant

-    If you have liver disease

-    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 Cardura. This is because Cardura may cause complications during the surgery which can be managed if your specialist is prepared in advance.

If any of these apply to you speak to your doctor before taking this medicine.

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

When you start to take Cadura 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.

Taking other medicines:

There are some medicines that may interact with Cardura

-    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.

-    Cardura 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.

You should always tell your doctor if you are taking or have recently taken any other medicine, even those not prescribed, because they might interact with Cardura.

Taking Cardura with food and drink:

Cardura can be taken with or without food.

Pregnancy:

The safety of using Cardura 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 Cardura is suitable for you. Breast-feeding:

Do not take Cardura if you are breast-feeding.

Driving and using machinery:

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.

3. HOW TO TAKE CARDURA

2. BEFORE YOU TAKE CARDURA

Do not take Cardura:

-    If you have had an allergic reaction in the past to Cardura, the active ingredient doxazosin, other types of quinazolines (such as prazosin or terazosin) or any of the other ingredients listed in section 6. This may have been itching, reddening of the skin or difficulty in breathing.

-    If you are breast-feeding

-    If you are under 16 years of age

-    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.

-    The usual dose of Cardura is one tablet taken as a single daily dose each day.

-    If you are taking Cardura 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 2 mg or 4 mg daily. In some circumstances this may be increased to a maximum of 8 mg daily if you are being treated for prostate enlargement, or to a maximum of 16 mg if you are being treated for high blood pressure.

-    Cardura 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.

-    Take your tablet as your doctor told you or by following the days and arrows on the blister foil.

-    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.

If you take more Cardura 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 Cardura: Do not worry. If you forget to take a tablet, leave that dose out completely. Then go on as before.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Cardura can cause side effects although not everybody gets them.

STOP taking Cardura 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 Cardura:

•    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 bruising or easy bleeding

The following events have been reported in patients being treated with Cardura. 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) inflammation of bladder (cystitis)

•    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

•    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 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 Cardura”.

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

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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CARDURA

   KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store your tablets above 30°C.

•    Do not use Cardura after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.

•    Tablets should not be thrown in your bin or put down the drain. If they are out of date, or no longer suitable for you, return them to your pharmacist.

6. FURTHER INFORMATION

What Cardura contains

•    Cardura contains 2mg of doxazosin (as mesilate) as the active ingredient.

•    The other ingredients are: lactose, microcrystalline cellulose, magnesium stearate, sodium starch glycollate and sodium lauryl sulphate.

What Cardura looks like and contents of the pack

Cardura are white, capsule-shaped and marked ‘Pfizer' on one side and ‘CN 2 with a breakline on the other.

Cardura are available in blister packs of 30 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Parallel Import Product Licence holder: Chemilines Ltd, Chemilines House,

Alperton Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by Pfizer Manufacturing Deutschland GmbH, Heinrich Mack Strasse 35, D-89257 Illertissen, Germany.

| POM | PL: 08747/0143 Leaflet revision date: 16 June 2015

Cardura is a registered trade mark of Pfizer Ltd, UK.

143 LEAFLET Cardura 20150616