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Cardura Xl 8mg

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Document: leaflet MAH BRAND_PL 00057-0418 change

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Package leaflet: Information for the patient

CARDURA®XL

Doxazosin mesilate    Prolonged release tablets



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.

•    I f you have any further questions, 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.

•    You should take CARDURA XL regularly to get the maximum benefit, even if you are feeling well.

•    Most people do not have serious problems when taking CARDURA XL but side effects can occur. If you experience swelling of the face, tongue or windpipe, see your doctor immediately. 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.

•    Taking other medicines may sometimes cause problems. Check with your doctor or pharmacist before taking this or any other medicines.

•    I f you are, or are trying to become pregnant, do not take CARDURA XL and tell your doctor or pharmacist.


What is in this leaflet

1.    What CARDURA XL is and what it is used for

2.    What you need to know before you take CARDURA XL

3.    How to take CARDURA XL

4.    Possible side effects

5.    How to store CARDURA XL

6.    Contents of the pack and other information



1. What CARDURA XL is and what it is used for


CARDURA XL contains the active substance doxazosin mesilate and 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 XL 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 XL is taken to treat poor and/or frequent passing of urine. This is common in patients with an enlarged prostate gland. CARDURA XL 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 CARDURA XL


Do not take CARDURA XL:

•    If you are allergic to doxazosin, other types of quinazolines (such as prazosin or 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.

•    I f you are breast-feeding

•    If you have any form of obstruction of the digestive tract

•    If you have an enlarged prostate gland (benign prostatic hyperplasia) and have low blood pressure

•    I f 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

•    I f 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 CARDURA XL

as it may not be suitable for you:

•    If you are pregnant or trying to become pregnant

•    I f you have liver disease


•    I f you have heart disease

•    If you are also taking other medicines

If you are undergoing eye surgery because of cataract (cloudiness of the lens of the eye), please inform your eye specialist before the operation that you are using or have previously used CARDURA XL. This is because CARDURA XL 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.

When you start to take CARDURA XL 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.

Prolonged and sometimes painful erections: this occurs very rarely. If you have an erection which lasts for more than 4 hours, you should contact a doctor immediately.

Before starting treatment with CARDURA XL your doctor may perform tests to rule out other conditions such as prostate cancer that may cause the same symptoms as benign prostatic hyperplasia.

Children and adolescents

CARDURA XL 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 CARDURA XL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. There are some medicines that may interact with CARDURA XL:

•    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 XL 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.

CARDURA XL with food and drink

See section 3 How to take CARDURA XL

Pregnancy and breast-feeding

Pregnancy

The safety of using CARDURA XL during pregnancy has not been established. If you are pregnant or trying to become pregnant speak to your doctor who will decide if CARDURA XL is suitable for you.

Breast-feeding

Do not take CARDURA XL 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.



3. How to take CARDURA XL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. CARDURA XL is a prolonged release tablet. The medicine is contained within a non-absorbable shell that has been specially designed to slowly release the medicine. Once swallowed, doxazosin is slowly released into the body from the tablet, until the tablet is empty.

Since the empty tablet is eliminated from the body in bowel movements, you may occasionally observe in the stools, something that looks like a tablet. This is to be expected and you should not be concerned.


YOU WILL FIND MORE ABOUT

UNITED KINGDOM    CARDURA ON THE BACK OF THIS LEAFLET



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MORE INFORMATION ON CARDURA XL

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How to take your medicine

-    The usual dose of CARDURA XL is one 4mg prolonged release tablet taken as a single daily dose each day.

-    Your doctor may wish to increase your dose to 8mg. This is the maximum dose of CARDURA XL.

-    Swallow CARDURA XL whole with water. Do not chew, divide or crush the tablets.

-    Take your tablets 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.

-    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.

If you take more CARDURA XL than you should:

Taking 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 immediately.

If you forget to take CARDURA XL:

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.

4. POSSIBLE SIDE EFFECTS

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

STOP taking CARDURA XL 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

•    Allergic reactions (hypersensitivity). Symptoms include sudden wheeziness, tightness in the chest, difficulty in breathing, swelling of the face, tongue or throat, rash or itching (especially the whole body)

Tell your doctor immediately if you experience any of the following symptoms after taking CARDURA XL:

•    Chest pain, angina

•    Shortness of breath, difficulty breathing, wheezing

•    Increased, decreased or irregular heartbeat

•    Feeling your heartbeat (palpitations)

•    Skin rash or itching (especially the whole body)

•    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 XL. 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: may affect up to 1 in 10 people

•    dizziness, feeling of spinning or rotation of surroundings (vertigo), headache

•    l ow 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 the bladder (cystitis)

•    sleepiness, general weakness

•    i ndigestion, heartburn, dry mouth

•    back pain, painful muscles

•    flu-like symptoms

Uncommon side effects: 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, needing to pass urine more often than usual, blood in urine

•    i nflammation of the joints (gout), painful joints, general pain

•    swelling of the face

•    sleeplessness, anxiety, depression

•    reduced or altered sense of touch or sensation of the hands and feet

•    i ncreased appetite or loss of appetite, weight gain

•    nose bleeds

•    ringing in the ears, tremor

•    failure/ inability to achieve penile erection

•    abnormal results for blood tests which show changes in the way the liver is working

Rare side effects: may affect up to 1 in 1,000 people

•    blockage of the digestive tract

Very Rare side effects: 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

•    agitation, nervousness

•    tiredness, generally feeling unwell

•    aggravated wheezing

•    muscle cramps, muscle weakness

•    blurred vision

•    flushing

•    disorder in passing urine, needing to pass urine at night, increased volume of urine passed, increased production of urine causing an increase in the number of times of passing urine

•    discomfort or enlargement of the breasts in men

•    painful persistent erection of the penis

Not known: frequency cannot be estimated from the 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can report side effects directly via the Yellow Card Scheme website: 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 XL

Keep this medicine out of the sight and reach of children.

Do not use CARDURA XL after the expiry date which is stated on carton and blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C. Store in the original package.

The tablets should be whole to work effectively, if you notice any defects (such as broken tablets) consult your pharmacist immediately.

Do not throw away any medicines via wastewater or household waste. Ask you 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 CARDURA XL contains

The active substance is doxazosin. Each tablet contains either 4.85mg doxazosin mesilate equivalent to 4mg doxazosin or 9.70mg doxazosin mesilate equivalent to 8mg doxazosin within a shell that has been specially designed to slowly release the drug. The other ingredients are: polyethylene oxide, sodium chloride, hypromellose, red ferric oxide (E172), titanium dioxide (E171), magnesium stearate, cellulose acetate, Macrogol, pharmaceutical glaze, black iron oxide (E172), ammonium hydroxide and propylene glycol.

What CARDURA XL looks like and contents of the pack

CARDURA XL tablets are white, round, biconvex shaped with a hole in one side and marked CXL 4 for the 4mg and CXL 8 for the 8mg.

They are available in strengths of 4mg and 8mg prolonged release tablets and in packs of 28 or 30 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation Holder

Pfizer Limited, Sandwich, Kent, CT13 9NJ, United Kingdom.

Manufacturer

R-Pharm Germany GmbH,

Heinrich-Mack-Str. 35, 89257 Illertissen, Germany.

This leaflet was last revised in 02/2016

Ref: CX 14_0

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Pfizer Limited Sandwich, England


MU_GI_CXL_GBR-MLT_CX97.indd 2 04.10.16 15:27