Informations for option: Cardura Tablets 2mg, show other option

Select option:

1. Cardura Tablets 2mg
2. Cardura Tablets 2mg

Document: document 0 change

• document 0
• document 1
• document 2

---

PACKAGE LEAFLET: INFORMATION FOR THE USER

CARDURA® 1 mg and 2 mg

Tablets

Doxazosin mesilate

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

I.What CARDURA is and what it is used for

2. BEFORE YOU TAKE CARDURA

-    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.

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 CARDURA 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.

Mill!

MORE INFORMATION ON CARDURA

3. HOW TO TAKE CARDURA

-    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 1 mg daily. Your doctor may increase this after a couple of weeks to the usual dose of 2mg or

4 mg 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 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.

5. HOW TO STORE CARDURA

Keep your tablets out of the reach and sight of children. Do not use CARDURA after the expiry date which is stated on carton. The expiry date refers to the last day of that month.

Do not store above 30 °C.

6. FURTHER INFORMATION

What CARDURA contains and its package:

The active substance is Doxazosin. Each tablet contains either 1.213 mg doxazosin mesilate equivalent to 1 mg doxazosin or 2.43 mg doxazosin mesilate equivalent to 2mg doxazosin

The other ingredients in each tablet are: magnesium stearate, microcrystalline cellulose, sodium lauril sulfate, sodium starch glycollate and lactose.

The 1 mg tablets are white, round and marked with CN1 on one side and ‘PFIZER’ on the other. The 2mg tablets are white and oblong and marked with CN2 on one side and ‘PFIZER’ on the other. They are available in packs of 28 tablets.

Marketing Authorisation Holder

Pfizer Limited, Ramsgate Road, Sandwich, Kent,

CT13 9NJ, United Kingdom

Manufacturer

R-Pharm Germany GmbH

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

This leaflet was last revised on 10/2014

Ref: 14_0 UK

|^58420

-