PATIENT INFORMATION LEAFLET

Cardozin XL 4mg Prolonged-release Tablets

(doxazosin)

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 any further questions, ask your doctor or your pharmacist.

_- 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.

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

1. WHAT CARDOZIN XL 4MG IS AND WHAT IT IS USED FOR_

Cardozin XL contains the active substance doxazosin (as doxazosin mesilate) which is one of a group of medicines called alpha-blockers.

Cardozin XL is used to treat

•    high blood pressure, or

•    the symptoms caused by enlargement of the prostate gland in men (e.g. poor and/or frequent passing of urine)

In patients taking Cardozin XL 4mg to treat high blood pressure (hypertension), doxazosin works by relaxing the blood vessels so that blood passes through them more easily. This helps to lower blood pressure.

In patients with enlargement of the prostate gland, Cardozin XL 4mg is taken to treat poor and/or frequent 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.

Do not take Cardozin XL 4mg:

•    if you are allergic (hypersensitive) to doxazosin or any of the other ingredients of Cardozin XL

•    if you know that you are sensitive to quinazolines (e.g. prazosin, terazosin) which is the chemical family of medicines to which doxazosin belongs

•    if you have or ever have had low blood pressure which makes you feel faint or dizzy when you stand up after sitting or lying down (postural or orthostatic hypotension)

•    if you have an enlarged prostate gland and have any kind of congestion or blockage in your urinary tract, a chronic infection of the urinary tract or have bladder stones

•    if you have a serious kidney disorder (anuria or progressive renal insufficiency)

•    if you suffer from a loss of bladder control (bladder overflow)

•    if you have or have ever had any form of obstruction of the digestive tract

•    if you are being given this medicine to treat an enlarged prostate gland and have low blood pressure

•    if you are breast-feeding.

Take special care with Cardozin XL 4mg:

Talk to your doctor if any of the following apply to you:

•    you have problems with your heart or a history of heart disease

•    you have liver disease

•    you have had surgery to remove part of your gastrointestinal tract.

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 Cardozin XL 4mg. This is because Cardozin XL 4mg may cause complications during the surgery which can be managed if your specialist is prepared in advance.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that can be bought without a prescription.

It is especially important that you tell your doctor if you are taking or have recently taken any of the following:

•    medicines to lower your blood pressure (e.g. fosinopril and lisinopril) as Cardozin XL 4mg can increase their effect

•    certain medicines used to treat erectile problems (e.g. sildenafil, tadalafil and vardenafil).

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.

Taking Cardozin XL 4mg with food and drink

Cardozin XL 4mg can be taken with or without food. The tablets should be swallowed whole with a glass of water.

Pregnancy and breast-feeding

Pregnancy

Do not take Cardozin XL 4mg if you are pregnant unless your doctor tells you to. If you become pregnant whilst taking this medicine you should contact your doctor as soon as possible.

Breast-feeding

You must not breast-feed whilst you are taking Cardozin XL 4mg.

Driving and using machines

Cardozin XL 4mg can affect your judgement and concentration, especially when you start taking your tablets. Make sure that you are not affected before you drive or operate machinery.

3. HOWTO TAKE CARDOZIN XL 4MG_

Always take this medicine exactly as your doctor told you. Do not take more than the doctor told you to.

Read and follow the instructions on the pharmacist's label. You should check with your doctor or pharmacist if you are unsure of how to take your medicine.

Your tablets should be swallowed whole with a glass of water. Do not chew, crush or divide them. The tablets can be taken at any time of the day and before, during or after meals. Choose a time that is convenient for you and take your tablet at this time each day.

The usual dose of Cardozin XL 4mg is one tablet (4mg) taken as a single dose each day.

Your doctor may wish to increase your dose to 8mg per day. This is the maximum daily dose of Cardozin XL 4mg.

Cardozin XL 4mg is not recommended for patients under the age of 18 years.

It is important that you continue to take Cardozin XL 4mg for as long as your doctor recommends. Do not change the dose or stop taking your tablets unless your doctor tells you to.

If you have taken more Cardozin XL 4mg than you should, contact your doctor immediately or go to the nearest casualty department. Remember to take the pack and any remaining tablets with you.

If you forget to take your Cardozin XL 4mg:

Take your next dose at the normal time. Do not take the missed dose or a double dose to make up for the one you missed.

If you stop taking Cardozin XL 4mg:

Keep taking your tablets until your doctor tells you to stop.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

| 4. POSSIBLE SIDE EFFECTS

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

Tell your doctor immediately if:

•    You get any swelling of the face, tongue or throat, intense itching, skin rashes, difficulty in swallowing and/or breathing. This may be the sign of a serious allergic reaction.

•    You feel pain in your chest, shoulder and/or arms and tightening of your chest (angina) or any other effects on your heart (including a rapid or irregular heartbeat).

•    You develop severe fatigue, loss of appetite or if your skin or eyes look yellow (signs of jaundice).

You may feel faint or dizzy when standing up from a sitting or lying position especially at the beginning of your treatment or if you restart your treatment after a break. If this happens do not worry but make sure that you do not drive, operate machinery or carry out any activity which might be dangerous should you feel faint. If these symptoms persist or become a problem please contact your doctor.

The following side effects have been reported. Tell your doctor or pharmacist if you get any troublesome symptoms which you think might be side effects.

Common (probably affecting less than one person in 10 but more than one person in 100j:

•    chest pain

•    low blood pressure with or without dizziness when you get up from a sitting or lying position

•    shortness of breath

•    swelling or irritation inside the nose (rhinitis)

•    giddiness

•    general feeling of being unwell and weakness

•    dizziness

•    abdominal pain

•    dry mouth

•    back pain

•    sleepiness

Uncommon (probably affecting less than one person in 100 but more than one person in 1,000j:

•    heart attack

•    angina (tightening and pain in the chest and shoulder)

•    change in frequency of urination

•    blood in the urine

•    impotence

•    gout (causing gout pain)

•    insensitivity to touch, pain, heat or cold

•    depression

•    skin rash

•    shaking (tremor)

•    increased appetite

•    fainting

•    diarrhoea

•    flatulence ('wind')

•    stroke

The following side effects have been observed in patients taking doxazosin but the frequency is not known:

• eye problems    • difficulty with

(especially in patients ejaculation with cataracts)    • taste disturbances.

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.

15. HOWTO STORE CARDOZIN XL 4MG Keep out of the sight and reach of children.

Do not use Cardozin XL 4mg after the expiry date which is printed on the carton after the word “EXP".

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines which are no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION What Cardozin XL 4mg contains:

• This medicine contains the active substance doxazosin (as doxazosin mesilate).

• The other ingredients in the tablet core are macrogol, microcrystalline cellulose, povidone, butylhydroxytoluene (E-321), a-tocopherol, silica colloidal anhydrous and sodium stearyl fumarate. The other ingredients in the tablet coat are methacrylic copolymer, silica colloidal anhydrous, macrogol and titanium dioxide (E-171).

What Cardozin XL 4mg looks like and contents of the pack:

Cardozin XL 4mg is in the form of prolonged-release tablets. These tablets are white, round and biconvex with the embossing 'DL'.

Cardozin XL 4mg is available in blister packs of 10, 28, 30, 56, 98 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Arrow Generics Limited, Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, United Kingdom.

Manufacturer:

Arrow Pharm (Malta) Limited, 62 Hal Far Industrial Estate, Birzebbugia, BBG3000, Malta.

This leaflet was last approved in 03/2012.

L3024/5