PACKAGE LEAFLET: INFORMATION FOR THE USER

Doxadura XL 4 mg 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 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. See section 4.

In this leaflet:

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

2.    Before you take Doxadura XL

3.    How to take Doxadura XL

4.    Possible side-effects

5.    How to store Doxadura XL

6.    Further information

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

The active substance in your tablets, doxazosin, belongs to a group of medicines known as alpha-1 antagonists. Doxadura XL is used to treat the following conditions:

-    High blood pressure. If left uncontrolled, high blood pressure can increase the risk of heart disease or stroke.

Doxadura XL works by widening your blood vessels making it easier for your heart to pump blood through them. This helps to lower raised blood pressure and reduce the risk of heart disease.

-    Symptoms of benign prostatic hyperplasia (BPH). This condition causes enlargement of the prostate gland, which is just underneath the bladder in men. This makes it difficult to pass urine.

Doxadura XL works by relaxing muscle around the bladder exit and prostate gland, making it easier to pass urine.

2.    Before you take Doxadura XL Do not take Doxadura XL

-    if you have ever suffered an allergic reaction to the active ingredient, doxazosin, to quinazolines (e.g. prazosin, terazosin) which is the chemical family of medicines to which doxazosin belongs, or any of the other ingredients listed at the end of the leaflet. Allergic reactions may be, for example, itching, reddening of the skin or difficulty breathing

-    if you have low blood pressure (hypotension) or have had a fall in blood pressure on standing up which caused dizziness, light-headedness or fainting (orthostatic hypotension)

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

-    if you have benign prostatic hyperplasia (BPH) and additionally suffer from a blockage of your upper urinary tract, chronic urinary infections or bladder stones

-    if you have an overflowing bladder, almost no production of urine (anuria) or if your kidneys fail to function properly (progressive renal insufficiency)

-    if you are breast-feeding.

Take special care with Doxadura XL

-    if you suffer from liver disease

-    if you have suffered acute heart disease such as heart failure

-    if you are under 18 years of age

-    dizziness, weakness and in rare occasions fainting may occur, especially when you first start taking this medicine. You should therefore be careful in the beginning of treatment, and avoid situations that could lead to injury if these symptoms occur.

Your physicians will advise you what to do in the event of postural hypotensive symptoms (a decrease in blood pressure with symptoms when changing positions, e.g. from lying down or sitting to standing). You should not be concerned if occasionally you observe remains in the stools that look like a tablet. This is because Doxadura XL has a non absorbable coating that is designed to control the release of the medicine over a prolonged period.

If you are undergoing eye surgery because of a cataract (cloudiness of the lens) please inform your eye specialist before the operation that you are using or have previously used Doxadura XL. This is because Doxadura XL may cause complications during the surgery, which can be managed if your specialist is prepared in advance.

If you are not sure what to do, ask your doctor or pharmacist.

Taking other medicines

Tell your doctor if you are already taking any of the following:

-    Non-steroidal anti-inflammatory drugs (NSAIDs), e.g. ibuprofen

-    Other medicines used in the treatment of high blood pressure

-    Oestrogens (female hormones)

-    Dopamine, ephedrine, adrenaline, metaraminol, metoxamine, phenylephrine (medicines called sympathomimetics used e.g. for the treatment of heart problems, low blood pressure, asthma, or congestion of the nose)

-    Doxazosin and the so-called phosphodiesterase-5 inhibitors (e.g. sildenafil, tadalafil or vardenafil). Some patients who take alpha-blocker therapy for the treatment of high blood pressure or prostate enlargement may experience dizziness or lightheadedness, 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. Furthermore, it is recommended to respect a 6-hour time interval from intake of doxazosin and phosphodiesterase-5 inhibitors.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Doxadura XL with food and drink

Doxadura XL can be taken with or without food.

Pregnancy and breast-feeding

Do not take Doxadura XL if you are breast-feeding. If you are pregnant do not take this medicine without consulting your doctor first. The safety of this medicine in pregnancy is not sufficiently established.

Driving and using machines

Doxadura XL may cause dizziness or tiredness. If you feel tired, dizzy or light-headed, you must not drive or operate machinery. Be especially careful when you take your first dose or if your dose is increased.

3. How to take Doxadura XL

You must keep taking your Doxadura XL as instructed by your doctor. The directions should be given on the label.Your pharmacist may also be able to help if you are not sure.

Dosage

The dose of Doxadura XL is the same whether you are taking it for high blood pressure or to treat the symptoms of BPH. The usual dose is one tablet (4mg) each day. Your doctor may increase your dose to the maximum recommended dose of two tablets each day.

Choose any time of the day that is convenient for you and take your tablets at this time each day. The tablets must be swallowed whole with a sufficient amount of water. Do not chew, divide or crush the tablets. Doxadura XL releases the active substance slowly throughout the day.

For the treatment of high blood pressure, Doxadura XL can be used as single therapy, or in combination with other blood pressure-lowering medications (e.g. diuretics, water tablets).

It may take up to four weeks to reach the optimal blood pressure-lowering effect of Doxadura XL. Because high blood pressure is treated in order to prevent problems from arising, you may have no

Please read the back of this leaflet.

GENUS PHARMACEUTICALS 25153201

*Trademark

GEN/DOXXL/PIL/267_01

symptoms at all while taking Doxadura XL. Even if this is so and you feel well, you should not stop taking your medication unless instructed to by your doctor. Don't change the dose or stop taking the tablets without first checking with your doctor.

If you take more Doxadura XL than you should If you take too many tablets you should lie down on your back with your feet higher than your head. The most likely symptoms of overdose would be a feeling of light-headedness or dizziness due to a fall in blood pressure. If you have any of these symptoms, you should tell your doctor or pharmacist or go to the nearest casualty department immediately.

If you forget to take Doxadura XL If you miss a dose, do not worry. Simply take the next day’s tablet when it is due. Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side-effects

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

The evaluation of the side-effects is based on the following frequencies:

Common:

-    respiratory tract infection

-    dizziness, headache, drowsiness

-    loss of balance

-    sensation of irregular and/or forceful heartbeat (palpitations), increased heart rate

-    low blood pressure and low blood pressure as a result of getting up from a sitting or lying position (postural hypotension)

-    inflammation of the air passages within the lungs, cough, shortage of breath, nasal stuffiness and/or runny nose

-    abdominal pain, indigestion, dry mouth, feeling sick (nausea)

-    itching (pruritus)

-    back pain, painful muscles

-    inflammation of the bladder (cystitis), urinary incontinence

-    general weakness, chest pain, influenza-like symptoms, swelling.

Uncommon:

-    allergic drug reaction

-    loss of appetite, gout, increased appetite

- anxiety,    emotional instability (depression), sleeplessness (insomnia)

-    stroke, reduced sense of touch or sensation, fainting, tremor, ringing or noise in the ears (tinnitus)

-    chest pain (angina pectoris), heart attack (myocardial infarction), nosebleed

-    constipation, diarrhoea, flatulence, being sick (vomiting), inflammation of the gastrointestinal tract

-    abnormal liver function test

-    skin rash

-    joint pain

-    painful or difficult urination, presence of red blood cells in the urine (haematuria), frequent desire to urinate

-    abnormal accumulation of fluid beneath the skin causing swelling of the face (facial oedema)

-    difficulty to develop an erection (impotence)

-    pain

-    weight increase.

Very Rare:

-    reduced numbers of blood platelets

-    reduced numbers of red or white blood cells

-    dizziness postural

-    restlessness, nervousness

-    pins and needles

-    blurred vision

-    reduced heart rate, irregular heartbeat

-    flushing

-    bronchial spasm

-    blocked flow of bile (cholestasis), inflammation of the liver (hepatitis), yellowish discoloration of the skin

-    hair loss (alopecia), rash caused by bleeding under the skin (purpura), hives

-    muscle cramps, muscle weakness

-    urination disorder, frequent urinating during the night, increased volume of urine passed

-    temporary enlargement of the breasts (gynaecomastia), painful persistent erection

-    feeling tired (fatigue), malaise Not known:

-    intraoperative floppy iris syndrome

-    taste disturbances

-    retrograde ejaculation.

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 Doxadura XL

Keep out of the reach and sight of children.

Do not use Doxadura XL after the expiry date which is stated on the carton.

This medicinal product does not require any special storage conditions.

After you have been told to stop taking your tablets, return any unused tablets to your pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. These measures will help to protect the environment.

6.    Further information

What Doxadura XL contains

The active substance is doxazosin (as mesilate).

The other ingredients are polyethylene oxide, microcrystalline cellulose, povidone, butyl-hydroxytoluene (E321), all-rac-a-Tocopherol, colloidal anhydrous silica, sodium stearyl fumarate, methacrylic acid ethyl acrylate copolymer (1:1) dispersion 30%, macrogol, and titanium dioxide (E171).

What Doxadura XL looks like and contents of the pack

The tablets are white, round, biconvex tablets with "DL" embossed on one side.

Your medicine is available in PVC/PVDC/aluminium blister packs:

Cartons with 10, 20, 28, 30, 50, 56, 60, 90, 98, 100, 140 (10 x 14) prolonged-release tablets.

Calendar packs of 28 and 98 prolonged-release tablets

Unit dose pack of 50 x 1 prolonged-release tablets Not all pack sizes may be marketed

POM

PL 06831/0171 Doxadura XL 4mg

Prolonged-release Tablets

Marketing Authorisation Holder and Manufacturer:

Genus Pharmaceuticals,

ParkView House, 65 London Road,

Newbury, Berkshire RG14 1JN, UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

Estonia

Latvia

Lithuania The Netherlands Spain Sweden Great Britain

Doxalfa

Doxalfa 4 mg ilgstosas darblbas tabletes Doxalfa

Doxazosine retard CF DOXAZOSINA NEO STADA Doxastad Doxadura XL

This leaflet was last revised in July 2014

* Trademark 25153201

GENUS PHARMACEUTICALS

GEN/DOXXL/PIL/267_01