PACKAGE LEAFLET: INFORMATION FOR THE USER

Dazular XL Tablets 10mg

Alfuzosin hydrochloride

What Dazular XL Tablets 10 mg is and what it is used for

Dazular XL Tablets 10 mg belongs to a group of medicines called alpha-adrenoreceptor antagonists or alpha-blockers.

It is used to treat moderate to severe symptoms caused by an enlarged prostate gland, a condition that is also called benign prostatic hyperplasia. Enlarged prostate glands can cause urinary problems such as frequent and difficult urination, especially at night. Alpha-blockers relax the muscles in the prostate and bladder neck. This allows urine to flow out of the bladder more easily.

□ What you need to know before you take Dazular XL Tablets 10 mg

Do not take Dazular XL Tablets 10 mg

•    If you are allergic (hypersensitive) to alfuzosin, other quinazolines (e.g. terazosin, doxazosin, prazosin) or any of the other ingredients of Dazular XL Tablets 10 mg.

•    If you suffer from conditions that cause a marked drop in blood pressure when standing up.

•    If you have liver problems.

•    If you take other medicines that belong to the group of alpha-blockers.

Warnings and precautions

•    If you have severe kidney problems, since the safety of Dazular XL Tablets 10 mg has not been established in these patients.

•    If you take medicines to treat high blood pressure.

In this case your doctor will check your blood pressure regularly, especially at the beginning of treatment. Normally, there is no need to stop treatment.

•    If you experienced a marked drop in blood pressure or a hypersensitivity (allergic) reaction in the past after taking another medicine belonging to the group of alpha-blockers. In this case your doctor will start treatment with Dazular at low doses and will gradually increase the dose.

•    If you suffer from acute heart failure.

•    If you suffer from chest pain (angina) and are treated with a nitrate as this may increase the risk of a drop in blood pressure.Your doctor will decide whether to treat your angina with a nitrate medicine or stop treatment with Dazular XL Tablets 10 mg, if your angina returns or gets worse.

•    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 Dazular XL Tablets 10 mg. This is because Dazular XL Tablets 10 mg may cause complications during the surgery which can be managed if your specialist is prepared in advance.

• If you suffer from a heart beat abnormality known as "prolonged QT-interval".

Swallow the tablets whole. Do not crush, powder or chew the tablets as too much of the active substance alfuzosin may reach your body too quickly. This may raise the risk of unwanted effects.

Children and adolescents

Dazular XL Tablets 10 mg is not indicated for use in children and adolescent.

Other medicines and Dazular XL Tablets 10 mg

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

Dazular XL Tablets 10 mg must not be taken if you take other medicines that belong to the group of alpha-blockers.

Dazular XL Tablets 10 mg and some medicines may interfere with each other. These include:

•    medicines containing ketoconazole or itraconazole (medicines used to treat fungal infections) or ritonavir (medicine used to treat HIV).

•    medicines to lower blood pressure.

•    medicines (nitrates) used to treat the symptoms of chest pain (angina). Please note that taking Dazular XL Tablets 10 mg together with medicines used to treat high blood pressure and nitrates used e.g. to treat cardiac diseases may lead to low blood pressure.

•    medicines you receive before an operation (general anaesthetics). Your blood pressure can drop markedly. If you have to undergo an operation, please tell the doctor that you are taking Dazular XL Tablets 10 mg.

•    medicines that are known to increase the QT-interval.

Dazular XL Tablets 10 mg with food and drink

Dazular XL Tablets 10 mg should be taken after a meal.

Pregnancy and breast-feeding

This information is not relevant as Dazular XL Tablets 10 mg is only for men.

Driving and using machines

At the beginning of treatment with Dazular XL Tablets 10 mg you may feel light-headed, dizzy or weak. Do not drive or operate machinery or perform any hazardous tasks until you know how your body responds to the treatment.

Dazular XL Tablets 10 mg contains a small amount of lactose

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

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How to take Dazular XL Tablets 10 mg

Always take Dazular XL Tablets 10 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose for adults, the elderly (over 65 years) and those with mild or moderate kidney problems is 1 Dazular XL Tablets 10 mg once daily. Take the first tablet at bed time. Take the tablets immediately after the same meal each day and swallow them whole with a sufficient amount of fluid. Do not crush, chew or divide the tablets.

If you take more Dazular XL Tablets 10 mg than you should

If you take large amounts of Dazular XL Tablets 10 mg your blood pressure may suddenly drop and you may feel dizzy or even faint. If you begin to feel dizzy, sit or lie down until you feel better. If the symptoms do not disappear, call your doctor as the drop in blood pressure may have to be treated in hospital.

If you forget to take Dazular XL Tablets 10 mg

Do not take a double dose to make up for a forgotten tablet as this may cause a sudden drop in blood pressure, especially if you take blood-pressure lowering medicines. Take the next tablet as directed.

If you stop taking Dazular XL Tablets 10 mg

You should not interrupt or stop taking Dazular XL Tablets 10 mg without speaking to your doctor first. If you want to stop the treatment or have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Dazular XL Tablets 10 mg can cause side effects, although not everybody gets them.

You should see your doctor immediately if you experience any of the following symptoms:

•    Swollen face, tongue or throat

•    Difficulty in swallowing

•    Difficulty in breathing and hives

The above symptoms are symptoms of angioedema, which is a very rare side effect (may affect up to 1 in 10,000 people).

Other side effects that can occur with Dazular XL Tablets 10 mg are:

Common (may affect up to 1 in 10 people): Faintness/dizziness, headache, stomach pain, feeling sick (nausea), feeling of weakness, erection (priapism), decrease in white blood cells.

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.

How to store Dazular XL Tablets 10 mg

Do not store above 30 °C.

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

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Dazular XL Tablets 10 mg contains

The active substance is alfuzosin hydrochloride.

One prolonged-release tablet contains 10 mg alfuzosin hydrochloride.

The other ingredients are: lactose monohydrate, hypromellose (E 464), povidone K25, magnesium stearate (E 470 b).

What Dazular XL Tablets 10 mg looks like and contents of the pack

Dazular XL Tablets 10 mg are white, round, bevelled-edged, uncoated tablets.

Dazular XL Tablets 10 mg is available in blister packs with 10, 20, 30, 50, 60, 60x1,90, 100 and 180 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tillomed Laboratories Ltd.,

3 Howard Road, Eaton Socon St.Neots, Cambridgeshire PE19 8ET United Kingdom

Manufacturers:

Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben Germany

Uncommon (may affect up to 1 in 100 people):

Feeling drowsy, a spinning sensation in the head (vertigo), loss of consciousness resulting from insufficient blood flow to the brain, faster heartbeat, marked drop in blood pressure when standing up (especially when starting treatment with too high a dose and when treatment is resumed), runny nose, diarrhoea, skin rash, itching, swelling of ankles and feet, reddening of the face (flushing), chest pain.

Very rare (may affect up to 1 in 10,000 people): Angina pectoris in patients with known coronary heart disease, hives, angioedema.

HEXAL A/S Kanalholmen 8-12 2650 Hvidovre Denmark

Tillomed Laboratories Ltd.

3 Howard Road, Eaton Socon St Neots. Cambridgeshire, PE19 8ET United Kingdom

PL 11311/0310

This leaflet was last revised in 16 November 2012

Not known (frequency cannot be estimated from the available data):

If you must undergo eye surgery because of a cataract and are taking Dazular XL Tablets 10 mg or have taken it in the past, difficulties during surgery may occur (see "Take special care with Dazular XL Tablets 10 mg"). Very rapid uncoordinated contractions of the heart, vomiting, liver damage, persistent and painful penile

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