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Package leaflet: Information for the user

Zochek 10 mg prolonged-release tablets

alfuzosine hydrochloride

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.

-    If 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.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Zochek is and what it is used for

2.    What you need to know before you take Zochek

3.    How to take Zochek

4.    Possible side effects

5.    How to store Zochek

6.    Contents of the pack and other information

1. What Zochek is and what it is used for

Zochek belongs to a group of medicines called alpha-1-blockers.

Zochek is used to treat moderate to severe symptoms of Benign Prostate Hyperplasia. This is a condition where the prostate gland enlarges (hyperplasia), but the growth in itself is not cancerous (benign). It occurs most often in older men.

The prostate gland is situated under the bladder surrounding the urethra (the tube that takes your urine to the outside of the body). With age, the prostate gland may grow and press the urethra making it smaller. This may cause problems with urination such as frequent urination and difficulty in passing urine.

Zochek works by relaxing the prostate gland muscle. This reduces the narrowing of the urethra and so makes it easier to pass urine.

2. What you need to know before you take Zochek

Do not take Zochek

-    if you are allergic to alfuzosine or the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: a rash, swelling of your lips, throat, or tongue, difficulty in swallowing or breathing.

-    If you are allergic (hypersensitive) to alfuzosin-equivalent substances (such as terazosin, doxazosin).

-    If you have, or have had in the past, low blood pressure when standing up from a sitting or lying position (the medical term for this is orthostatic hypotension). It can make you feel dizzy, light-headed or faint when you stand or sit up quickly.

-    If you are already taking another alpha-1-blocker (such as terazosin, doxazosin). See section below on ‘Other medicines and Zochek. In case of doubt please ask your pharmacist or doctor.

-    If you have liver problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Zochek if:

-    You have severe kidney problems.

-    You have a heart disease.

-    You have chest pain (angina).

-    You are known to have an abnormality of electrocardiogram (ECG ), called “QT prolongation”

Other medicines and Zochek

Tell your doctor or pharmacist if you are taking, have recently taken

or might take any other medicines.

Do not take Zochek if you are taking:

•    Other alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin or phenoxybenzamine.

Check with your doctor or pharmacist before taking your medicine

if:

•    In the past, you have had a large fall in blood pressure while taking an alpha-blocker (this could include previous use of alfuzosin). See paragraph immediately above for examples of other alpha-blockers.

•    You are taking a medicine for high blood pressure, as you may get dizzy, weak or start sweating within a few hours of taking this medicine. If this happens, lie down until the symptoms have completely gone. Tell your doctor as the dose of your medicine may be changed.

•    You are taking medicines for chest pain (angina).

•    You are taking medicines for fungal infections (such as ketoconazole, itraconazole).

•    You are taking medicines for HIV (such as ritonavir).

•    You are taking medicines for bacterial infections (such as clarithromycin, telithromycin).

•    You are taking medicines for treatment of depression (such as nefazodone).

Operations while taking Zochek

•    If you are going to have an operation that needs a general anaesthetic, tell your doctor you are taking Zochek before the operation. This is because it can be dangerous as it can lower your blood pressure.

•    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 Zochek. This is because Zochek may cause complications during the surgery which can be managed if your specialist is prepared in advance.

Zochek with food and drink and alcohol

- Take Zochek after a meal.

Pregnancy, breast-feeding and fertility

This section does not apply as alfuzosine is only used by men.

Driving and using machines

You may feel dizzy and weak while taking Zochek. If this happens

do not drive or operate any tools or machines.

3. How to take Zochek

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

•    Swallow your tablets whole with plenty a fluid (for instance a glass of water).

•    Do not break, crush or chew your tablets. This can affect the release of your medicine into the body

•    Take this medicine after a meal

•    The first dose should be taken at bedtime.

Use in children

Zochek is not recommended for children.

Adults:

The usual dose is one Zochek 10 mg prolonged release tablet once a day.

Older patients (> 65 years):

The usual dose is one Zochek 10 mg prolonged release tablet once a day. The dose does not need to be adjusted for elderly (over 65 years).

Patients with mild to moderate kidney problems

Your dose does not need to be adjusted for mild to moderate

kidney problems.

If you take more Zochek than you should

Contact your doctor or your local hospital Accident and Emergency department straight away. Tell the doctor how many tablets you have taken. Lie down as much as possible to help stop the side effects. Do not try to drive to the hospital yourself.

If you forget to take Zochek

Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next tablet as directed.

If you stop taking Zochek

Keep taking your tablets, even if your symptoms improve. Only stop if your doctor tells you to. The symptoms are better controlled if you continue taking the same dose of this medicine.

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

4. Possible side effects

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

Chest pain (angina)

Normally, this only happens if you have had angina before. If you get chest pain stop taking your tablets and contact a doctor or go to a hospital immediately. This happens in less than 1 in 10,000 people.

Allergic reactions

You could notice symptoms of angioedema, such as a red and lumpy skin rash, swelling (on the eyelids, face, lips, mouth and tongue), difficulty breathing or swallowing.

These are symptoms of an allergic reaction. If this happens, stop taking your tablets and contact a doctor or go to a hospital immediately. This happens in less than 1 in 10,000 people.

Other side effects include:

Common (affects less than 1 in 10 people)

•    Feeling dizzy

•    Headache

•    Feeling sick (nausea)

•    Stomach pain

•    Weakness or tiredness

Uncommon (affects less than 1 in 100 people)

•    Feeling dizzy, lightheaded, or faint when you stand or sit up quickly.

•    Fast heart beat (tachycardia)

•    Chest pain

•    Runny nose, itching, sneezing, and stuffy nose.

•    Diarrhoea

•    Rashes and itching

•    Water retention (may cause swollen arms or legs)

•    Hot flushes.

Additional side effects (frequency not known) which may occur are:

If you are having an operation on your eyes because of cataracts (where the lens of the eye is cloudy), the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure.

•    Irregular and fast heart beat

•    Decrease in white blood cells. Signs may include more frequent infections, sore throat or mouth ulcers.

•    Low numbers of blood platelets. Signs may include bleeding from your gums and nose, bruising, prolonged bleeding from cuts, rash (pinpoint red spots called petechia).

•    Abnormal liver function (liver problem). Signs may include yellowing of your skin or the whites of your eyes.

•    If you are undergoing eye surgery because of cataract (cloudiness of the lens) and are using or have previously used Zochek, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure. This only occurs during the operation and it is important for the eye specialist to be aware of this possibility as the operation may need to be performed differently (see section “Operations while taking Zochek”).

•    Abnormal, often painful, persistent erection of the penis unrelated to sexual activity (priapism).

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Malta    The United    Kingdom

ADR Reporting    Yellow Card    Scheme

Website:    Website:

www.medicinesauthority.gov.mtwww.mhra.gov.uk/yellowcard e-mail:

postlicensing.medicinesauthority@gov.mt

5. How to store Zochek

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

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label, carton, bottle after EXP. 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.

6. Contents of the pack and other information

What Zochek contains

-    The active substance is alfuzosine hydrochloride. Each prolonged-release tablet contains 10 mg alfuzosine hydrochloride.

-    The other ingredients

Tablet Core: Hypromellose (E464), hydrogenated vegetable oil, povidone (K-30) (E1201), calcium hydrogen phosphate anhydrous, carbomer, silica colloidal anhydrous (E551), magnesium stearate (E572).

Film-coating: Hypromellose (E464), propylene glycol, titanium dioxide (E 171).

The tablet has a prolonged effect which means that after taking the active substance is not released immediately but gradually from the tablet and therefore acts longer.

What Zochek looks like and contents of the pack

Prolonged-release tablet

White to off-white round, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘47’ on other side.

Zochek tablets are available in PA/Aluminium/PVC/Aluminium blister packs and white opaque round HDPE bottles containing silica gel sachets. A cotton coil is used to fill the void in the HDPE bottle.

Package size:

Blister pack: 30, 50 and 100 tablets HDPE bottle pack: 30 and 1000 tablets

Not all pack sizes may be marketed

Marketing Authorization Holder

UK - Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

MT_ Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront Floriana FRN 1913 Malta

Manufacturer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

or

Milpharm Limited

Ares Block, Odyssey Business Park West End Road Ruislip HA4 6QD United Kingdom

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

An#y3ocMH AypoSMHgo 10 mg taSneTKM c ygtgxeHO ocBoSowgaBaHe Alfuzosin Aurobindo 10 mg 5iaKa napaT£Ta|j£vr|i;

Alfuzosin Aurobindo 10 mg tablety s prodlouzenym uvolnovanfm ALFUZOSINE AUROBINDO 10 mg, comprime a liberation prolongee Alfuzosin Aurobindo 10 mg Retardtabletten

ALFUZOZIN AUROBINDO 10 mg tablete s produljenim oslobadanjem Alfuzosina Aurobindo 10 mg compresse a rilascio prolungato Alfu 10 mg prolonged release tablets Zochek 10 mg prolonged-release tablets Alfuzosine HCl Aurobindo 10 mg, tabletten met verlengde afgifte Alfuzosina Aurobindo 10 mg comprimate cu eliberare prelungita ALFUZOSINA AUROBINDO 10 mg comprimidos de liberation prolongada EFG

Zochek 10 mg prolonged-release tablets

This leaflet was last revised in 04/2014.