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ZOCHEK 10 MG PROLONGED-RELEASE TABLET

Active substance(s): ALFUZOSIN HYDROCHLORIDE

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Package leaflet: Information for the user

Zochek 10 mg prolonged-release tablets
alfuzosin 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.
See section 4.
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.







P1511919

P1511919

Zochek 10 mg

Zochek 10 mg

Pharmacode position may change as per Supplier's m/c requirement &additional
small pharma code may appear on the front / back panel

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 alfuzosin 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.

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

Use in children
Zochek is not recommended for children.

Do not take Zochek
if you are allergic to alfuzosin 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.

Black

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.mt
www.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.

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 clear PVC/PVdC-Aluminium blister
packs and white opaque round HDPE bottles containing silica gel.
Package size:
Blister pack: 30, 50 and 100 tablets
HDPE bottle pack: 30, 500 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:
Bulgaria:
Cyprus:
Czech Republic:
Germany:
Italy:
Ireland:
Malta:
The Netherlands:
Romania:
Spain:
The United Kingdom:

Aлфузoсин Ауробиндо 10 mg tаблетки
с удължено освобождаване
Alfuzosin Aurobindo 10 mg δισκία
παρατεταμένης
Alfuzosin Aurobindo 10 mg tablety s
prodlouženým uvolňováním
Alfuzosin Aurobindo 10 mg
Retardtabletten
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 prelungită
ALFUZOSINA AUROBINDO 10 mg
comprimidos de liberación prolongada
EFG
Zochek 10 mg prolonged-release tablets

This leaflet was last revised in 02/2016.

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

-

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).

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What Zochek contains
The active substance is alfuzosin hydrochloride. Each
prolonged-release tablet contains 10 mg alfuzosin
hydrochloride.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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