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ZOCHEK 10 MG PROLONGED-RELEASE TABLET

Active substance(s): ALFUZOSIN HYDROCHLORIDE

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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.
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 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 alpha1-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 alphablocker (this could include previous use
of alfuzosin). See paragraph immediately
above for examples of other alpha-blockers.
Black









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 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.

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.

P15XXXXX

Package leaflet:
Information for the user

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
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
e-mail: postlicensing.medicinesauthority@gov.mt
The United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
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.

6. Contents of the pack and other
information
What Zochek contains
- The active substance is alfuzosin
hydrochloride. Each prolongedrelease tablet contains 10 mg alfuzosin
hydrochloride.
-

The other ingredients
Tablet Core: Hypromellose (E464),
hydrogenated vegetable oil, povidone (K30) (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 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:
Aлфузoсин Ауробиндо
10 mg tаблетки с удължено
освобождаване
Cyprus:
Alfuzosin Aurobindo 10 mg
δισκία παρατεταμένης
Czech Republic: Alfuzosin Aurovitas
Germany:
Alfuzosin Aurobindo 10 mg
Retardtabletten
Italy:
Alfuzosina Aurobindo
10 mg compresse a rilascio
prolungato
Ireland:
Alfu 10 mg prolonged
release tablets
Malta:
Zochek 10 mg prolongedrelease tablets
The Netherlands: Alfuzosine HCl Aurobindo
10 mg, tabletten met
verlengde afgifte
Romania:
Alfuzosina Aurobindo
10 mg comprimate cu
eliberare prelungită
Spain:
ALFUZOSINA AUROBINDO
10 mg comprimidos de
liberación prolongada EFG
The United
Kingdom:
Zochek 10 mg prolongedrelease tablets
This leaflet was last revised in 08/2017.

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.

P15XXXXX

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.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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