Zochek 10 mg prolonged-release tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALFUZOSIN HYDROCHLORIDE

Available from:

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

ATC code:

G04CA01

INN (International Name):

ALFUZOSIN HYDROCHLORIDE 10 mg

Pharmaceutical form:

PROLONGED-RELEASE TABLET

Composition:

ALFUZOSIN HYDROCHLORIDE 10 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Authorised

Authorization date:

2014-04-11

Patient Information leaflet

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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.
Zochek works by relaxing the prostate gland muscle. This reduces the
narrowing of the urethra and so makes
it easier to pass urine.
In a few patients with benign prostatic hypertrophy, the prostate
gland gets so big that it stops the flow of
urine completely. This is called Acute Urinary Retention.
•
This is very painful and you may need a short stay in hospital.
•
A thin, flexible tube (catheter) is passed into the bladder. This
drains the water and relieves the pain.
•
During this time,

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Zochek 10 mg prolonged-release tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 10 mg alfuzosin hydrochloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release tablet.
White to off-white round (diameter 8.1 mm), biconvex, film-coated
tablets debossed with ‘X’ on one
side and ‘47’ on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of moderate to severe functional symptoms of benign prostate
hyperplasia (BPH).
Adjunctive therapy with urethral catheterisation for Acute Urinary
Retention related to BPH.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults: _
BPH: The recommended dose is one 10 mg prolonged-release tablet once
daily to be taken after a
meal.
Acute urinary retention:
One 10mg tablet daily after a meal to be taken from the first day of
catheterisation. The treatment
should be administered for 3-4 days, 2-3 days during catheterisation
and 1 day after catheter removal.
In this indication, No benefit on progression of acute urinary
retention has been established in patients
under 65 years of age or if treatment is extended beyond 4 days.
_Elderly (over the age of 65 years) _
The recommended dose is the same as that for adults. Pharmacokinetic
and clinical safety studies
have shown that dose adjustment is not necessary in the case of
elderly patients.
_Impaired renal function _
Mild to moderate renal insufficiency (creatinine clearance > 30
ml/min): Dose reduction is usually not
necessary (see section 5.2).
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_Severe renal insufficiency _
Alfuzosin 10 mg should not be given to patients with severely impaired
renal function (creatinine
clearance < 30 ml/min) as there are no clinical safety data available
for this patient group.
_ _
_Hepatic insufficiency: _
Alfuzosin, given as 10 mg prolonged-release tablets are
contraindicated in patients with hepatic
insufficiency (see section 4.3). Preparations