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ALFUZOSIN HYDROCHLORIDE 2.5 MG FILM-COATED TABLETS

Active substance(s): ALFUZOSIN HYDROCHLORIDE

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ALFUZOSIN HYDROCHLORIDE 2.5 mg
FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you
start taking this medicine.
• 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.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

• 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 Alfuzosin. This is because
Alfuzosin may cause complications during
the surgery which can be managed if your
specialist is prepared in advance
• if you are incontinent.
Consult your doctor if one of the above
warnings applies to you or has applied to you
in the past.

Taking other medicines:
Note: the following comments can also apply
to the use of medicines some time ago or in
the near future.
IN THIS LEAFLET:
The medicines mentioned in this section might
be known to you by another name, often the
1. What Alfuzosin Hydrochloride 2.5 mg
Film-Coated Tablets are and what they are trade name.
In this section, only the name of the active
used for
substance or the category of active substances
2. Before you take Alfuzosin Hydrochloride
of the medicine is mentioned and not the trade
2.5 mg Film-Coated Tablets
3. How to take Alfuzosin Hydrochloride 2.5 mg name. For this reason, you should always take
a good look at the packaging or the package
Film-Coated Tablets
insert to see what is the active substance of
4. Possible side effects
the medicine you are using.
5. How to store Alfuzosin Hydrochloride
2.5 mg Film-Coated Tablets
Interaction means that medicines will have a
6. Further information
bearing on each other’s effect and/or side
effects when used together. Interaction can
WHAT
ALFUZOSIN
HYDROCHLORIDE
1 2.5 mg FILM-COATED TABLETS ARE
occur when these tablets are used with:
• other alpha1-blockers (concomitant use
AND WHAT THEY ARE USED FOR
should be avoided)

antihypertensives (it might be necessary to
Alfuzosin belongs to a group of medicines
adjust the dose of these because of the
called alpha-blockers, medicines for problems
possibility of a drop in blood pressure)
with urination in the case of prostate disorders.
• nitrates (anti-anginal medicines) (it might be
necessary to adjust the dose of these because
Use for:
of the possibility of a drop in blood pressure)
Alfuzosin is indicated for treatment of functional
• products such as ketoconazole and
symptoms of benign prostatic hypertrophia.
itraconazole which treat fungal infections,
Problems with urination in the case of benign
clarithromycine and erythromycine which
prostate enlargement.
treat bacterial infections or ritonavir which
is used for HIV. These products affect the
YOU TAKE ALFUZOSIN
2 BEFORE
way that alfuzosin works
HYDROCHLORIDE 2.5 mg
• general anaesthetics. If you are to undergo
FILM-COATED TABLETS
an operation which requires a general
anaesthetic you should tell the anaesthetist,
DO NOT take Alfuzosin if you:
as your blood pressure could fall too low.
• are allergic (hypersensitive) to alfuzosin, other
quinazolines (e.g. terazosin, doxazosin) or any Please tell your doctor or pharmacist if you
are taking or have recently taken any other
of the other components of this medicine
medicines, including medicines obtained
• suffer (have suffered) from dizziness,
particularly when standing up from a sitting without a prescription.
or lying position
Pregnancy and breast-feeding:
• are also using other alpha1-blockers such as As Alfuzosin is not used in women, this
doxazosin
section does not apply.
• have serious liver disease.
Driving and using machines:
The use of Alfuzosin can sometimes result in
Take special care with Alfuzosin:
dizziness or general weakness (see “Possible
• if you have a condition which affects the
coronary arteries (any treatment of a reduction side effects”). If you suffer from these side
in the supply of blood to the cardiac muscle effects, do not drive any vehicle and/or operate
should be continued); if symptoms of pain in any machinery which requires you to be alert.
the chest (angina pectoris) recur or become
worse, the use of alfuzosin should be stopped
• if you belong to one of the following patient
groups:
• elderly patients
• patients with an increased sensitivity to
alpha1-blockers
• patients who are treated for high blood
pressure
• in some patients, a drop in blood pressure
can occur on standing or sitting up within
the first few hours of taking the tablet,
particularly when sitting or standing up from
a lying position. In this case, you should lie
down until the symptoms have completely
disappeared. This symptom usually occurs
at the start of the treatment and is usually
of a temporary nature. It is usually possible
to continue with the treatment

Important information about some of the
ingredients of Alfuzosin:
This medicine contains 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.

3

HOW TO TAKE ALFUZOSIN
HYDROCHLORIDE 2.5 mg
FILM-COATED TABLETS

Dosage and method of use
Always take Alfuzosin exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
The usual dose is one 2.5 mg tablet three
times a day. Your doctor may increase this to
four times a day if needed.

In patients with poor kidney function:
The usual dose is two 2.5 mg tablets daily.
Take the first tablet in the evening.

Very rare (affecting fewer than one person in
10,000):
• people with pre-existing disease of the
blood vessels of the heart may either
In patients with liver problems: The usual
experience heart pain (angina pectoris) for
dose is one 2.5 mg tablet daily. Your doctor
the first time or aggravate existing angina
may increase this to one 2.5 mg tablet twice a • hives
day (in the morning and evening).
• liver damage.
Adults over 65, patients taking other
medicines for high blood pressure, or
patients with poor kidney function: The
initial dose is one 2.5 mg tablet twice a day
(morning and evening).

Not known (cannot be estimated from the
available data):
• decrease in the number of white blood cells
(neutropenia)
• Intraoperative Floppy Iris Syndrome (IFIS) - if
you are undergoing eye surgery because of
Children and adolescents (aged 2 to 16
cataract (cloudiness of the lens) please
years): Efficacy of Alfuzosin has not been
inform your eye specialist before the
demonstrated in children aged 2 to 16 years,
operation that you are using or have
therefore, Alfuzosin is not indicated for use in
previously used Alfuzosin, as your pupil may
children and adolescents (aged 2 to 16 years).
dilate poorly and the iris (coloured part of the
eye) may become floppy during the operation
If you are starting the treatment, it is best if
• abnormal heart rhythm (atrial fibrillation)
you take the first tablet before you go to bed. • vomiting
• problems with your liver
If you notice that Alfuzosin has too strong or • persistent and painful penile erection
too weak an effect, consult your doctor or
(priapism).
pharmacist.
If any of the side effects get serious, or if you
How long will the treatment last ?
notice any side effects not listed in this
Your doctor or pharmacist will tell you how
leaflet, please tell your doctor or pharmacist.
long you should use Alfuzosin. Alfuzosin is
prescribed for a fairly long period of time.
HOW TO STORE ALFUZOSIN
If you take more Alfuzosin than you should
If you (or someone else) have taken too much
Alfuzosin, or you think a child has swallowed
any of the tablets, contact your nearest
hospital casualty department or your doctor
immediately. If you have taken too much
Alfuzosin, you might suffer from low blood
pressure. Lie down as much as possible, as
this will help minimise the side effects.
If you forget to take Alfuzosin
If you forget to take a tablet, take one as soon
as you remember, unless it is nearly time to
take the next one. Do not take a double dose
to make up for a forgotten tablet. Take your
next dose at the usual time.
If you have any further questions on the use
of this product, ask your doctor or pharmacist.

5

HYDROCHLORIDE 2.5 mg
FILM-COATED TABLETS

Keep out of the reach and sight of children.
Store in the original package in order to
protect from light.
Do not use Alfuzosin after the expiry date
which is stated on the outer packaging. The
expiry date refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
protect the environment.

6

FURTHER INFORMATION

What Alfuzosin contains:
• the active substance is alfuzosin
hydrochloride. Each tablet contains 2.5 mg
Like all medicines, Alfuzosin can cause side
of alfuzosin hydrochloride
effects, although not everybody gets them.
• the other ingredients are: Tablet core:
You should see your doctor immediately if
lactose monohydrate, povidone, sodium
you experience the following symptoms:
starch glycolate, microcrystalline cellulose,
Swollen face, tongue or throat; difficulty in
magnesium stearate. Tablet coat:
swallowing; difficulty in breathing and hives
hypromellose, titanium dioxide (E171), lactose
(these symptoms occur in less than 1 in 10,000
monohydrate, macrogol, glycerol triacetate.
persons treated).
The following side effects have been reported What Alfuzosin Hydrochloride 2.5 mg
film-coated tablets look like and contents of
at the approximate frequencies shown:
the pack:
Common (affecting fewer than one person in Alfuzosin are white, round, film-coated
10 but more than one person in 100):
tablets, debossed “LFN” on one side and
• nausea, abdominal pain, diarrhoea and dry “2.5” on the other.
mouth
The tablets are available in blister packs of 30,
• weakness, dizziness (vertigo), malaise and 50, 60, 90, 100 tablets and 50 tablets in
headache
unit-dose blisters.
• low blood pressure (orthostatic hypotension) Not all pack sizes may be marketed.
• asthenia (general weakness of the body).
Marketing Authorisation Holder:
Uncommon (affecting fewer than one person
TEVA UK Limited, Eastbourne, East Sussex,
in 100 but more than one person in 1,000):
BN22 9AG.
• rapid heartbeat (tachycardia), palpitations
and fainting episodes
Manufacturer
• drowsiness
Teva Pharmaceutical Works Private Limited
• disturbances of vision
• blocked nose, sneezing and nasal discharge Company, Pallagi út 13, 4042 Debrecen,
Hungary.
(rhinitis)
• skin rash and itching
This leaflet was revised in January 2012.
• incontinence
• accumulation of fluid (oedema), flushes and
PL 00289/1120
chest pain.

4

POSSIBLE SIDE EFFECTS

TEVA UK Limited

86510-V

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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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