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ALFUZOSIN HCL 2.5 MG FILM-COATED TABLETS

Active substance(s): ALFUZOSIN HYDROCHLORIDE

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Alfuzosin HCl 2.5 mg film-coated tablets
alfuzosin hydrochloride
Read all of this leaflet carefully before you start using 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 gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Alfuzosin HCl is and what it is used for
2. Before you use Alfuzosin HCl
3. How to use Alfuzosin HCl
4. Possible side effects
5. How to store Alfuzosin HCl
6. Further information
1. WHAT ALFUZOSIN HCl IS AND WHAT IT IS USED FOR
Alfuzosin belongs to a group of medicines called alpha-blockers,
medicines for problems with urination in the case of prostate
disorders.
Use for:
- Alfuzosin HCl is indicated for treatment of functional symptoms
of benign prostatic hyperplasia.
- Problems with urination in the case of benign prostate
enlargement.
2. BEFORE YOU USE ALFUZOSIN HCl
Do not use Alfuzosin HCl
·
are allergic (hypersensitive) to alfuzosin, other quinazolines
(e.g. terazosin, doxazosin) or any of the other components of
this medicine
·
suffer (have suffered) from dizziness, particularly when standing
up from a sitting or lying position
·
are also using other alpha1-blockers such as doxazosin and /
or other dopamine receptor agonists such as ropinirole.
·
have serious liver disease.
Take special care with Alfuzosin HCl
·
if you have a condition which affects the coronary arteries (any
treatment of a reduction in the supply of blood to the cardiac
muscle should be continued); if symptoms of pain in the chest
(angina pectoris) recur or become worse, the use of alfuzosin
should be stopped.
·
if you are known to have an abnormality of electrocardiogram
(ECG), called “QT prolongation”
·
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
·
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 HCl . This is because Alfuzosin HCl may cause
complications during the surgery which can be managed if your
specialist is prepared in advance
·
if you are incontinent (unable to hold urine).
Consult your doctor if one of the above warnings applies to you or
has applied to you in the past.

Black

Alfuzosin HCl 2.5 mg
P150

P150

Alfuzosin HCl 2.5 mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Using other medicines
Note: the following comments can also apply to the use of
medicines some time ago or in the near future.
The medicines mentioned in this section might be known to you by
another name, often the trade name. In this section, only the name
of the active substance or the category of active substances of the
medicine is mentioned and not the trade name. For this reason,
you should always take a good look at the packaging or the
package insert to see what is the active substance of the medicine
you are using.
Interaction means that medicines will have a bearing on each
other's effect and/or side effects when used together. Interaction
can occur when these tablets are used with:
·
other alpha1-blockers (concomitant use should be avoided)
·
antihypertensives (it might be necessary to adjust the dose of
these because of the possibility of a drop in blood pressure)
·
nitrates (anti-anginal medicines) (it might be necessary to
adjust the dose of these because of the possibility of a drop in
blood pressure)
·
products such as ketoconazole and itraconazole which treat
fungal infections or ritonavir which is used for HIV. These
products affect the way that alfuzosin works
·
general anaesthetics. If you are to undergo an operation which
requires a general anaesthetic you should tell the anaesthetist,
as your blood pressure could fall too low.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
As Alfuzosin HCl is not used in women, this section does not apply.
Driving and using machines
The use of Alfuzosin HCl can sometimes result in dizziness or
general weakness (see “Possible side effects”). If you suffer from
these side effects, do not drive any vehicle and/or operate any
machinery which requires you to be alert.
Important information about some of the ingredients of
Alfuzosin HCl
This medicinal product 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 USE ALFUZOSIN HCl
Always use Alfuzosin HCl exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Use in children
Alfuzosin HCl is not recommended for children.
Dosage and method of use
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.
In patients with liver problems:
The usual dose is one 2.5 mg tablet daily. Your doctor may
increase this to one 2.5 mg tablet twice a day (in the morning and
evening).
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).
If you are starting the treatment, it is best if you take the first tablet
before you go to bed.
If you notice that Alfuzosin HCl has too strong or too weak an
effect, consult your doctor or pharmacist.

How long will the treatment last?
Your doctor or pharmacist will tell you how long you should use
Alfuzosin HCl. Alfuzosin HCl is prescribed for a fairly long period of
time.
If you use more Alfuzosin HCl than you should
If you (or someone else) have taken too much Alfuzosin HCl, 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 HCl, 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 use Alfuzosin HCl
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Alfuzosin HCl can cause side effects, although
not everybody gets them.
You should see your doctor immediately if you experience the
following symptoms:
Swollen face, tongue or throat; difficulty in swallowing; difficulty in
breathing and hives (these symptoms occur in less than 1 in 10,000
persons treated).
The following side effects have been reported at the approximate
frequencies shown:
Common (affecting fewer than one person in 10 but more than one
person in 100):
·
nausea, abdominal pain, diarrhoea and dry mouth
·
weakness, dizziness (vertigo), malaise and headache
·
low blood pressure (orthostatic hypotension)
·
asthenia (general weakness of the body).
Uncommon (affecting fewer than one person in 100 but more than
one person in 1,000):
·
rapid heartbeat (tachycardia), palpitations and fainting episodes
·
drowsiness
·
disturbances of vision
·
blocked nose, sneezing and nasal discharge (rhinitis)
·
vomiting
·
skin rash and itching
·
accumulation of fluid (oedema), flushes and chest pain.
Very rare (affecting fewer than one person in 10,000):
·
people with pre-existing disease of the blood vessels of the
heart may either experience heart pain (angina pectoris) for the
first time or aggravate existing angina
·
hives
Additional side effects (frequency unknown) which may occur are:
Decrease in white blood cells. Signs may include more frequent
·
infections, sore throat or mouth ulcers.
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
Alfuzosin HCl, 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.
Abnormal heart rhythm (Atrial fibrillation)
·
Abnormal, often painful, persistent erection of the penis
·
unrelated to sexual activity (priapism).
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. HOW TO STORE ALFUZOSIN HCL
Keep out of the reach and sight of children.
Do not use Alfuzosin HCl after the expiry date which is stated on
the carton after EXP. The first 2 digits indicate the month, the last
year figures. The expiry date refers to the last day of the month.
This medicinal product does not require any special storage
conditions
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 to protect the environment.
6. FURTHER INFORMATION
What Alfuzosin HCl contains
- The active ingredient of Alfuzosin HCl 2.5 mg is alfuzosin
hydrochloride.
- The other ingredients (excipients) are
Tablet core: Sodium starch glycolate (Type A), cellulose
microcrystalline, lactose monohydrate, povidone, magnesium
stearate.
Coating: Hypromellose, macrogol 400, titanium dioxide (E 171).
What Alfuzosin HCl looks like and contents of the pack
Film-coated tablet
White to off-white round, biconvex, film-coated tablets debossed
with 'X' on one side and '31' on other side.
Alfuzosin HCl is packed in PVC / PVdC- Aluminium foil blister
packs or (HDPE) bottle packs.
Pack sizes:
Blister pack: 15, 30, 50, 60, 90, 100
Bottle pack: 100, 250,1000
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
This medicinal product is authorised in the Member States of
the EEA under the following names:
The Netherlands:
Alfuzosine HCl Aurobindo 2,5 mg,
filmomhulde tabletten
United Kingdom:
Alfuzosin HCl 2.5 mg film-coated tablets
This leaflet was last approved in 04/2015.

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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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