Alfuzosin Mylan Generics: detailed information

Package leaflet: Information for the patient

ALFUZOSIN MYLAN GENERICS 10 mg prolonged-release tablets

alfuzosin hydrochloride
Generic medicine
For adult men
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Alfuzosin Mylan Generics is and what it is used for
What you need to know before taking Alfuzosin Mylan Generics
How to take Alfuzosin Mylan Generics
Possible side effects
How to store Alfuzosin Mylan Generics
Contents of the pack and other information

1. What Alfuzosina Mylan Generics is and what it is used for

Alfuzosina Mylan Generics contains the active substance alfuzosin, which belongs to a group of
medicines called alpha-adrenergic receptor antagonists or alpha-blockers.
It is used to treat mild to severe symptoms caused by an enlarged prostate, a condition also known as benign prostatic hyperplasia (non-cancerous). The prostate is a gland located below the bladder. It surrounds the urethra, the tube through which urine passes. When the prostate enlarges, it presses on the urethra, narrowing it. Enlargement of the prostate gland can cause urinary problems such as frequent and difficult urination, especially at night. Alpha-blockers relax the muscles of the prostate and the bladder neck.
This allows urine to flow more easily from the bladder.
In some patients with benign prostatic hyperplasia, the prostate gland becomes so large that it completely blocks the flow of urine. This is called Acute Urinary Retention. It is very painful and may require a short hospital stay. A thin, flexible tube (catheter) is inserted into the bladder. This drains the urine and relieves pain. Alfuzosin may be used to help facilitate the passage of urine.

2. What you should know before taking Alfuzosina Mylan Generics

Do not take Alfuzosina Mylan Generics:

if you are allergic to alfuzosin, to other quinazoline medicines (e.g. terazosin, doxazosin), or to any of the other ingredients of this medicine (listed in section 6).
if you have conditions that may cause a marked drop in blood pressure when standing up (your doctor may have told you this is called "postural" or "orthostatic" hypotension). This may cause dizziness.
if you have liver problems.
if you are taking other medicines belonging to the group known as alpha-blockers (see section below "Other medicines and Alfuzosina Mylan Generics").

Do not take this medicine if any of the above conditions apply to you. If you are in doubt,
speak with your doctor or pharmacist before taking alfuzosin.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alfuzosina Mylan Generics:

if you have severe kidney problems.
if you are taking medicines for high blood pressure. In this case, your doctor will monitor your blood pressure regularly, especially at the beginning of treatment.
if you previously experienced a marked drop in blood pressure after taking another medicine from the group known as alpha-blockers. In this case, your doctor will start treatment with alfuzosin at a low dose and gradually increase it.
if you have or have had heart failure (weakness of the heart muscle), or other heart problems.
if you have or have had problems with reduced blood flow to parts of the brain (cerebrovascular disorders).
if you suffer from chest pain (angina) and are being treated with a nitrate. Concomitant use of nitrates and alfuzosin may increase the risk of low blood pressure. Your doctor may stop treatment with Alfuzosina Mylan Generics if angina recurs or worsens.
if you were born with or have had any condition associated with an abnormal heart rhythm (which may be seen on an ECG recording the heart's electrical activity), or if you are taking medicines known to affect heart rhythm.

While taking this medicine, you may experience a sudden drop in
blood pressure when standing up (you may feel dizzy, tired, weak, or
sweaty), particularly in the first few hours after taking the dose. If this occurs, lie down
with your legs and feet raised until symptoms disappear. These effects are usually
short-lived and occur at the beginning of treatment. Usually, treatment does not need
to be stopped. Talk to your doctor, as they may decide to adjust the dose.
In case of erection (often painful), unrelated to sexual activity, lasting more than 4 hours,
you should contact a doctor or go immediately to hospital, as treatment may be required.
See the section below "Possible side effects".
If you are scheduled for cataract surgery (clouding of the lens), inform your ophthalmologist
before the procedure if you are currently taking or have previously taken alfuzosin. This is because
alfuzosin during surgery may lead to complications that the specialist, if informed in advance, can manage.

Children and adolescents
The use of Alfuzosina Mylan Generics is not recommended in children and adolescents (patients
under 16 years of age).

Other medicines and Alfuzosina Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Do not take Alfuzosina Mylan Generics if you are taking other medicines belonging to the group known as
alpha-blockers, such as doxazosin, indoramin, terazosin, prazosin, or tamsulosin.
Alfuzosina Mylan Generics and certain medicines may interact with each other. Inform your doctor or
pharmacist if you are taking any of the following medicines:

medicines used to treat fungal infections (such as ketoconazole and itraconazole)
medicines used to treat HIV (such as ritonavir)
medicines for bacterial infections (such as clarithromycin and telithromycin)
medicines used for depression (such as nefazodone)
medicines that lower blood pressure
medicines used for chest pain (angina)
medicines commonly used to treat erectile dysfunction (impotence)
Using Alfuzosina Mylan Generics together with medicines used to treat high blood pressure, or nitrates used to treat heart conditions such as chest pain (angina), or to treat erectile dysfunction, may lead to a drop in blood pressure. If this occurs, lie down until symptoms have completely subsided. Inform your doctor, as they may decide to change the dose of your medicine.

If you are about to undergo surgery requiring general anaesthesia, inform your
doctor and hospital staff that you are taking this medicine. Your doctor may
advise you to stop taking this medicine for 24 hours before surgery, to help prevent
the risk of blood pressure fluctuations.

Pregnancy and breastfeeding
Alfuzosina Mylan Generics is indicated only for use in men.

Alfuzosina Mylan Generics with food and drink
Take alfuzosin after meals.

Driving and using machines
Especially at the beginning of treatment with Alfuzosina Mylan Generics, you may feel drowsy, dizzy, or weak. Do not drive, operate machinery, or engage in risky activities until you know how this medicine affects you.

Alfuzosina Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking
this medicine.

3. How to take Alfuzosina Mylan Generics

Always take this medicine exactly as directed by your doctor. If you have any doubts, you must
consult your doctor or pharmacist.
How much to take
Benign prostatic hyperplasia

The recommended dose is one tablet (10 mg of alfuzosin) once daily.
Take the tablet after the evening meal.

Acute urinary retention

Alfuzosin will be administered to you by your doctor on the day the catheter is inserted.
You must continue taking alfuzosin once daily after a meal. Follow your doctor's prescription instructions.

Swallow the tablets whole with a sufficient amount of water. Do not crush, pulverize, chew, or divide the tablets, as inappropriate release of the active substance alfuzosin could enter your body too quickly. This may increase the risk of adverse effects.
If you have kidney problems
If you have mild to moderate renal impairment, your doctor may recommend starting with a lower dose of alfuzosin. If the lower dose is not effective for you, your doctor may subsequently prescribe one tablet (10 mg of alfuzosin) once daily. Take the tablet after dinner.
If you take more Alfuzosina Mylan Generics than you should
If you have taken a large amount of alfuzosin, your blood pressure may drop suddenly and you may experience dizziness or even fainting. If you start feeling dizzy, you should sit or lie down until you feel better. If symptoms do not resolve, contact your doctor, as your low blood pressure may require hospital treatment.
Do not attempt to drive yourself to hospital.
If you forget to take Alfuzosina Mylan Generics
Do not take a double dose to make up for a forgotten tablet, as this could cause a sudden drop in blood pressure. Take the next tablet as prescribed.
If you stop taking Alfuzosina Mylan Generics
You must not interrupt or stop taking Alfuzosina Mylan Generics without first talking to your doctor.
If you wish to discontinue treatment or have any further questions regarding the use of this medicine, consult your doctor or pharmacist.
Use in children
Alfuzosin is not indicated for use in children.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following side effects, stop taking the medicine and contact your doctor
immediately or go to the nearest hospital emergency department :

worsening of chest pain (angina) or new onset of chest pain. Normally, this occurs only if you have previously had angina.
red, lumpy skin rash (urticaria), swelling of the eyelids, face, lips, mouth or tongue, difficulty breathing or swallowing. These are symptoms of serious allergic reactions.
an increase in the number of infections (e.g. sore throat, mouth ulcers, etc., and fever). This may be a sign of a reduced number of white blood cells.
an unusual or abnormal heart rhythm – you may notice a very fast or irregular heartbeat, which may cause shortness of breath, dizziness or fainting.
liver problems, which may be caused by a blockage in the bile duct. You may feel unwell, notice loss of appetite, pale stools, dark urine or yellowing of the skin and whites of the eyes.
sudden collapse, numbness or weakness of arms or legs, dizziness and confusion, vision disturbances, difficulty swallowing, difficulty speaking or loss of speech (these may be signs of a stroke or mini-stroke caused by changes in blood circulation to parts of the brain). This is more likely in patients who have previously had problems with blood flow to the brain.
- persistent erection (priapism) – Priapism is an abnormal, often painful, persistent erection of the penis unrelated to sexual activity. If you experience an erection as described here lasting more than 4 hours, contact a doctor or go to hospital immediately, as treatment may be required. This condition may lead to permanent impotence if not adequately treated.

Other possible side effects
Common (may affect up to 1 in 10 people):
Tiredness, dizziness, headache, weakness, stomach pain, nausea, indigestion, feeling of general weakness, general feeling of being unwell.
Uncommon (may affect up to 1 in 100 people):
Drowsiness, eye/vision problems, increased heart rate, fainting (especially when starting treatment with too high a dose or when restarting treatment), sensation of pounding or rapid heartbeat, dry mouth, runny nose, skin rash, itching, urinary incontinence, fluid retention (e.g. swelling of the ankles and feet), facial or body redness (flushing), sweating, sensation of dizziness (vertigo), feeling of nausea (vomiting), diarrhoea, marked drop in blood pressure upon standing (especially when starting treatment with too high a dose or when restarting treatment).
Not known (frequency cannot be estimated from the available data):
Persistent and painful erection (priapism), unexplained bruising or bleeding (this may be a sign of reduced platelet count, which helps blood to clot).
If you are undergoing eye surgery for cataract (if the lens is clouded) and you are currently taking or have previously taken alfuzosin, your pupil may not dilate properly and the iris (the coloured part of the eye) may become floppy during surgery. This occurs only during the procedure, and it is important that your ophthalmologist is aware of this, as the surgery may need to be performed differently (see "Warnings and precautions").
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alfuzosina Mylan Generics

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging after Exp. The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Alfuzosina Mylan Generics contains

The active substance is alfuzosin hydrochloride. One prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
The excipients are: monohydrate lactose, hypromellose, povidone, magnesium stearate.

Description of the appearance of Alfuzosina Mylan Generics and contents of the pack
Alfuzosina Mylan Generics prolonged-release tablets are white, round, with bevelled edges, uncoated.
The tablets are available in blister packs containing 10, 20, 30, 50, 60, 60x1, 90, 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan - Italy

Responsible Pharmacist for Batch Release
McDermott Laboratories t/a Gerard Laboratories
Baldoyle Industrial Estate,
Grange Road, Dublin 13 – Ireland
Mylan BV
Krijgsman 20
Amstelveen, 1186DM - Netherlands
Mylan Hungary Kft
Mylan utca 1
H-2900 Komárom - Hungary

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Czech Republic: Alfuzosin Mylan 10 mg
Denmark: Lafunomyl 10 mg
Ireland: Xatger 10 mg prolonged release tablet
Italy: Alfuzosina Mylan Generics 10 mg
Netherlands: Alfuzosine HCl Retard Mylan 10 mg, tabletten met gereguleerde afgifte
Poland: Alugen 10 mg
Portugal: Alfuzosina Mylan 10 mg
Slovakia: Alfuzosin Mylan 10mg
Spain: Alfuzosina Mylan 10 mg comprimidos de liberación prolongada
Sweden: Lafunomyl 10 mg
United Kingdom: Taurazil SR 10 mg Tablets

This leaflet was last updated on