Alfuzosin Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

ALFUZOSIN DOC Generici 10 mg prolonged-release tablets

Generic medicine
Please read this leaflet carefully before using this medicine.

• 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 personally. Never give it to others. This medicine may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

In this leaflet :

1. What ALFUZOSIN DOC Generici is and what it is used for
2. Before you take ALFUZOSIN DOC Generici
3. How to take ALFUZOSIN DOC Generici
4. Possible side effects
5. How to store ALFUZOSIN DOC Generici
6. Further information

1. WHAT ALFUZOSIN DOC Generici IS AND WHAT IT IS USED FOR

ALFUZOSIN DOC Generici contains the active substance alfuzosin, which belongs to a group of medicines called alpha-adrenergic receptor antagonists or "alpha blockers".
Alfuzosin is used to treat the symptoms of a condition called Benign Prostatic Hyperplasia (BPH). Benign prostatic hyperplasia means that the prostate gland has become enlarged (hypertrophy), but this growth is not cancerous (it is benign). Symptoms include: frequent need to go to the bathroom to pass urine (especially at night), difficulty in passing urine, and the feeling of not having completely emptied the bladder.
Alfuzosin works by relaxing the muscles of the prostate and the bladder, making urination easier.

2. BEFORE USING ALFUZOSIN DOC Generics

Do not use ALFUZOSIN DOC Generics

• if you are allergic (hypersensitive) to alfuzosin or to other "alpha-blockers" (e.g. terazosin, doxazosin)
• if you are allergic to any of the other ingredients of ALFUZOSIN DOC Generics (the ingredients are listed in Section 6, Other information)
• if you have fainted or felt dizzy when sitting or standing up suddenly
• if you have liver disorders
• if you are taking any other medicine called an "alpha-blocker" (e.g. terazosin, doxazosin)

Take special care with ALFUZOSIN DOC Generics, especially if

• you have severe liver impairment
• you are taking medicines for high blood pressure. Your doctor should monitor your blood pressure regularly, especially at the beginning of treatment
• you experience a sudden drop in blood pressure upon standing. This may cause dizziness, weakness or sweating a few hours after taking ALFUZOSIN DOC Generics. In such cases, you should lie down until symptoms completely disappear. These effects are usually temporary and occur at the beginning of treatment
• you have previously been treated with an alpha-blocker that caused a significant drop in blood pressure. Your doctor will start alfuzosin treatment at a low dose and gradually increase it, depending on how you feel
• you suffer from acute heart failure
• you have congenital QTc interval prolongation, or a history of acquired QTc prolongation, or if you are taking medicines known to prolong the QTc interval. Your doctor must monitor you before and during treatment with alfuzosin
• you suffer from coronary artery disease; specific treatment for coronary insufficiency must be maintained. If angina pectoris recurs or worsens, you must stop taking alfuzosin
• you experience chest pain (angina) and are being treated with a "nitrate". Taking alfuzosin may increase the risk of low blood pressure
• before undergoing cataract surgery (clouding of the lens), you are advised to inform your ophthalmologist if you are currently or have previously been treated with ALFUZOSIN DOC Generics. ALFUZOSIN DOC Generics may cause complications during surgery, which can be managed if the specialist is informed in advance
• you are over 65 years of age, due to the risk of developing hypotensive events and related clinical manifestations.

Talk to your doctor if any of these situations apply to you.
The tablet must be swallowed whole. Do not chew, crush, powder or break it.
Doing so may result in inappropriate release and absorption, and possibly lead to adverse effects.

Taking ALFUZOSIN DOC Generics with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those not requiring a prescription.
It is particularly important to inform your doctor if you are taking any of the following medicines, as they may interact with your medicine:

• ketoconazole and itraconazole (medicines used to treat fungal infections)
• ritonavir (a medicine used to treat HIV)
• medicines to lower blood pressure
• medicines (nitrates) used to treat symptoms of chest pain (angina)

Concomitant use of ALFUZOSIN DOC Generics with medicines used to treat hypertension or chest pain may cause a drop in blood pressure.

ALFUZOSIN DOC Generics must not be taken together with other "alpha-blockers", such as terazosin or doxazosin.
If you are scheduled for surgery requiring anaesthetics, inform your doctor that you are taking ALFUZOSIN DOC Generics.

Taking ALFUZOSIN DOC Generics with food and drink
ALFUZOSIN DOC Generics should be taken after meals.

Driving and using machines
At the beginning of treatment with ALFUZOSIN DOC Generics, you may experience a sensation of light-headedness, dizziness or fainting. If you experience such symptoms, do not drive, operate machinery or perform hazardous tasks until symptoms have resolved.

Important information about some of the excipients in ALFUZOSIN DOC Generics
This medicine contains a small amount of lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO USE ALFUZOSIN DOC Generici

Always use ALFUZOSIN DOC Generici exactly as directed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
How many tablets should you take?
The usual recommended dose is one tablet daily, taken after a meal.
On the first day, take the tablet in the evening before going to bed. Afterwards, take the tablet at the same
time each day, after a meal.
The tablet must be swallowed whole with a glass of water.
The tablets must not be crushed, chewed or divided, to avoid rapid absorption of too high a dose of the active
substance, alfuzosin; this could increase the risk of side effects.
Elderly patients (over 65 years) and patients with mild to moderate renal impairment:
Your doctor will prescribe a lower starting dose of alfuzosin. If you tolerate the medicine well and require a
higher dose, your doctor will prescribe one tablet of ALFUZOSIN DOC Generici daily.
Use in children:
The efficacy of alfuzosin in children between 2 and 16 years of age has not been demonstrated. Therefore, the
use of alfuzosin in the paediatric population is not recommended.
If you take more ALFUZOSIN DOC Generici than you should:
If you take high doses of ALFUZOSIN DOC Generici, your blood pressure may drop suddenly and you may
feel dizzy or even faint. If you start to feel dizzy, sit or lie down until you feel better. If symptoms do not
improve, contact your doctor, as you may require hospital treatment.
If you forget to take ALFUZOSIN DOC Generici
If you forget to take a dose, take the next tablet at your usual time. Do not take a double dose to make up for
a missed tablet, as this may cause a sudden drop in blood pressure, especially if you are being treated with
medicines that lower blood pressure.
If you stop using ALFUZOSIN DOC Generici
Do not stop treatment without first consulting your doctor. If you wish to stop treatment, or if you have any
doubts about the medicine you are taking, speak to your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, ALFUZOSINA DOC Generici may cause adverse reactions, although not everyone experiences them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. If your face or throat swells after taking these tablets, contact your doctor immediately.
A common adverse effect when starting treatment is dizziness, especially when standing up from a sitting or lying position (postural hypotension). If you begin to feel lightheaded or dizzy, sit or lie down until you feel better.

The following adverse reactions have been reported. If any of these effects worsen, consult your doctor.

Common adverse reactions (more than 1 in 100 and less than 1 in 10 patients):

• fatigue – dizziness – dry mouth
• headache – abdominal pain – feeling of weakness
• indigestion – feeling unwell
• nausea (general stomach upset)

Uncommon adverse reactions (more than 1 in 1,000 and less than 1 in 100 patients):

• fatigue – runny nose – skin rash
• eye disorders – chest pain – itching
• rapid heartbeat – diarrhea – swelling of the ankles and feet
• facial flushing – marked drop in blood pressure (postural hypotension) – edema
• fainting (especially at the beginning of treatment) – vertigo

Rare adverse reactions (less than 1 in 10,000 patients):

• worsening or recurrence of chest pain (angina pectoris) – generalized body swelling – hives (angioedema)

Frequency not known (cannot be estimated from available data):

• iris floppiness syndrome (floppy iris syndrome) – vomiting – persistent and painful erection (priapism)
• alteration of heart rhythm (atrial fibrillation) – reduction in white blood cell count (neutropenia) – marked drop in blood pressure (circulatory collapse) in at-risk patients

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. HOW TO STORE ALFUZOSIN DOC Generici

Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use ALFUZOSIN DOC Generici after the expiry date stated on the carton and packaging.
The expiry date refers to the last day of the month.
Medicinal products must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. OTHER INFORMATION

What ALFUZOSINA DOC Generici contains

• The active substance is alfuzosin hydrochloride. One prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
• The tablet core also contains lactose monohydrate, hypromellose, microcrystalline cellulose, povidone K25, colloidal anhydrous silica, magnesium stearate.
• The tablet coating contains poly(vinyl alcohol), titanium dioxide (E171), macrogol 4000, talc (E553b), ethylcellulose (20cP), medium-chain triglycerides, oleic acid.

Description of the appearance of ALFUZOSINA DOC GENERICS and contents of the pack
ALFUZOSINA DOC Generici
ALFUZOSINA DOC Generici prolonged-release tablets are white, round, film-coated tablets.
Pack sizes of 30 tablets in PVC/PVDC/aluminium blisters are available.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan, Italy.

Responsible manufacturers for batch release:
Kern Pharma, S.L., Venus 72, Polígono Ind. Colón II, 08228 Terrassa, Barcelona, Spain.
Mipharm S.p.A. – Via B. Quaranta 12 – 20141 Milan, Italy.

This medicinal product is authorized for sale in the European Economic Area countries under the following names:
Greece: Rilif 10 mg, δισκία παρατεταμένης αποδέσμευσης
Italy: ALFUZOSINA DOC Generici 10 mg, prolonged-release tablets

Latest approval of the package leaflet: