ALFUZOSINA 10 mg Extended-Release Tablet

Зміст інструкції

1. ALFUZOSINA DOC Generici 10 mg prolonged-release tablets
   1. WHAT ALFUZOSINA DOC Generici IS AND WHAT IT IS USED FOR
   2. BEFORE USING ALFUZOSINA DOC Generici
   3. HOW TO USE ALFUZOSINA DOC Generici
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ALFUZOSINA DOC Generici
   6. FURTHER INFORMATION

ALFUZOSINA DOC Generici 10 mg prolonged-release tablets

Generic medicine

• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. Indeed, this medicine may be dangerous to other individuals even if their symptoms are the same as yours.
• If any of the side effects worsen or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
• 1. What ALFUZOSINA DOC Generici is and what it is used for
• 2. Before you use ALFUZOSINA DOC Generici
• 3. How to use ALFUZOSINA DOC Generici
• 4. Possible side effects
• 5. How to store ALFUZOSINA DOC Generici
• 6. Further information

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

ALFUZOSINA DOC Generici contains the active ingredient alfuzosin, which belongs to the group of drugs
called alpha-adrenergic receptor antagonists or “alpha blockers”.
Alfuzosin is used to treat the symptoms of a disease called Benign Prostatic Hyperplasia ( Benign

Prostatic Hyperplasia= BPH). Benign prostatic hyperplasia means that the prostate increases in volume
(hypertrophy), but this formation is not cancerous (it is benign). The symptoms include: frequent
need to go to the bathroom to urinate (especially at night), difficulty urinating and a feeling of not
having completely emptied the bladder.
Alfuzosin works by relaxing the muscles of the prostate and bladder, making urination easier.

2. BEFORE USING ALFUZOSINA DOC Generici

Do not use ALFUZOSINA DOC Generici

• if you are allergic (hypersensitive) to alfuzosin or other “alpha-blockers” (for example terazosin, doxazosin)
• if you are allergic to any of the other ingredients of ALFUZOSINA DOC Generici (the ingredients are listed in Section 6 Further information)
• if you have fainted or experienced a feeling of dizziness when sitting or standing up suddenly
• if you have liver disorders
• if you are taking any other medicine called "alpha-blocker" (for example terazosin, doxazosin)

Take special care with ALFUZOSINA DOC Generici especially

• if you have severe liver disorders
• if you are taking medicines to treat high blood pressure. Your doctor will need to check your blood pressure regularly, especially at the beginning of treatment
• if you experience a sudden drop in blood pressure when you stand up. This may cause dizziness, weakness or sweating a few hours after taking ALFUZOSINA DOC Generici. In these cases, you should lie down until the symptoms completely disappear. These effects are generally temporary and occur at the beginning of treatment
• if you have previously been treated with an alpha-blocker that caused a significant decrease in blood pressure. Your doctor will start treatment with alfuzosin at a low dose and gradually increase the dose, depending on how you feel
• if you suffer from acute heart failure
• if you suffer from congenital prolongation of the QT interval or have a history of acquired prolongation or if you are taking medicines known to increase the QT interval. The doctor must check you before and during treatment with alfuzosin
• if you suffer from coronary artery disease, the specific treatment for coronary insufficiency must be maintained. If angina pectoris recurs or worsens, you should stop alfuzosin
• if you experience chest pain (angina) and are being treated with a “nitrate”. Taking alfuzosin may increase the risk of a decrease in blood pressure
• before undergoing cataract surgery (clouding of the lens), it is advisable to inform your ophthalmologist about ongoing or previous treatment with ALFUZOSINA DOC Generici. ALFUZOSINA DOC Generici may cause complications during the operation that can be treated if the specialist has been warned in time
• If you are over 65 years of age, due to the risk of developing a hypotensive event and its 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, pulverize or triturate it.
This may lead to inappropriate release and absorption and therefore to possible undesirable effects.

Taking ALFUZOSINA DOC Generici with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including
those available without a prescription.
It is particularly important to tell 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 (medicine used to treat HIV)
• medicines to reduce blood pressure
• medicines (nitrates) used to treat the symptoms of chest pain (angina) The concomitant use of ALFUZOSINA DOC Generici with medicines used to treat hypertension or chest pain may cause a drop in blood pressure.

ALFUZOSINA DOC Generici must not be taken with other “alpha-blockers”, such as terazosin or
doxazosin.
If you have scheduled a surgery that requires the administration of anesthetics, tell your
doctor that you are taking ALFUZOSINA DOC Generici.

Taking ALFUZOSINA DOC Generici with food and drink
ALFUZOSINA DOC Generici should be taken after meals.

Driving and using machines
At the beginning of treatment with ALFUZOSINA DOC Generici you may experience a feeling of lightheadedness,
dizziness or fainting. If you feel this way, you should not drive vehicles or use machines or perform
risky operations until the symptoms have passed.

Important information about some ingredients of ALFUZOSINA DOC Generici
This medicine contains a small amount of lactose. If your doctor has told you that you are
intolerant to some sugars, contact your doctor before taking this medicine.

3. HOW TO USE ALFUZOSINA DOC Generici

Always use ALFUZOSINA DOC Generici exactly as your doctor has instructed. If you have any doubts
you should consult your doctor or pharmacist.

How many tablets should you take?
The generally recommended dose is one tablet a day, after eating.
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 eating.
The tablet must be swallowed whole with a glass of water.
The tablets must not be crushed, chewed or divided to avoid the body absorbing a very
rapidly high amount of the active ingredient, alfuzosin; this may lead to
increased exposure to the risk of side effects.

Elderly patients (over 65 years) and patients with mild to moderate renal impairment:
Your doctor will prescribe you to start treatment with a lower dose of alfuzosin. If you are able to
tolerate the medicine well and require a higher dose, your doctor will prescribe you one tablet of
ALFUZOSINA DOC Generici a day.

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 indicated.

If you use more ALFUZOSINA DOC Generici than you should:
If you take high doses of ALFUZOSINA DOC Generici, your blood pressure may suddenly
drop and you will feel dizzy or even faint. If you start to feel dizzy, sit or lie down until you feel better. If the symptoms do not disappear, call your
doctor, as you may need hospital treatment.

If you forget to use ALFUZOSINA DOC Generici
If you forget to take a dose, take the next tablet at the 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 medications that lower blood pressure.

If you stop taking ALFUZOSINA DOC Generici
You should not stop treatment without first consulting your doctor. If you wish to stop the
treatment or if you have any doubts about the medicine you are taking, consult your doctor or
pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, ALFUZOSINA DOC Generici can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions occur very rarely. If your face or throat swells after taking these tablets, consult your doctor immediately.
A common side effect when starting treatment is a feeling of dizziness, especially when getting up from a chair or bed (postural hypotension). If you begin to feel lightheaded or dizzy, sit or lie down until you feel better.
The following side effects have been reported. If any of these effects gets worse, consult your doctor.

Common side effects(more than 1 in 100 and less than 1 in 10 patients):

• fatigue
• headache
• dizziness
• abdominal pain
• indigestion
• nausea (stomach
• dry mouth
• feeling of weakness
• general feeling of discomfort

Uncommon side effects(more than 1 in 1,000 and less than 1 in 100 patients):
disorders)

• fatigue
• eye disorders
• fast heartbeat
• facial flushing
• runny nose
• heart pain
• diarrhoea
• marked reduction of
• skin rash
• itching
• swelling of ankles and feet
• incontinence
• edema
• vertigo

Rare side effects(less than 1 in 10,000):
(hot flushes)

• fainting (especially at the beginning of treatment)
• worsening or - body swelling - hives reappearance of chest pain (angina pectoris) general (angioedema)

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

• iris syndrome
• vomiting
• liver damage
• reduction in the number
• persistent and painful
• pronounced drop in

blood pressure
(circulatory collapse) in
patients at risk

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili . Reporting side effects helps to provide more information on the safety of this medicine.

5. HOW TO STORE ALFUZOSINA DOC Generici

Keep out of the reach and sight of children
This medicinal product does not require special storage conditions.
Do not use ALFUZOSINA DOC Generici after the expiry date indicated on the package and the container.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

6. FURTHER INFORMATION

What ALFUZOSINA DOC Generici contains

• The active ingredient is alfuzosin hydrochloride. One prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
• The inside of the tablet also contains lactose monohydrate, hypromellose, microcrystalline cellulose, povidone K25, anhydrous colloidal 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 GENERICI and contents of the pack of
ALFUZOSINA DOC Generici
ALFUZOSINA DOC Generici prolonged-release tablets are white, round
tablets coated with a film.
They are available in PVC/PVDC/aluminium blister packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l. - Via Turati 40 - 20121 Milan - Italy.
Manufacturers responsible 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.

ThismedicinalproductisauthorisedforsaleintheMemberStatesofthe
European Economic Area with the following denominations:
cardiac (atrial
fibrillation)
of white blood
cells (neutropenia)
Greece: Rilif 10 mg, δισκία παρατεταμένης αποδέσμευσης
Italy: ALFUZOSINA DOC Generici 10 mg, prolonged-release tablets