FARALZIN 10 mg Extended-Release Tablet

Зміст інструкції

1. FARALZIN 10 mg prolonged-release tablets
   1. WHAT IS FARALZIN AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING FARALZIN
   3. HOW TO USE FARALZIN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE FARALZIN
   6. PACKAGE CONTENTS AND OTHER INFORMATION

FARALZIN 10 mg prolonged-release tablets

Alfuzosin hydrochloride
Generic medicine

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What FARALZIN is and what it is used for
• 2. What you need to know before you use FARALZIN
• 3. How to use FARALZIN
• 4. Possible side effects
• 5. How to store FARALZIN
• 6. Contents of the pack and other information

1. WHAT IS FARALZIN AND WHAT IT IS USED FOR

FARALZIN 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”
( BenignProstatic 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. WHAT YOU NEED TO KNOW BEFORE USING FARALZIN

Do not use FARALZIN

• if you are allergic to alfuzosin, to other “alpha-blockers” (for example terazosin, doxazosin) or to any of the other ingredients of this medicine (listed in section 6)
• if you have fainted or had a feeling of dizziness when sitting or standing up suddenly
• if you have liver problems
• if you are taking any other medicine called "alpha-blocker" (for example terazosin, doxazosin)

Warnings and precautions
Talk to your doctor before taking FARALZIN.
Talk to your doctor if any of these situations apply to you:

• if you have severe liver problems.
• 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 have a sudden drop in blood pressure when you stand up. This may cause dizziness, weakness or sweating within a few hours of taking FARALZIN. In these cases, you should lie down until the

symptoms completely disappear. These effects are usually temporary and occur at the beginning of the
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 have congenital prolongation of the QTc interval, or have a known history of acquired QTc prolongation or are taking medicines known to increase the QTc interval. Your doctor will need to evaluate you both before and during the use of alfuzosin.
• If you suffer from coronary artery disease, you should continue the specific treatment for coronary insufficiency. If angina pectoris occurs again or worsens, the use of alfuzosin should be discontinued.
• if you experience chest pain (angina) and are being treated with a “nitrate”. Taking alfuzosin may increase the risk of decreased blood pressure.
• before undergoing cataract surgery (clouding of the lens), inform your ophthalmologist about your current or previous treatment with FARALZIN. This is because FARALZIN may cause complications during the operation, which 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 related clinical manifestations. The tablet must be swallowed whole. It should not be crushed, or broken, or chewed, or reduced to powder. This may determine an inappropriate release and absorption of the medicine with the risk of early side effects.

Other medicines and FARALZIN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
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 FARALZIN with medicines used to treat hypertension or chest pain may cause a drop in blood pressure.

FARALZIN should not be taken with other “alpha1-blockers”, such as terazosin or doxazosin because
they may cause you to have a further lowering of blood pressure.
If you are scheduled for surgery that requires the administration of anesthetics, tell your
doctor that you are taking FARALZIN.

FARALZIN with food and drink
FARALZIN should be taken after meals.

Driving and using machines
At the beginning of treatment with FARALZIN, you may feel lightheaded, dizzy or
faint. If you feel like this, you should not drive vehicles or use machines or perform risky operations
until the symptoms have passed.

FARALZIN contains lactose
This medicine contains a small amount of lactose. If your doctor has diagnosed you as having an intolerance
to certain sugars, contact your doctor before taking this medicine.

3. HOW TO USE FARALZIN

Use this medicine following the instructions of your doctor exactly. If you have any doubts, 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 too much of the active
ingredient, alfuzosin, very quickly; this may lead to
greater 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 tolerate the
medicine well and require a higher dose, your doctor will prescribe one FARALZIN tablet a
day.

Use in children
The efficacy of alfuzosin in children aged between 2 and 16 years has not been demonstrated. Therefore,
the use of alfuzosin is not indicated in the paediatric population.

If you use more FARALZIN than you should
If you take high doses of FARALZIN, 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 the symptoms do not disappear, call your doctor, as you may need
hospital treatment.

If you forget to use FARALZIN
If you forget to take a dose, take the next dose at the usual time. Do not take a double
dose to make up for a missed dose, 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 FARALZIN
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, this medicine can cause side effects, although not everybody gets them.
manifest.

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 worsen, consult your doctor.

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

• dry mouth
• feeling unwell

Uncommon side effects(more than 1 in 1000 and less than 1 in 100 patients)

• fatigue
• headache
• dizziness
• abdominal pain
• indigestion
• nausea
• fast heartbeat
• facial flushing (hot flushes)
• runny nose
• heart pain
• diarrhea
• significant drop in blood pressure (postural hypotension)
• syncope (loss of consciousness)
• skin rash
• itching
• incontinence
• edema
• vertigo
• vomiting

Very rare side effects(less than 1 in 10,000):

• worsening or recurrence of chest pain (angina pectoris)
• generalised swelling of the body (angioedema)
• urticaria

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

• persistent and painful erection (priapism)
• pronounced drop in blood pressure (circulatory collapse) in at-risk patients

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national
reporting system at https://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 FARALZIN

Keep this medicine out of the sight and reach of children.
This medicinal product does not require special storage conditions.
Do not use this medicine after the expiry date which is reported on the package and on the packaging. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What FARALZIN contains

• The active ingredient is alfuzosin hydrochloride. A prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
• The other ingredients are: Inside 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 FARALZIN and package contents
FARALZIN prolonged-release tablets are white, round, film-coated tablets.

• iridescent pupil syndrome (IFIS)
• altered heart rhythm (atrial fibrillation)
• liver damage
• decreased white blood cells (neutropenia)
• decreased number of platelets (thrombocytopenia)

Available pack sizes are PVC/PVDC/aluminium blister packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farma Group S.r.l., Via Strampelli, 18 - 63074 San Benedetto del Tronto (AP)
Manufacturer 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 Milano

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Greece: Ofuxal 10 mg, prolonged-release tablets
Italy: FARALZIN 10 mg prolonged-release tablets