PROFUZO 10 mg Extended-Release Tablet

Зміст інструкції

1. Profuzo 10 mg prolonged-release tablets
   1. What is Profuzo and what is it used for
   2. What you need to know before taking Profuzo
   3. How to take Profuzo
   4. Possible side effects
   5. How to store Profuzo
   6. Contents of the pack and other information

Profuzo 10 mg prolonged-release tablets

Alfuzosin hydrochloride

Generic medicine

Read this leaflet carefully before using this medicine, as 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 pass it on to others even if their symptoms are the same as yours, as it could 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 Profuzo is and what it is used for
• 2. What you need to know before you take Profuzo
• 3. How to take Profuzo
• 4. Possible side effects
• 5. How to store Profuzo
• 6. Contents of the pack and other information

1. What is Profuzo and what is it used for

Profuzo is a medicine in tablet form that must be taken orally.
Alfuzosin belongs to a group of medicines for prostate diseases called alpha-1-blockers.
It promotes the relaxation of the muscular tissue in the prostate and urethra, allowing urine to flow
more easily from the bladder.
Alfuzosin is used to treat the symptoms of Benign Prostatic Hyperplasia .
Benign Prostatic Hyperplasia
The prostate gland is located below the bladder. The urethra passes through the prostate to the outside of the
body. In addition to glandular tissue (for the production of prostatic fluid), the prostate also contains
muscular tissue. This muscular tissue is also present in the urethra. In Benign Prostatic Hyperplasia,
this muscular tissue of the prostate and urethra tends to tighten, causing narrowing of the urethra. This
makes it more difficult for urine to flow from the bladder causing lower urinary tract disorders.
Acute Urinary Retention
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 a short hospital stay may be necessary.
• A thin, flexible tube (catheter) is passed into the bladder. This drains the water and relieves the pain.
• During this period, alfuzosin can be used to help the water flow again. This treatment has been shown to be useful only in men over the age of 65.

2. What you need to know before taking Profuzo

Do not take Profuzo:

• if you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include: a skin rash, difficulty swallowing or breathing, swelling of the lips, throat or tongue;
• if you have previously experienced a drop in blood pressure while sitting or when standing up;
• if you are already taking another alpha-1 blocker;
• if you have liver problems;
• if you are under 16 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Profuzo.

• if you have a problem with the coronary arteries. Any treatment to reduce blood flow to the heart muscle should be continued;
• if symptoms of chest pain (angina pectoris) recur or worsen. The use of Profuzo should be stopped;
• if you have a condition in which your kidneys are barely functioning;
• if you have heart problems, or if your heart has suddenly stopped pumping efficiently (acute heart failure);
• if you have a hereditary condition affecting the way your heart beats (congenital prolongation of the QTc interval);
• if you are elderly, if you have increased sensitivity to alpha-1 blockers or if you are being treated for high blood pressure;
• if you experience a drop in blood pressure when sitting or standing in the first few hours after taking the tablet. This effect may be accompanied by symptoms such as: dizziness, fatigue or sweating. In this case, you should lie down until the symptoms have completely disappeared. These symptoms are usually transient and may occur at the beginning of treatment. Usually, treatment can be continued;
• if you are scheduled for eye surgery for cataracts (clouding of the lens), inform your specialist that you are using or have used Profuzo before the operation. This is because Profuzo can cause complications during the operation that can be managed if the ophthalmologist is aware of this information before performing the operation;
• if you continue to have a prolonged erection of the penis without being sexually excited. This is a serious condition that can lead to permanent impotence if not treated properly.

Consult your doctor if you experience or have experienced in the past any of the warnings mentioned above.

Children
Profuzo should not be used in children.

Other medicines and Profuzo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This includes medicines you obtain without a prescription.
Some medicines can influence each other’s actions or cannot be used
together for other reasons.
Do not use Profuzo if:

• You are using other alpha-1-blockers (medicines for prostate problems) such as doxazosin, indoramin, prazosin, terazosin, tamsulosin or phenoxybenzamine.

Talk to your doctor before taking this medicine if:

• You are taking medicines for high blood pressure. It may be necessary to adjust the dose of the medicine, due to the possible drop in blood pressure.
• You are going to have surgery. You must inform the doctor that you are taking Profuzo.
• If combined with nitrates (medicines to relieve chest pain), it may be necessary to adjust the dosage of the medicine, due to the possible occurrence of a drop in blood pressure.
• You are taking medicines for bacterial infections (such as clarithromycin, telithromycin).
• You are taking medicines for the treatment of depression (such as nefazodone).
• If you are taking ketoconazole tablets (to treat Cushing's syndrome - when your body produces too much cortisol).
• The dose may need to be adjusted if used at the same time as medicines that inhibit the liver enzyme CYP3A4, such as itraconazole and ritonavir.

Profuzo with food and drinks

• Take Profuzo immediately after a meal.
• Drinking alcohol increases the undesirable effects of alfuzosin. You may feel dizzy and weak when taking Profuzo. If this happens, do not drink alcohol.

Pregnancy and breastfeeding
Not applicable. Profuzo is prescribed only to men.

Driving and using machines
No data are known regarding the effect on the ability to drive or operate machinery. Disorders such as dizziness or general weakness may occur. This should be taken into consideration when driving
vehicles or using machinery.

Profuzo contains lactose
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars, contact
him/her before taking this medicine.

3. How to take Profuzo

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
For oral use.

Benign prostatic hyperplasia
The usual dose is one tablet a day.

Acute urinary retention
Profuzo will be given to you by your doctor on the day of catheter insertion.
You must continue to take Profuzo once a day.
You must stop taking Profuzo the day after the catheter is removed (3-4 days in total).
Take one Profuzo tablet after each evening meal. Take the tablet with a sufficient amount
of liquid (e.g. a glass of water). The prolonged-release tablet must not be crushed,
chewed or divided.
Taking the tablet every day at the same time allows you to have the best effect. It also helps to
remember when to take the tablet.

Patients with kidney problems
It is not necessary to adjust the dose in case of mild to moderate kidney problems, while the doctor will not
prescribe it if you have severe kidney problems.

Patients with liver problems
Profuzo tablets should not be used in patients with liver problems. However, in case of
mild to moderate liver problems, other medicines containing low doses of
alfuzosin may be used according to the appropriate dosage regimen. Your doctor will inform you about this.

Use in children and adolescents
The efficacy of Profuzo in children aged between 2 and 16 years has not been established.
Therefore, Profuzo is not indicated in children and adolescents (from 2 to 16 years of age).

If you take more Profuzo than you should
Contact your doctor or pharmacist immediately if you take more Profuzo than you should.

If you forget to take Profuzo
You may forget to take a tablet. In this case, you do not need to take the forgotten
tablet. Take the next tablet the next day, as prescribed.
Do not take a double dose to make up for a forgotten tablet.

If you stop taking Profuzo
You must not stop or discontinue taking Profuzo without first talking to your doctor. Take the
tablets for the duration of the treatment, as prescribed by your doctor. Do not stop taking the tablet
even if you feel better, because the symptoms may reappear.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Serious side effects:
If any of the following side effects occur, stop taking Profuzo and contact your doctor or
go to the nearest hospital emergency room immediately:

Very rare (may affect up to 1 in 10,000 people)

• Rapid swelling of eyelids, face, lips, mouth and tongue, difficulty breathing or swallowing, skin rashes, hives and itching. These are the symptoms of a very serious allergic reaction (the medical term for these symptoms is angioedema).
• A feeling of tightness, heaviness, discomfort or acute pain under the breastbone and radiating to the arms, neck and jaw (these may be symptoms of angina). These usually only occur if you have suffered from angina before.

Not known (frequency cannot be estimated from available data):

• Prolonged and painful erection of the penis, not related to sexual activity (this may be due to a medical condition called priapism).

Other side effects:

Common (may affect up to 1 in 10 people)

• feeling unwell (nausea)
• stomach pain
• dry mouth
• weakness or fatigue
• feeling sick (malaise)
• headache
• feeling dizzy or faint
• general body weakness (asthenia)

Uncommon (may affect up to 1 in 100 people)

• loose stools (diarrhoea)
• vision disturbances
• fast heartbeat (tachycardia)
• fast or irregular heartbeat (palpitations)
• sudden loss of consciousness (syncope)
• a drop in blood pressure caused, for example, by getting up quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension)
• feeling warm, flushing (hot flushes)
• runny or blocked nose, sneezing, pressure or pain in the face (rhinitis)
• skin rash
• itching
• fluid retention (can cause swelling of arms and legs)
• chest pain
• drowsiness
• feeling of spinning or whirling when stationary (vertigo)

Very rare (may affect up to 1 in 10,000 people)

• damage or injury to the liver caused by a medicine or chemical substance (hepatic toxicity)
• itching, pinpoint skin rash (urticaria)

Not known (frequency cannot be defined based on available data)

• damage to liver cells
• certain liver diseases caused by narrowing or blockage of the bile duct (cholestatic liver disease). Signs may include yellowing of the skin or whites of the eyes.
• feeling sick (vomiting)
• if you are about to undergo eye surgery for cataracts (where the lens of the eye is cloudy) and are already taking or have taken Profuzo in the past, the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure. This only happens during the operation and it is important that the ophthalmologist is aware of this as the operation may have to be performed differently (See section "Warnings and precautions")
• irregular and often rapid heartbeat of the atria (atrial fibrillation)
• reduced number of white blood cells (neutropenia). You may have more infections than usual
• increased risk of bleeding (including nosebleeds or bleeding gums) and bruising. This may be a sign of a blood problem called “thrombocytopenia” which consists of a reduced number of platelets in the blood.

Reporting of side effects
If you get any side effects, talk to your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazione-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. How to store Profuzo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is reported on the packaging after “Scad.”. 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. Contents of the pack and other information

What Profuzo contains

• The active ingredient is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
• The other ingredients are: anhydrous lactose, anhydrous colloidal silica (E551), povidone (E1201), talc (E553B), magnesium stearate (E572), hypromellose (E464), hydroxypropylcellulose (E463). The tablet is prolonged-release, which means that after administration the active ingredient is not released immediately but gradually and therefore acts for longer.

Description of the appearance of Profuzo and contents of the pack
Profuzo tablets are white to off-white, round, uncoated, biconvex with bevelled edges, with
“RY 10” imprinted on one side.
Profuzo tablets are available in packs of 10, 30 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ecupharma S.r.l.
Via Mazzini, 20
20123 Milan

Manufacturers
Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.
124 Fabricii Str.
400 632 Cluj-Napoca - Romania

This medicinal product is authorised in the Member States of the European Economic Area and in the United
Kingdom (Northern Ireland) under the following denominations:
France: ALFUZOSINE CRISTERS PHARMA LP 10 mg, prolonged-release tablet
Italy: Profuzo
Netherlands: Alfuzosine HCl SUN 10 mg Tablets, prolonged-release tablets
Poland: Alfabax SUN
United Kingdom (Northern Ireland): Vasran XL 10 mg Prolonged-release Tablets