PROFUZO

Package leaflet: Information for the user

Profuzo 10 mg prolonged-release tablets

Alfuzosin hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 Profuzo is and what it is used for

Profuzo is a medicine presented in tablet form to be taken orally.
Alfuzosin belongs to a group of medicines used in prostate disorders known as alpha-1-blockers.
It promotes relaxation of the muscle 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 (which produces prostatic fluid), the prostate also contains muscle tissue. This muscle tissue is also present in the urethra. In Benign Prostatic Hyperplasia, this muscle tissue in the prostate and urethra contracts, causing narrowing of the urethra. This makes it more difficult for urine to pass from the bladder, resulting in lower urinary tract symptoms.

Acute Urinary Retention
In some patients with benign prostatic hyperplasia, the prostate gland becomes so enlarged 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.
• During this period, alfuzosin may be used to help restore urine flow. This treatment has been shown to be beneficial only in men over 65 years of age.

2. What you need to know before taking Profuzo

Do not take Profuzo:

• if you are allergic to alfuzosin or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, throat or tongue;
• if you have previously experienced low blood pressure while sitting or 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 your coronary arteries. Any treatment aimed at improving blood flow to the heart muscle should be continued;
• if symptoms of chest pain (angina pectoris) recur or worsen. Use of Profuzo must be discontinued;
• if you have a condition in which your kidneys are almost non-functional;
• if you have heart problems, or if your heart has suddenly stopped pumping effectively (acute heart failure);
• if you have an inherited condition affecting your heart rhythm (congenital QTc prolongation);
• if you are elderly, if you are particularly sensitive 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 up during the first few hours after taking the tablet. This effect may occur with symptoms such as: dizziness, fatigue, or sweating. In such cases, you should lie down until symptoms have completely disappeared. These symptoms are usually temporary and may occur at the beginning of treatment. Generally, treatment can be continued;
• if you are scheduled for cataract surgery (clouding of the lens), inform your specialist that you are using or have used Profuzo before the procedure. This is because Profuzo may cause complications during surgery, which can be managed if the ophthalmologist is aware of this information beforehand;
• if you continue to have a prolonged erection of the penis without sexual stimulation. This is a serious condition that may lead to permanent impotence if not properly treated.

Consult your doctor if you have experienced or have previously experienced any of the above warnings.
Children
Profuzo must not be used in children.
Other medicines and Profuzo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. This also applies to medicines you obtain without a prescription.
Some medicines may affect each other’s actions or cannot be used together for other reasons.
Do not use Profuzo if:

• You are taking 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. A dose adjustment may be necessary due to the possible drop in blood pressure.
• You need to undergo surgery. You must inform your doctor that you are taking Profuzo.
• If used together with nitrates (medicines to relieve chest pain), a dose adjustment may be needed due to the possible occurrence of low blood pressure.
• You are taking medicines for bacterial infections (such as clarithromycin, telithromycin).
• You are taking medicines for depression (such as nefazodone).
• You are taking ketoconazole tablets (to treat Cushing's syndrome - when your body produces too much cortisol).
• A dose adjustment may be required if used together with medicines that inhibit the liver enzyme CYP3A4, such as itraconazole and ritonavir.

Profuzo with food and drink

• 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 for men.
Driving and using machines
There are no known data on the effect on the ability to drive or use machines. Dizziness or general weakness may occur. This should be taken into account when driving or using machines.
Profuzo contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Profuzo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
For oral use.

Benign prostatic hyperplasia
The usual dose is one tablet daily.

Acute urinary retention
Profuzo will be given to you by your doctor on the day the catheter is inserted.
You must continue to take Profuzo once daily.
You must stop taking Profuzo the day after catheter removal (3–4 days in total).
Take one tablet of Profuzo after each evening meal. Swallow the tablet with sufficient liquid (e.g. a glass of water). The prolonged-release tablet must not be crushed, chewed, or divided.

Taking the tablet at the same time each day ensures the best effect and helps you remember when to take it.

Patients with kidney problems
Dose adjustment is not necessary in cases of mild to moderate kidney problems. However, your doctor will not prescribe Profuzo if you have severe kidney problems.

Patients with liver problems
Profuzo tablets must not be used in patients with liver problems. However, in cases of mild to moderate liver problems, other medicinal products containing low doses of alfuzosin may be used according to the appropriate dosage regimen. Your doctor will advise you accordingly.

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

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

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

If you stop taking Profuzo
Do not stop or discontinue treatment with Profuzo without first talking to your doctor. Take the tablets for the full duration of treatment as prescribed by your doctor. Do not stop taking the tablets even if you feel better, because symptoms may return.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
If you experience any of the following side effects, stop taking Profuzo and contact your doctor or go to the nearest hospital emergency department immediately:
Very rare (may affect up to 1 in 10,000 people)

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

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

• Prolonged and painful erection of the penis not related to sexual activity (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 tiredness
• feeling ill (malaise)
• headache
• feeling dizzy or faint
• weakness of the whole body (asthenia)

Uncommon (may affect up to 1 in 100 people)

• loose stools (diarrhea)
• visual disturbances
• rapid heartbeat (tachycardia)
• rapid or irregular heartbeat (palpitations)
• sudden loss of consciousness (syncope)
• drop in blood pressure, for example, when standing up quickly from a sitting or lying position, sometimes accompanied by dizziness (orthostatic hypotension)
• feeling hot, flushing (hot flushes)
• runny or blocked nose, sneezing, feeling of pressure in the face or pain (rhinitis)
• skin rash
• itching
• fluid retention (may cause swelling of arms and legs)
• chest pain
• drowsiness
• sensation of dizziness and spinning when still (vertigo)

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

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

Not known (frequency cannot be estimated from 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 unwell (vomiting)
• if you are about to undergo eye surgery for cataract (where the eye's lens is cloudy) and you are currently taking or have previously taken Profuzo, the pupil may not dilate properly and the iris (the coloured part of the eye) may become floppy during the procedure. This occurs only during surgery, and it is important that your ophthalmologist is aware of this, as the surgery may need to be performed differently (See section "Warnings and precautions")
• irregular and often rapid heart rhythm originating in the atria (atrial fibrillation)
• reduced number of white blood cells (neutropenia). You may get more infections than usual
• increased risk of bleeding (including nosebleeds or bleeding gums) and bruising. This may be a sign of a blood disorder called "thrombocytopenia", which involves a reduced number of platelets in the blood.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via 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 stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Profuzo contains

• The active substance is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
• The other components are: anhydrous lactose, anhydrous colloidal silica (E551), povidone (E1201), talc (E553B), magnesium stearate (E572), hypromellose (E464), hydroxypropylcellulose (E463). The tablet is prolonged-release, meaning that after administration, the active substance is not released immediately but gradually, thus providing a longer duration of action.

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

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

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

This medicinal product is authorized in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
France: ALFUZOSINE CRISTERS PHARMA LP 10 mg, comprimé à libération prolongée
Italy: Profuzo
The Netherlands: Alfuzosine HCl SUN 10 mg Tabletten, tabletten met verlengde afgifte
Poland: Alfabax SUN
United Kingdom (Northern Ireland): Vasran XL 10 mg Prolonged-release Tablets