ALFUZOSTAD 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. ALFUZOSTAD 10 mg
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Package Leaflet
3. What is ALFUZOSTAD 10 mg and what is it used for
4. Important information before taking ALFUZOSTAD 10 mg
   1. When not to take ALFUZOSTAD 10 mg:
   2. Warnings and precautions
   3. ALFUZOSTAD 10 mg and other medicines
   4. ALFUZOSTAD 10 mg with food and drink
   5. Pregnancy and breastfeeding
   6. Driving and using machines
5. How to take ALFUZOSTAD 10 mg
   1. Taking a higher dose of ALFUZOSTAD 10 mg than recommended
   2. Missing a dose of ALFUZOSTAD 10 mg
   3. Stopping treatment with ALFUZOSTAD 10 mg
6. Possible side effects
   1. Reporting side effects
7. How to store ALFUZOSTAD 10 mg
8. Contents of the package and other information
   1. What ALFUZOSTAD 10 mg contains
   2. What ALFUZOSTAD 10 mg looks like and contents of the package.
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   8. Date of last revision of the package leaflet: 12/2022

Package Leaflet: Information for the Patient

ALFUZOSTAD 10 mg

10 mg, prolonged-release tablets
(Alfuzosine hydrochloride)

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is ALFUZOSTAD 10 mg and what is it used for
• 2. Important information before taking ALFUZOSTAD 10 mg
• 3. How to take ALFUZOSTAD 10 mg
• 4. Possible side effects
• 5. How to store ALFUZOSTAD 10 mg
• 6. Contents of the package and other information

1. What is ALFUZOSTAD 10 mg and what is it used for

ALFUZOSTAD 10 mg belongs to a group of medicines called alpha-adrenergic receptor antagonists or alpha-adrenolytics.
The medicine is used to treat moderate to severe symptoms of benign prostatic hyperplasia, a condition also known as enlarged prostate. An enlarged prostate can cause problems with the urinary system, such as frequent and difficult urination, especially at night. Treatment with alpha-adrenolytics causes relaxation of the prostate and bladder neck muscles. This makes it easier for urine to flow out of the bladder.

2. Important information before taking ALFUZOSTAD 10 mg

When not to take ALFUZOSTAD 10 mg:

• if the patient is allergic to alfuzosin, other quinazolines (e.g., terazosin, doxazosin, prazosin), or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, swelling of the lips, throat, or tongue, difficulty swallowing or breathing.
• if the patient has conditions associated with a significant drop in blood pressure when changing position to standing,
• if the patient has liver problems,
• if the patient is taking other alpha-adrenolytic medicines.

Warnings and precautions

Before starting treatment with ALFUZOSTAD 10 mg, the patient should discuss it with their doctor or pharmacist:

• if the patient has significant kidney problems, as the safety of using ALFUZOSTAD 10 mg in such cases has not been established,
• if the patient is taking other medicines used to treat high blood pressure. In this case, the doctor will regularly monitor the patient's blood pressure, especially at the beginning of treatment;
• blood pressure should be monitored regularly, especially at the beginning of treatment with this medicine, due to the possibility of a significant drop in blood pressure. If the patient experiences a sudden drop in blood pressure, dizziness, weakness, or excessive sweating within a few hours of taking ALFUZOSTAD 10 mg, they should lie down on their back with their legs raised until the symptoms disappear. These symptoms usually last for a short time and occur at the beginning of treatment. Usually, there is no need to discontinue treatment;
• in patients who have experienced a significant drop in blood pressure when taking other alpha-adrenolytic medicines in the past. In this case, the doctor will start treatment with alfuzosin at a low dose and gradually increase it;
• if the patient's heart is not working properly (acute heart failure);
• if the patient has chest pain (angina pectoris) and is being treated with nitrates, treatment with alfuzosin may increase the risk of a drop in blood pressure. If the symptoms of angina pectoris recur or worsen, the doctor will discontinue treatment with alfuzosin;
• the doctor will decide whether to continue treatment with medicines for chest pain or discontinue treatment with ALFUZOSTAD 10 mg, especially if the pain recurs or worsens;
• if the patient is to have eye surgery for cataracts, they should inform the ophthalmologist before the operation that they are taking or have taken ALFUZOSTAD 10 mg. ALFUZOSTAD 10 mg may cause complications during the surgical procedure, which the doctor can control if they are informed;
• if the patient has heart rhythm disorders or is taking medicines that may cause heart rhythm disorders (medically referred to as QT interval prolongation). In this case, the doctor should assess the patient before and during treatment with ALFUZOSTAD 10 mg.

ALFUZOSTAD 10 mg and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
ALFUZOSTAD 10 mg should not be taken if the patient is taking other alpha-adrenolytic medicines.
ALFUZOSTAD 10 mg and some medicines may interact with each other. These include:

• ketokonazole and itraconazole (medicines used to treat fungal infections),
• ritonavir (a medicine used to treat HIV).

ALFUZOSTAD 10 mg may cause a drop in blood pressure if the patient is currently taking or needs to take any of the following medicines:

• medicines used to treat high blood pressure,
• medicines (nitrates) used to treat chest pain (angina),
• medicines given before surgery (general anesthesia). In this case, blood pressure may drop significantly. In the event of surgery, the doctor must be informed that the patient is taking ALFUZOSTAD 10 mg.

ALFUZOSTAD 10 mg with food and drink

ALFUZOSTAD 10 mg should be taken after a meal.

Pregnancy and breastfeeding

This information is not relevant, as ALFUZOSTAD 10 mg is used only in men.

Driving and using machines

At the beginning of treatment with ALFUZOSTAD 10 mg, the patient may experience dizziness, balance disorders, or weakness. They should not drive vehicles or perform hazardous tasks until they know how their body reacts to the treatment.
ALFUZOSTAD 10 mg contains lactose monohydrate.If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take ALFUZOSTAD 10 mg

The medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be swallowed whole. Do not crush, chew, or break the tablet, as this may cause too much of the active substance to enter the body quickly. This may increase the risk of side effects.
The first dose of the medicine should be taken before bedtime. Then, the tablet should be taken directly after a meal, always at the same time, with a sufficient amount of liquid. Do not crush, chew, or divide the tablets.
Adults
The usual dose is 1 prolonged-release tablet (10 mg of alfuzosin) once a day.
Elderly patients
The usual dose for elderly patients (over 65 years) is 1 prolonged-release tablet (10 mg of alfuzosin) once a day, if the recommended lower initial dose of alfuzosin is well tolerated and a stronger effect is required.
Patient with renal impairment
The usual dose for patients with mild to moderate renal impairment is 1 prolonged-release tablet (10 mg of alfuzosin) once a day, if a lower dose is not sufficient, depending on the clinical response.

Taking a higher dose of ALFUZOSTAD 10 mg than recommended

If the patient has taken a large number of ALFUZOSTAD 10 mg tablets, they should immediately contact their doctor or the emergency department of the nearest hospital for advice. The patient's blood pressure may drop sharply, they may experience dizziness or even faint. If the patient starts to feel dizzy, they should sit or lie down until they feel better.

Missing a dose of ALFUZOSTAD 10 mg

A double dose should not be taken to make up for a missed dose, as this may cause a sharp drop in blood pressure, especially if the patient is taking blood pressure-lowering medicines. The next tablet should be taken at the scheduled time.

Stopping treatment with ALFUZOSTAD 10 mg

Treatment with ALFUZOSTAD 10 mg should not be stopped without prior consultation with a doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, ALFUZOSTAD 10 mg can cause side effects, although not everybody gets them.
In very rare cases (may occur in up to 1 in 10,000 patients), life-threatening reactions, so-called angioedema, have been reported. The patient should stop taking ALFUZOSTAD 10 mg and immediatelygo to the doctor if they experience symptoms of angioedema, such as:

• swelling of the face, tongue, or throat
• difficulty swallowing
• hives and difficulty breathing.

Frequent (may occur in up to 1 in 10 patients):
Fatigue, fainting/dizziness, headache, feeling of spinning (dizziness), significant drop in blood pressure when standing up (especially at the beginning of treatment with too high a dose and if treatment is resumed after a short break), stomach pain, nausea (nausea), indigestion, diarrhea, dry mouth, general malaise, feeling of weakness or illness.
Uncommon (may occur in up to 1 in 100 patients):
Feeling of drowsiness, vision problems, rapid heartbeat, fainting (especially at the beginning of treatment), feeling of palpitations or pounding heart, runny nose, vomiting, rash (hives, urticaria), itching, urinary incontinence, swelling of the ankles and feet, flushing (hot flashes), chest pain.
Rare (may occur in up to 1 in 10,000 patients):
First occurrence, worsening, or recurrence of chest pain (angina pectoris), liver damage, skin and mucous membrane swelling, especially on the face and around the mouth, prolonged and painful erection (priapism).
Unknown (frequency cannot be estimated from the available data):
Low white blood cell count (neutropenia), intraoperative floppy iris syndrome (IFIS, English Intraoperative Floppy Iris Syndrome) - a complication that occurs during cataract surgery, irregular heartbeat, liver problems or liver disease (symptoms may include yellowing of the skin or whites of the eyes), low platelet count. Symptoms may include bleeding from the gums, nose, bruising, prolonged bleeding from cuts, rash (red spots called petechiae).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store ALFUZOSTAD 10 mg

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Do not use ALFUZOSTAD 10 mg after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What ALFUZOSTAD 10 mg contains

The active substance of the medicine is alfuzosin hydrochloride. One prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
The other ingredients are: lactose monohydrate, hypromellose, povidone K25, magnesium stearate.

What ALFUZOSTAD 10 mg looks like and contents of the package.

ALFUZOSTAD 10 mg is a white, round, uncoated tablet with a beveled edge.
ALFUZOSTAD 10 mg is available in blisters; the package contains 30 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany

Manufacturer:

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Germany
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Vienna, Austria

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

AT: Alfuzosin STADA 10 mg - Retardtabletten
CZ: Alfuzostad 10mg tablets with prolonged release
DK: Alfuzosin STADA 10 mg
ES: ALFUZOSINA STADA 10 mg prolonged-release tablets
HU: Alfuzostad 10 mg retard tablet
IT:
Alfuzosina EG 10 mg prolonged-release tablets
PL: Alfuzostad 10 mg
SE: Alfuzosin Stada 10 mg depot tablet

Date of last revision of the package leaflet: 12/2022