Dalfaz Uno

Patient Information Leaflet: User Information

DALFAZ UNO, 10 mg, prolonged-release tablets

Alfuzosin hydrochloride

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

• Keep this 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 another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Dalfaz Uno and what is it used for
• 2. Important information before taking Dalfaz Uno
• 3. How to take Dalfaz Uno
• 4. Possible side effects
• 5. How to store Dalfaz Uno
• 6. Package contents and other information

1. What is Dalfaz Uno and what is it used for

Dalfaz Uno is available in the form of prolonged-release tablets and contains the active substance alfuzosin. Alfuzosin is a quinazoline derivative, active after oral administration.
Alfuzosin reduces the symptoms of the lower urinary tract, such as the feeling of a full bladder and difficulty urinating.
Dalfaz Uno is used:

• For the treatment of functional disorders caused by benign prostatic hyperplasia, when surgical treatment has been postponed.
• As an adjunctive treatment in patients with a catheter due to acute urinary retention caused by benign prostatic hyperplasia.

2. Important information before taking Dalfaz Uno

Do not take the medicine if:

• the patient is allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6),
• there is liver failure,
• other alpha-adrenergic receptor blockers are being taken at the same time (see "Taking other medicines" below),
• ritonavir is being taken alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir (see "Taking other medicines" below).

Be particularly cautious when taking Dalfaz Uno in the following cases:

• in patients who have experienced a significant decrease in blood pressure as a reaction to alpha-adrenergic receptor blockers;
• in patients with symptomatic orthostatic hypotension;
• in patients taking blood pressure-lowering medications or nitrates;
• in elderly patients due to the increased risk of decreased blood pressure.

In some patients taking blood pressure-lowering medications, a few hours after taking the medicine, asymptomatic or symptomatic orthostatic drops in blood pressure (dizziness, weakness, sweating) may occur. In such cases, the patient should lie down and wait until the symptoms completely disappear. These symptoms are usually transient, occur at the beginning of treatment, and do not always require discontinuation of the medicine. Frequent blood pressure monitoring is recommended.
In post-marketing studies, cases of significant decreases in blood pressure have been reported in patients with existing risk factors (such as concomitant heart and/or blood vessel disease and/or concomitant use of blood pressure-lowering medications). The risk of decreased blood pressure and related side effects may be higher in elderly patients.
In patients with coronary heart disease, treatment for coronary heart disease should be continued. If symptoms of coronary heart disease worsen, alfuzosin should be discontinued.
As with other alpha-adrenergic receptor blockers, caution should be exercised when taking alfuzosin in patients with acute heart failure.
Patients with heart rhythm disorders (congenital QTc interval prolongation, previous QTc interval prolongation, or taking medications known to prolong the QTc interval) should be thoroughly examined by a doctor before starting treatment and remain under medical supervision during alfuzosin treatment.
Alfuzosin may cause priapism (prolonged, painful erection without sexual activity). Since this condition can lead to permanent impotence if not properly treated, the doctor will inform the patient about the potential consequences of this condition.
In some patients taking alpha-adrenergic receptor blockers currently or in the past, intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery.
Although the risk of this syndrome with alfuzosin is very low, the ophthalmologist should be informed before planned cataract surgery that the patient is or has been treated with alpha-adrenergic receptor blockers, as IFIS may increase the risk of complications during the procedure.
Ophthalmologists should be prepared for possible changes in surgical technique.
There are no clinical data on the safety of using Dalfaz Uno in patients with severe renal impairment (creatinine clearance below 30 ml/min). Alfuzosin 10 mg prolonged-release tablets should not be used in this patient population.
Taking Dalfaz Uno with food and drink:
The medicine should be taken immediately after a meal.
Pregnancy:
The medicine is not intended for use in women.
Breast-feeding:
Not applicable.
Driving and using machines:
At the beginning of treatment, symptoms such as dizziness (including vertigo) and weakness may occur. This should be taken into account when driving vehicles and operating machinery.
Important information about some ingredients of Dalfaz Uno:
Dalfaz Uno contains hydrogenated castor oil as an excipient. Hydrogenated castor oil may cause gastrointestinal upset and diarrhea.
Taking other medicines:
Inform your doctor about all medicines taken recently, including those available without a prescription.
Studies in healthy volunteers have shown no interaction between alfuzosin and the following medicines:

• warfarin, digoxin, hydrochlorothiazide, and atenolol.

Concomitant use of the medicine with the following is contraindicated:

• other alpha-adrenergic receptor blockers due to the risk of orthostatic hypotension,
• ritonavir taken alone or in combination with lopinavir (commonly used in HIV treatment) or ritonavir in combination with ombitasvir/paritaprevir (commonly used in chronic hepatitis C treatment) or ritonavir in combination with nirmatrelvir (commonly used in mild to moderate COVID-19 treatment).

The doctor will consider concomitant use with:

• blood pressure-lowering medications (see section 2: Be particularly cautious when taking Dalfaz Uno),
• anesthetics used for general anesthesia: administration of these medications to a patient taking alfuzosin may cause a significant decrease in blood pressure. The medicine should be discontinued 24 hours before the planned surgical procedure under general anesthesia,
• nitrates (see section 2: Be particularly cautious when taking Dalfaz Uno),
• medicines used in fungal infections (such as itraconazole),
• medicines used in bacterial infections (such as clarithromycin, telithromycin),
• medicines used in depression treatment (such as nefazodone),
• ketokonazole tablets (a medicine used in Cushing's syndrome - when the body produces excessive amounts of cortisol).

3. How to take Dalfaz Uno

Take the medicine as directed by your doctor. In case of doubts, consult your doctor again.
The recommended dose is 10 mg once daily (1 tablet), taken immediately after the evening meal.
Adjunctive treatment in patients with a catheter due to acute urinary retention caused by benign prostatic hyperplasia:
The recommended dose is 10 mg once daily (1 tablet), taken after a meal, starting from the first day of catheterization.
Treatment should be continued for three to four days, i.e., 2 to 3 days while the catheter is in place and 1 day after catheter removal.
Tablets should be swallowed whole (do not chew, crush, or grind).
In elderly patients and patients with moderate renal impairment, dose reduction is not necessary.
Children and adolescents:
The efficacy of alfuzosin in children and adolescents aged 2 to 16 years has not been established.
Alfuzosin is not recommended for use in children and adolescents.
If you feel that the effect of Dalfaz Uno is too strong or too weak, consult your doctor.
In case of overdose:
If you have taken more than the recommended dose, consult your doctor or pharmacist immediately.
In case of overdose, the doctor will decide whether to hospitalize the patient, where, if blood pressure drops occur, the doctor will monitor cardiovascular function and, if necessary, administer vasoconstrictor medications.
Alfuzosin is highly bound to plasma proteins and is difficult to remove from the body by dialysis.
The doctor may perform gastric lavage and administer activated charcoal.
In case of a missed dose:
If a dose is missed, take it as soon as possible, unless it is close to the time of the next dose. Do not take two doses at the same time or in a short period.
In case of doubts, consult your doctor.

4. Possible side effects

Like all medicines, Dalfaz Uno can cause side effects.
Side effects are presented according to the following frequency classification:
very common (more than 1 in 10), common (less than 1 in 10 but more than 1 in 100), uncommon (less than 1 in 100 but more than 1 in 1000), rare (less than 1 in 1000 but more than 1 in 10,000), very rare (less than 1 in 10,000), frequency not known (cannot be estimated from available data).
The following side effects may occur:
Common side effects include:

• dizziness, headache,
• nausea, abdominal pain,
• weakness.

Uncommon side effects include:

• fainting, dizziness of vestibular origin,
• tachycardia (rapid heart rate),
• rhinitis,
• diarrhea,
• vomiting,
• rash, itching,
• edema, chest pain,
• orthostatic hypotension (see section 2: Be particularly cautious when taking Dalfaz Uno), hot flashes.

Very rare side effects include:

• angina pectoris in patients with pre-existing coronary heart disease (see section 2: Be particularly cautious when taking Dalfaz Uno),
• urticaria, angioedema.

Frequency not known:

• atrial fibrillation,
• intraoperative floppy iris syndrome (see section 2: Be particularly cautious when taking Dalfaz Uno),
• liver cell damage, cholestatic liver disease,
• priapism (prolonged, painful erection),
• neutropenia,
• thrombocytopenia (decreased platelet count, increasing the risk of bleeding and bruising).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Dalfaz Uno

Storage - no special requirements.
Keep the medicine out of the reach and sight of children.
Do not use the medicine after the expiration date stated on the packaging.

6. Package contents and other information

What Dalfaz Uno contains

1 prolonged-release tablet contains the active substance:
10 mg alfuzosin hydrochloride
and the excipients:
first layer of the tablet: hypromellose, hydrogenated castor oil, ethylcellulose 20, yellow iron oxide (E 172), colloidal silica, magnesium stearate;
second layer of the tablet: mannitol, hypromellose, povidone, microcrystalline cellulose, colloidal silica, magnesium stearate;
third layer of the tablet: hypromellose, hydrogenated castor oil, povidone, yellow iron oxide (E 172), colloidal silica, magnesium stearate.

What Dalfaz Uno looks like and package contents

The package contains 30 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France
Manufacturer:
Sanofi Winthrop Industrie
30-36, avenue Gustave Eiffel
37100 Tours
France
To obtain more detailed information, contact the local representative of the marketing authorization holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Date of last revision of the leaflet:October 2024