Dalfaz uno

DALFAZ UNO, 10 mg, prolonged-release tablets
Alfuzosini hydrochloridum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Dalfaz Uno is and what it is 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. Contents of the pack and other information

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

Dalfaz Uno is available as prolonged-release tablets and contains the active substance
alfuzosin. Alfuzosin is a quinazoline derivative, active when administered orally.
Alfuzosin reduces lower urinary tract symptoms such as bladder fullness and difficulty in urinating.
Dalfaz Uno is indicated:

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

2. Important information before using Dalfaz Uno

Do not use Dalfaz Uno:

• if the patient is allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6),
• in case of liver impairment,
• when taking other drugs that block α-adrenergic receptors (see section "Taking other medicines" below),
• when taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir (see section "Taking other medicines" below).

Exercise special caution when using Dalfaz Uno in the following cases:

• in patients who have experienced a marked drop in blood pressure as a reaction to α-adrenergic receptor-blocking drugs;
• in patients with symptomatic orthostatic hypotension;
• in patients receiving antihypertensive drugs or nitrates;
• in elderly patients due to increased risk of low blood pressure.

In some patients receiving antihypertensive drugs, orthostatic drops in blood pressure (with or without symptoms such as dizziness, weakness, sweating) may occur several hours after taking the medicine. In such cases, the patient should lie down and remain in that position until symptoms have completely subsided. These symptoms are usually transient, occur at the beginning of treatment, and do not necessarily require discontinuation of the drug. Regular monitoring of blood pressure is recommended.
Post-marketing studies have reported cases of marked decrease in arterial blood pressure in patients with existing risk factors (e.g., concomitant heart disease and/or concomitant use of antihypertensive drugs). The risk of hypotension and associated adverse reactions may be higher in elderly patients.
In patients with ischemic heart disease, treatment for ischemic heart disease should be continued concomitantly. If symptoms of coronary heart disease worsen, alfuzosin should be discontinued.
As with other α-adrenergic receptor-blocking drugs, caution should be exercised when using alfuzosin in patients with acute heart failure.
Patients with cardiac conduction disorders (congenital QTc prolongation, history of QTc prolongation, or those taking drugs known to prolong the QTc interval) should be carefully evaluated by a physician before starting treatment and remain under medical supervision during alfuzosin therapy.
Alfuzosin may cause priapism (a prolonged, painful erection unrelated to sexual activity). Since this condition may lead to permanent impotence if not treated appropriately, the physician should inform the patient about the potential consequences of this condition.
In some patients currently or previously treated with α-adrenergic receptor-blocking drugs, intraoperative floppy iris syndrome (IFIS) – a type of small pupil syndrome – has been observed during cataract surgery.
Although the risk of IFIS with alfuzosin is very low, ophthalmologists should be informed prior to planned cataract surgery that the patient is or has been treated with α-adrenergic receptor-blocking drugs, as IFIS may increase the risk of surgical complications.
Ophthalmologists should be prepared to modify surgical techniques if necessary.
There are no clinical data on the safety of use in patients with severe renal impairment (creatinine clearance below 30 ml/min). Alfuzosin 10 mg extended-release tablets should not be used in this patient group.

Taking Dalfaz Uno with food and drink:
The medicine should be taken immediately after a meal.

Pregnancy:
This medicine is not intended for use in women.

Breast-feeding:
Not applicable.

Driving and operating machinery:
At the beginning of treatment, symptoms such as dizziness (including vertigo) and weakness may occur. This should be taken into account when driving or operating machinery.

Important information about some of the ingredients of Dalfaz Uno:
Dalfaz Uno contains hydrogenated castor oil as an excipient. Hydrogenated castor oil may cause indigestion and diarrhea.

Taking other medicines:
Inform your doctor about all medicines you are currently taking, including those obtained 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 Dalfaz Uno is contraindicated with:

• other α-adrenergic receptor-blocking drugs 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 the treatment of chronic hepatitis C virus infection), or ritonavir in combination with nirmatrelvir (commonly used in the treatment of mild to moderate COVID-19).

Your doctor may consider concomitant use with:

• antihypertensive drugs (see section 2: Exercise special caution when using Dalfaz Uno),
• anaesthetics used for general anaesthesia: administration of these drugs to patients treated with alfuzosin may cause a significant drop in blood pressure. The medicine should be discontinued 24 hours before a planned surgical procedure under general anaesthesia,
• nitrates (see section 2: Exercise special caution when using Dalfaz Uno),
• antifungal drugs (such as itraconazole),
• antibacterial drugs (such as clarithromycin, telithromycin),
• antidepressants (such as nefazodone),
• ketoconazole tablets (a medicine used in Cushing's syndrome – when the body produces excessive cortisol).

3. How to use Dalfaz Uno

Take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor again.
The recommended dose is 10 mg once daily (1 tablet), taken immediately after the evening meal.
Supportive treatment in patients with an indwelling 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 on the first day of catheter placement.
Treatment should be continued for three to four days: 2 to 3 days while the patient has the catheter in place and 1 day after catheter removal.
Tablets should be swallowed whole (do not chew, crush, suck, or divide).
Dose reduction is not required in elderly patients or in patients with moderate renal impairment.
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 taking more Dalfaz Uno than recommended:
If you take more than the prescribed dose, contact your doctor or pharmacist immediately.
In the event of overdose, the doctor may decide to transfer the patient to hospital, where, if hypotension occurs, cardiovascular function will be monitored and vasoconstrictor agents administered if necessary.
Alfuzosin is highly protein-bound and is difficult to remove from the body by dialysis.
The doctor may perform gastric lavage and administer activated charcoal.
In case of missing a dose of Dalfaz Uno:
If you miss a dose, take it as soon as possible, except when it is almost time for the next dose. Do not take a double dose or two doses close together in time.
If in doubt, consult your doctor.

4. Possible adverse effects

Like all medicines, Dalfaz Uno may cause adverse effects.
Adverse effects are listed according to the following frequency categories:
very common (affects at least 1 in 10 people), common (affects less than 1 in 10 but more than
1 in 100), uncommon (affects less than 1 in 100 but more than 1 in 1,000),
rare (affects less than 1 in 1,000 but more than 1 in 10,000), very rare (affects less than
1 in 10,000), frequency not known (cannot be estimated from available data).

The following adverse effects may occur:

Common:

• feeling faint, dizziness, headache,
• nausea, abdominal pain,
• fatigue.

Uncommon:

• fainting, labyrinthine dizziness,
• tachycardia (increased heart rate),
• rhinitis,
• diarrhoea,
• vomiting,
• rash, itching,
• oedema, chest pain,
• orthostatic hypotension (see section 2: Special warnings and precautions for use of Dalfaz Uno), hot flushes.

Very rare:

• angina pectoris in patients with pre-existing coronary artery disease (see section 2: Special warnings and precautions for use of Dalfaz Uno),
• urticaria, angioedema.

Frequency not known:

• atrial fibrillation,
• intraoperative floppy iris syndrome (see section 2: Special warnings and precautions for use of Dalfaz Uno),
• liver cell damage, cholestatic liver disease,
• priapism (persistent, painful penile erection),
• neutropenia,
• thrombocytopenia (reduced platelet count leading to increased risk of bleeding and bruising).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the 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
Adverse effects can also be reported to the marketing authorisation holder or its representative in Poland.
Reporting adverse effects helps to provide 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 expiry date stated on the packaging.

6. Contents of the pack and other information

What Dalfaz Uno contains
One prolonged-release tablet contains the active substance:
10 mg alfuzosin hydrochloride
and the following excipients:
First tablet layer: hypromellose, hydrogenated castor oil, ethylcellulose 20, yellow iron oxide
(E 172), hydrated colloidal silica, magnesium stearate;
Second tablet layer: mannitol, hypromellose, povidone, microcrystalline cellulose, hydrated
colloidal silica, magnesium stearate;
Third tablet layer: hypromellose, hydrogenated castor oil, povidone, yellow iron oxide (E 172),
hydrated colloidal silica, magnesium stearate.

What the medicine looks like and contents of the pack
The pack contains 30 prolonged-release tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi Winthrop Industrie
82, Avenue Raspail
94250 Gentilly
France

Manufacturer:
Sanofi Winthrop Industrie
30-36, avenue Gustave Eiffel
37100 Tours
France

For further information, contact the local representative of the Marketing Authorisation Holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw