Dalfaz Sr 5

Package Leaflet: Information for the User

DALFAZ SR 5, 5 mg, prolonged-release tablets

Alfuzosin hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Dalfaz SR 5 and what is it used for

Dalfaz SR 5 is available as 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 SR 5 is used:

• For the treatment of functional disorders caused by benign prostatic hyperplasia, when surgical treatment has been postponed.

2. Important information before taking Dalfaz SR 5

Do not take the medicine if:

• you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6),
• you are taking other medicines that block alpha-1 adrenergic receptors (see section "Using other medicines" below),
• you are taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir (see section "Using other medicines" below),
• you have severe liver impairment.

Be particularly cautious when taking Dalfaz SR 5 in the following cases:

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

In some patients taking blood pressure-lowering medicines, a few hours after taking the medicine, asymptomatic or symptomatic orthostatic decreases 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 marked decreases in blood pressure have been reported in patients with existing risk factors (such as concomitant heart and/or simultaneous use of blood pressure-lowering medicines). The risk of decreased blood pressure and related adverse reactions 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.
There is a risk of cerebral hypoperfusion in patients with concomitant cerebrovascular disorders, due to hypotension that may occur after administration of alfuzosin.
As with other alpha-adrenergic receptor blockers, caution should be exercised when using alfuzosin in patients with acute heart failure.
Patients with heart rhythm disorders (congenital QTc interval prolongation, who have had QTc interval prolongation in the past or who are taking medicines known to prolong the QTc interval) should be thoroughly examined by a doctor before starting treatment and remain under medical supervision during the use of alfuzosin.
Alfuzosin may cause priapism (prolonged, painful erection of the penis 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 treated with 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 the possibility of changing the surgical technique.
Using Dalfaz SR 5 with food and drink:
Food does not affect the absorption of the medicine from the gastrointestinal tract.
The medicine can be taken with or without food.
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 machines.
Important information about some ingredients of Dalfaz SR 5:
Dalfaz SR 5 contains hydrogenated castor oil as an excipient. Hydrogenated castor oil may cause gastrointestinal upset and diarrhea.
Using other medicines:
Inform your doctor about all medicines you have taken recently, even those that are 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:

• other alpha-adrenergic receptor blockers is contraindicated 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).

The doctor will consider concomitant use with:

• blood pressure-lowering medicines (see section 2: Be particularly cautious when taking Dalfaz SR 5),
• anesthetics used for general anesthesia: administration of these medicines to a patient treated with 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 SR 5),
• medicines used in fungal infections (such as itraconazole),
• medicines used in bacterial infections (such as clarithromycin, telithromycin),
• medicines used in the treatment of depression (such as nefazodone),
• ketokonazole tablets (a medicine used in Cushing's syndrome - when the body produces too much cortisol).

3. How to take Dalfaz SR 5

Take the medicine as directed by your doctor. If you are unsure, consult your doctor again.
The first dose of the medicine should be taken in the evening, before bedtime. The tablets should be swallowed whole (not chewed).
Adults:
1 tablet of Dalfaz SR 5 twice a day (in the morning and in the evening).
Elderly patients (over 65 years):
In elderly patients and patients treated for hypertension, the initial dose is 1 tablet of Dalfaz SR 5 in the evening. Then, depending on the clinical response, the doctor may increase the dose of the medicine to 2 tablets a day (1 tablet in the morning and 1 tablet in the evening).
Patients with renal impairment:
In patients with renal impairment, treatment starts with 1 tablet of Dalfaz SR 5 at night, and depending on the clinical response, the doctor may increase the dose to 1 tablet twice a day.
Patients with hepatic impairment:
In patients with mild and moderate hepatic impairment, Dalfaz 2.5 mg is used.
Children and adolescents:
The efficacy of alfuzosin has not been demonstrated in children and adolescents from 2 to 16 years of age.
Alfuzosin is not recommended for use in children and adolescents.
If you feel that the effect of Dalfaz SR 5 is too strong or too weak, consult your doctor.
In case of overdose:
If you have taken more than the recommended dose of Dalfaz SR 5, consult your doctor or pharmacist immediately.
In case of overdose, the doctor will decide whether to hospitalize the patient, where, in case of decreased blood pressure, the doctor will monitor the cardiovascular system and, if necessary, administer vasoconstrictor medicines.
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.
If you miss a dose of Dalfaz SR 5:
If you miss a dose of the medicine, take it as soon as possible, unless it is almost time for the next dose. Do not take two doses of the medicine at the same time or with a short interval.
If you are unsure, consult your doctor.

4. Possible side effects

Like all medicines, Dalfaz SR 5 can cause side effects.
Side effects are presented according to the following frequency classification:
very common (not less 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 the available data).
The following side effects may occur:
Common side effects include:

• dizziness, vertigo, headache,
• nausea, abdominal pain, diarrhea, dry mouth,
• weakness, malaise,
• orthostatic hypotension (see section 2: Be particularly cautious when taking Dalfaz SR 5).

Uncommon side effects include:

• fainting, drowsiness,
• abnormal vision,
• tachycardia (rapid heart rate), palpitations,
• rhinitis,
• vomiting,
• rash, itching,
• edema, chest pain,
• hot flushes.

Very rare side effects include:

• angina pectoris in patients with pre-existing coronary heart disease (see section 2: Be particularly cautious when taking Dalfaz SR 5),
• urticaria, angioedema.

Frequency not known:

• cerebral hypoperfusion in patients with concomitant cerebrovascular disorders,
• intraoperative floppy iris syndrome (see section 2: Be particularly cautious when taking Dalfaz SR 5),
• atrial fibrillation,
• liver cell damage, cholestatic liver disease,
• priapism (prolonged, painful erection of the penis),
• neutropenia,
• thrombocytopenia (decreased platelet count, leading to increased risk of bleeding and bruising).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 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 to gather more information on the safety of the medicine.

5. How to store Dalfaz SR 5

Storage - no special requirements.
The medicine should be stored in a place inaccessible and invisible to children.
Do not use the medicine after the expiry date stated on the packaging.

6. Contents of the pack and other information

What Dalfaz SR 5 contains

1 prolonged-release tablet contains as the active substance:
5 mg of alfuzosin hydrochloride
and the excipients:
microcrystalline cellulose, calcium hydrogen phosphate dihydrate, hydrogenated castor oil, povidone, magnesium stearate.
Coating: hypromellose, titanium dioxide (E 171), propylene glycol, iron oxide red, iron oxide yellow.

What Dalfaz SR 5 looks like and contents of the pack

The pack contains 20, 56, or 60 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, please contact the local representative of the marketing authorization holder:
Sanofi Sp. z o. o.
Kasprzaka 6 Street
01-211 Warsaw
Date of last revision of the leaflet:October 2024