Leaflet: information for the user

Unibenestan 10 mg prolonged-release tablets

Alfuzosin hydrochloride

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Unibenestan is and for what it is used

2. What you need to know before starting to take Unibenestan

3. How to take Unibenestan

4. Possible side effects

5. Storage of Unibenestan

6. Contents of the pack and additional information

Unibenestan belongs to a group of medications that act on the bladder, urethra (duct that communicates the kidney with the exterior through the penis) and prostate.

Unibenestan is indicated for the treatment of functional symptoms of benign prostatic hyperplasia (prostate enlargement).

Do not take Unibenestan

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)
• if you have orthostatic hypotension (a decrease in blood pressure when standing up)
• if you are taking other medications of the same type as this medication (alpha 1-blockers). See section “Use of Benestan Retard with other medications”.
• if you have liver insufficiency (liver disease)
• if you have severe kidney disease (severe kidney disease)
• if you have intestinal obstruction
• if you are taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, nirmatrelvir. See section “Use of Benestan Retard with other medications”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Unibenestan:

- If you are taking other medications such as ketoconazole and itraconazole (antibiotics).

- Before starting treatment with Unibenestan, your doctor may perform some tests to rule out the presence of other diseases that may cause the same symptoms as benign prostatic hyperplasia. Before treatment and at regular intervals, a rectal examination and blood tests may be performed.

- If you are to undergo any surgical intervention, you should inform the anesthesiologist, prior to the intervention, that you are taking Unibenestan (see section “Use of Unibenestan with other medications”).

- If you have previously been treated with a similar medication to Unibenestan, inform your doctor.

- Taking Unibenestan may cause you to feel dizziness, sweating, or fatigue (due to a decrease in blood pressure when standing up) in the hours following the medication intake (see section “Possible side effects”), especially in patients who also take medications for high blood pressure or nitrates (for the treatment of heart disease). If you notice these symptoms, you should remain lying down until you feel better. This is more common at the beginning of treatment and generally does not prevent its continuation.Inform your doctor if you have ever experienced a strong drop in blood pressure when treated for high blood pressure with other medications.

- If you have or have had heart disease, as this medication may increase the risk of hypotension (decrease in blood pressure) when administered concurrently with nitrates (heart disease medication) (see section “Possible side effects”). If angina pectoris reappears or worsens, treatment with alfuzosin should be interrupted. Inform your doctor if you have any heart-related problems related to the QT interval.

- If you have any liver or kidney disease, your doctor may modify the dose to be taken.

• If you are an elderly patient, as there may be a higher risk of hypotension and other adverse effects related to this.

- If you are to undergo eye surgery for cataracts, please inform your doctor before the operation if you are taking or have taken Unibenestan previously. This is because Unibenestan may cause complications during the operation, which can be taken into account and controlled by your ophthalmologist if you have been informed in advance.

Alfuzosin, like other medications in the same family, may cause priapism (persistent and painful erection of the penis). If this occurs, go immediately to an emergency service for treatment.

Consult your doctor even if any of the circumstances mentioned above have occurred at any time.

Use of Unibenestan with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication (especially medications for high blood pressure), even those purchased without a prescription, homeopathic, herbal, or other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Certain medications, such as those listed below, may increase the risk of hypotension (decrease in blood pressure) when administered concurrently with Unibenestan:

Medications that should not be used:

• Alpha 1-blockers: medications of the same type as this medication
• Ritonavir, either alone or in combination with lopinavir (commonly used for the treatment of HIV) or ritonavir in combination with ombitasvir/paritaprevir (commonly used for the treatment of chronic hepatitis C) or ritonavir in combination with nirmatrelvir (commonly used for the treatment of mild to moderate COVID-19).

Medications that should be taken with caution:

• Antihypertensive medications (medications that lower blood pressure)
• Nitrates (medications for the treatment of coronary artery disease)
• Antifungal medications (such as itraconazole)
• Antibacterial medications (such as clarithromycin, telithromycin)
• Depression medications (such as nefazodone)
• Ketoconazole tablets (used to treat Cushing's syndrome - when the body produces an excess of cortisol)

Additionally, the administration of general anesthetics to patients treated with Unibenestan may cause instability of blood pressure, so, in the event of surgical intervention, you should inform the anesthesiologist of the use of Unibenestan.

Unibenestan intake with food and beverages

This medication should be taken after ingesting some food.

Pregnancy and Lactation

This is not applicable as its use is only in males.

Driving and operating machinery

It should be taken into account that the ability to drive vehicles or operate machinery may be impaired by the possibility of adverse effects such as dizziness and fatigue, especially at the beginning of treatment, at usual doses. If so, refrain from driving and operating hazardous machinery.

Unibenestan contains hydrogenated ricin oil

This medication may cause stomach discomfort and diarrhea due to the presence of hydrogenated ricin oil.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. In these cases, it is advisable to request written instructions from your doctor and ensure that you have understood them well.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Unibenestan. Do not discontinue treatment before.

If you estimate that the action of Unibenestan is too strong or weak, inform your doctor or pharmacist.

The tablet must be swallowed whole. Any other mode of administration, such as chewing, crushing, crushing, or pulverizing, should be avoided, as these actions may cause inappropriate absorption of the medication, and therefore the rapid appearance of possible adverse reactions.

Unibenestan is for oral administration.

The recommended dose is one tablet(10 mg of alfuzosin)per day, which means a maximum dailyof one tablet (10 mg of alfuzosin).

Make sure to take the tablets every day at the same time.

Renal Insufficiency

In patients with mild to moderate renal insufficiency, it is recommended to start treatment with a lower dose, which will be increased to 10 mg based on clinical response.

Use in Children

The efficacy of alfuzosin has not been demonstrated in children aged 2 to 16 years. Therefore, alfuzosin is not indicated for use in children.

If You Take More Unibenestan Than You Should

If you have taken more Unibenestan than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount of Unibenestan taken.You may need to go to the hospital.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

You should remain lying down.

If You Forget to Take Unibenestan

In case of forgotten dose, wait for the next one. But do nottake a double dose to compensate for the missed doses.

If you have any other questions about the use of this leaflet, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects observed, according to their frequency of presentation: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); infrequent (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); unknown frequency (cannot be estimated from available data), have been:

Nervous System

Frequent: weakness/dizziness, headache

Infrequent: syncope (loss of consciousness), vertigo

Eye Disorders

Unknown frequency: Intraoperative Iris Flaccidity Syndrome (characterized by pupil constriction and iris deformation)

Cardiac Disorders

Infrequent: tachycardia (increased heart rate)

Very rare: angina pectoris in patients with coronary disease (intense chest pain with radiation to the left arm) (see "Warnings and Precautions" section)

Unknown frequency: atrial fibrillation (irregular, uncontrolled, and very rapid heartbeats)

Vascular Disorders

Infrequent: orthostatic hypotension (blood pressure drop upon changing position, e.g., from lying down to standing) (see "Warnings and Precautions" section), flushes (sudden reddening)

Respiratory System

Infrequent: inflammation of the nasal mucosa (rhinitis)

Gastrointestinal Disorders

Frequent: nausea, abdominal pain

Infrequent: diarrhea, vomiting

Hepatobiliary Disorders

Unknown frequency: liver injury and hepatic cholestasis (condition in which bile flow from the liver is obstructed)

Skin and Subcutaneous Tissue Disorders

Infrequent: skin rash, itching

Very rare: hives, skin irritation and itching (urticaria), swelling of blood vessels due to fluid accumulation (angioedema)

Reproductive System and Breast Disorders

Unknown frequency: priapism (persistent and painful erection of the penis)

General and Injection Site Disorders

Frequent: asthenia (fatigue)

Infrequent: edema (swelling), chest pain (pain in the chest)

Blood and Lymphatic System Disorders

Unknown frequency: neutropenia (decreased number of neutrophil white blood cells), thrombocytopenia (decreased number of platelets)

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Unibenestan

- The active ingredient is alfuzosin hydrochloride. Each tablet contains 10 mg of alfuzosin hydrochloride.

- The other components (excipients) are: hydrogenated ricin oil, mannitol, ethylcellulose, hypromellose, yellow iron oxide, magnesium stearate, microcrystalline cellulose, povidone, and hydrated colloidal silica.

Appearance of the product and content of the packaging

Unibenestan is presented in the form of prolonged-release tablets. C Each tablet is round, biconvex, with three layers. Each package contains 30 tablets for oral administration.

Holder of the marketing authorization and responsible for manufacturing

Holder:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing:

SANOFI WINTHROP INDUSTRIE

30-36 av. Gustave Eiffel

37000 Tours (France)

OTHER PRESENTATIONS

Benestan Retard 5 mg prolonged-release tablets: packages with 60 tablets

This prospectus was approved on 10/2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/