UNIBENESTAN 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Unibenestan 10 mg prolonged-release tablets

Alfuzosin hydrochloride

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

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Unibenestan and what is it used for
2. What you need to know before you take Unibenestan
3. How to take Unibenestan
4. Possible side effects
5. Storage of Unibenestan
6. Contents of the pack and other information

1. What is Unibenestan and what is it used for

Unibenestan belongs to a group of medicines that act on the bladder, urethra (the tube that connects the kidney to the outside through the penis) and prostate.

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

2. What you need to know before you take Unibenestan

Do not take Unibenestan

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have orthostatic hypotension (decrease in blood pressure when standing up)
• if you are taking other medicines of the same type as this medicine (alpha-1 blockers). See section "Use of Benestan Retard with other medicines".
• if you have liver failure (liver disease)
• if you have severe kidney failure (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 medicines".

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Unibenestan:

• If you are taking other medicines 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 produce the same symptoms as benign prostatic hyperplasia. Before and after treatment, at regular intervals, a rectal examination may be performed and, if necessary, a blood test may be done.

• If you are going to undergo surgery, you should inform the anesthesiologist beforehand that you are taking Unibenestan (see section "Use of Unibenestan with other medicines").

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

• Taking Unibenestan may make you feel dizzy, sweaty, or tired (due to a drop in blood pressure when standing up) in the hours following administration of the medicine (see section "Possible side effects"), especially in patients who also take medicines 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 usually does not prevent continuation of treatment. Inform your doctor if you have ever had a severe drop in blood pressure when treated for high blood pressure with other medicines.

• If you have or have had heart disease, as this medicine may increase the risk of hypotension (drop in blood pressure) when administered together with nitrates (medicine for heart disease) (see section "Possible side effects"). If angina pectoris reappears or worsens, treatment with alfuzosin should be discontinued. Inform your doctor if you have any heart problems related to the QT interval.

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

• If you are an elderly patient, due to the increased risk of hypotension and other side effects related to it.

• If you are going to undergo cataract surgery, please inform your doctor before surgery if you are taking or have taken Unibenestan. This is because Unibenestan may cause complications during surgery, which can be taken into account and controlled by your ophthalmologist if informed beforehand.

Alfuzosin, like other medicines of the same family, may cause priapism (persistent and painful erection of the penis). If this happens, go immediately to the emergency room so that it can be treated.

Talk to your doctor even if any of the above circumstances have occurred to you.

Use of Unibenestan with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine (especially medicines for the treatment of high blood pressure), including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Certain medicines, such as those listed below, may increase the risk of hypotension (drop in blood pressure) when administered at the same time as Unibenestan:

Medicines that should not be used:

• Alpha-1 blockers: medicines of the same type as this medicine
• Ritonavir, 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 infection) or ritonavir in combination with nirmatrelvir (commonly used for the treatment of mild to moderate COVID-19).

Medicines that should be taken with caution:

• Antihypertensive medicines (medicines that lower blood pressure)
• Nitrates (medicines for the treatment of coronary disease)
• Medicines for fungal infections (such as itraconazole)
• Medicines for bacterial infections (such as clarithromycin, telithromycin)
• Medicines for the treatment of depression (such as nefazodone)
• Ketoconazole tablets (used to treat Cushing's syndrome - when the body produces an excess of cortisol).

In addition, the administration of general anesthetics to patients treated with Unibenestan may cause instability of blood pressure, so in the case of surgery, the anesthesiologist should be informed of the use of Unibenestan.

Taking Unibenestan with food and drinks

This medicine should be taken after eating some food.

Pregnancy and Breastfeeding

This is not applicable as it is only used in men.

Driving and using machines

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

Unibenestan contains hydrogenated castor oil

This medicine may cause stomach upset and diarrhea because it contains hydrogenated castor oil.

3. How to take Unibenestan

Follow exactly the instructions of administration of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. In these cases, it is advisable to ask the doctor for the instructions in writing and to make sure you have understood them well.

Remember to take your medicine.

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

If you think the action of Unibenestan is too strong or too weak, tell your doctor or pharmacist.

The tablet should be swallowed whole. Any other way of administration, such as chewing, crushing, sucking, grinding, or pulverizing, should be avoided, as these actions could cause inappropriate absorption of the medicine 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 daily dose of one tablet (10 mg of alfuzosin).

Try to take the tablets every day at the same time.

Renal Impairment

In patients with mild to moderate renal impairment, 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 from 2 to 16 years old. 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, talk to your doctor, pharmacist, or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken of Unibenestan. It may be necessary to go to the hospital. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

You should stay in bed.

If you forget to take Unibenestan

In case of forgetting a dose, wait for the next one. But do not take a double dose to make up for the forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects observed, according to their frequency of presentation: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (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); frequency not known (cannot be estimated from the available data), have been:

Nervous System

Common: weakness/dizziness, headache

Uncommon: syncope (loss of consciousness), vertigo

Ocular

Frequency not known: Intraoperative Floppy Iris Syndrome (characterized by contraction of the pupil and deformation of the iris)

Cardiac

Uncommon: tachycardia (increased heart rate)

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

Frequency not known: atrial fibrillation (very rapid and uncontrolled irregular heartbeats)

Vascular

Uncommon: orthostatic hypotension (drop in blood pressure when changing position, e.g., from lying down to standing up) (see section "Warnings and precautions"), flushing (sudden reddening)

Respiratory

Uncommon: inflammation of the nasal mucosa (rhinitis)

Gastrointestinal

Common: nausea, abdominal pain

Uncommon: diarrhea, vomiting

Hepatobiliary

Frequency not known: liver injury and hepatic cholestasis (a condition in which the flow of bile from the liver is obstructed)

Skin and subcutaneous tissue

Uncommon: skin rash, itching

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

Reproductive system

Frequency not known: priapism (persistent and painful erection of the penis)

General and administration site

Common: asthenia (fatigue)

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

Blood and lymphatic system

Frequency not known: neutropenia (decrease in the number of white blood cells), thrombocytopenia (decrease in the number of platelets).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Unibenestan

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

No special storage conditions are required.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Unibenestan

• The active substance is alfuzosin hydrochloride. Each tablet contains 10 mg of alfuzosin hydrochloride.

• The other ingredients (excipients) are: hydrogenated castor oil, mannitol, ethylcellulose, hypromellose, yellow iron oxide, magnesium stearate, microcrystalline cellulose, povidone, hydrated silica.

Appearance of the product and contents of the pack

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

Marketing authorization holder and manufacturer

Holder:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

SANOFI WINTHROP INDUSTRIE

30-36 av. Gustave Eiffel

37000 Tours (France)

OTHER PRESENTATIONS

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

This leaflet was approved in 10/2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/