Unibenestan 10 mg prolonged-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Unibenestan 10 mg prolonged-release tablets

Alfuzosin hydrochloride

Read the entire 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 should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Unibenestan is and what it is used for

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

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

2. What you need to know before taking 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 (a drop in blood pressure upon standing)
• if you are taking other medicines of the same type as this medicine (alpha1-blockers). See section “Use of Benestan Retard with other medicines”.
• if you have hepatic insufficiency (liver disease)
• if you have severe renal insufficiency (severe kidney disease)
• if you have intestinal obstruction
• if you are taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir. See section “Use of Benestan Retard with other medicines” below.

Warnings and precautions

Talk to your doctor or pharmacist before starting Unibenestan:

• If you are taking other medicines such as ketoconazole and itraconazole (antifungals).

• Before starting treatment with Unibenestan, your doctor may perform tests to rule out other diseases that could cause the same symptoms as benign prostatic hyperplasia. Before treatment and periodically thereafter, you may undergo a digital rectal examination and, if necessary, blood tests.

• If you are scheduled for surgery, you must inform the anaesthetist in advance 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 cause dizziness, sweating, or fatigue (due to a drop in blood pressure upon standing) in the hours following administration (see section “Possible side effects”), especially in patients also taking medicines for hypertension (high blood pressure) or nitrates (for heart disease). If you experience these symptoms, lie down until you feel better. These effects are more likely at the beginning of treatment, but generally do not prevent continuation of therapy. Inform your doctor if you have ever experienced a significant drop in blood pressure while being treated for hypertension with other medicines.

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

• If you have liver or kidney disease, your doctor may adjust your dose.

• If you are elderly, as the risk of hypotension and other adverse effects may be higher.

• If you are scheduled for cataract eye surgery, please inform your doctor before the procedure if you are currently taking or have previously taken Unibenestan. This is because Unibenestan may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if informed in advance.

Alfuzosin, like other medicines in the same class, may cause priapism (a persistent and painful penile erection). If this occurs, seek immediate medical attention at an emergency department for prompt treatment.

Consult your doctor even if any of the above-mentioned conditions occurred in the past.

Use of Unibenestan with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines (especially medicines for high blood pressure), including over-the-counter products, homeopathic remedies, herbal supplements, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more of these medicines.

Certain medicines, such as those listed below, may increase the risk of hypotension (low blood pressure) when taken together with Unibenestan:

Medicines that must not be used:

• Alpha1-blockers: drugs of the same type as this medicine
• Ritonavir, either alone or in combination with lopinavir (commonly used for HIV treatment), or ritonavir in combination with ombitasvir/paritaprevir (commonly used for chronic hepatitis C infection), or ritonavir in combination with nirmatrelvir (commonly used for mild to moderate COVID-19 treatment).

Medicines that should be used with caution:

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

In addition, administration of general anaesthetics to patients treated with Unibenestan may cause blood pressure instability; therefore, if undergoing surgery, you must inform the anaesthetist that you are taking Unibenestan.

Taking Unibenestan with food and drink

This medicine should be taken after eating a meal.

Pregnancy and breastfeeding

Not applicable, as this medicine is intended for use only in males.

Driving and using machines

You should be aware that your ability to drive or operate machinery may be impaired due to possible adverse effects such as dizziness and fatigue, especially at the beginning of treatment and at usual doses. If this occurs, refrain from driving and operating dangerous machinery.

Unibenestan contains hydrogenated castor oil

This medicine may cause stomach discomfort and diarrhoea because it contains hydrogenated castor oil.

3. How to take Unibenestan

Follow exactly the instructions for administration of this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again. In such cases, it is advisable to request written instructions from your doctor and ensure you have fully understood them.

Remember to take your medicine.

Your doctor will determine the duration of your treatment with Unibenestan. Do not stop the treatment prematurely.

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

The tablet must be swallowed whole. Any other method of administration, such as chewing, crushing, breaking, grinding, or pulverizing, should be avoided, as these actions could lead to inappropriate absorption of the medicine and, consequently, to the rapid onset of possible adverse reactions.

Unibenestan is for oral administration.

The recommended dose is one tablet (10 mg of alfuzosin) daily, which corresponds to a maximum daily dose of one tablet (10 mg of alfuzosin).

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

Renal impairment

In patients with mild to moderate renal impairment, treatment should be initiated with a lower dose, which may be increased to 10 mg according to 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medication and the amount of Unibenestan taken. It may be necessary to go to a hospital. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

You should remain lying down.

If you forget to take Unibenestan

If you miss a dose, wait until the next scheduled dose. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The adverse effects observed, according to their frequency of occurrence: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from available data), have been:

Nervous System

Common: weakness/dizziness, headache

Uncommon: syncope (loss of consciousness), vertigo

Eye Disorders

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

Cardiac Disorders

Uncommon: tachycardia (increased heart rate)

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

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

Vascular Disorders

Uncommon: orthostatic hypotension (drop in blood pressure upon changing position, e.g. from lying down to standing up) (see section “Warnings and precautions”), hot flushes (sudden reddening of the skin)

Respiratory System

Uncommon: inflammation of the nasal mucosa (rhinitis)

Gastrointestinal Disorders

Common: nausea, abdominal pain

Uncommon: diarrhea, vomiting

Hepatobiliary Disorders

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

Skin and Subcutaneous Tissue Disorders

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 penile erection)

General Disorders and Administration Site Conditions

Common: asthenia (fatigue)

Uncommon: edema (swelling), chest pain

Blood and Lymphatic System Disorders

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

Reporting of adverse effects

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

5. Storage of Unibenestan

Keep this medicine out of sight and reach of children.

Special storage conditions are not required.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components (excipients) are: hydrogenated castor oil, mannitol, ethylcellulose, hypromellose, yellow iron oxide, magnesium stearate, microcrystalline cellulose, povidone, colloidal hydrated silica.

Appearance of the product and contents of the pack

Unibenestan is presented as prolonged-release tablets. Each tablet is round, biconvex, and three-layered. Each pack contains 30 tablets for oral administration.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 of 60 tablets

This leaflet was approved in 10/2024

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/