BENESTAN RETARD 5 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What Benestan Retard is and what it is used for

Benestan Retard belongs to a group of medicines that act specifically on the urinary tract (bladder, urethra, and prostate).

Benestan Retard 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 Benestan Retard

Read the following sections carefully.

Do not take Benestan Retard

• 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 (low blood pressure when standing up)
• if you are taking other medicines of the same type as this medicine (alpha-1 blockers). See section “Using Benestan Retard with other medicines”.
• if you have severe liver impairment (severe liver disease)
• if you have gastrointestinal obstruction
• if you are taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir. See section “Using Benestan Retard with other medicines”.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Benestan:

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

• Before starting treatment with Benestan Retard, 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 thereafter, you may undergo a rectal examination and, if necessary, a blood test.

• If you are going to undergo surgery, you should inform the anesthesiologist beforehand that you are taking Benestan Retard (see section “Using Benestan Retard with other medicines”).

• If you have previously been treated with a medicine similar to Benestan Retard.

• If you are taking medicines for high blood pressure or nitrates (for the treatment of heart diseases), you may experience a drop in blood pressure when standing up, which can be accompanied by dizziness, sweating, or fatigue (see section “Possible side effects”). If you notice these symptoms, you should remain lying down until you feel better. This is more common at the start of treatment and usually does not prevent continuation of treatment. Inform your doctor if you have ever experienced a severe drop in blood pressure when treated for high blood pressure with other medicines.

• If you have ischemic cerebral disorders (blood circulation problems in the brain) because this medicine can cause hypotension (low blood pressure). You may have ischemic cerebral disorders that have not yet manifested (see section “Possible side effects”).

• If you have or have had a heart condition, as this medicine can increase the risk of hypotension (low blood pressure) when administered together with nitrates (medicine 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 problems related to the QT interval.

• If you are an elderly patient, as you may be at greater risk of hypotension and other side effects.

• If you have renal impairment, your doctor may adjust the dose to be taken.

• If you are going to undergo cataract surgery, please inform your doctor before the operation if you are taking or have taken Benestan Retard. This is because Benestan Retard can 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, can cause priapism (persistent and painful erection of the penis). If this happens, go immediately to the emergency room so that it can be treated.

Consult your doctor or pharmacist even if any of the above circumstances have occurred to you at any time.

Using Benestan Retard with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines (especially medicines for 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, can increase the risk of hypotension (low blood pressure) when administered at the same time as Benestan Retard:

Medicines that must not be used:

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

Medicines that must be used with caution:

• Antihypertensive medicines (medicines that lower blood pressure)
• Nitrates (medicines for coronary insufficiency)
• 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 too much cortisol).

Additionally, the administration of general anesthetics to patients treated with Benestan Retard can cause blood pressure instability, so in the event of surgery, you should inform the anesthesiologist that you are taking Benestan Retard.

Your doctor will determine whether you should stop taking the medicines or if it is necessary to perform close monitoring or adjust the doses or treatment regimens.

Pregnancy and breastfeeding

This is not applicable, as the use of this medicine is only in males.

Driving and using machines

You should be aware that the ability to drive vehicles or operate machinery may be impaired by the possibility of side effects such as dizziness and fatigue, especially at the start of treatment. If this is the case, you should avoid driving and operating hazardous machinery.

Benestan Retard contains hydrogenated castor oil

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

3. How to take Benestan Retard

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

If you think the effect of Benestan Retard is too strong or too weak, tell your doctor or pharmacist.

The recommended dosage is orientative and variable. The establishment of the dosage regimen is left to medical discretion.

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

Adults

1 tablet, twice a day (morning and night), which corresponds to 10 mg of alfuzosin per day.

Elderly patients

As a precaution, it is recommended to start treatment with a dose of 1 tablet at night (5 mg of alfuzosin), which will be increased to 1 tablet twice a day, according to the clinical response, without exceeding 10 mg of alfuzosin per day.

Renal impairment

In patients with mild or moderate renal impairment, as a precaution, it is recommended to start treatment with 1 tablet at night (5 mg of alfuzosin), which will be increased to 1 tablet twice a day, according to the clinical response, without exceeding 10 mg of alfuzosin per day.

In patients with severe renal impairment, it is recommended not to use Benestan Retard. Therefore, your doctor will prescribe a treatment with a lower dose, which will be increased according to the clinical response.

Hepatic impairment

In patients with mild to moderate hepatic impairment (liver disease), it is recommended not to use Benestan Retard. Therefore, your doctor will prescribe a treatment with Benestan 2.5 mg.

In Benestan Retard, the medication is located in the middle of a non-absorbable tablet, specially designed for controlled release of the active substance. When this process is complete, the empty tablet is eliminated from the body through the feces, so it is possible that you will find the tablet coating in your stool.

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 Benestan Retard than you should

If you have taken more Benestan Retard than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken. It may be necessary to go to the hospital. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

You should remain lying down.

If you forget to take Benestan Retard

If you accidentally miss a daily dose, take the next dose normally. Do not take a double dose to make up for the missed doses.

If you have any other questions about the use of this product, 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: fainting/dizziness, vertigo, headache

Uncommon: syncope (loss of consciousness), somnolence (drowsiness)

Frequency not known: ischemic cerebral disorders (blood circulation problems in the brain) in patients who may have had this problem previously but it has not yet manifested

Eye disorders

Uncommon: abnormal vision

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

Cardiac disorders

Uncommon: increased heart rate, palpitations

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 and uncontrolled irregular heartbeats)

Vascular disorders

Common: orthostatic hypotension (low blood pressure when standing up) (see section “Warnings and precautions”)

Uncommon: hot flashes

Respiratory, thoracic and mediastinal disorders

Uncommon: nasal congestion (rhinitis)

Gastrointestinal disorders

Common: nausea, abdominal pain, diarrhea, dry mouth

Uncommon: vomiting

Hepatobiliary disorders

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 disorders

Uncommon: skin rash, itching

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

Reproductive system and breast disorders

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

General disorders and administration site conditions

Common: fatigue, malaise

Uncommon: edema (swelling), chest pain

Blood and lymphatic system disorders

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. This includes any possible side effects not listed in this leaflet. You can also report side effects 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 Benestan Retard

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

Do not remove the tablets from their packaging until you are about to take the medicine.

Do not store above 30°C.

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. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Benestan Retard

• The active substance is alfuzosin hydrochloride. Each tablet contains 5 mg of alfuzosin hydrochloride.
• The other ingredients are: hydrogenated castor oil, microcrystalline cellulose, calcium phosphate dihydrate, povidone, magnesium stearate, hypromellose, propylene glycol, titanium dioxide, and iron oxide (III) monohydrate.

Appearance and packaging of the product

Benestan Retard is presented in the form of prolonged-release tablets, round, biconvex, pale yellow in color. Pack of 60 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

sanofi-aventis, S.A.

C/ Roselló i Porcel, 21

08016 Barcelona

Spain

Manufacturer:

SANOFI WINTHROP INDUSTRIE

Avenue Gustave Eiffel, 30-36

37000 Tours (France)

OTHER PRESENTATIONS:

Unibenestan 10 mg prolonged-release tablets: pack of 30 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/