Benestan retard 5 mg comprimidos de liberacion prolongada

Leaflet: information for the user

Benestan Retard 5 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, ask 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 Benestan Retard is and what it is used for

2. What you need to know before you start taking Benestan Retard

3. How to take Benestan Retard

4. Possible side effects

5. Storage of Benestan Retard

6. Contents of the pack and additional information

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

Benestan Retard is indicated for thetreatment of functional symptoms of benign prostatic hyperplasia (prostate enlargement).

Read carefully the following sections.

Do not take Benestan Retard

• if you are allergic to the active ingredient or any of the other components of this medication (listed in section 6)
• if you have orthostatic hypotension (decrease in blood pressure when standing up)
• if you are taking other medications of the same type as this medication (alpha1-blockers). See section “Use of Benestan Retard with other medications”.
• if you have severe liver disease (serious liver disease)
• if you have gastrointestinal 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 Benestan:

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

- Before starting treatment with Benestan Retardyour 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, you may undergo a rectal examination and, if necessary, blood tests..

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

- If you have previously been treated with a similar medication to Benestan Retard.

• If you are taking medications for high blood pressure (elevated blood pressure) or nitrates (for the treatment of heart disease), a decrease in blood pressure when standing up in the hours following medication intake may occur, accompanied by dizziness, sweating, or fatigue (see section “Possible side effects”). If you experience these symptoms, 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 significant drop in blood pressure when treated for high blood pressure with other medications.

- If you have cerebral ischemic disorders (circulation problems in the brain) due to the fact that this medication can cause hypotension (decrease in blood pressure). You may have cerebral ischemic disorders that have not yet manifested (see section “Possible side effects”).

- If you have or have had heart disease, as this medication may increase the risk of hypotension (decrease in blood pressure) when administered with nitrates (heart disease medication)(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-related problems related to the QT interval.

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

• If you have renal insufficiency,your doctor may modify the dose to be taken.

- If you are to undergo eye surgery for cataracts, please inform your doctor before the surgery if you are taking or have taken Benestan Retard previously. This is because Benestan Retard may cause complications during the surgery, 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 or pharmacist even if any of the circumstances mentioned above have occurred at any time.

Use of Benestan Retard 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 the treatment of elevated blood pressure), even those purchased without a prescriptionmédica, homeopathic, herbal, and other health-related products, as it may be necessary to discontinue treatment or adjust the dose of one or more of them.

Certain medications, such as those listed below, may increase the risk of hypotension (decrease in blood pressure) when administered at the same time as Benestan Retard:

Medications that should not be used:

• Alpha1-blockers: medications of the same type asthis 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 insufficiency)
• 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).

In addition, the administration of general anesthetics to patients treated with Benestan Retard may cause instability of blood pressure, so, in the event of surgical intervention, you should inform the anesthesiologist of the intake of Benestan Retard.

Your doctor will determine whether you should stop taking the medications or if it is necessary to perform a close control or adjust the doses or guidelines.

Pregnancy and breastfeeding

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

Driving and operating machinery

You should be aware that your ability to drive vehicles or operate machinery may be impaired by the possibility of side effects such as dizziness and fatigue, especially at the beginning of treatment. If so, refrain from driving and operating hazardous machinery.

Benestan Retard 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 of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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

The recommended dosage is orientative and variable. The establishment of the dosing schedule is left to the doctor's discretion.medical

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.

Adults

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

Older patients

As a precautionary measure, 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 clinical response, without exceeding 10 mg of alfuzosin per day.

Renal insufficiency

In patients with mild or moderate renal insufficiency, 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 clinical response, without exceeding 10 mg of alfuzosin per day.

In patients with severe renal insufficiency, 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 clinical response.

Liver insufficiency

In patients with mild to moderate liver insufficiency, 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 contained in the middle of an unabsorbable tablet, especially designed to have a controlled release of the active principle. When this process is completed, the empty tablet is eliminated from the body through the feces, so it is possible that you may find the coating of the tablet in your stools.

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 Benestan Retard than you should

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

You should remain lying down.

If you forgot to take Benestan Retard

If you accidentally forget a daily dose, take the next normal dose. Do not take a double dose to compensate for the missed doses.

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

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

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

Eye Disorders

Infrequent: abnormal vision

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

Cardiac Disorders

Infrequent: increased heart rate, palpitations

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 rapid heartbeats)

Vascular Disorders

Frequent: orthostatic hypotension (blood pressure drop when changing position, e.g., from lying down to standing) (see "Warnings and precautions" section)

Infrequent: hot flashes

Respiratory System Disorders

Infrequent:inflammation of the nasal mucosa (rhinitis)

Gastrointestinal Disorders

Frequent: nausea, abdominal pain, diarrhea, dry mouth

Infrequent: vomiting

Hepatobiliary Disorders

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

Skin and Subcutaneous Tissue Disorders

Infrequent: skin rash, skin itching

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

Reproductive System Disorders

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

General and at the site of administration

Frequent: fatigue, discomfort

Infrequent:edema (swelling), chest pain

Blood and Lymphatic System Disorders

Unknown frequency: neutropenia (decrease in the number of white blood cell neutrophils), thrombocytopenia (decrease in the 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 prospectus. 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.

Do not remove the tablets from their packaging until it is time to take the medication.

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears 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 Benestan Retard

-The active ingredient is alfuzosin hydrochloride. Each tablet contains 5 mg of alfuzosin hydrochloride.

• The other components are: hydrogenated ricin oil, microcrystalline cellulose, dihydrogen phosphate of calcium dihydrate, povidone, magnesium stearate, hypromellose, propylene glycol, titanium dioxide, and iron (III) oxide monohydrate.

Appearance of the product and contents of the packaging

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

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

Avenue Gustave Eiffel, 30-36

37000 Tours (France)

OTHER PRESENTATIONS:

Unibenestan 10 mg prolonged-release tablets: packaging with 30 tablets.

This prospectus was approved in 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/