Package Insert: Information for the User

Alfuzosin Aurovitas 10 mg Extended-Release Tablets EFG

Alfuzosin, hydrochloride

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

• Keep this package insert, 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 should not be given 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 package insert. See section 4.

Alfuzosina belongs to a group of medications known as alpha-1 blockers.

Alfuzosina is used to treat moderate to severe symptoms in benign prostatic hyperplasia. This disease causes an increase in the size of the prostate gland (hyperplasia), but the growth of the gland is not cancerous (benign). It occurs more frequently in older men.

The prostate gland is located below the bladder, which surrounds the urethra (tube that allows for the expulsion of urine). With age, the prostate gland can grow and press on the urethra, reducing its size. This can cause problems such as frequent urination and difficulties in passing urine.

Alfuzosina acts by relaxing the muscle of the prostate gland. This reduces the narrowing of the urethra and facilitates the passage of urine.

In some patients with benign prostatic hyperplasia, the prostate grows so much that it completely stops the flow of urine. This is called acute urinary retention.

Do not take Alfuzosina Aurovitas:

• If you are allergic to alfuzosina or any of the other components of this medication (listed in section 6).

The symptoms of an allergic reaction include: rash, swelling of the lips, tongue, or throat, difficulty swallowing or breathing.

• If you are allergic (hypersensitive) to substances equivalent to alfuzosina (such as terazosina or doxazosina).
• If you have or have had conditions that cause a sudden drop in blood pressure, when standing up or sitting from a reclined position (the medical term is orthostatic hypotension). The medication may make you feel dizzy or weak if you stand up or sit up suddenly.
• If you are taking medications belonging to the group of alpha-1 blockers (such as terazosina or doxazosina) or dopamine receptor agonists at the same time. See below the section “Other medications and Alfuzosina Aurovitas”. In case of doubt, ask your doctor or pharmacist.
• If you have liver problems.

Warnings and precautions

Consult your doctor or pharmacist before starting to take alfuzosina if:

• You have severe kidney problems.
• You have heart diseases.
• You have chest pain (angina).
• You have an alteration in the electrocardiogram (ECG), called prolongation of the QT interval.
• You are over 65 years old. This is due to the increased risk of developing low blood pressure (hypotension) and related side effects in elderly patients.
• Before starting treatment with Alfuzosina Aurovitas, 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 afterwards, a digital rectal examination may be performed, and if necessary, an analysis may be performed.
• You have ever had painful erections of the penis, unrelated to sexual activity, that do not disappear, before or during treatment.

Other medicationsandAlfuzosina Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication.

This is because alfuzosina may affect the functioning of other medications. Some medications may also affect the way alfuzosina works.

Do not take Alfuzosina Aurovitas if you are taking:

• Other alpha-blockers such as doxazosina, indoramina, prazosina, terazosina, tamsulosina, or phenoxybenzamine or dopamine receptor agonists.

Consult your doctor or pharmacist before starting to take the medication if:

• You experienced a sudden drop in blood pressure after taking an alpha-blocker medication (may include previous use of alfuzosina). Read attentively the previous paragraph with examples of other alpha-blockers.
• You are taking medications for high blood pressure, as you may feel dizzy, weak, or start to sweat a few hours after taking the medication. If this happens, lie down until the symptoms have completely passed. Inform your doctor, as they may need to change your dose.
• You are taking medications for chest pain or angina (nitrates).
• You are taking medications for fungal infections (such as ketoconazol or itraconazol).
• You are taking medications used to treat HIV (such as ritonavir).
• You are taking certain medications used to treat hepatitis C (e.g., ritonavir, ombitasvir, and paritaprevir).
• You are taking medications for bacterial infections (such as claritromicina or telitromicina).
• You are taking medications for depression (such as nefazodona).
• You are taking ketoconazol tablets (to treat Cushing's syndrome, when the body produces an excess of cortisol).
• You are taking medications to treat premature ejaculation (e.g., dapoxetina).

Operations while taking Alfuzosina Aurovitas

• If you are undergoing a surgery that requires general anesthesia, and you are taking alfuzosina, consult your doctor before the surgery. Your doctor may decide that you stop taking alfuzosina 24 hours before the surgery. This is because it may be dangerous as you may experience a drop in blood pressure.
• If you are being treated for high blood pressure, your doctor should measure your blood pressure regularly, especially at the beginning of treatment.
• If you are undergoing cataract surgery, please inform your ophthalmologist before the surgery that you are taking or have taken alfuzosina previously. Alfuzosina may cause complications during the surgery that can be taken into account and controlled by your ophthalmologist if you have been informed beforehand.

Alfuzosina Aurovitas with food, drinks, and alcohol

• Take alfuzosina after a meal.
• You may feel dizzy and weak while taking alfuzosina. If this happens, do not drink alcohol.

Pregnancy, breastfeeding, and fertility

This section is not applicable as alfuzosina is only used in males.

Driving and operating machinery

You may feel dizzy or weak while taking alfuzosina. As adverse reactions during treatment, you may experience a significant drop in blood pressure when standing up, along with dizziness, vertigo, visual disturbances, and asthenia. If this happens, especially at the beginning of treatment, do not drive or operate heavy machinery.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Dosage

• Take your tablet with sufficient liquid (for example, a glass of water).
• Do not crush, chew, or divide the tablets. It may affect the release of the medication in your body.
• Take the tablets after a meal.
• The first dose should be taken before going to bed.

Benign Prostatic Hyperplasia

The usual dose is one alfuzosin tablet once a day (after a meal).

Acute Urinary Retention

Use in Children and Adolescents

Children

Alfuzosin is not indicated in children and adolescents.

Older Patients (65 years or older)

The usual dose in adults is one alfuzosin tablet once a day.

No dose adjustment is needed in older patients (65 years or older).

Patients with Mild or Moderate Renal Impairment

No dose adjustment is needed in patients with mild or moderate renal impairment.

If You Take More Alfuzosin Aurovitas Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Try to lie down as much as possible to help limit the adverse effects.

Do not attempt to drive just to go to the hospital.

If You Forget to Take Alfuzosin Aurovitas

Do not take a double dose to compensate for the missed doses. Omit the dose and take the next tablet as instructed.

If You Interrupt Treatment with Alfuzosin Aurovitas

Continue taking the tablets, even if your symptoms improve. Only interrupt treatment when your doctor tells you to. Symptoms are better controlled if you continue taking the same dose of the medication.

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

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

These side effects are more likely to occur at the beginning of treatment.

Chest pain (angina)(initial, worsening or recurrence)

Chest pain usually only occurs if you have had a previous heart attack.If you experience chest pain while taking the tablets, contact your doctor or go to the hospital immediately.This occurs in less than 1 in 10,000 people.

Allergic reactions

You may notice symptoms of angioedema, such as a red and swollen rash on the skin, swelling (on the eyelids, face, lips, mouth, or tongue), difficulty breathing or swallowing.

These symptoms are allergic reactions.If this happens, stop taking the tablets and contact your doctor or go to the hospital immediately.This occurs in less than 1 in 10,000 people.

Other side effects include:

Frequent (may affect up to 1 in 10 people)

• Dizziness.
• Headache.
• Feeling unwell (nausea).
• Stomach pain.
• Weakness or fatigue.

Less common (may affect up to 1 in 100 people)

• Dizziness or weakness when standing up quickly (postural hypotension).
• Fast heart rate (tachycardia) and palpitations in the chest and irregular heartbeats (palpitations).
• Drowsiness.
• Stuffy nose, itching, runny nose, or sneezing.
• Diarrhea.
• Dry mouth.
• Rashes and itching.
• Urinary incontinence.
• Water retention (may cause swollen arms and legs).
• Chest pain.
• Hot flashes.
• General feeling of discomfort.
• Visual disturbances.

Very rare(may affect up to 1 in 10,000 people)

• Hepatotoxicity.
• Hives with itching and bumps, also known as urticaria or nettle rash (urticaria).

Possible additional side effects that may occur (frequency unknown):

If you are undergoing cataract surgery (where the lenses of the eyes become opaque), the pupil may dilate slightly, and the iris (the colored part of the eye), may become more flexible during the procedure.

• Irregular and rapid heartbeat (atrial fibrillation).
• Decreased white blood cells (neutropenia). Symptoms may include increased frequency of infections, ulcers in the throat or mouth.
• Increased risk of bleeding (including nosebleeds and/or bleeding gums) and hematomas. This could be a blood disorder called "thrombocytopenia", which is a decrease in the number of platelets in the blood.
• Abnormal liver function (liver problems). Symptoms may include yellowing of the skin or the white of the eyes.
• If you are undergoing cataract surgery (opacity of the lenses) and are taking or have previously taken alfuzosin, the pupil may be slightly dilated, and the iris (the colored circular part of the eyes), may become more flexible during the process. This only occurs during the procedure and is important that the ophthalmologist is aware as they may have to perform the procedure differently (see sectionSurgeries while taking Alfuzosin Aurovitas).
• Abnormal penile erection, frequently painful and persistent without relation to sexual activity (priapism).
• Vomiting.
• Stroke (insufficient blood flow to the brain). This is more likely in patients who have had previous problems with blood flow to the brain.

Reporting of side effects

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

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need atthe SIGRE point of the pharmacy.Pregunte to your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Alfuzosina Aurovitas

• The active ingredient is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
• The other components (excipients) are:

Tablet core:hypromellose (E464), hydrogenated vegetable oil, povidone (K30) (E1201), calcium hydrogen phosphate, carbomer, anhydrous colloidal silica (E551), magnesium stearate (E572).

Covering:hypromellose (E464), propylene glycol, titanium dioxide (E171).

The tablet has a prolonged effect, meaning that after taking the tablet, the active ingredient does not releaseimmediately, but rather gradually, which means it acts for a longer time.

Appearance of the product and contents of the package

Prolonged-release tablet.

Coated tablets with a white to off-white film, biconvex, rounded, marked with “X” on one face of the tablet and “47” on the other.

Alfuzosina Aurovitas tablets are available in transparent PVC/PVdC – aluminium blisters, and in white, opaque high-density polyethylene (PEAD) containers containing silica gel.

Package sizes:

Blister: 30, 50, 90, and 100 prolonged-release tablets.

PEAD containers: 30, 500, and 1,000 prolonged-release tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Cyprus:Alfuzosin Aurobindo 10 mg δισκ?α παρατεταμ?νης

Czech Republic:Alfuzosin Aurovitas

Germany:Alfuzosin Aurobindo 10 mg Retardtabletten

Italy:Alfuzosina Aurobindo 10 mg compresse a rilascio prolungato

Ireland:Alfu 10 mg prolonged release tablets

Malta:Zochek 10 mg prolonged-release tablets

Netherlands:Alfuzosine HCl Aurobindo 10 mg, tabletten met verlengde afgifte

Spain:Alfuzosina Aurovitas 10 mg comprimidos de liberación prolongada EFG

Last review date of this leaflet:February 2023

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