ALFUZOSINE AUROVITAS 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Alfuzosin Aurovitas 10 mg prolonged-release tablets EFG

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

1. What Alfuzosin Aurovitas is and what it is used for

Alfuzosin belongs to a group of medicines called alpha-1 blockers.

Alfuzosin is used to treat moderate to severe symptoms of 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 under the bladder, which surrounds the urethra (the tube that allows 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 difficulty passing urine.

Alfuzosin works 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.

• This is very painful and you may need a short stay in the hospital.
• A thin, flexible tube (catheter) is inserted into the bladder. This drains the water and relieves the pain.
• During this time, alfuzosin can be used to help urine flow again. It has only been shown to help in men over 65 years old.

2. What you need to know before you take Alfuzosin Aurovitas

Do not take Alfuzosin Aurovitas:

• If you are allergic to alfuzosin or any of the other ingredients of this medicine (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 alfuzosin (such as terazosin or doxazosin).
• If you have or have had diseases that cause a sudden drop in blood pressure when standing up or sitting down from a lying position (the medical term is orthostatic hypotension). The medicine may make you feel dizzy or weak if you get up or sit down suddenly.
• If you are taking medicines belonging to the group of alpha-1 blockers (such as terazosin or doxazosin) or dopamine receptor agonists at the same time. See the section "Other medicines and Alfuzosin Aurovitas" below. If in doubt, ask your doctor or pharmacist.
• If you have liver problems.

Warnings and precautions

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

• You have severe kidney problems.
• You have heart disease.
• You suffer from 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 Alfuzosin Aurovitas, your doctor may perform some tests to rule out the presence of other diseases that can 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 carried out.
• You have ever suffered from painful erections of the penis, not related to sexual activity, that do not disappear, before or during treatment.

Other medicines and Alfuzosin Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This is because alfuzosin can affect the functioning of other medicines. Some medicines can also affect how alfuzosin works.

Do not take Alfuzosin Aurovitas if you are taking:

• Other alpha-blockers such as doxazosin, indoramine, prazosin, terazosin, tamsulosin or phenoxybenzamine or dopamine receptor agonists.

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

• You have experienced a sudden drop in blood pressure after taking an alpha-blocker medicine (this may include previous use of alfuzosin). Read the previous paragraph with examples of other alpha-blockers carefully.
• You are taking high blood pressure medicines, as you may feel dizzy, weak or start sweating a few hours after taking the medicine. If this happens, lie down until the symptoms have passed completely. Tell your doctor, they may need to change the dose.
• You are taking medicines for chest pain or angina (nitrates).
• You are taking medicines for fungal infections (such as ketoconazole or itraconazole).
• You are taking medicines used to treat HIV (such as ritonavir).
• You are taking certain medicines used to treat hepatitis C (e.g. ritonavir, ombitasvir and paritaprevir.
• You are taking medicines for bacterial infections (such as clarithromycin or telithromycin).
• You are taking medicines for the treatment of depression (such as nefazodone).
• You are taking ketoconazole tablets (to treat Cushing's syndrome, when the body produces too much cortisol).
• You are taking medicines to treat premature ejaculation (e.g. dapoxetine).

Operations while taking Alfuzosin Aurovitas

• If you are going to undergo an operation that requires general anesthesia, and you are taking alfuzosin, consult your doctor before the operation. Your doctor may decide that you should stop taking alfuzosin 24 hours before the operation. This is because it can be dangerous as you may suffer a drop in blood pressure.
• If you are being treated for high blood pressure, your doctor should check your blood pressure regularly, especially at the start of treatment.
• If you are going to undergo cataract surgery, please inform your ophthalmologist before the operation that you are taking or have previously taken alfuzosin. Alfuzosin can cause complications during the operation that can be taken into account and controlled by your ophthalmologist if they have been informed beforehand.

Alfuzosin Aurovitas with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

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

Driving and using machines

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

3. How to take Alfuzosin Aurovitas

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

Posology

• Take your tablet with enough liquid (e.g. a glass of water).
• Do not crush, chew or divide the tablets. It can affect the release of the medicine in your body.
• Take the tablets after a meal.
• The first dose should be taken before bedtime.

Benign prostatic hyperplasia

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

Acute urinary retention

• Your doctor will give you alfuzosin on the day the catheter is inserted.
• You should continue taking alfuzosin once a day.
• You should stop taking alfuzosin the day after the catheter is removed (3-4 days in total).

Use in children and adolescents

Children

Alfuzosin is not indicated in children and adolescents.

Elderly patients (over 65 years old)

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

No dose adjustment is needed in elderly patients (over 65 years old).

Patient with mild or moderate kidney problems

No dose adjustment is needed in patients with mild or moderate kidney problems.

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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

Lie down as much as possible to help limit the adverse effects.

Do not try to drive alone to go to the hospital.

If you forget to take Alfuzosin Aurovitas

Do not take a double dose to make up for forgotten doses. Omit the dose and take the next tablet as indicated.

If you stop taking Alfuzosin Aurovitas

Continue taking the tablets, even if your symptoms improve. Only stop treatment when your doctor indicates. The symptoms are better controlled if you continue taking the same dose of the medicine.

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

4. Possible side effects

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

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

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

Normally, chest pain only occurs if you have suffered from angina before. If you suffer from 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 (in 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:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Hepatotoxicity.
• Itchy rash with bumps, also called urticaria or nettle rash (urticaria).

Additional side effects that may occur (frequency not known):

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

• Irregular and fast heartbeat (atrial fibrillation).
• Decrease in white blood cells (neutropenia). The symptoms may include increased frequency of infections, ulcers in the throat or mouth.
• Increased risk of bleeding (including nosebleeds and/or bleeding gums) and bruising. This could be a blood problem called "thrombocytopenia", which is a decrease in the number of platelets in the blood.
• Abnormal liver function (liver problems). The symptoms may include yellowing of the skin or the whites of the eyes.
• If you are going to have cataract surgery (clouding of the lenses) and you 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 it is important that the ophthalmologist is aware of it, as they may need to perform the procedure differently (see section Operations while taking Alfuzosin Aurovitas).
• Abnormal and often painful erections of the penis (priapism).
• Being sick (vomiting).
• Stroke (there is not enough 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 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 Alfuzosin Aurovitas

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month shown.

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 Alfuzosin Aurovitas

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

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

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

The tablet has a prolonged release effect, which means that after taking the tablet, the active substance is not released immediately, but gradually, which means it acts for a longer time.

Appearance of the product and pack contents

Prolonged-release tablet.

White to off-white, biconvex, rounded film-coated tablets, marked with "X" on one face of the tablet and "47" on the other.

Alfuzosin Aurovitas tablets are available in transparent PVC/PVdC-aluminum blisters and in white, opaque high-density polyethylene (HDPE) bottles containing silica gel.

Package sizes:

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

HDPE bottles: 30, 500 and 1,000 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid,

Spain

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 under 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

Date of last revision of this leaflet:February 2023

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