Alfuzosin Aurovitas 10 mg prolonged-release tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alfuzosin Aurovitas 10 mg prolonged-release tablets EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Alfuzosina 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 condition 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 and surrounds the urethra (the tube through which urine passes). With age, the prostate gland may enlarge and press on the urethra, reducing its diameter. This can lead to problems such as frequent urination and difficulty passing urine.

Alfuzosin works by relaxing the muscle in the prostate gland. This reduces the narrowing of the urethra and helps urine to pass more easily.

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

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

2. What you need to know before taking Alfuzosina Aurovitas

Do not take Alfuzosina Aurovitas:

• If you are allergic to alfuzosin or to any of the other ingredients of this medicine (listed in section 6).

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 related to alfuzosin (such as terazosin or doxazosin).
• If you have or have had conditions causing a sudden drop in blood pressure when standing up or sitting from a lying position (the medical term is orthostatic hypotension). This medicine may make you feel dizzy or weak if you stand 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 section below “Other medicines and Alfuzosina Aurovitas”. If in doubt, consult your doctor or pharmacist.
• If you have liver problems.

Warnings and precautions

Consult your doctor or pharmacist before taking alfuzosin if:

• You have severe kidney problems.
• You have heart disease.
• You suffer from chest pain (angina).
• You have an abnormality on the electrocardiogram (ECG), known as QT interval prolongation.
• You are over 65 years of age. 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 certain tests to rule out other diseases that may cause the same symptoms as benign prostatic hyperplasia. Before treatment and at regular intervals thereafter, a digital rectal examination may be performed and, if necessary, a blood test.
• You have ever experienced painful penile erections not related to sexual activity that do not go away, either before or during treatment.

Other medicines and Alfuzosina Aurovitas

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

This is because alfuzosin may affect how other medicines work. Some medicines may also affect how alfuzosin works.

Do not take Alfuzosina Aurovitas if you are taking:

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

Consult your doctor or pharmacist before starting the medicine if:

• You previously experienced a sudden drop in blood pressure after taking an alpha-blocking medicine (this may include prior use of alfuzosin). Read carefully the paragraph above with examples of other alpha-blockers.
• You are taking medicines for high blood pressure, as you may feel dizzy, weak or start sweating several hours after taking the medicine. If this happens, lie down until the symptoms have completely passed. Inform your doctor, who may need to adjust your 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 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).

Surgery while taking Alfuzosina Aurovitas

• If you are scheduled for surgery requiring general anesthesia and you are taking alfuzosin, consult your doctor before the procedure. Your doctor may decide that you should stop taking alfuzosin 24 hours before surgery. This is because it could be dangerous, as you may experience a drop in blood pressure.
• If you are being treated for high blood pressure, your doctor should monitor your blood pressure regularly, especially at the beginning of treatment.
• If you are scheduled for cataract surgery, please inform your ophthalmologist before the procedure that you are currently taking or have previously taken alfuzosin. Alfuzosin may cause complications during surgery, which can be anticipated and managed by your ophthalmologist if they are informed in advance.

Alfuzosina Aurovitas with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

This section does not apply, as alfuzosin is only used in men.

Driving and using machines

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

3. How to take Alfuzosina Aurovitas

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If you are unsure, 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. This may affect the release of the medicine in your body.
• Take the tablets after a meal.
• The first dose should be taken at bedtime.

Benign prostatic hyperplasia

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

Acute urinary retention

• Your doctor will give you alfuzosin on the day your catheter is inserted.
• You must continue taking alfuzosin once daily.
• You must 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 of age)

The usual adult dose is one alfuzosin tablet once daily.

Dosage adjustment is not required in elderly patients (over 65 years of age).

Patients with mild or moderate kidney problems

Dosage adjustment is not required in patients with mild or moderate kidney problems.

If you take more Alfuzosina Aurovitas than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.

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

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

If you forget to take Alfuzosina Aurovitas

Do not take a double dose to make up for forgotten doses. Skip the missed dose and take the next tablet as instructed.

If you stop taking Alfuzosina Aurovitas

Continue taking the tablets, even if your symptoms improve. Only stop treatment when instructed by your doctor. Symptoms are best controlled if you continue taking the same dose of the medicine.

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

4. Possible adverse effects

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

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

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

Normally, chest pain only occurs if you have previously suffered from angina. If you experience chest pain while taking the tablets, contact your doctor or go to hospital immediately. This occurs in fewer than 1 in 10,000 people.

Allergic reactions

You may experience symptoms of angioedema, such as red, raised rash on the skin, swelling (of 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 hospital immediately. This occurs in fewer than 1 in 10,000 people.

Other adverse effects include:

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

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

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

• Hepatotoxicity.
• Itchy rash with hives, also known as urticaria or nettle rash (urticaria).

Additional possible adverse effects (frequency not known):

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

• Irregular and rapid heartbeat (atrial fibrillation).
• Decrease in white blood cells (neutropenia). Symptoms may include increased frequency of infections, throat or mouth ulcers.
• Increased risk of bleeding (including nosebleeds and/or bleeding gums) and bruising. 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 whites of the eyes.
• If you are undergoing cataract surgery (clouding of the lenses) and are currently taking or have previously taken alfuzosin, the pupil may be slightly dilated and the iris (the coloured circular part of the eye) may become more flexible during the procedure. This only occurs during surgery, and it is important that the ophthalmologist is aware, as they may need to perform the surgery differently (see section Surgery while taking Alfuzosin Aurovitas).
• Abnormal, often painful and prolonged erection of the penis unrelated to sexual activity (priapism).
• Being sick (vomiting).
• Stroke (insufficient blood flow to the brain). This is more likely in patients who have previously had problems with blood flow to the brain.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via 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 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 stated on the container and blister pack after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly 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 Alfuzosin Aurovitas

• The active substance 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).

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

The tablet has a prolonged effect, meaning that after taking the tablet, the active substance is not released immediately but gradually, ensuring a longer duration of action.

Nature of the product and pack contents

Prolonged-release tablet.

Film-coated tablets, white to off-white in colour, biconvex, rounded, marked with “X” on one side and “47” on the other.

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

Pack sizes:

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

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area member states 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 the most recent review of this leaflet: February 2023

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