Prospect: information for the patient

Alfuzosin Viatris 10 mg prolonged-release tablets EFG

Alfuzosin hydrochloride

For adult men

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

2. What you need to know before starting to take Alfuzosin Viatris.

3. How to take Alfuzosin Viatris.

4. Possible adverse effects.

5. Storage of Alfuzosin Viatris.

6. Contents of the package and additional information

AlfuzosinViatris contains the active ingredient alfuzosin hydrochloride, whichbelongs to a group of medicines called alpha-adrenergic receptor antagonists or alpha-blockers.

Alfuzosin Viatris is used to treat symptoms, from moderate to severe, caused by an enlarged prostate, also known as benign prostatic hyperplasia(non-cancerous). The prostate gland is located below the bladder surrounding the urethra, the tube that carries urine out of the body. If the prostate gland becomes enlarged, it exerts pressure on the urethra making it smaller.The enlargement of the prostate gland can cause urinary problems such as frequent urination and difficulty urinating, especially at night.

Alpha-blockers relax the muscles of the prostate and the bladder neck. This allows urine to flow out of the bladder more easily..

In some patients with benign prostatic hyperplasia, the prostate gland becomes so enlarged that it blocks the flow of urine completely. This is calledacute urinary retention.This is very painful and you may need to stay in the hospital for a short time. A thin and flexible tube (catheter) is inserted into the bladder. This drains the urine and relieves the pain. Alfuzosin may be used to help urine flow again.

Do not take Alfuzosina Viatris:

• If you are allergic to alfuzosina, other quinazolines-type medications (such as terazosina, doxazosina) or any of the other components of this medication (listed in section 6).
• If you have severe drops in blood pressure when standing up (your doctor may have mentioned that this is called “hypotension orthostatic” or “postural”), which may cause dizziness.
• If you have any liver disease.
• If you are taking other medications of the same type as this medication known as alpha-blockers (see below the section “Taking Alfuzosina Viatris with other medications”).

Do not take this medication if any of the above applies to you. If you are unsure, speak with your doctor or pharmacist before taking alfuzosina.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Alfuzosina Viatris..

• If you have severe kidney problems.
• If you are taking medications for high blood pressure. In this case, your doctor will monitor your blood pressure regularly, especially at the beginning of treatment.
• If you have experienced a sudden drop in blood pressure after taking another medication belonging to the group known as alpha-blockers. In this case, your doctor will start treatment with low doses and gradually increase the dose.
• If you have heart failure (weakness of the heart muscle) or other heart problems.
• If you have or have had problems with decreased blood flow to parts of the brain (cerebral circulatory disorders).
• If you have chest pain (angina) and are being treated with nitrates. The use of nitrates and alfuzosina at the same time may increase the risk of low blood pressure. Your doctor may suspend treatment with Alfuzosina Viatris if angina of the chest recurs or worsens.
• If you were born with, or have had any condition associated with an abnormal heart rhythm (which may be seen on an ECG, heart activity recording) or if you are taking medications that are known to increase heart rhythm.

When taking this medication, you may experience a sudden drop in blood pressure when standing up (you may feel dizziness, fatigue, weakness, or sweating), especially in the first hours after taking Alfuzosina Viatris. If you experience a drop in blood pressure, stay with your legs and feet elevated until the symptoms disappear. Usually, these effects last a short time and usually appear at the beginning of treatment. Normally, it is not necessary to interrupt treatment.Inform your doctor as they may decide to adjust your dose.

In case of an erection (often painful), not related to sexual activity, that persists for more than 4 hours, contact a doctor or go to the hospital immediately as you may need treatment.See the section below“Possible side effects”.

If you need to undergo eye surgery for cataracts (opacity of the crystalline lens), please inform your ophthalmologist before the surgery if you are taking or have taken Alfuzosina Viatris. This is because Alfuzosina Viatris may cause complications during the surgery, which can be taken into account and controlled by your ophthalmologist if you have been informed in advance.

Children and adolescents:

Alfuzosina Viatris is not recommended for use in children and adolescents (patients under 16 years of age).

Taking Alfuzosina Viatris with other medications:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Do not take Alfuzosina Viatris if you are taking other medications belonging to the group known as alpha-blockers, such as doxazosina, indoramina, terazosina, prazosina, or tamsulosina.

Alfuzosina Viatris may modify the action of other medications.Inform your doctor or pharmacist if you are taking any of the following medications:

• Medications for fungal infections (such as ketoconazol and itraconazol).
• Medications used to treat HIV infection (such as ritonavir).
• Medications for bacterial infections (such as claritromicina and telitromicina).
• Medications to treat depression (such as nefazodona).
• Medications to lower blood pressure.
• Medications for treating chest pain (angina).
• Medications that are normally used to treat impotence (erectile dysfunction).
• The use of Alfuzosina Viatris at the same time as certain medications used to treat high blood pressure and nitrates, used to treat heart problems such as chest pain (angina) or treat impotence, may increase the risk of hypotension (low blood pressure). If this happens, lie down until the symptoms have completely disappeared. Inform your doctor as your medication dose may change.

If you are to undergo surgery that requires general anesthesia, inform your doctor or hospital staff that you are taking this medication. Your doctor may recommend that you stop taking this medication 24 hours before surgery to prevent the risk of changes in blood pressure.

Pregnancy and breastfeeding:

Alfuzosina Viatris is only indicated for use in men.

Alfuzosina with food and drinks:

Take alfuzosina after meals.

Driving and operating machinery:

Especially at the beginning of treatment, Alfuzosina Viatris may cause dizziness, vertigo, or weakness. Do not drive, operate machinery, or perform hazardous tasks until you know how your body reacts to this medication.

Alfuzosina Viatris contains lactose:

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

How much to take

Benign Prostatic Hyperplasia

• The recommended dose is one tablet (10 mg of alfuzosin) once a day.
• Take the tablet after dinner.

Acute Urinary Retention

• Your doctor will administer alfuzosin on the day they insert the catheter.
• You should continue taking alfuzosin once a day after a meal. Follow the instructions on your doctor's prescription.

Swallow the tablet whole with sufficient liquid. Do not crush, pulverize, or chew the tablets as excessive amounts of the active ingredient alfuzosin may enter your body too quickly. This could increase the risk of adverse effects.

If you have kidney problems

If you have moderate or severe kidney disease, your doctor may recommend starting with a lower dose of alfuzosin. If a lower dose does not work, your doctor may recommend taking one tablet (10 mg of alfuzosin) once a day. Take the tablet after dinner.

If you take more Alfuzosina Viatris than you should

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

If you take large amounts of Alfuzosina Viatris, you may experience a sudden drop in blood pressure and feel dizzy or even faint. If you start to feel dizzy, sit or lie down until you feel better. If symptoms do not subside, call your doctor as this drop in blood pressure should be treated in a hospital.Do not drive yourself to the hospital.

If you forgot to take Alfuzosina Viatris

Do not take a double dose to compensate for the missed doses as it may cause a sudden drop in blood pressure. Take the next tablet as instructed.

If you interrupt treatment with Alfuzosina Viatris

You should not interrupt or stop taking alfuzosin without consulting your doctor first.

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

Use in children

Alfuzosin is not indicated for use in children.

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

If you experience any of the following side effects, stop taking this medicine, consult your doctor or go to the nearest hospital emergency department immediately:

• Worsening or onset of chest pain (angina). This usually only happens if you have had angina before.
• Red rash on the skin (urticaria), swelling of the eyelids, face, lips, mouth, or tongue, difficulty breathing or swallowing. These are symptoms of severe allergic reactions.
• You may experience a higher number of infections (e.g., sore throat, mouth ulcers, etc. and fever). This can be a symptom of a reduction in the number of white blood cells in the blood.
• Abnormal or irregular heart rhythm - you may notice a very fast or irregular heartbeat, with a feeling of lack of air, dizziness, or fainting.

• Liver changes due to bile duct obstruction. You may feel unwell, notice a loss of appetite, pale stools, dark urine, or yellowish discoloration of the skin and the white of the eyes.
• Sudden collapse, numbness, or weakness in the arms or legs, dizziness, and confusion, vision changes, difficulty swallowing, difficulty or loss of speech (these may be signs of a stroke or cerebral accident caused by changes in blood supply to the brain parts). These are more likely in patients who have had previous problems with blood flow to the brain.
• Persistent erection(priapism) - Priapism is an abnormal, often painful, and persistent erection of the penis unrelated to sexual activity. If you have an erection like the one described here that persists for more than 4 hours, contact a doctor or go to a hospital immediately because you may need treatment. This condition can lead to permanent impotence if not properly treated.

Other possible side effects

Frequent(may affect up to 1 in 10 people):

• Fatigue, dizziness, headache, weakness, stomach pain, feeling of nausea (nausea), indigestion, general feeling of weakness, general feeling of discomfort.

Rare(may affect up to 1 in 100 people):

• Drowsiness, eye problems/vision, increased heart rate, fainting (especially at the start of treatment with too high a dose or when treatment is resumed), palpitations or rapid heartbeats, dry mouth, nasal discharge, skin rashes, itching, urinary incontinence, water retention (e.g., swelling of ankles and feet), facial or body flushing (flushing/sudores), sweating, feeling of spinning (dizziness), discomfort (vomiting), diarrhea, marked drop in blood pressure when standing (especially at the start of treatment with too high a dose or when treatment is resumed).

Unknown(frequency cannot be estimated from available data):

• Painful or prolonged erection (priapism), hematomas or hemorrhages (this may be a symptom of a decrease in the number of platelets in the blood that are responsible for blood clotting).

If you are to undergo eye surgery due to cataracts (opacity of the crystalline lens of the eye) and are already taking or have taken alfuzosin in the past, the pupil may dilate slightly and the iris (the colored part of the eye) may become flaccid during the procedure. This only occurs during the operation and it is essential that the ophthalmologist is informed as it may be necessary to perform the operation differently (see “Warnings and precautions”).

Reporting 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 prospectus. You can also report them directly through the Spanish System for 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.

Do not store above a temperature of30°C.

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

Do not use this medication after the expiration date that appears on the blister and on the packaging after CAD. 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 the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment

Composition of Alfuzosin Viatris

The active ingredient is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.

The other components are: lactose monohydrate, hypromellose, povidone, and magnesium stearate.

Appearance of the product and contents of the package

Alfuzosin Viatris 10 mg are prolonged-release white, round, beveled-edge tablets without coating.

They are available in blisters of 10, 20, 30, 50, 60, 90, and 100 tablets and in perforated single-dose blisters of 30 and 60 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

DenmarkLafunomyl 10 mg

AustriaAlfuzosin 'Arcana' 10 mg Retardtabletten

BelgiumAlfuzosine Mylan 10 mg

Czech RepublicAlfuzosin Mylan 10 mg

FinlandLafunomyl 10 mg

SpainAlfuzosina Viatris 10 mg prolonged-release tablets EFG

HungaryAlfugen 10 mg

IrelandXatger 10 mg prolonged-release tablet

ItalyAlfuzosina Mylan 10 mg

NetherlandsAlfuzosine HCl Retard Mylan 10 mg, tablets with regulated release

PolandAlugen 10 mg

PortugalAlfuzosina Mylan 10 mg

SwedenLafunomyl 10 mg

SlovakiaAlfuzosin Mylan 10 mg

United Kingdom (Northern Ireland)Taurazil SR 10 mg Tablets

Last review date of this leaflet: December 2021

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