ALFUZOSIN VIATRIS 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Viatris Alfuzosin 10 mg prolonged-release tablets EFG

Alfuzosin hydrochloride

For adult men

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

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

Viatris Alfuzosin contains the active substance alfuzosin hydrochloride, which belongs to a group of medicines called alpha-adrenergic receptor antagonists or alpha-blockers.

Viatris Alfuzosin is used to treat the symptoms of benign prostatic hyperplasia (a non-cancerous enlargement of the prostate gland). The prostate gland is located beneath the bladder, surrounding the urethra. If the prostate gland enlarges, it can put pressure on the urethra, making it narrower. An enlarged prostate gland can cause urinary problems such as frequent and difficult urination, especially at night.

Alpha-blockers relax the muscles in the prostate and the neck of the bladder, making it easier for urine to flow out of the bladder.

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

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

Do not take Viatris Alfuzosin:

• If you are allergic to alfuzosin, other quinazoline-type medicines (e.g. terazosin, doxazosin), or any of the other ingredients of this medicine (listed in section 6).
• If you have severe low blood pressure when standing up (your doctor may have told you that this is called "orthostatic" or "postural" hypotension), which can cause dizziness.
• If you have liver disease.
• If you are taking other medicines of the same type as this medicine, known as alpha-blockers (see also section "Taking Viatris Alfuzosin with other medicines").

Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking alfuzosin.

Warnings and precautions

Talk to your doctor or pharmacist before taking Viatris Alfuzosin.

• If you have severe kidney problems.
• If you are taking medicines for high blood pressure. In this case, your doctor will regularly check your blood pressure, especially at the start of treatment.
• If you have had a sudden drop in blood pressure after taking another medicine of the same type as this medicine (alpha-blocker). In this case, your doctor will start treatment with a low dose and gradually increase it.
• If you have heart failure (weakness of the heart muscle) or other heart problems.
• If you have had problems with reduced blood flow to parts of the brain (cerebrovascular disorders).
• If you have chest pain (angina) and are being treated with nitrates. The use of nitrates and alfuzosin at the same time can increase the risk of low blood pressure. Your doctor may stop your treatment with Viatris Alfuzosin if your angina gets worse or comes back.
• If you were born with, or have had, a condition associated with an abnormal heart rhythm (which can be seen on an ECG, a recording of the electrical activity of the heart) or if you are taking medicines that are known to increase the heart rate.

When taking this medicine, you may experience a sudden drop in blood pressure when standing up (you may feel dizzy, tired, weak, or sweaty), especially in the first few hours after taking Viatris Alfuzosin. If you experience low blood pressure, you should remain lying down with your legs and feet elevated until the symptoms disappear. Usually, these effects are short-lived and occur at the start of treatment. Normally, it is not necessary to stop treatment. Inform your doctor as they may decide to adjust your dose.

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

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

Children and adolescents

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

Taking Viatris Alfuzosin with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Do not take Viatris Alfuzosin if you are taking other medicines of the same type as this medicine, known as alpha-blockers, such as doxazosin, indoramin, terazosin, prazosin, or tamsulosin.

Viatris Alfuzosin may affect the action of other medicines. Tell your doctor or pharmacist if you are taking any of the following medicines:

• Medicines for fungal infections (such as ketoconazole and itraconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Medicines for bacterial infections (such as clarithromycin and telithromycin).
• Medicines for treating depression (such as nefazodone).
• Medicines for lowering blood pressure.
• Medicines for treating chest pain (angina).
• Medicines that are normally used to treat impotence (erectile dysfunction).
• The use of Viatris Alfuzosin at the same time as certain medicines used to treat high blood pressure and nitrates, used to treat heart problems such as chest pain (angina) or to treat impotence, may increase the risk of low blood pressure. If this happens, lie down until the symptoms have completely disappeared. Inform your doctor as they may decide to change your dose.

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

Pregnancy and breastfeeding

Viatris Alfuzosin is only indicated for use in men.

Viatris Alfuzosin with food and drinks

Take alfuzosin after meals.

Driving and using machines

Especially at the start of treatment, Viatris Alfuzosin may cause dizziness, drowsiness, or weakness. Do not drive, operate machinery, or perform hazardous tasks until you know how your body reacts to this medicine.

Viatris Alfuzosin contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Viatris Alfuzosin

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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 give you alfuzosin on the day the catheter is inserted.
• You should continue taking alfuzosin once a day after a meal. Follow the advice of your doctor's prescription.

Swallow the tablet whole with a sufficient amount of liquid. Do not crush, chew, or break the tablets, as too much of the active ingredient alfuzosin may enter your body too quickly. This could increase the risk of side effects.

If you have kidney problems

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

If you take more Viatris Alfuzosin 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 medicine and the amount taken.

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

If you forget to take Viatris Alfuzosin

Do not take a double dose to make up for forgotten doses, as this may cause a sudden drop in blood pressure. Take the next tablet as directed.

If you stop taking Viatris Alfuzosin

Do not stop or discontinue treatment with alfuzosin without consulting your doctor first.

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

Use in children

Alfuzosin is not indicated for use in children.

4. Possible side effects

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

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

• Worsening or appearance of chest pain (angina). This usually only happens if you have had angina before.
• Red skin rash (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 may be a symptom of a reduction in the number of white blood cells in the blood.
• Abnormal or unusual heart rhythm - you may notice a very fast or irregular heartbeat, with a feeling of shortness of breath, dizziness, or fainting.

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

Other possible side effects

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

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

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

• Drowsiness, eye problems/vision problems, 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, runny nose, skin rash, itching, urinary incontinence, water retention (e.g. swelling of ankles and feet), flushing of the face or body, sweating, feeling of dizziness (vertigo), nausea (vomiting), diarrhea, marked drop in blood pressure when standing up (especially at the start of treatment with too high a dose or when treatment is resumed).

Rare(frequency cannot be estimated from the available data):

• Painful or prolonged erection (priapism), bruising or bleeding (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 going to undergo eye surgery for cataracts (clouding of the lens in the eye) and are already taking or have taken alfuzosin in the past, the pupil may not dilate properly and the iris (the colored part of the eye) may become flaccid during the procedure. This only happens during the operation and it is important that the ophthalmologist is informed as they may need to perform the operation differently (see "Warnings and precautions").

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 via the Spanish Medicines Vigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Viatris Alfuzosin

Do not store above 30°C.

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

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. If you are unsure, ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Viatris Alfuzosin

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

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

Appearance and packaging

Viatris Alfuzosin 10 mg are white, round, prolonged-release tablets with beveled edges and no coating.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Mylan Hungary Kft.

H-2900 Komárom

Mylan utca 1

Hungary

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Denmark Lafunomyl 10 mg

Austria Alfuzosin ’Arcana’ 10 mg Retardtabletten

Belgium Alfuzosine Mylan 10 mg

Czech Republic Alfuzosin Mylan 10 mg

Finland Lafunomyl 10 mg

Spain Alfuzosina Viatris 10 mg prolonged-release tablets EFG

Hungary Alfugen 10 mg

Ireland Xatger 10 mg prolonged release tablet

Italy Alfuzosina Mylan 10 mg

Netherlands Alfuzosine HCl Retard Mylan 10 mg, tabletten met gereguleerde afgifte

Poland Alugen 10 mg

Portugal Alfuzosina Mylan 10 mg

Sweden Lafunomyl 10 mg

Slovakia Alfuzosin Mylan 10 mg

United Kingdom (Northern Ireland) Taurazil SR 10 mg Tablets

Date of last revision of this leaflet: December 2021

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