ALFUZOSINE TEVA-RATIOPHARM 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Alfuzosina Teva-ratiopharm 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 and other information

1. What Alfuzosina Teva-ratiopharm 10 mg is and what it is used for
2. What you need to know before you take Alfuzosina Teva-ratiopharm 10 mg
3. How to take Alfuzosina Teva-ratiopharm 10 mg
4. Possible side effects
5. Storage of Alfuzosina Teva-ratiopharm 10 mg
6. Contents of the pack and other information

1. What Alfuzosina Teva-ratiopharm 10 mg is and what it is used for

This medicinal product belongs to a group of medicines called alpha-blockers.

It is used to treat the functional symptoms of benign prostatic hyperplasia (enlargement of the prostate). Enlargement of the prostate can cause urinary problems such as frequent and difficult urination.

2. What you need to know before you take Alfuzosina Teva-ratiopharm 10 mg

Do not take Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets

• If you are allergic to alfuzosin, other quinazolines (e.g. terazosin, doxazosin) or any of the other ingredients of this medicine (described in section 6)
• If you have diseases that cause a sudden drop in blood pressure when standing up
• If you are taking other medicines belonging to a group called alpha1-blockers (such as tamsulosin)
• If you have liver failure (liver disease)
• If you have severe kidney failure (severe kidney disease)

Warnings and precautions

Before starting treatment with Alfuzosina Teva-ratiopharm 10 mg, 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 thereafter, you may undergo a rectal examination and, if necessary, a blood test.

Consult your doctor or pharmacist before starting to take Alfuzosina Teva-ratiopharm 10 mg

• If you have severe kidney problems.
• If you have mild to moderate liver failure, your doctor will prescribe a lower dose
• If you are taking other medicines to treat high blood pressure. In this case, your doctor will check your blood pressure regularly, especially at the start of treatment.
• If you experience a sudden drop in blood pressure when standing up, characterized by dizziness, weakness, or sweating a few hours after taking Alfuzosina Teva-ratiopharm 10 mg. If you experience a sudden drop in blood pressure, you should lie down with your legs and feet up until the symptoms disappear.

Normally, these effects only last for a short time and occur at the start of treatment.

Normally, it is not necessary to interrupt treatment.

• If you have experienced a sudden drop in blood pressure in the past after taking another medicine belonging to the group of alpha-blockers. In this case, your doctor will start treatment with alfuzosin at a low dose and gradually increase the dose.
• If you have acute heart failure.
• If you have chest pain (angina) and are being treated with a nitrate, as this may increase the risk of a drop in blood pressure. You should consult your doctor if you should continue or stop your treatment with Alfuzosina Teva-ratiopharm 10 mg, especially when the chest pain recurs or worsens.
• If you have an abnormal heart rhythm called prolonged QTc interval (long QT) or are taking medicines that may increase the risk of prolonged QTc interval.

Consult your doctor if you suffer from this disease or are taking other medicines.

• If you are an elderly patient (over 65 years old). This is due to the increased risk of developing low blood pressure (hypotension) and related adverse effects in elderly patients.

Alfuzosin, like other medicines in the same family, can cause priapism (persistent and painful erection of the penis). If this happens, go immediately to an emergency department so that you can be treated.

Consult your doctor or pharmacist even if any of the above circumstances have occurred to you at any time.

Surgical interventions while taking Alfuzosina

• If you are going to undergo surgery that requires general anesthesia, you should inform the anesthesiologist before the operation that you are taking Alfuzosina Teva-ratiopharm (see section "Other medicines and Alfuzosina Teva-ratiopharm")
• If you are going to undergo eye surgery due to cataract surgery, please inform your ophthalmologist before the operation that you have been using Alfuzosina Teva-ratiopharm. This is because treatment with Alfuzosina Teva-ratiopharm may cause complications during surgery that can be controlled if your specialist has been previously warned.

Other medicines and Alfuzosina Teva-ratiopharm

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

Certain medicines, such as those listed below, may increase the risk of hypotension (drop in blood pressure) when administered at the same time as Alfuzosina Teva-ratiopharm.

Medicines that must not be used:

• Medicines that belong to the group of alpha-blockers: you must not take these medicines at the same time as Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets (see above "Do not take Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets")

Medicines that must be used with caution:

• Antihypertensive medicines (medicines that lower blood pressure)
• Nitrates (medicines for the treatment of coronary insufficiency)
• Medicines for fungal infections (such as itraconazole or ketoconazole)
• Medicines for HIV (AIDS virus) (such as ritonavir)
• Medicines for bacterial infections (antibiotics such as clarithromycin, erythromycin, and telithromycin)
• Medicines for the treatment of depression (such as nefazodone)

Additionally, the administration of general anesthetics to patients treated with alfuzosin may cause instability of blood pressure, so in the case of surgical intervention, you should inform the anesthesiologist of the use of Alfuzosina Teva-ratiopharm.

Alfuzosina Teva-ratiopharm 10 mg with food and drinks

The tablets should be taken after a meal.

Pregnancy and Breastfeeding

Alfuzosina Teva-ratiopharm 10 mg is only indicated in men.

Driving and using machines

At the start of treatment with Alfuzosina Teva-ratiopharm 10 mg, you may feel faint, dizzy, or weak. Do not drive or operate machinery or perform any hazardous tasks until you know how you react to the treatment.

Alfuzosina Teva-ratiopharm 10 mg 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 Alfuzosina Teva-ratiopharm 10 mg tablets

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have doubts.

AdultsThe recommended dose is one prolonged-release tablet (10 mg of alfuzosin) once a day, which is the maximum daily dose. Take the first tablet at bedtime. Take the tablets after the same meal every day and swallow them whole with a sufficient amount of liquid. Do not crush, chew, or divide the tablets.

Elderly patients

No dose adjustment is necessary for elderly patients (over 65 years old).

Renal insufficiency

In patients with mild or moderate renal insufficiency, it is recommended to start treatment with a lower dose, which can then be increased to 10 mg based on the clinical response.

In patients with severe renal insufficiency, it is recommended not to use Alfuzosina Teva-ratiopharm 10 mg because there are no clinical safety data to support that the medicine is safe in this group of patients.

Use in children and adolescents

The efficacy of alfuzosin in children or adolescents from 2 to 16 years old has not been demonstrated. Therefore, alfuzosin is not indicated in this group of patients.

If you take more Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets than you should:if you take large amounts of Alfuzosina Teva-ratiopharm 10 mg, your blood pressure may drop suddenly and you 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 the drop in blood pressure may need to be treated in the hospital.

Contact your doctor, pharmacist, or call the Toxicology Information Service, Phone: 91-562 04 20, indicating the medicine and the amount taken.

If you forget to take Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets:do not take a double dose to make up for forgotten doses, as this may cause a sudden drop in blood pressure, especially if you are taking medicines to lower blood pressure. Take the next tablet as indicated.

If you stop taking Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets

Do not stop or discontinue taking Alfuzosina Teva-ratiopharm 10 mg without consulting your doctor first. If you have any further questions on 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:

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

• Dizziness/weakness, headaches, vertigo;
• Orthostatic hypotension (drop in blood pressure when changing from lying down to standing up (especially at the start of treatment with a dose that is too high or when treatment is resumed) (see section 2 "Warnings and precautions");
• Gastrointestinal disorders such as nausea, abdominal pain, diarrhea, dry mouth;
• Feeling of weakness, malaise.

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

• Syncope (loss of consciousness)
• Somnolence
• Visual disturbances;

• Fast heart rate, palpitations (the heart beats faster than normal and is also more noticeable);
• Hot flashes
• Rhinitis
• Nausea (vomiting)
• Skin disorders such as rash or itching, pruritus;
• Edema (swelling), chest pain (see section 2 "Warnings and precautions".

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

• Worsening or recurrence of chest pain (angina pectoris) in patients with coronary artery disease (see section 2 "Warnings and precautions").
• Angioedema (swelling of the face, lips, tongue, and/or throat), urticaria.
• Skin disorders such as urticaria

Frequency not known (cannot be estimated from the available data):

• Decrease in the number of white blood cells (neutropenia), which can lead to more frequent infections than usual;
• Decrease in the number of platelets (thrombocytopenia)
• Stroke in patients who have problems with blood circulation in the brain.
• Intraoperative floppy iris syndrome (IFIS) (characterized by contraction of the pupil and deformation of the iris).
• Abnormal heart rhythm (atrial fibrillation);
• Liver problems: the signs may include yellowing of the skin or the white part of the eyes;
• Abnormal, often painful, and persistent erection of the penis not related to sexual activity (priapism).

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 Medicines Surveillance System for Human Use website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alfuzosina Teva-ratiopharm 10 mg tablets

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 carton or blister after EXP. The expiry date is the last day of the month shown.

Keep the blister in the original packaging to protect it from light.

Store below 30°C.

For bottles (HDPE):

The shelf life of the product after the first opening is 1 year, but not later than the expiry date included in the package or on the blister after EXP.

Medicines should not be disposed of via wastewater or household waste. Return the containers and medicines you no longer need to the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets

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

• The other ingredients are lactose monohydrate, hypromellose (E464), povidone K25, and magnesium stearate.

Appearance of Alfuzosina Teva-ratiopharm 10 mg prolonged-release tablets and contents of the pack

Alfuzosina Teva-ratiopharm 10 mg is a round, white prolonged-release tablet in

blisters (PVC/PVDC/aluminum) of 10, 28, 30, 50, 90, or 100 tablets per pack, or bottles (HDPE) of 100 tablets per pack. Not all pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Manufacturer

Merckle GmbH

Ludwig-Merckle Str. 3

89143 Blaubeuren / Germany

This medicine is registered in the EEA Member States with the following names

Estonia: ALFUZOSIN-TEVA

Latvia: Alfuzosin-Teva 10 mg ilgstosâs darbibas tablets

Lithuania: Alfuzosin-Teva 10 mg pailginto atpalaidavimo tabletés

Portugal: Alfuzosina Teva 10 mg comprimido de libertação prolongada

Spain: Alfuzosina Teva 10 mg comprimidos de liberación prolongada EFG

United Kingdom: Fuzatal XL 10mg prolonged release tablets

This leaflet was last revised in September 2022

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