ALFUZOSIN STADA 10 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the Patient

Alfuzosina STADA 10 mg prolonged-release tablets EFG

Alfuzosine hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Alfuzosina STADA is and what it is used for
2. What you need to know before taking Alfuzosina STADA
3. How to take Alfuzosina STADA
4. Possible side effects
5. Storage of Alfuzosina STADA
6. Contents of the pack and further information

1. What Alfuzosina STADA is and what it is used for

Alfuzosina STADA belongs to a group of medications called alpha-adrenergic receptor antagonists or alpha-blockers.

Alfuzosine is used to treat symptoms of moderate to severe benign prostatic hyperplasia (enlargement of the prostate gland). Enlargement of the prostate gland can cause urinary problems such as increased frequency and difficulty urinating, especially at night. Alpha-blockers relax the muscles in the prostate and bladder, making it easier for urine to flow out of the bladder.

2. What you need to know before taking Alfuzosina STADA

Do not take Alfuzosina STADA:

• If you are allergic to alfuzosine, other quinazolines (e.g., terazosine, doxazosine, prazosine), or any other component of this medication (listed in section 6). Symptoms of an allergic reaction include: rash, swelling of the lips, tongue, or throat, difficulty swallowing or breathing.
• If you have any condition that causes a marked decrease in blood pressure when standing up.
• If you have liver problems.
• If you are taking other medications that belong to the group of alpha-blockers.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alfuzosina STADA:

• If you have severe kidney problems, as the safety of Alfuzosina STADA has not been established in this case.
• If you are taking other medications to treat high blood pressure. In this case, your doctor will check your blood pressure regularly, especially at the start of treatment.
• Blood pressure should be monitored regularly, especially at the start of treatment with this medication, due to the possibility of a pronounced decrease in blood pressure. If you experience a sudden drop in blood pressure when standing up, characterized by dizziness, sweating, or fatigue in the hours following the intake of Alfuzosina STADA. If you experience a drop in blood pressure, you should lie down with your legs and feet elevated until the symptoms disappear completely. Usually, these effects are short-lived and occur at the beginning of treatment. Normally, it is not necessary to interrupt treatment.
• If you have experienced a marked decrease in blood pressure after taking another alpha-blocker medication in the past. In this case, your doctor will start treatment with alfuzosine at a low dose and gradually increase the dose.
• If you have a heart condition (acute heart failure).
• If you have chest pain (angina) and are being treated with nitrates, treatment with alfuzosine may increase the risk of a decrease in blood pressure. Your doctor will stop treatment with alfuzosine if angina returns or worsens.
• Your doctor will decide whether to continue treatment for chest pain or discontinue treatment with Alfuzosina STADA, especially when chest pain returns or worsens.
• If you are going to have cataract surgery, inform your eye specialist before the operation that you are taking or have previously taken Alfuzosina STADA. This is because Alfuzosina STADA may cause complications during surgery that can be avoided if your specialist is prepared in advance.
• If you have a heart rhythm disorder or are taking medications that can cause a heart rhythm disorder (the medical term for this disorder is QTc interval prolongation). In this case, your doctor should evaluate you before and during the administration of Alfuzosina STADA.

Taking Alfuzosina STADA with other medications

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

Do not take Alfuzosina STADA if you are being treated with other alpha-blocker medications.

Alfuzosina STADA and certain medications may interact with each other. These include:

• Ketoconazole and itraconazole (medications used to treat fungal infections) and ritonavir (a medication used to treat HIV).

If you are using or are going to use any of the following medications, treatment with Alfuzosina STADA may cause a decrease in blood pressure:

• Medications used to treat high blood pressure.
• Medications (nitrates) used to treat symptoms of chest pain (angina).
• Medications that must be administered before surgery (general anesthetics). Your blood pressure may drop significantly. If you are going to have surgery, inform your doctor that you are taking Alfuzosina STADA.

Taking Alfuzosina STADA with food and drinks

Alfuzosina STADA should be taken after meals.

Pregnancy and breastfeeding

This information is not relevant, as Alfuzosina STADA 10 mg is only used in men.

Driving and using machines

At the start of treatment with Alfuzosina STADA 10 mg, you may feel dizzy, lightheaded, or weak. Do not drive or use machines or perform hazardous tasks until you know how you react to the treatment.

Alfuzosina STADA 10 mg prolonged-release tablets EFG contain lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Alfuzosina STADA

Follow the instructions for administration of this medication indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Swallow the tablets whole. Do not break, crush, or chew the tablets, as too much of the active ingredient could enter your body too quickly. This could increase the risk of unwanted effects.

Take the first tablet just before bedtime. Take the tablets immediately after the same meal each day and swallow them whole with a sufficient amount of liquid. Do not break, chew, or divide the tablets.

Adults:

The recommended dose is 1 prolonged-release tablet (10 mg of alfuzosine) once a day.

Elderly patients:

The recommended dose in elderly patients (over 65 years) is 1 prolonged-release tablet (10 mg of alfuzosine) once a day if the lower recommended initial dose is well tolerated and greater efficacy is required.

Patients with kidney problems:

The recommended dose in patients with mild to moderate kidney impairment is 1 prolonged-release tablet (10 mg of alfuzosine) if the lower dose is not sufficient and depending on the response to treatment.

If you take more Alfuzosina STADA than you should

If you take large amounts of Alfuzosina STADA, consult your doctor or go to the nearest hospital immediately. 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.

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 taken.

If you forget to take Alfuzosina STADA

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 medications to lower blood pressure. Take the next tablet at the usual time.

If you stop taking Alfuzosina STADA

Do not stop taking or interrupt treatment with Alfuzosina STADA without informing your doctor first. If you want to stop treatment or have any other questions about the use of this product, ask your doctor or pharmacist.

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4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them. In very rare cases (may affect up to 1 in 10,000 people), a serious side effect called angioedema has been observed.

Stop taking Alfuzosina STADA and consult your doctor immediately if you experience symptoms of angioedema, such as:

• Swelling of the face, tongue, or throat.
• Difficulty swallowing.
• Hives and difficulty breathing.

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

Fatigue, dizziness, headache, vertigo, marked decrease in blood pressure when standing up (especially at the start of treatment with a high dose or when treatment is resumed after an interruption), stomach pain, nausea, indigestion, diarrhea, dry mouth, feeling of weakness, and general malaise.

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

Somnolence, abnormal vision, increased heart rate, loss of consciousness (especially at the start of treatment), palpitations, inflammation of the nasal mucosa (rhinitis), vomiting, skin rash (redness, exanthema), itching, urinary incontinence, swelling of the feet and ankles, flushing of the face (rubor), chest pain.

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

Worsening, recurrence, or onset of chest pain (angina pectoris), liver disorders, swelling of the skin and mucous membranes, especially on the face and around the eyes, prolonged and painful erection of the penis (priapism).

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

Low white blood cell count (neutropenia), intraoperative floppy iris syndrome (IFIS) (a complication that can occur during cataract surgery), abnormal heart rhythm, liver problems or liver disease (symptoms may include yellowing of the skin or the whites of the eyes), low platelet count in the blood. Signs may include bleeding gums and nose, bruising, prolonged bleeding from cuts, rash (small red spots called petechiae).

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Alfuzosina STADA

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

Do not store above 30°C.

Do not use this medication after the expiration date shown on the packaging and blister pack after EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Alfuzosina STADA 10 mg prolonged-release tablets EFG

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

The other ingredients are: lactose monohydrate, hypromellose, povidone K 25, and magnesium stearate.

Appearance of the product and pack contents

The tablets are white, round, beveled, and uncoated.

Alfuzosina STADA is available in packs containing 10, 28, 30, 90, and 100 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

info@stada.es

Manufacturer

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel (Germany)

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

This medication has been authorized in the EEA member states under the following names:

AT: Alfuzosin STADA 10 mg – Retardtabletten

CZ: Alfuzostad 10 mg tablety s prodlouzenym uvolnovanim

DK: Alfuzosin STADA 10 mg

ES: Alfuzosina STADA 10 mg comprimidos de liberación prolongada EFG

HU: Alfuzostad 10 mg retard tablette

IT: Alfuzosina EG 10 mg Comprese a rilasciato prolungato

PL: Alfuzostad 10 mg

SE: Alfuzosin STADA 10 mg depottablett

Date of the last revision of this package leaflet: March 2022

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