Patient Information Leaflet

Alfuzosin STADA 10 mg prolonged-release tablets EFG

Alfuzosin hydrochloride

Read this leaflet carefully before you start taking this medicine, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.

−If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Alfuzosin STADA

3. How to take Alfuzosin STADA

4. Possible side effects

5. Storage of Alfuzosin STADA

6. Contents of the pack and additional information

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

Alfuzosina is used in the treatment of moderate to severe symptoms caused by an enlarged prostate, also known as benign prostatic hyperplasia. An enlarged prostate can cause urinary changes such as increased frequency and difficulty urinating, especially at night. Alpha blockers relax the muscle tissue of the prostate and bladder. This allows urine to flow out of the bladder more easily.

Do not take Alfuzosina STADA:

•If you are allergic to alfuzosina, other quinazolines (for example, terazosina, doxazosina, prazosina) or to any of the other components of this medication (listed in section 6). Symptoms of an allergic reaction include: rash, swelling in 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 any 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 any severe kidney problems, as the safety of Alfuzosina STADA has not been established in this case.

•If you are taking other medications for the treatment of high blood pressure. In this case, your doctor will check your blood pressure regularly, especially at the beginning of treatment.

•Your blood pressure should be monitored regularly, especially at the beginning 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, lie down with your legs and feet elevated until the symptoms completely disappear. These effects usually last a short time 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 in the past after taking another medication belonging to the group of alpha blockers. In this case, your doctor will start treatment with alfuzosina at low doses 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 alfuzosina may increase the risk of a decrease in blood pressure. Your doctor will interrupt treatment with alfuzosina if angina returns or worsens.

•Your doctor will decide whether to continue treatment for chest pain or interrupt treatment with Alfuzosina STADA, especially when chest pain returns or worsens.

•If you are to undergo cataract surgery (opacity of the crystalline lens), inform your eye specialist before the operation that you are taking or have taken Alfuzosina STADA previously. This is because Alfuzosina STADA may cause complications during the operation that can be avoided if your specialist is previously prepared.

•If you have a heart rhythm defect or are taking medications that may cause a heart rhythm defect (the medical term for this defect is QTc prolongation). In this case, your doctor must evaluate you before and during the period of administration of Alfuzosina STADA.

Taking Alfuzosina STADA with other medications

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

Do not take Alfuzosina STADA if you are being treated with other medications belonging to the group of alpha blockers.

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

•Ketoconazol and itraconazol (medications used for the treatment of fungal infections) and ritonavir (medication used for the treatment of HIV).

If you are using or will 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 for the treatment of symptoms of chest pain (angina).

• Medications that must be administered before a surgical intervention (general anesthetics). Your blood pressure may drop significantly. If you are to undergo a surgical intervention, 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 operating machines

At the beginning of treatment with Alfuzosina STADA 10 mg, you may feel dizziness, vertigo or weakness. Do not drive or use machines or perform hazardous tasks until you know how you respond to 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 him before taking this medication.

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

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

Take the first tablet just before going to bed. Take the tablets immediately after the same meal every day and swallow them whole with sufficient liquid. Do not break, chew, or divide the tablets.

Adults:

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

Older patients:

The recommended dose in older patients (over 65 years) is 1 prolonged-release tablet (10 mg of alfuzosina) once a day if the initial recommended lower 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 alfuzosina) if the lower dose was 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 experience dizziness or even fainting. 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 Toxicological 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 the missed doses as it may cause a sudden drop in blood pressure, especially if you are taking medications to reduce blood pressure. Take the next tablet at the usual time.

If you interrupt treatment with Alfuzosina STADA

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

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Like all medicines, this medicine may cause side effects, although not everyone will experience them. In very rare cases (it may affect up to 1 in 10,000 people), a severe adverse reaction 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.

• Urticaria and difficulty breathing

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

Fatigue, dizziness, headache, vertigo, marked drop in blood pressure when standing (especially at the beginning 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 discomfort.

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

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

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

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

Unknown frequency (frequency cannot be estimated from available data):

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

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse 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 adverse effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store at a temperature above 30°C.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Alfuzosina STADA 10 mg prolonged-release tablets EFG

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

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

Appearance of the product and contents of the packaging

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

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

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L. Laboratory

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible for manufacturing

STADA Arzneimittel AG

Stadastrasse, 2-18

61118 Bad Vilbel (Germany)

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Vienna

Austria

This medicine has been authorized in the EEA member states with 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 prolonged-release tablets 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 depot tablet

Last review date of this leaflet: March 2022

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