ALFUZOSIN RATIOPHARM 10 mg PROLONGED-RELEASE TABLETS

Introduction

Patient Information Leaflet

Alfuzosina ratiopharm 10 mg prolonged-release tablets EFG

Read the entire leaflet carefully before starting to take 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 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 leaflet. See section 4.

Contents of the package leaflet:

1. What is Alfuzosina ratiopharm and what is it used for
2. What you need to know before taking Alfuzosina ratiopharm
3. How to take Alfuzosina ratiopharm
4. Possible side effects
5. Storage of Alfuzosina ratiopharm
6. Package contents and additional information

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

Alfuzosina ratiopharm belongs to a group of medicines called alpha-blockers.

Alfuzosina is indicated for the treatment of symptoms of benign prostatic hyperplasia. This disease occurs when there is an increase in the size of the prostate gland (hyperplasia), but the growth is not cancerous (benign). This can cause difficulties in passing urine.

• The prostate gland is located below the bladder and surrounds the urethra (the tube that carries urine out of the body).
• If the prostate enlarges, it puts pressure on the urethra, making it smaller. This makes it difficult to pass urine.
• This medicine works by relaxing the muscle of the prostate gland, which makes the urethra larger. This allows urine to flow out more easily.

In some patients with benign prostatic hyperplasia, the prostate grows so much that it completely stops the flow of urine. This is called acute urinary retention. This is very painful and you may need a short stay in the hospital.

• A thin, flexible tube (catheter) is inserted into the bladder. This drains the water and relieves the pain.
• During this time, alfuzosina can be used to help urine flow again.

2. What you need to know before taking Alfuzosina ratiopharm

Do not take Alfuzosina ratiopharm

• if you are allergic to alfuzosina or any of the other ingredients of this medicine (described in section 6).
• if you have something called postural hypotension. This is a drop in blood pressure that usually occurs when standing up. It can make you feel dizzy, faint, or pass out when standing up or sitting down quickly.
• if you have severe liver problems,
• if you are taking other medicines that belong to the group of alpha-blockers (see section Other medicines and Alfuzosina ratiopharm).

Warnings and precautions

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

• if you have severe kidney problems,

• if you are taking other medicines to treat high blood pressure. In this case, your doctor should monitor your blood pressure regularly, especially at the start of treatment,
• if you experience a sudden drop in blood pressure when standing up, accompanied by dizziness, weakness, or sweating, in the first few hours after taking Alfuzosina ratiopharm. If you experience a drop in blood pressure, you should lie down with your legs and feet raised until the symptoms disappear. Normally, these effects last for a short time and occur at the start of treatment. Generally, it is not necessary to stop treatment,
• if you have experienced significant drops 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 low doses and gradually increase the dose,
• if you have acute heart failure,
• if you have chest pain (angina) and are being treated with nitrate, as this can increase the risk of a sudden drop in blood pressure. You should discuss with your doctor whether to continue treatment for angina or whether treatment with Alfuzosina ratiopharm should be stopped, especially if chest pain recurs or worsens,
• if you have a congenital or acquired change in heart activity (prolongation of the QT interval, resulting in a change in the ECG) or are taking medicines that can increase the prolongation of the QT interval in the ECG before and during the administration of Alfuzosina ratiopharm.
• if you have pre-existing risk factors (such as underlying heart disease and/or concomitant treatment with antihypertensive medication) that have been reported to cause a pronounced decrease in blood pressure.
• if you are over 65 years old. This is due to the increased risk of developing low blood pressure (hypotension) and related side effects in elderly patients.
• if you are going to undergo eye surgery for cataracts, please inform your ophthalmologist if you are taking or have taken Alfuzosina ratiopharm previously. This is because Alfuzosina ratiopharm can cause complications during surgery that can be controlled if your ophthalmologist is prepared in advance.
• In case of an erection (often painful), not related to sexual activity, that persists 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".

Swallow the tablet whole. Do not crush, powder, chew, or divide the tablet, as the active substance alfuzosina may enter the body too quickly. This can increase the risk of unwanted effects.

Other medicines and Alfuzosina ratiopharm

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

This is because Alfuzosina can affect the way other medicines work. Some medicines can also have an effect on how Alfuzosina works.

Alfuzosina ratiopharm should not be taken if you are taking other medicines that belong to the group of alpha-blockers, such as doxazosina, indoramina, prazosina, terazosina, tamsulosina, or fenoxibenzamina.

Consult your doctor or pharmacist before taking your medicine if:

• In the past, you have had a significant drop in blood pressure while taking an alpha-blocker (this could include previous use of alfuzosina). See the previous paragraph for examples of other alpha-blockers.
• You are taking a medicine for high blood pressure, as you may feel dizzy, weak, or start sweating a few hours after taking this medicine. If this happens, lie down until the symptoms have completely disappeared. Inform your doctor, as the dose of your medicine may need to be changed.
• You are taking medicines for chest pain (angina).
• You are taking medicines for fungal infections (such as ketoconazole or itraconazole).
• You are taking medicines for HIV (such as ritonavir).
• You are taking medicines for bacterial infections (such as clarithromycin or telithromycin).
• You are taking medicines for the treatment of depression (such as nefazodone).
• You are taking ketoconazole tablets (used to treat Cushing's syndrome, when the body produces too much cortisol).

Surgical interventions during Alfuzosina ratiopharm treatment

• If you are going to undergo an operation that requires general anesthesia, inform your doctor that you are taking Alfuzosina before the operation. This is because it can be dangerous, as it can lower blood pressure.
• If you are going to undergo eye surgery for cataracts, inform your ophthalmologist before the operation that you are using or have used Alfuzosina previously.

This is because Alfuzosina can cause complications during surgery that can be managed if your specialist is prepared in advance.

Alfuzosina ratiopharm with food and drinks

Alfuzosina ratiopharm should be taken after meals.

Pregnancy and breastfeeding

This information is not relevant, as this medicine is only prescribed to male patients.

Driving and using machines

At the start of treatment with Alfuzosina ratiopharm, you may feel faint, dizzy, or weak. Do not drive or operate machinery or perform hazardous activities until you know how your body reacts to the treatment.

Alfuzosina ratiopharm contains lactose

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

3. How to take Alfuzosina ratiopharm

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

How much to take

Benign prostatic hyperplasia.

• The recommended dose is 1 prolonged-release tablet (10 mg of alfuzosina) once a day.
• Take the first tablet at bedtime after dinner.

Acute urinary retention.

• Your doctor will administer alfuzosina on the day the catheter is inserted.
• You should continue taking alfuzosina once a day after a meal. Follow the advice of your doctor's prescription.

The recommended dose for elderly patients (over 65 years old) is 1 prolonged-release tablet (10 mg of alfuzosina) once a day.

The recommended dose in patients with mild or moderate kidney problems is 1 prolonged-release tablet (10 mg of alfuzosina) once a day.

Method of administration

• Swallow the tablets whole with plenty of water.
• Do not break, crush, chew, or divide your tablets. This can affect the release of your medicine in the body.
• Take this medicine after a meal.

Use in children and adolescents

Alfuzosina ratiopharm is not indicated for use in children or adolescents.

If you take more Alfuzosina ratiopharm than you should

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

When you take large amounts of Alfuzosina, your blood pressure may drop suddenly, and you may feel dizzy or weak. If this is the case, contact your local hospital immediately. Inform the doctor how many tablets you have taken. Lie down as much as possible to help stop the side effects. Do not drive yourself to the hospital.

If you forget to take Alfuzosina ratiopharm

Do not take a double dose to make up for forgotten doses, as this can cause a sudden drop in blood pressure, especially if you are taking blood pressure-lowering medicines. Take the next tablet as indicated.

If you stop taking Alfuzosina ratiopharm

Do not stop taking Alfuzosina ratiopharm without talking to your doctor first. If you want to stop treatment, ask your doctor.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. It is more likely that these side effects will occur at the start of treatment.

• Chest pain (angina)

Normally, this only happens if you have had angina before. If you have chest pain, stop taking the tablets and contact a doctor or go to the hospital immediately. This can affect up to 1 in 10,000 people.

• Allergic reactions

You may notice symptoms of angioedema, such as a red and bumpy skin rash, swelling (in the eyelids, face, lips, mouth, and tongue), difficulty breathing or swallowing.

These are symptoms of an allergic reaction. If this happens, stop taking your tablets and contact a doctor or go to the hospital immediately.This can affect up to 1 in 10,000 people.

• Prolonged erection (priapism)

Priapism is an abnormal, often painful, and persistent erection of the penis that is not related 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 the hospital immediately because you may need treatment.This condition can lead to permanent impotence if not treated properly.

Other side effects

Frequent (May affect up to 1 in 10 people)

• weakness, fatigue, dizziness;
• headache;
• stomach pain;
• feeling sick (nausea),
• uncomfortable feeling in the stomach and indigestion (dyspepsia),
• feeling of weakness (asthenia);
• malaise.

Uncommon (May affect up to 1 in 100 people)

• dizziness, drowsiness,
• visual impairment,
• irregular and rapid heartbeat,
• sensation of palpitations or rapid heartbeat (tachycardia)
• fainting (especially at the start of treatment);
• marked drop in blood pressure when standing up (especially when starting treatment with a dose that is too high and when treatment is resumed);
• feeling that the head is spinning (vertigo);
• marked decrease in blood pressure when standing up (especially at the start of treatment with a dose that is too high and when treatment is resumed),
• feeling of strong or rapid heartbeat,
• runny nose, itching, sneezing, and nasal congestion,
• being sick (vomiting);
• diarrhea;
• dry mouth;
• skin rash (urticaria, exanthema),
• itching,
• urinary incontinence,
• swelling of feet and ankles (edema),
• redness of the face (flushing),
• chest pain.

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

• decrease in white blood cells (neutropenia),
• decrease in blood platelets,
• irregular heartbeats with a risk to life (atrial fibrillation);

liver damage,

• suppression of bile flow (cholestatic liver disease)

If you are going to undergo eye surgery for cataracts and are taking or have taken Alfuzosina ratiopharm previously, you may experience complications during surgery (see section 2 "Surgical interventions during Alfuzosina ratiopharm treatment").

Reporting of side effects

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

5. Storage of Alfuzosina ratiopharm

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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Alfuzosina ratiopharm 10 mg prolonged-release tablets

• The active substance is alfuzosina hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosina hydrochloride.
• The other ingredients are lactose monohydrate, hypromellose (E-464), povidone K25, and magnesium stearate (E-470b).

Appearance of the product and package contents

Alfuzosina ratiopharm 10 mg is presented as white, round, beveled-edge, uncoated prolonged-release tablets.

It is available in PVC/PVDC-aluminum blister packs containing 10, 10x1, 15, 20, 30, 30x1, 50, 60, 60x1, 90, 90x1, 100 tablets, and in HDPE (high-density polyethylene) bottles with 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

c/ Anabel Segura, nº 11 Edificio Albatros B 1ª planta

28108 Alcobendas – Madrid (Spain)

Manufacturer

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren (Germany)

or

Medikalla Oy MediPharmia

Teollisuustie 16

60100 Seinäjoki (Finland)

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

Denmark:Alfuzosin Teva 10 mg depottaletter

Finland:Alfuzosin hydrochlorid ratiopharm 10 mg depottabletti

Germany:Alfuzosin-ratiopharm® uno 10 mg Retardtabletten

Italy:Alfuzosina ratiopharm 10 mg compresse a rilascio prolungato

Netherlands:Alfuzosin HCL ratiopharm 10 mg, tabletten met verlengde afgifte

Spain:Alfuzosina ratiopharm 10 mg comprimidos de liberación prolongada EFG

Sweden:Alfuzosin Teva

This leaflet was approved in March 2024

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.gob.es/