Package Insert: Information for the Patient

Alfuzosin ratiopharm 10 mg prolonged-release tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given 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 package insert. See section 4.

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

Alfuzosina is indicated for the treatment of the 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 non-cancerous (benign). This can cause difficulties in urination.

• The prostate glandis locatedbelow the bladder and surrounds the urethra (the tube that carries urine out of the body).
• If the prostate gland enlarges,it exerts pressure onthe urethra, making it smaller. This makes it difficult for urine to pass.
• This medicine acts by relaxing the muscle of the prostate gland, which makes the urethra wider.This allows urine to flow out more easily.

In some patients with benign prostatic hyperplasia, the prostate gland 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 to stay in the hospital for a short time.

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

Do not take Alfuzosina ratiopharm

• if you are allergic to alfuzosin or any of the other ingredients of this medication (listed in section 6).
• if you have something called postural hypotension. This is a drop in blood pressure that usually occurs when standing up. It may make you feel dizzy, lightheaded, or faint when standing up or sitting down quickly
• if you have severe liver problems,
• if you are taking other medications that belong to the group of alpha-blockers (see section Other Medications 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 medications to treat high blood pressure. In this case, your doctor will need to monitor your blood pressure regularly, especially at the beginning 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, lie down with your legs and feet up until the symptoms disappear. Normally, these effects are short-lived and occur at the beginning of treatment. Generally, it is not necessary to interrupt treatment,
• if you have experienced significant drops in blood pressure after taking another medication 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 nitrates, as this may increase the risk of sudden drop in blood pressure. You should discuss with your doctor whether to continue treatment for angina or if Alfuzosina ratiopharm treatment should be interrupted, especially if chest pain recurs or worsens,
• if you have a congenital or acquired change in heart activity (prolongation of the QT interval, which results in a change in the ECG) or are taking medications that may 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 anti-hypertensive 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 a drop in blood pressure (hypotension) and related adverse effects in elderly patients.
• if you are about to undergo eye surgery for cataracts (clouding of the lenses), please inform your ophthalmologist if you are taking or have taken Alfuzosina ratiopharm previously. This is because Alfuzosina ratiopharm may cause complications during surgery that can be controlled if your ophthalmologist is prepared in advance.
• If you experience an erection (often painful) that is not related to sexual activity and persists for more than 4 hours, you should contact a doctor or go to the hospital immediately as 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 alfuzosin may reach the body too quickly. This may increase the risk of unwanted effects.

Other Medications and Alfuzosina ratiopharm

Inform your doctor or pharmacist if you are taking/using, have taken/used recently, or may need to take/use any other medication, including those purchased without a prescription.

This is because Alfuzosina may affect the functioning of other medications.Some medications may also have an effect on how Alfuzosina works.

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

Consult your doctor or pharmacist before taking your medication if:

• You have had a significant drop in blood pressure while taking an alpha-blocker (this may include previous use of alfuzosin). See the paragraph immediately above for examples of other alpha-blockers.
• You are taking a medication for high blood pressure, as you may feel dizzy, weak, or start to sweat a few hours after taking this medication. If this happens, lie down until the symptoms have completely disappeared. Inform your doctor as your medication dose may change.
• You are taking medications for chest pain (angina).
• You are taking medications for fungal infections (such as ketoconazol or itraconazol).
• You are taking medications for HIV (such as ritonavir).
• You are taking medications for bacterial infections (such as claritromicina or telitromicina).
• You are taking medications for depression (such as nefazodona).
• You are taking ketoconazol tablets (used to treat Cushing's syndrome, when the body produces an excess of cortisol).

Surgical interventions during Alfuzosina ratiopharm treatment

• If you are about to undergo an operation that requires general anesthesia, inform your doctor that you are taking Alfuzosina before the operation. This is because it may be hazardous as it may lower blood pressure.
• If you are about to undergo eye surgery for cataracts (opacity of the lens), inform your ophthalmologist before the operation that you are using or have used Alfuzosina previously.

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

Alfuzosina ratiopharm with food and drinks

Alfuzosinaratiopharm should be taken after meals.

Pregnancy and breastfeeding

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

Driving and operating machines

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

Alfuzosina ratiopharm contains lactose

This medication contains 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 of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

How to take

Benign prostatic hyperplasia.

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

Acute urinary retention.

• Your doctor will administer alfuzosin on the day they insert the catheter.
• You should continue taking alfuzosin once a day after a meal. Follow your doctor's prescription instructions.

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

The recommended dose in patients with mild or moderate kidney problems is 1 prolonged-release tablet (10 mg of alfuzosin) 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 medication in the body.
• Take this medication after a meal.

Use in children and adolescents

Alfuzosin 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

When you take large amounts of Alfuzosin, your blood pressure may drop suddenly and you may feel dizzy or even weak. If this is the case, contact your local hospital immediately. Inform your doctor of 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 forgot to take Alfuzosina ratiopharm

Do not take a double dose to compensate for the missed doses as it may cause a sudden drop in blood pressure, especially if you are taking hypotensive medications. Take the next tablet as indicated.

If you interrupt the treatment with Alfuzosina ratiopharm

You should not stop taking Alfuzosina ratiopharm without previously talking to your doctor. If you want to interrupt the treatment, ask your doctor.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. It is more likely that these side effects will occur at the beginning 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, itchy rash, swelling (on 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 a hospital immediately.This can affect up to 1 in 10,000 people.

• Persistent erection (priapism)

Priapism is an abnormal, often painful and persistent erection of the penis that is not related to sexual activity.If you had an erection like the one described here that persisted 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 (Can affect up to 1 in 10 people)

• Weakness, fatigue, dizziness;
• Headache;
• Stomach pain;
• Sensation of feeling sick (nausea),
• Uncomfortable sensation in the stomach and indigestion (dyspepsia),
• Sensation of weakness (asthenia);
• Discomfort.

Rare (Can affect up to 1 in 100 people)

• Dizziness, somnolence,
• Visual impairment,
• Irregular and rapid heartbeats,
• Accelerated heart palpitations (tachycardia)
• Fainting (especially at the beginning of treatment);
• Marked drop in blood pressure when standing up (especially at the start of treatment with a too high dose and when treatment is resumed);
• Sensation of spinning (dizziness);
• Marked drop in blood pressure when standing up (especially at the start of treatment with a too high dose and when treatment is resumed),
• Sensation of strong or accelerated heartbeats,
• Runny nose, itching, sneezing, and nasal congestion,
• Vomiting;
• Diarrhea;
• Dry mouth;
• Rash (urticaria, exanthema),
• Itching,
• Urinary incontinence,
• Swelling of feet and ankles (edema),
• Face redness (flushing),
• Chest pain.

Unknown frequency (Cannot be estimated from available data)

• Decreased white blood cells (neutropenia),
• Decreased platelet count,
• Life-threatening irregular heartbeats (atrial fibrillation);

Liver damage,

• Suppression of bile flow (hepatic colestasis)

If you are undergoing cataract eye surgery and are taking or have taken Alfuzosina ratiopharm previously, you may experience complications during surgery (see section 2 “Surgeries during Alfuzosina ratiopharm treatment”)

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Do not store above 86°F (30°C).

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

Do not use this medication after the expiration date that appears on the packaging 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 packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Alfuzosina ratiopharm 10 mg prolonged-release tablets

• 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 (E-464), povidone K25 and magnesium stearate (E-470b).

Appearance of the product and contents of the package

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

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

c/ Anabel Segura, nº 11 Edificio Albatros B 1st floor

28108 Alcobendas – Madrid (Spain)

Responsible for manufacturing

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 with the following names:

Following names:

Denmark:Alfuzosin Teva 10 mg depot tablets

Finland:Alfuzosin hydrochlorid ratiopharm 10 mg depot tablets

Germany:Alfuzosin-ratiopharm®uno 10 mg Retard tablets

Italy:Alfuzosina ratiopharm 10 mg prolonged-release tablets

Netherlands:Alfuzosin HCL ratiopharm 10 mg, tablets with prolonged release

Spain:Alfuzosina ratiopharm 10 mg prolonged-release tablets EFG

Sweden:Alfuzosin Teva

This leaflet has been approved in March 2024

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