Alfuzosin Ratiopharm 10 mg prolonged-release tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Alfuzosine ratiopharm 10 mg prolonged-release tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Alfuzosine ratiopharm is and what it is used for
2. What you need to know before taking Alfuzosine ratiopharm
3. How to take Alfuzosine ratiopharm
4. Possible adverse effects
5. How to store Alfuzosine ratiopharm
6. Contents of the pack and other information

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

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

Alfuzosin is indicated for the treatment of symptoms of benign prostatic hyperplasia. This condition occurs when the prostate gland increases in size (hyperplasia), but the growth is not cancerous (benign). This can cause difficulties in the passage of 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 narrower. This makes it difficult for urine to pass through.
• This medicine works by relaxing the muscle of the prostate gland, thereby widening the urethra. This allows urine to pass more easily.

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

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

2. What you need to know before taking Alfuzosin ratiopharm

Do not take Alfuzosin ratiopharm

• if you are allergic to alfuzosin or to any of the other ingredients of this medicine (listed in section 6),
• if you have a condition 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 you stand up or sit up quickly,
• if you have severe liver problems,
• if you are taking other medicines belonging to the group of alpha-blockers (see section Other medicines and Alfuzosin ratiopharm).

Warnings and precautions

Talk to your doctor or pharmacist before taking Alfuzosin ratiopharm:

• if you have severe kidney problems,
• if you are taking other medicines for high blood pressure. In this case, your doctor should monitor your blood pressure regularly, especially at the beginning of treatment,
• if you experience a sudden drop in blood pressure upon standing, accompanied by dizziness, weakness, or sweating, within the first few hours after taking Alfuzosin ratiopharm. If you experience a drop in blood pressure, lie down with your legs and feet raised until symptoms subside. These effects are usually short-lived and occur at the beginning of treatment. Generally, treatment does not need to be stopped,
• if you have previously experienced significant drops in blood pressure after taking another medicine belonging to the group of alpha-blockers. In this case, your doctor will start treatment with a low dose and gradually increase it,
• 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 a sudden drop in blood pressure. You should discuss with your doctor whether to continue angina treatment or whether treatment with Alfuzosin ratiopharm should be interrupted, especially if chest pain recurs or worsens,
• if you have a congenital or acquired change in heart activity (QT interval prolongation, which results in an ECG change) or are taking medicines that may increase QT interval prolongation on the ECG before and during administration of Alfuzosin ratiopharm,
• if you have pre-existing risk factors (such as underlying heart conditions and/or concomitant treatment with antihypertensive medication) which have been reported to cause a marked decrease in blood pressure,
• if you are over 65 years of age. This is due to the increased risk of developing low blood pressure (hypotension) and related adverse effects in elderly patients,
• if you are undergoing cataract eye surgery (clouding of the lens), please inform your ophthalmologist if you are currently taking or have previously taken Alfuzosin ratiopharm. This is because Alfuzosin ratiopharm may cause complications during surgery, which can be managed if your ophthalmologist is prepared in advance.
• In case of an erection (often painful) unrelated to sexual activity that lasts longer than 4 hours, contact a doctor or go to hospital immediately, as you may require 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 enter your body too quickly. This may increase the risk of unwanted effects.

Other medicines and Alfuzosin ratiopharm

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

This is because Alfuzosin may affect how other medicines work. Some medicines may also affect how Alfuzosin works.

Alfuzosin ratiopharm must not be taken if you are taking other medicines belonging to the group of alpha-blockers such as doxazosin, indoramin, prazosin, terazosin, tamsulosin, or phenoxybenzamine.

Talk to your doctor or pharmacist before taking your medicine if:

• In the past, you experienced a large drop in blood pressure while taking an alpha-blocker (this could include previous use of alfuzosin). See the paragraph immediately above for examples of other alpha-blockers.
• You are taking a medicine for high blood pressure, as you may feel dizzy, weak, or start sweating within a few hours of taking this medicine. If this happens, lie down until symptoms have completely disappeared. Inform your doctor, as your medicine dosage may need to be adjusted.
• You are taking medicines for chest pain (angina pectoris).
• 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 depression (such as nefazodone).
• You are taking ketoconazole tablets (used to treat Cushing's syndrome, when the body produces excess cortisol).

Surgical procedures while taking Alfuzosin ratiopharm

• If you are undergoing surgery requiring general anesthesia, inform your doctor that you are taking Alfuzosin before the procedure. This is because it may be dangerous, as it can lower blood pressure.
• If you are undergoing cataract eye surgery (clouding of the lens), inform your ophthalmologist before the procedure that you are currently taking or have previously taken Alfuzosin.

This is because Alfuzosin may cause complications during surgery, which can be managed if your specialist is prepared in advance.

Alfuzosin ratiopharm with food and drink

Alfuzosin ratiopharm should be taken after meals.

Pregnancy and breastfeeding

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

Driving and using machines

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

Alfuzosin ratiopharm contains lactose

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

3. How to take Alfuzosina ratiopharm

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, please consult your doctor or pharmacist again.

How much to take

Benign prostatic hyperplasia.

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

Acute urinary retention.

• Your doctor will administer alfuzosin on the day your catheter is inserted.
• You must continue taking alfuzosin once daily after a meal. Follow your doctor's prescription instructions.

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

The recommended dose for patients with mild or moderate kidney problems is 1 prolonged-release tablet (10 mg of alfuzosin) once daily.

Method of administration

• Swallow the tablets whole with plenty of water.
• Do not break, crush, chew or divide your tablets. This may affect the release of the 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 Poison Information Service at telephone: 91 562 04 20, indicating the medicine 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 occurs, contact your local hospital immediately. Inform the doctor how many tablets you have taken. Lie down as much as possible to help reduce 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 missed doses, as this may cause a sudden drop in blood pressure, especially if you are taking antihypertensive medicines. Take the next tablet as instructed.

If you stop taking Alfuzosina ratiopharm

Do not stop taking Alfuzosina ratiopharm without first talking to your doctor. If you wish to discontinue treatment, consult your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. These side effects are more likely to occur at the beginning of treatment.

• Chest pain (angina)

This usually only occurs if you have previously had angina. If you experience chest pain, stop taking the tablets and contact a doctor or go to hospital immediately. This may affect up to 1 in 10,000 people.

• Allergic reactions

You may experience symptoms of angioedema, such as red, raised rash, swelling (of the eyelids, face, lips, mouth, and tongue), difficulty breathing or swallowing.

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

• Prolonged erection (priapism)

Priapism is an abnormal, often painful and persistent erection of the penis not related to sexual activity. If you have an erection as described here lasting more than 4 hours, contact a doctor or go to hospital immediately, as you may require treatment. This condition may lead to permanent impotence if not properly treated.

Other side effects

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• dizziness, somnolence;
• visual disturbances;
• irregular and rapid heartbeat;
• sensation of palpitations or fast heartbeat (tachycardia);
• fainting (especially at the beginning of treatment);
• marked drop in blood pressure upon standing (especially when starting treatment with too high a dose and when resuming treatment);
• sensation of the head spinning (dizziness);
• marked decrease in blood pressure upon standing (especially at the beginning of treatment with too high a dose and when treatment is resumed);
• sensation of strong or rapid heartbeats;
• runny nose, itching, sneezing, and nasal congestion;
• vomiting;
• diarrhoea;
• dry mouth;
• skin rash (urticaria, exanthema);
• itching;
• urinary incontinence;
• swelling of feet and ankles (oedema);
• facial redness (flushing);
• chest pain.

Frequency not known (cannot be estimated from available data)

• decrease in white blood cells (neutropenia);
• decrease in number of blood platelets;
• life-threatening irregular heartbeats (atrial fibrillation);
• liver damage;
• paralysis or suppression of bile flow (cholestatic liver disease).

If you are scheduled to undergo cataract eye surgery and are currently taking or have previously taken Alfuzosin ratiopharm, you may experience complications during surgery (see section 2 “Surgical interventions while taking Alfuzosin ratiopharm”).

Reporting of adverse effects

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

5. Storage of Alfuzosin 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 refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Alfuzosin ratiopharm 10 mg prolonged-release tablets

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

Appearance of the medicine and contents of the pack

Alfuzosin ratiopharm 10 mg is presented as prolonged-release tablets, white, round, bevelled-edged, and uncoated.

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

Only certain 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, 1st floor
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 up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/