Alfuzosin Teva-Ratiopharm 10 mg prolonged-release tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets EFG

alfuzosin hydrochloride

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

Leaflet contents:

1. What Alfuzosin Teva-ratiopharm 10 mg is and what it is used for
2. What you need to know before taking Alfuzosin Teva-ratiopharm 10 mg
3. How to take Alfuzosin Teva-ratiopharm 10 mg
4. Possible side effects
5. How to store Alfuzosin Teva-ratiopharm 10 mg
6. Contents of the pack and other information

1. What Alfuzosin Teva-ratiopharm 10 mg is and what it is used for

This medicine belongs to a group of medicines called alpha-blockers.

It is used to treat the functional symptoms of benign prostatic hyperplasia (enlargement of the prostate gland). Enlargement of the prostate may cause urinary problems such as frequent and difficult urination.

2. What you need to know before taking Alfuzosin Teva-ratiopharm 10 mg

Do not take Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets

• If you are allergic to alfuzosin, to another quinazoline (e.g. terazosin, doxazosin), or to any of the other ingredients of this medicine (listed in section 6)
• If you have conditions that cause a sudden drop in blood pressure upon standing
• If you are taking other medicines belonging to a group called alpha1-blockers (such as tamsulosin)
• If you have liver failure (liver disease)
• If you have severe renal failure (serious kidney disease)

Warnings and precautions

Before starting treatment with Alfuzosin Teva-ratiopharm 10 mg, your doctor may carry out tests to rule out other diseases that may cause the same symptoms as benign prostatic hyperplasia. Before treatment and subsequently at regular intervals, you may be given a digital rectal examination and, if necessary, blood tests.

Talk to your doctor or pharmacist before starting Alfuzosin Teva-ratiopharm 10 mg

• If you have serious kidney problems.
• If you have mild to moderate liver impairment, your doctor will prescribe lower doses.
• If you are taking other medicines for high blood pressure. In this case, your doctor will monitor your blood pressure regularly, especially at the beginning of treatment.
• If you experience a sudden drop in blood pressure when standing up, characterized by dizziness, weakness, or sweating, a few hours after taking Alfuzosin Teva-ratiopharm 10 mg. If you experience a sudden drop in blood pressure, you should lie down with your legs and feet raised until symptoms subside.

These effects usually last only a short time and occur at the beginning of treatment.

Usually, it is not necessary to interrupt treatment.

• If you have previously experienced a sudden drop in blood pressure after taking another medicine belonging to the alpha-blocker group. In this case, your doctor will start treatment with alfuzosin at a low dose and gradually increase it.
• If you have acute heart failure.
• If you have chest pain (angina) and are being treated with a nitrate, as this may increase the risk of low blood pressure. You should consult your doctor about whether to continue or stop your treatment with Alfuzosin Teva-ratiopharm 10 mg, especially if chest pain recurs or worsens.
• If you have an abnormal heart rhythm known as QTc interval prolongation (long QT), or if you are taking medicines that may increase the risk of QTc prolongation.

Talk to your doctor if you have this condition or are taking other medicines.

• If you are an elderly patient (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.

Alfuzosin, like other medicines in the same class, may cause priapism (a persistent and painful erection). If this occurs, seek immediate medical attention at an emergency department so it can be treated.

Talk to your doctor or pharmacist even if any of the circumstances mentioned above have occurred to you in the past.

Surgery while taking Alfuzosin

• If you are undergoing surgery requiring general anesthesia, you must inform the anaesthetist before the operation that you are taking Alfuzosin Teva-ratiopharm (see section “Other medicines and Alfuzosin Teva-ratiopharm”).
• If you are undergoing eye surgery due to cataract (clouding of the lens), please inform your ophthalmologist before the operation that you have been taking Alfuzosin Teva-ratiopharm. This is because treatment with Alfuzosin Teva-ratiopharm may cause complications during surgery, which can be managed if your specialist has been previously informed.

Other medicines and Alfuzosin Teva-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.

Certain medicines, such as those listed below, may increase the risk of hypotension (low blood pressure) when taken at the same time as Alfuzosin Teva-ratiopharm.

Medicines that must not be used:

• Medicines belonging to the group of alpha-blockers: you must not take these medicines at the same time as Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets (see above “Do not take Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets”)

Medicines to be used with caution:

• Antihypertensive medicines (drugs that lower blood pressure)
• Nitrates (medicines for the treatment of coronary insufficiency)
• Medicines for fungal infections (such as itraconazole or ketoconazole)
• Medicines for HIV (AIDS virus) (such as ritonavir)
• Medicines for bacterial infections (antibiotics such as clarithromycin, erythromycin, and telithromycin)
• Medicines for the treatment of depression (such as nefazodone)

In addition, administration of general anaesthetics to patients treated with alfuzosin may cause blood pressure instability; therefore, in the case of surgery, you must inform the anaesthetist that you are taking Alfuzosin Teva-ratiopharm.

Alfuzosin Teva-ratiopharm 10 mg with food and drink

The tablets should be taken after a meal.

Pregnancy and breastfeeding

Alfuzosin Teva-ratiopharm 10 mg is indicated only for use in men.

Driving and using machines

At the beginning of treatment with Alfuzosin Teva-ratiopharm 10 mg, you may feel faint, dizzy, or weak. Do not drive or operate machinery or perform any hazardous tasks until you know how you respond to the treatment.

Alfuzosin Teva-ratiopharm 10 mg 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 Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Adults The recommended dose is one prolonged-release tablet (10 mg of alfuzosin) once daily, which is the maximum daily dose. Take the first tablet at bedtime. Take the tablets after the same meal each day and swallow them whole with an adequate amount of liquid. Do not crush, chew, or divide the tablets.

Elderly patients

Dosage adjustment is not required for elderly patients (over 65 years of age).

Renal impairment

In patients with mild or moderate renal impairment, treatment should be initiated with a lower dose; the dose may subsequently be increased up to 10 mg depending on clinical response.

In patients with severe renal impairment, Alfuzosin Teva-ratiopharm 10 mg is not recommended because there are no clinical safety data supporting the safety of the medicine in this patient group.

Use in children and adolescents

The efficacy of alfuzosin in children or adolescents aged 2 to 16 years has not been demonstrated. Therefore, alfuzosin is not indicated in this patient group.

If you take more Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets than you should: If you take large amounts of Alfuzosin Teva-ratiopharm 10 mg, your blood pressure may suddenly decrease and you may feel dizzy or even faint. If you start to feel dizzy, sit or lie down until you feel better. If symptoms do not resolve, contact your doctor, as low blood pressure may require treatment in a hospital.

Contact your doctor, pharmacist, or call the Toxicology Information Service, Telephone: 91-562 04 20, indicating the medicine and the amount taken.

If you forget to take Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets: 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 medicines to lower your blood pressure. Take the next tablet as instructed.

If you stop taking Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets

Do not interrupt or stop taking Alfuzosin Teva-ratiopharm 10 mg without first consulting your doctor. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them:

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

• Dizziness/weakness, headache, dizziness;
• Orthostatic hypotension (drop in blood pressure when changing from lying down to standing up (especially at the beginning of treatment with too high a dose or when treatment is resumed) (see section 2 “Warnings and precautions”);
• Gastrointestinal disorders such as nausea, abdominal pain, diarrhoea, dry mouth;
• Feeling of weakness, malaise.

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

• Syncope (loss of consciousness);
• Somnolence;
• Visual disturbances;
• Faster heartbeat, palpitations (the heart beats faster than normal and is also more noticeable);
• Hot flushes;
• Nausea (vomiting);
• Skin disorders such as rash or itching, pruritus;
• Oedema (swelling), chest pain (see section 2 “Warnings and precautions”).

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

• Worsening or recurrence of chest pain (angina pectoris), in patients with coronary artery disease (see section 2 “Warnings and precautions”);
• Angioedema (swelling of the face, lips, tongue and/or throat), urticaria;
• Skin disorders such as urticaria.

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

• Reduction in the number of white blood cells (neutropenia), which may lead to infections more frequent than usual;
• Decrease in the number of platelets (thrombocytopenia);
• Stroke in patients with problems related to blood circulation in the brain;
• Intraoperative floppy iris syndrome (IFIS) (characterized by pupillary constriction and iris deformation);
• Abnormal heart rhythm (atrial fibrillation);
• Liver problems: signs may include yellowing of the skin or the whites of the eyes;
• Abnormal, often painful and persistent erection of the penis not related to sexual activity (priapism).

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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alfuzosin Teva-ratiopharm 10 mg tablets

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

Do not use this medicine after the expiry date stated on the carton or blister after EXP. The expiry date refers to the last day of the month indicated.

Keep the blister in the original packaging to protect it from light.

Store below 30°C.

For bottles (HDPE):

The shelf life of the product after first opening is 1 year, but not beyond the expiry date stated on the carton or blister after EXP.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alfuzosin Teva-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 (E464), povidone K25 and magnesium stearate.

Appearance of Alfuzosin Teva-ratiopharm 10 mg prolonged-release tablets and contents of the pack

Alfuzosin Teva-ratiopharm 10 mg is a prolonged-release, round, white tablet.

Blister packs (PVC/PVDC/aluminium) containing 10, 28, 30, 50, 90 or 100 tablets per package, or bottles (HDPE) containing 100 tablets per package. Not all pack sizes may be marketed.

Marketing Authorization Holder

Teva Pharma S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Manufacturer responsible for manufacturing

Merckle GmbH

Ludwig-Merckle Str. 3

89143 Blaubeuren / Germany

This medicinal product is authorised in EEA Member States under the following names

Estonia: ALFUZOSIN-TEVA

Latvia: Alfuzosin-Teva 10 mg ilgstosās darbības tabletes

Lithuania: Alfuzosin-Teva 10 mg pailginto atpalaidavimo tabletės

Portugal: Alfuzosina Teva 10 mg comprimido de libertação prolongada

Spain: Alfuzosina Teva 10 mg comprimidos de liberación prolongada EFG

United Kingdom: Fuzatal XL 10mg prolonged release tablets

This leaflet was last reviewed in September 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69418/P_69418.html