Alfuzosin Sandoz

PACKAGE LEAFLET: INFORMATION FOR THE USER

Alfuzosin Sandoz 10 mg prolonged-release tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you

• Keep this leaflet. 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. Never give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT ALFUZOSIN SANDOZ IS AND WHAT IT IS USED FOR

Alfuzosin Sandoz belongs to a group of medicines called alpha-adrenergic receptor antagonists or alpha-blockers.
It is used to treat moderate to severe symptoms of an enlarged prostate, a condition also known as benign prostatic hyperplasia. An enlarged prostate can cause urinary problems such as increased frequency or difficulty in urinating, especially at night. Alpha-blockers relax the muscles of the prostate and the bladder neck. This allows urine to pass more easily from the bladder.

2. WHAT YOU NEED TO KNOW BEFORE TAKING ALFUZOSIN SANDOZ

Do not take Alfuzosin Sandoz

• if you are allergic to alfuzosin, to other quinazolines (for example terazosin, doxazosin, prazosin), or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from any condition causing a significant drop in blood pressure when standing up.
• if you have liver disorders.
• if you are taking other medicines belonging to the group of alpha-blockers.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alfuzosin Sandoz.

• if you have severe kidney problems, as the safety of Alfuzosin Sandoz has not yet been established in these patients.
• if you are taking other medicines for high blood pressure. In this case, your doctor will monitor your blood pressure regularly, especially during the initial phase of treatment.
• if, within a few hours after taking Alfuzosin Sandoz, you experience a sudden drop in blood pressure when standing up, accompanied by dizziness, weakness, or sweating. If you experience a drop in blood pressure, remain lying down with your legs and feet raised until symptoms completely disappear. These effects usually last only a short time and occur at the beginning of treatment. Usually, there is no need to discontinue treatment.
• if you have heart diseases.
• if you have previously experienced significant drops in blood pressure or hypersensitivity reactions (allergy) after taking other medicines belonging to the group of alpha-blockers. In this case, your doctor will start treatment with alfuzosin at a low dose and gradually increase it.
• if you have chest pain (angina) and are being treated with nitrates, as this may increase the risk of a drop in blood pressure. If your angina returns or worsens, your doctor will decide whether to treat your angina with a medicine containing nitrates or to discontinue treatment with Alfuzosin Sandoz.
• if you are scheduled for eye surgery due to cataract (clouding of the lens), inform your ophthalmologist before the operation that you are currently taking or have previously taken Alfuzosin Sandoz. This is because Alfuzosin Sandoz may cause complications during surgery, which can be managed if the specialist is informed in advance.

The tablets should be swallowed whole. Do not break, crush, or chew the tablets, otherwise an excessive amount of the active substance (alfuzosin) may enter your body too quickly. This could increase the risk of adverse effects.
Children and adolescents
Alfuzosin Sandoz is not indicated for use in children and adolescents.
Other medicines and Alfuzosin Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Alfuzosin Sandoz if you are already taking other medicinal products belonging to the group of alpha-blockers.
Alfuzosin Sandoz and certain medicines may affect each other's effects. These medicines include:

• medicines containing ketoconazole and itraconazole (medicines used to treat fungal infections) and ritonavir (used to treat HIV).
• medicines used to lower blood pressure.
• medicines (nitrates) used to treat symptoms of chest pain (angina). Please note that the concomitant use of Alfuzosin Sandoz with medicines used to treat high blood pressure and with nitrates used, for example, to treat heart conditions may cause a drop in blood pressure.
• medicines administered before surgery (general anaesthetics). Your blood pressure may decrease significantly. If you are undergoing surgery, inform your doctor that you are taking Alfuzosin Sandoz.
• Medicines known to prolong the QT interval.

Alfuzosin Sandoz with food and drink
Alfuzosin Sandoz should be taken after meals.
Pregnancy and breastfeeding
This information is not relevant, as Alfuzosin Sandoz is a medicine intended for male use only.
Driving and using machines
At the beginning of treatment with Alfuzosin Sandoz, you may experience dizziness, lightheadedness, or weakness. Do not drive or operate machinery or perform hazardous activities until you know how your body responds to the treatment.
Alfuzosin Sandoz contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE ALFUZOSIN SANDOZ

Always take Alfuzosin Sandoz exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults, elderly patients (over 65 years of age), and those with mild to moderate renal impairment is 1 prolonged-release tablet (10 mg of alfuzosin) once daily. Take the first tablet in the evening, before going to bed. Take the tablets every day after the same meal, swallowing them whole with a sufficient amount of liquid. Do not crush, chew, or divide the tablets.
If you take more Alfuzosin Sandoz than you should
If you take too high a dose of Alfuzosin Sandoz, your blood pressure may drop suddenly, and you may experience dizziness or even fainting. If you begin 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 hospital treatment.
If you forget to take Alfuzosin Sandoz
Do not take a double dose to make up for a missed tablet, as this could cause a sudden drop in blood pressure, especially if you are taking other medicines that lower blood pressure. Take the next dose as prescribed.
If you stop taking Alfuzosin Sandoz
Do not stop or discontinue treatment with Alfuzosin Sandoz without first consulting your doctor. If you wish to stop treatment or have any questions about the use of Alfuzosin Sandoz, speak to your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience chest pain, stop taking Alfuzosin Sandoz and contact your doctor or go immediately
to the nearest hospital. Chest pain (angina) normally occurs if you have previously suffered from angina.
This side effect is very rare and may affect up to 1 in 10,000 people. If you develop symptoms such as a
skin rash with redness and swelling (of the face, tongue or throat), difficulty breathing or swallowing,
stop taking Alfuzosin Sandoz and contact your doctor immediately. These are symptoms of
angioedema, which is a very rare side effect that may affect up to 1 in 10,000 people.

Other side effects that may occur with Alfuzosin Sandoz are:

Common (may affect up to 1 in 10 patients):
Weakness/dizziness, headache, stomach pain, feeling of heaviness in the stomach and indigestion (dyspepsia), feeling unwell (nausea), feeling of weakness.

Uncommon (may affect up to 1 in 100 patients):
Drowsiness, sensation of spinning (dizziness), loss of consciousness due to insufficient blood supply to the brain, rapid heartbeat, significant drops in blood pressure when moving into an upright position (especially when starting treatment with too high a dose or when resuming therapy), runny nose, diarrhoea, dry mouth, skin rash, itching, fluid retention (may cause swelling of the arms, ankles or legs), facial flushing (hot flushes), chest pain, vomiting.

Not known (frequency cannot be estimated from the available data):
If you are undergoing eye surgery due to cataract and are currently taking or have previously taken Alfuzosin Sandoz, difficulties may occur during surgery (see "Warnings and precautions"). Very rapid, uncoordinated heart contractions, altered liver function (signs may include yellowing of the skin or whites of the eyes), persistent and painful penile erection (priapism), decreased white blood cells, low platelet count. Signs may include bleeding from gums and nose, bruising, prolonged bleeding from wounds, skin rash (red spots called petechiae).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE ALFUZOSIN SANDOZ

Do not store above 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and packaging.
The expiry date refers to the last day of the month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Alfuzosina Sandoz contains
The active substance is alfuzosin hydrochloride.
Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
The excipients are monohydrate lactose, hypromellose (E464), povidone K25, magnesium stearate (E
470b).
Description of the appearance of Alfuzosina Sandoz and packaging contents
Alfuzosina Sandoz is presented as white, round, uncoated tablets with bevelled edges, approximately 10 mm in diameter.
Alfuzosina Sandoz is available in blisters containing 10, 20, 30, 50, 60, 60x1, 90, 100 and 180 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA), Italy
Manufacturer responsible for batch release
Salutas Pharma GmbH - Otto-von-Guericke Allee, 1 - 39179 Barleben (Germany)
Lek S.A. - Ul. Domaniewska 50 c - 02-672 Warszawa (Poland)
Lek Pharmaceuticals d.d. - Verovškova 57 - 1526 Ljubljana (Slovenia)
Lek Pharmaceuticals d.d. - Trimlini 2D - 9220 Lendava (Slovenia)
This medicinal product has been authorized in the Member States of the European Economic Area under the following names:
Sweden: Alfuro 10 mg
Spain: Alfuzosina UR 10 mg Comprimidos de liberación prolongada EFG
Italy: Alfuzosina Sandoz 10 mg prolonged-release tablets
Poland: AlfuLEK 10
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