Package leaflet: Information for the user

Alfuzosin Pensa 10 mg, prolonged-release tablets

Alfuzosin hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you take 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. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

What Alfuzosin Pensa 10 mg is and what it is used for
What you need to know before taking Alfuzosin Pensa 10 mg
How to take Alfuzosin Pensa 10 mg
Possible side effects
How to store Alfuzosin Pensa 10 mg
Contents of the pack and other information

1. What Alfuzosina Pensa 10 mg is and what it is used for

Alfuzosina Pensa 10 mg belongs to a group of medicines called alpha-adrenergic receptor antagonists or alpha-blockers. It is used in the treatment of moderate to severe symptoms caused by enlargement of the prostate gland, a condition also known as benign prostatic hyperplasia. An enlarged prostate gland can cause urinary problems such as frequent and difficult urination, especially at night. Alpha-blockers relax the muscles of the prostate and the bladder neck. This allows urine to leave the bladder more easily.

2. What you need to know before taking Alfuzosina Pensa 10 mg

Do not take Alfuzosina Pensa 10 mg

if you are allergic (hypersensitive) to alfuzosin, to other quinazolines (e.g. terazosin, doxazosin) or to any of the other ingredients of this medicine
if you have conditions causing a marked drop in blood pressure upon standing
if you are taking other medicines belonging to the group of alpha-blockers
if you have liver problems.

Warnings and precautions

if you are taking other medicines for high blood pressure or if you are taking a nitrate for the treatment of chest pain (angina). In this case, your doctor will regularly monitor your blood pressure, especially at the beginning of treatment.
If within a few hours after taking Alfuzosina Pensa 10 mg you experience a sudden drop in blood pressure when standing up, manifested by dizziness, weakness or sweating. If your blood pressure drops, lie down with your legs and feet raised until symptoms disappear. Usually these effects are short-lived and occur at the beginning of treatment. Normally, treatment does not need to be discontinued.
If you have previously experienced a sudden drop in blood pressure after taking another medicine belonging to the group of alpha-blockers. In this case, your doctor will start treatment with alfuzosin at a low dose, gradually increasing it.
If you suffer from 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 discuss with your doctor whether to continue treatment for chest pain or discontinue treatment with Alfuzosina Pensa 10 mg, especially if chest pain recurs or worsens.
If you have a heart disorder characterized on ECG by QT interval prolongation, or if you are taking medicines that may cause QT interval prolongation. Your doctor will examine you before and during treatment with Alfuzosina Pensa 10 mg.
If you are undergoing cataract surgery (clouding of the lens), inform your ophthalmologist before the operation that you are currently taking or have previously taken Alfuzosina Pensa 10 mg. This is because Alfuzosina Pensa 10 mg may cause complications during surgery, which can be managed if your ophthalmologist is prepared in advance.
If you have severe kidney problems. Swallow the tablets whole. Do not crush, pulverize or chew the tablets, as too much active ingredient alfuzosin could reach your body too quickly. This may increase the risk of unwanted effects.

Other medicines and Alfuzosina Pensa 10 mg
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
Alfuzosina Pensa 10 mg must not be taken if you are taking other medicines belonging to the group of alpha-blockers.
Alfuzosina Pensa 10 mg and some medicines may interact with each other. These include:

medicines to lower blood pressure
medicines (nitrates) used to treat symptoms of chest pain (angina). Concomitant use of Alfuzosina Pensa 10 mg with medicines used to treat high blood pressure and with nitrates used, for example, in the treatment of heart diseases may lead to a decrease in blood pressure
ketoconazole and itraconazole (medicines used to treat fungal infections) and ritonavir (a medicine used to treat HIV infection)
medicines you receive before surgery (general anaesthetics). Your blood pressure may drop significantly. If you are to undergo surgery, inform your doctor that you are taking Alfuzosina Pensa 10 mg.

Alfuzosina Pensa 10 mg with food and drink
Alfuzosina Pensa 10 mg should be taken after meals.
Pregnancy and breastfeeding
This information is not relevant, as alfuzosin is intended only for male patients.
Driving and using machines
At the beginning of treatment, Alfuzosina Pensa 10 mg may cause dizziness or weakness. Do not drive or operate machinery or perform hazardous tasks until you know how your body reacts to the treatment.
Important information about some excipients in Alfuzosina Pensa 10 mg
This medicine contains small amounts of lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Alfuzosina Pensa 10 mg

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 prolonged-release tablet (10 mg of alfuzosin) once daily.
Take the first tablet at bedtime. Take the tablets every day immediately after the same meal, swallowing the tablets whole with a sufficient amount of liquid. Do not crush, chew or divide the tablets.
The dose for elderly patients (over 65 years) is 1 prolonged-release tablet once daily (10 mg of alfuzosin). Take the first tablet at bedtime. Take the tablets every day immediately after the same meal.
The usual dose for patients with mild to moderate renal impairment is 1 prolonged-release tablet (10 mg of alfuzosin). Take the first dose at bedtime.

If you take more Alfuzosina Pensa 10 mg than you should
If you take large amounts of Alfuzosina Pensa 10 mg, your blood pressure may drop suddenly and you may experience dizziness or even fainting. If you start feeling 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 Alfuzosina Pensa 10 mg
Do not take a double dose to make up for the missed tablet, 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 scheduled.

If you stop taking Alfuzosina Pensa 10 mg
Do not stop or discontinue treatment with Alfuzosina Pensa 10 mg without first talking to your doctor. If you wish to stop treatment or if you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alfuzosin Pensa 10 mg may cause side effects, although not everyone experiences them.

Common side effects (more than 1 in 100 and less than 1 in 10 patients treated) are fainting/dizziness, headache, stomach pain, nausea, indigestion, dry mouth, feeling of weakness, general malaise.
Uncommon side effects (more than 1 in 1,000 and less than 1 in 100 patients treated) are sensation of dizziness (vertigo), somnolence, fainting, visual disturbances, fast heartbeat, sensation of intense or rapid heartbeat, sudden drop in blood pressure when standing up (orthostatic hypotension), facial flushing (hot flushes), runny nose, diarrhoea, skin rash, itching, urinary incontinence, swelling of the ankles and feet, chest pain.
Very rare side effects (less than 1 in 10,000 patients): worsening or recurrence of chest pain (angina pectoris) in patients with coronary artery disease, urticaria, swelling of the skin and mucous membranes, especially of the face and around the mouth (angioedema), persistent and painful erection (priapism).
Not known (frequency cannot be estimated from the available data): low number of certain white blood cells (neutropenia), complication during cataract surgery known as intraoperative floppy iris syndrome, heart rhythm disorder (atrial fibrillation), vomiting, liver damage, alteration of liver values due to obstruction of bile flow, persistent and painful erection (priapism).

If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

5. How to store ALFUZOSIN PENSA 10 MG

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 blister pack and the outer carton. The expiry
date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Alfuzosina Pensa 10 mg contains

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

Description of the appearance of Alfuzosina Pensa 10 mg and package contents
Alfuzosina Pensa 10 mg prolonged-release tablets are white, round, uncoated tablets with bevelled edges.
Available in blister packs of PVC/PVDC-aluminium containing 10, 20, 30, 50, 60, 60x1, 90, or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano, Italy

Manufacturer:
PHAST GmbH
Kardinal-Wendel-Str. 16, 66424 Bad Homburg
Germany

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Denmark: Alfuzosinhydrochlorid "Pensa"
Italy: Alfuzosina Pensa 10 mg