ALFUZOSINA 10 mg Tabletki O Przedłużonym Uwalnianiu

Treść ulotki

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

Alfuzosina Aurobindo 10 mg prolonged-release tablets

Generic medicine

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. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Alfuzosina Aurobindo belongs to a group of medicines called alpha-1 blockers.
Alfuzosina Aurobindo is used to treat the symptoms of moderate to severe benign prostatic hyperplasia.
This is a condition in which the prostate gland enlarges (hyperplasia), but this enlargement is, in itself, non-cancerous (benign). This condition occurs more often in older men.
The prostate gland is located below the bladder and surrounds the urethra (the tube that allows urine to flow out).
With age, the prostate gland may enlarge and press on the urethra, narrowing it. This can cause urinary problems such as a frequent need to urinate and difficulty urinating.
Alfuzosina Aurobindo works by relaxing the muscle of the prostate gland. This reduces the narrowing of the urethra and makes it easier for urine to pass.
In some patients with benign prostatic hyperplasia, the prostate gland becomes so large that it completely interrupts 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 water and relieves the pain.
• During this period, Alfuzosina Aurobindo can be used to help the water flow again. This has been shown to help only men over the age of 65.

2. What you need to know before taking Alfuzosina Aurobindo

Do not take Alfuzosina Aurobindo

• If you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6). The symptoms of an allergic reaction include: skin rashes, swelling of lips, throat or tongue, difficulty swallowing or breathing.
• If you are allergic (hypersensitive) to substances similar to alfuzosin (such as terazosin or doxazosin).
• If you have, or have had in the past, a drop in blood pressure when getting up from a sitting or lying position (the medical term for this condition is “orthostatic hypotension”). This can cause dizziness, lightheadedness or a feeling of fainting when you stand up or sit quickly.
• If you are already taking another alpha-1 blocker (such as terazosin or doxazosin) or dopamine receptor agonists at the same time. See section “Other medicines and Alfuzosina Aurobindo”. If you are unsure, ask your doctor or pharmacist.
• If you have problems with your liver.

Warnings and precautions:
Talk to your doctor or pharmacist before taking Alfuzosina Aurobindo:

• if you have severe kidney problems;
• if you have a heart condition;
• if you have chest pain (angina);
• if you know you have an abnormality in your electrocardiogram (ECG), called “prolongation of the QT interval”;
• if you are more than 65 years old. This is due to the increased risk of developing low blood pressure (hypotension) and related side effects in elderly patients;
• before starting treatment with Alfuzosina Aurobindo, your doctor may perform some tests to rule out the presence of other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before treatment and at regular intervals, a digital rectal examination may be performed and, if necessary, an analysis will be carried out;
• if you have ever had a painful and persistent erection of the penis, not related to sexual activity, before or during treatment.

Other medicines and Alfuzosina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
This is because Alfuzosina Aurobindo can affect how some other medicines work. Some
medicines can also have an effect on how Alfuzosina Aurobindo works.
Do not take Alfuzosina Aurobindo if you are taking:

• other alpha-blockers, such as doxazosin, indoramin, prazosin, terazosin, tamsulosin or phenoxybenzamine, or dopamine receptor agonists.

Before taking the medicine, check with your doctor or pharmacist:

• if you have had a significant drop in blood pressure in the past while taking an alpha-blocker (including previous use of alfuzosin). See the previous section for examples of other alpha-blockers;
• if you are taking medicine for high blood pressure, as you may experience dizziness, feel weak or start to sweat within a few hours of taking this medicine. If this happens, you should lie down until the symptoms have completely disappeared. Tell your doctor, who may decide to change the dose of the medicine;
• if you are taking medicines for chest pain or angina (nitrates);
• if you are taking medicines for fungal infections (e.g. ketoconazole, itraconazole);
• if you are taking medicines for HIV (e.g. ritonavir);
• if you are taking some medicines used to treat hepatitis C (e.g. ritonavir, ombitasvir and paritaprevir);
• if you are taking medicines for bacterial infections (e.g. clarithromycin, telithromycin);
• if you are taking medicines for the treatment of depression (e.g. nefazodone);
• if you are taking ketoconazole tablets (used to treat Cushing's syndrome, when the body produces excess cortisol);
• if you are taking medicines for the treatment of premature ejaculation (e.g. dapoxetine).

Surgery during treatment with Alfuzosina Aurobindo

• If you are to have an operation that requires general anesthesia, tell your doctor before the operation that you are taking Alfuzosina Aurobindo. The doctor may decide to stop the

administration of Alfuzosina Aurobindo 24 hours before the operation. This is because it can be
dangerous as this medicine can lower blood pressure.

• If you are being treated for high blood pressure, your doctor should measure your blood pressure regularly, especially at the beginning of treatment.
• If you are to undergo eye surgery for a cataract (clouding of the lens), inform the specialist before the operation that you are taking or have taken Alfuzosina Aurobindo. This is because Alfuzosina Aurobindo can cause complications during surgery that can be managed if the specialist prepares in advance.

Alfuzosina Aurobindo with food, drinks and alcohol

• Take Alfuzosina Aurobindo after a meal.
• You may experience dizziness and weakness while taking Alfuzosina Aurobindo. If this happens, do not drink alcohol.

Pregnancy, breastfeeding and fertility
Not applicable as alfuzosin is not used in women.

Driving and using machines
When you take Alfuzosina Aurobindo you may experience dizziness and feel weak. Adverse reactions such as a significant
drop in blood pressure when standing up, along with dizziness, vertigo, visual disturbances
and asthenia can occur, especially at the beginning of treatment. If this happens, do not drive and do not use
tools or machinery.

3. How to take Alfuzosina Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.

• Swallow the tablets whole with plenty of liquid (e.g. a glass of water).
• Do not break, crush or chew the tablets: this may compromise the release of the medicine in the body.
• Take the medicine after a meal.
• The first dose of the medicine should be taken at bedtime.

Benign prostatic hyperplasia
The usual dose is one prolonged-release Alfuzosina Aurobindo tablet once a day (after
a meal).

Acute urinary retention

• Alfuzosina Aurobindo will be administered to you by the doctor on the day the catheter is inserted.
• You must continue to take Alfuzosina Aurobindo once a day.
• You must stop taking Alfuzosina Aurobindo the day after the catheter is removed (3-4 days in total).

Use in children and adolescents
Children
The use of Alfuzosina Aurobindo is not recommended in children and adolescents.
Elderly patients (> 65 years):
The usual dose is one prolonged-release Alfuzosina Aurobindo 10 mg tablet once a day. The dose does not need to be adjusted in the elderly (over 65 years).
Patients with mild to moderate renal impairment
The dose does not need to be adjusted for mild to moderate renal impairment.

If you take more Alfuzosina Aurobindo than you should
Contact your doctor or the local hospital emergency room immediately. Tell your doctor how many tablets you have
taken. Lie down for as long as possible to help stop the side effects. Do not try to drive
to the hospital.

If you forget to take Alfuzosina Aurobindo
Do not take a double dose to make up for a missed dose. Skip the missed dose and take the
next tablet as prescribed.

If you stop taking Alfuzosina Aurobindo
Continue taking the tablets, even if your symptoms improve. Stop treatment only if your doctor
tells you to do so. Symptoms will be better controlled if you continue to take the same dose of this
medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Chest pain (angina) (new onset, worsening or recurrence)
This usually only happens if you have had angina before. If you experience chest pain, stop taking the
tablets and contact your doctor immediately or go to hospital. This occurs in less than 1 in 10,000 people.

Allergic reactions
You may notice symptoms of angioedema, such as skin rash with redness and nodules, 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 the
tablets immediately and contact your doctor or go to hospital.This occurs in less than 1 in 10,000 people.

Other side effects include:
Common (affects less than 1 in 10 people)

• feeling dizzy;
• headache;
• feeling unwell (nausea);
• stomach pain;
• weakness or fatigue.

Uncommon (affects less than 1 in 100 people)

• feeling dizzy, lightheaded or fainting when getting up or sitting up quickly (postural hypotension);
• fast (tachycardia) and pounding heartbeat in the chest and irregular heartbeat (palpitations);
• drowsiness;
• runny nose, itching, sneezing and nasal congestion;
• diarrhoea;
• dry mouth;
• skin rashes and itching;
• urinary incontinence;
• fluid retention (can cause swelling of arms and legs);
• chest pain;
• hot flushes;
• general feeling of being unwell;
• vision problems.

Very rare (affects less than 1 in 10,000 people)

• hepatotoxicity;
• itchy and blistering rash (urticaria).

Additional side effects (frequency not known) that can occur are:
If you are to have eye surgery for cataracts (clouding of the lens), the pupil may
dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure.

• Irregular and rapid heartbeat (atrial fibrillation);
• decreased white blood cells (neutropenia). Signs can include more frequent infections, sore throat or mouth ulcers;
• increased risk of bleeding (including nosebleeds and/or bleeding gums) and bruising. This may be linked to a blood problem called "thrombocytopenia", i.e. a reduction in the number of platelets in the blood;
• abnormal liver function (liver problems). Signs can include yellowing of the skin and whites of the eyes;
• if you are to have eye surgery for cataracts (clouding of the lens) and are using or have previously used Alfuzosina Aurobindo, the pupil may dilate poorly and the iris (the circular coloured part of the eye) may become floppy during the procedure. This only happens during the operation and it is important that the specialist knows about this possibility as the operation may be carried out in a different way (see paragraph “Surgery duringAlfuzosina Aurobindo use”);
• persistent, abnormal, often painful erection of the penis not related to sexual activity (priapism);
• feeling sick (vomiting);
• stroke (insufficient blood flow to the brain). This is more likely in patients who have had previous problems with blood flow to the brain.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this
leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Alfuzosina Aurobindo

Keep this medicine out of the sight and reach of children .
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the label, on the carton, on the bottle
after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Alfuzosina Aurobindo contains

• The active ingredient is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
• Other ingredients are: Tablet core:hypromellose (E464), hydrogenated vegetable oil, povidone (K-30) (E1201), calcium hydrogen phosphate, carbomer, colloidal anhydrous silica (E551), magnesium stearate (E572).

Coating:hypromellose (E464), propylene glycol, titanium dioxide (E171).
The tablets have a prolonged effect, which means that after administration the active substance is not
released immediately from the tablet but gradually and therefore acts for longer.

Description of Alfuzosina Aurobindo and contents of the pack
Prolonged-release tablets.
White to off-white, round, biconvex, film-coated tablets imprinted with “X” on one side and
“47” on the other side.
Alfuzosina Aurobindo tablets are available in blister packs made of PVC/PVdC/Aluminum and in
round opaque white HDPE bottles containing silica gel.

Packs:
Blister packs: 30, 50 and 100 tablets.
HDPE bottle: 30, 500 and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturers
APL Swift Services (Malta) Limited – HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 –
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Cyprus: Alfuzosin Aurobindo 10 mg δισκία παρατεταμένης
Czech Republic: Alfuzosin Aurovitas
Germany: Alfuzosin Aurobindo 10 mg Retardtabletten
Italy: Alfuzosina Aurobindo
Ireland: Alfu 10 mg prolonged release tablets
Malta: Zochek 10 mg prolonged-release tablets
Netherlands: Alfuzosine HCl Aurobindo 10 mg, tabletten met verlengde afgifte
Spain: Alfuzosina Aurovitas 10 mg comprimidos de liberación prolongada EFG