ALFUZOSINA 10 mg Таблетки С Пролонгированным Высвобождением

Содержание инструкции

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

Alfuzosina Pensa 10 mg, prolonged-release tablets

Alfuzosin hydrochloride

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 their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is Alfuzosina Pensa 10 mg and what is it 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 an enlargement of the prostate gland, a condition which is also called 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 flow out of 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 components of this medicine
• if you suffer from conditions that cause a severe drop in blood pressure when standing up
• if you are taking other medicines that belong to the group of alpha-blockers
• if you have problems with your liver.

Warnings and precautions

• if you are taking other medicines to treat high blood pressure or if you are taking a nitrate to treat chest pain (angina). In this case your doctor will regularly check your blood pressure, especially at the beginning of treatment.
• If within a few hours of taking Alfuzosina Pensa 10 mg you experience a sudden drop in blood pressure when standing up, which manifests as dizziness, weakness or sweating. If you experience a drop in blood pressure, you should lie down with your legs and feet elevated, until the symptoms disappear. These effects are usually short-lived and occur at the beginning of treatment. Normally it is not necessary to interrupt the treatment.
• If you have had a sudden drop in blood pressure in the past after taking another medicine belonging to the group of alpha-blockers. In this case, the doctor will start treatment with alfuzosin at a low dose, then gradually increasing it.
• If you suffer from acute heart failure.
• If you suffer from chest pain (angina) and are undergoing treatment with a nitrate, as this may increase the risk of a drop in blood pressure. You should discuss with your doctor whether to continue treatment for chest pain or stop treatment with Alfuzosina Pensa 10 mg, especially if chest pain recurs or worsens.
• If you suffer from a heart condition that is highlighted on the ECG by a prolongation of the QT interval, or if you are taking medicines that can cause a prolongation of the QT interval. The doctor will examine you before and during treatment with Alfuzosina Pensa 10 mg,
• If you are undergoing eye surgery for cataracts (clouding of the lens), inform your ophthalmologist before the operation that you are using or have previously used Alfuzosina Pensa 10 mg. This is because Alfuzosina Pensa 10 mg can cause complications during surgery that can be treated if your ophthalmologist is prepared in advance.
• If you have severe kidney problems. Swallow the tablets whole. Do not crush, powder or chew the tablets as too much active ingredient alfuzosin may reach the 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 that belong to the
group of alpha-blockers
Alfuzosina Pensa 10 mg and some medicines can interfere with each other. These include:

• medicines to lower blood pressure
• medicines (nitrates) used in the treatment of symptoms of chest pain (angina). The concomitant use of Alfuzosina Pensa 10 mg with medicines used to treat high blood pressure and with nitrates used e.g. for the treatment of heart disease can lead to a lowering of blood pressure
• ketoconazole and itraconazole (medicines used to treat fungal infections) and ritonavir (medicine used to treat HIV infection)
• medicines that you receive before an operation (general anesthetics). Your blood pressure may drop markedly. If you are to undergo an operation, tell the 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 since alfuzosin is only for male patients.

Driving and operating machinery
At the beginning of treatment, Alfuzosina Pensa 10 mg may cause you to feel dizzy or weak. Do not
drive or operate machinery or perform dangerous operations until you know how your body reacts to the
treatment.

Important information about some excipients of Alfuzosina Pensa 10 mg
This medicine containssmall amounts of lactose. If your doctor has diagnosed you with
intolerance to some sugars, contact him before taking this medicine.

3. How to take Alfuzosina Pensa 10 mg

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is 1 extended-release tablet (10 mg of alfuzosin) once a day.
Take the first tablet at bedtime. Take the tablets every day immediately after the same meal, and
swallow the tablets whole with a sufficient amount of liquid. Do not crush, chew or split the tablets.
The dose for elderly patients (over 65 years) is 1 extended-release tablet once a day (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 kidney problems is 1 extended-release tablet (10 mg
of alfuzosin). Take the first dose at bedtime.

If you take more Alfuzosina Pensa 10 mg than you should
When you take large amounts of Alfuzosina Pensa 10 mg, your blood pressure may drop suddenly and
you may feel dizzy or even faint. If you start to feel dizzy, sit or lie down until you feel better. If
the symptoms do not disappear, call your doctor as the drop in 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 a missed tablet as this may cause a sudden drop in blood
pressure, especially if you are taking medicines to lower blood pressure. Take the next tablet as
indicated.

If you stop taking Alfuzosina Pensa 10 mg
You should not stop, or discontinue taking Alfuzosina Pensa 10 mg without first talking to your
doctor. If you want to stop the treatment or if you have any doubts about the use of this medicine,
ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alfuzosina Pensa 10 mg can cause side effects, although not everybody gets them.

• Common side effects (may affect more than 1 in 100 and less than 1 in 10 patients) are fainting/dizziness, headache, stomach pain, nausea, indigestion, dry mouth, feeling weak, general feeling of discomfort.
• Uncommon side effects (may affect more than 1 in 1,000 and less than 1 in 100 patients) are feeling of spinning (vertigo), drowsiness, fainting, vision problems, fast heartbeat, feeling of a pounding or racing heartbeat, sudden drop in blood pressure when standing up, flushing of the face, runny nose, diarrhoea, skin rash, itching, urinary incontinence, swelling of the ankles and feet, chest pain.
• Very rare side effects (may affect less than 1 in 10,000 patients): worsening or recurrence of chest pain (angina pectoris) in patients with coronary heart disease, hives, swelling of the skin and mucous membranes, especially on the face and around the mouth, 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 iris flag syndrome, irregular heartbeat (atrial fibrillation), vomiting, liver damage, alteration of liver values due to obstruction of bile flow, persistent and painful erection (priapism).

If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist.

5. How to store ALFUZOSINA PENSA 10 MG

Do not store at a temperature above 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in wastewater 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 Pensa 10 mg contains

• The active ingredient 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 contents of the pack
Alfuzosina Pensa 10 mg prolonged-release tablets are uncoated, white,
round tablets with bevelled edges.
They are available in packs of 10, 20, 30, 50, 60, 60x1, 90, 100 tablets in blisters made of
PVC/PVDC-aluminium.
Not all pack sizes may be marketed.

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

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

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Denmark: Alfuzosinhydrochlorid "Pensa"
Italy: Alfuzosina Pensa 10 mg