ALFABAX 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Alfabax, 10 mg, Prolonged-Release Tablets
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Package Leaflet Contents
3. What is Alfabax and What is it Used For
4. Important Information Before Taking Alfabax
   1. When Not to Take Alfabax
   2. Warnings and Precautions
   3. Children
   4. Alfabax and Other Medications
   5. Taking Alfabax with Food and Drink
   6. Pregnancy and Breastfeeding
   7. Driving and Operating Machinery
   8. Alfabax Contains Lactose
5. How to Take Alfabax
   1. Benign Prostatic Hyperplasia
   2. Acute Urinary Retention
   3. Elderly Patients (Over 65 Years) and Patients with Renal Impairment
   4. Patients with Hepatic Impairment
   5. Use in Children and Adolescents
   6. Overdose of Alfabax
   7. Missed Dose of Alfabax
   8. Stopping Alfabax Treatment
6. Possible Side Effects
   1. Severe Side Effects:
   2. Other Side Effects:
   3. Reporting Side Effects
7. How to Store Alfabax
8. Package Contents and Other Information
   1. What Alfabax Contains
   2. What Alfabax Looks Like and Package Contents
   3. Marketing Authorization Holder and Manufacturer
   4. Marketing Authorization Holder:
   5. Manufacturer:
   6. This Medicinal Product is Authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) Under the Following Names:

Package Leaflet: Information for the User

Alfabax, 10 mg, Prolonged-Release Tablets

Alfuzosine Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

Package Leaflet Contents

• 1. What is Alfabax and What is it Used For
• 2. Important Information Before Taking Alfabax
• 3. How to Take Alfabax
• 4. Possible Side Effects
• 5. How to Store Alfabax
• 6. Package Contents and Other Information

1. What is Alfabax and What is it Used For

Alfabax is a medication in the form of a tablet that should be taken orally.
Alfuzosine belongs to a group of medications used to treat prostate gland diseases, called alpha-1-adrenolytics. It causes relaxation of the muscles in the prostate gland and urethra, facilitating urine flow from the bladder.
Alfuzosine is used to treat symptoms of benign prostatic hyperplasia.
Benign Prostatic Hyperplasia
The prostate gland is located below the bladder. The urethra passes through the prostate gland and opens to the outside of the body. In addition to glandular tissue (producing seminal fluid), the prostate gland also contains muscle tissue. Muscle tissue is also found in the urethra. In benign prostatic hyperplasia, the muscle tissue of the prostate gland and urethra becomes tense, causing the urethra to narrow. As a result, urine flow from the bladder is impaired, and symptoms of the lower urinary tract occur.
Acute Urinary Retention
In some patients with benign prostatic hyperplasia, the prostate gland becomes so large that it completely blocks urine flow. This condition is called acute urinary retention.

• This is a very painful condition and may require a short hospital stay.
• A thin, flexible tube (catheter) is inserted into the bladder. This helps to empty the bladder of urine and relieve pain.
• During this time, alfuzosine treatment can be initiated to facilitate the restoration of urine flow from the bladder.

2. Important Information Before Taking Alfabax

When Not to Take Alfabax

Warnings and Precautions

Before starting Alfabax, discuss with your doctor or pharmacist:

You should consult your doctor if any of the above warnings apply to you or if such a situation has occurred in the past.

Children

Alfuzosine is not intended for use in children.

Alfabax and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
This includes medications taken without a prescription.
Some medications may affect the action of other medications or may not be taken at the same time for other reasons.
Alfabax should not be taken if:

• You are also taking other alpha-1-adrenolytics (used to treat prostate gland enlargement), such as doxazosin, indoramin, prazosin, terazosin, tamsulosin, or phenoxybenzamine.

You should consult your doctor before taking the medication:

• In case of combination with blood pressure medications, dose modification may be necessary due to the possibility of blood pressure drop.
• If you are scheduled to undergo surgery, you should inform your doctor about taking Alfabax.
• In case of combination with nitrates (medications that relieve chest pain), dose modification may be necessary due to the possibility of blood pressure drop.
• If you are taking medications usually used to treat impotence (erectile dysfunction).
• If you are taking medications used to treat premature ejaculation (dapoxetine).
• If you are taking medications used to treat hepatitis C (such as telaprevir and boceprevir).
• If you are taking medications used to treat bacterial infections (such as clarithromycin, erythromycin, telithromycin).
• If you are taking medications used to treat depression (such as nefazodone).
• If you are taking ketoconazole in tablet form (used to treat Cushing's syndrome, a condition where the body produces too much of the hormone cortisol).
• In case of concurrent use with medications that inhibit the activity of the liver enzyme CYP3A4, such as itraconazole, posaconazole, voriconazole, cobicistat, nelfinavir, and ritonavir, dose adjustment may be necessary.

Taking Alfabax with Food and Drink

• Alfabax should be taken immediately after a meal.
• Drinking alcohol may enhance the side effects of the medication. During Alfabax treatment, dizziness and weakness may occur. If these symptoms occur, do not drink alcohol.

Pregnancy and Breastfeeding

This does not apply. Alfabax is prescribed only to men.

Driving and Operating Machinery

There is no available data on the effect of this medication on the ability to drive or operate machinery. Symptoms such as dizziness or general weakness may occur. This should be taken into account when driving or operating machinery.

Alfabax Contains Lactose

This medication contains lactose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medication.

3. How to Take Alfabax

This medication should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Oral administration.

Benign Prostatic Hyperplasia

The usual dose is one tablet per day.

Acute Urinary Retention

Alfabax will be administered to you by your doctor on the day of catheter insertion.
You should continue taking Alfabax once a day.
You should take one Alfabax tablet after your evening meal. The tablet should be swallowed with a large amount of liquid (e.g., a glass of water). The prolonged-release tablets should not be crushed, chewed, or divided.
The best effect can be achieved by taking the tablet at the same time every day. This also helps remember to take the tablet.

Elderly Patients (Over 65 Years) and Patients with Renal Impairment

No dose adjustment is necessary in cases of mild or moderate renal impairment, but in cases of severe renal impairment, the doctor will not prescribe this medication.

Patients with Hepatic Impairment

Alfabax tablets should not be used in patients with hepatic impairment.
However, in cases of mild to moderate hepatic impairment, other products containing alfuzosine in a low dose can be used, according to the appropriate dosing schedule.
Your doctor will inform you about this.

Use in Children and Adolescents

The efficacy of Alfabax has not been established in children aged 2 to 16 years, therefore Alfabax is not recommended for use in children and adolescents (aged 2 to 16 years).

Overdose of Alfabax

In case of overdose, you should immediately consult your doctor or pharmacist.

Missed Dose of Alfabax

It may happen that you forget to take your medication. In such a case, there is no need to take the missed tablet. You can take the prescribed dose of Alfabax the next day.
Do not take a double dose to make up for the missed tablet.

Stopping Alfabax Treatment

Do not stop or discontinue Alfabax treatment without consulting your doctor first. You should take the tablets as directed and for as long as your doctor has prescribed. Do not stop taking them even if you feel better, as symptoms may return.
If you have any further questions about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Alfabax can cause side effects, although not everybody gets them.

Severe Side Effects:

If you experience any of the following side effects, stop taking Alfabax and immediately consult your doctor or go to the nearest hospital emergency department:
Very Rare (less than 1 in 10,000 people)

• Sudden onset of swelling of the eyelids, face, lips, mouth, and tongue, difficulty breathing or swallowing, rash, hives, and itching. These are symptoms of a severe allergic reaction. (The medical term for these symptoms is angioedema).
• A feeling of pressure, heaviness, discomfort, or crushing pain in the chest, which may radiate to the arms, neck, and jaw (these may be symptoms of angina pectoris). This usually occurs only in patients with a history of angina pectoris.

Unknown (frequency cannot be estimated from the available data)

• Prolonged and painful erections unrelated to sexual activity (this may be caused by a condition called priapism).

Other Side Effects:

Common (less than 1 in 10 people)

• feeling of nausea (nausea);
• abdominal pain;
• dry mouth;
• feeling of weakness or fatigue;
• malaise (feeling unwell);
• headache;
• dizziness or fainting;
• general weakness (asthenia).

Uncommon (less than 1 in 100 people)

• diarrhea;
• vision disturbances;
• rapid heartbeat (tachycardia);
• feeling of rapid or irregular heartbeat (palpitations);
• sudden loss of consciousness;
• drop in blood pressure caused by, for example, quickly standing up from a sitting or lying position, which may be accompanied by dizziness (orthostatic hypotension);
• hot flashes (flushing);
• nasal congestion or runny nose, sneezing, facial pressure or pain (rhinitis);
• skin rash;
• itching;
• fluid retention (which may cause swelling of the hands or feet);
• chest pain;
• lethargy;
• feeling of spinning or rotation while remaining still (vertigo).

Very Rare (less than 1 in 10,000 people)

• liver damage caused by the medication or a chemical substance (hepatotoxicity);
• an itchy, lumpy rash also known as hives.

Unknown (frequency cannot be estimated from the available data)

• liver cell damage
• certain liver diseases caused by narrowing or blockage of the bile duct (cholestatic liver disease). Symptoms may include yellowing of the skin or whites of the eyes.
• vomiting
• in the case of cataract surgery (when the lens of the eye is cloudy) and taking Alfabax currently or in the past, the pupil may not dilate properly, and the iris may become flaccid during the procedure. It is essential that the ophthalmologist is aware of this, as the surgery may require a different approach (see section "Warnings and Precautions").
• irregular and often rapid heart rhythm (atrial fibrillation)
• decreased white blood cell count (neutropenia), which may cause more frequent infections
• increased risk of bleeding (including nosebleeds and/or gum bleeding) and bruising. This may be a blood disorder called thrombocytopenia, characterized by a decrease in platelet count.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309.
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to Store Alfabax

The medication should be stored out of sight and reach of children.
There are no special storage recommendations.
Do not use this medication after the expiration date stated on the carton and blister pack, after "Expiration Date". The expiration date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Alfabax Contains

The active substance of Alfabax is alfuzosine hydrochloride.
Each prolonged-release tablet contains 10 mg of alfuzosine hydrochloride.
Other ingredients of the medication are: lactose anhydrous, colloidal silicon dioxide (E551), povidone (E1201), talc (E553B), magnesium stearate (E572), hypromellose (E464), hydroxypropyl cellulose (E463).
The tablet has a prolonged release, which means that after administration, the active substance is not released immediately but gradually, and therefore, the medication acts for a longer period.

What Alfabax Looks Like and Package Contents

Alfabax tablets are white to off-white, round, uncoated, biconvex, with smoothed edges, marked 'RY 10' on one side.
Alfabax is available in packs of 30 or 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw
tel. 22 642 07 75

Manufacturer:

Sun Pharmaceutical Industries Europe BV
Polarisavenue 87
2132 JH Hoofddorp
Netherlands
Terapia S.A.
Str. Fabricii Nr. 124
Cluj-Napoca 400 632
Romania
To obtain further information on this medicinal product or the package leaflet in another format, please contact the marketing authorization holder.

This Medicinal Product is Authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) Under the Following Names:

France: ALFUZOSINE CRISTERS PHARMA LP 10 mg prolonged-release tablets
Italy: Profuzo
Netherlands: Alfuzosine HC1 SUN 10 mg prolonged-release tablets
United Kingdom (Northern Ireland): Vasran XL 10 mg Prolonged-release Tablets
Date of Package Leaflet Approval:27.05.2023