ALFURION 10 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Alfurion
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Contents of the Package Leaflet:
3. What Alfurion is and what it is used for
4. Important information before taking Alfurion
   1. When not to take Alfurion
   2. Warnings and precautions
   3. Alfurion and other medicines
   4. Surgical procedures during Alfurion treatment
   5. Alfurion with food and drink
   6. Driving and using machines
5. How to take Alfurion
   1. Use in children
   2. If you take more Alfurion than you should
   3. If you forget to take Alfurion
   4. If you stop taking Alfurion
6. Possible side effects
   1. Prolonged erection of the penis (priapism)
   2. Reporting side effects
7. How to store Alfurion
8. Contents of the pack and other information
   1. What Alfurion contains
   2. What Alfurion looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. For further information about this medicine, contact the local representative of the marketing authorization holder:

Package Leaflet: Information for the User

Alfurion

10 mg, prolonged-release tablets
Alfuzosine hydrochloride

Read the package leaflet carefully before taking the medicine, 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 medicine 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 any not listed in this package leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

• 1. What Alfurion is and what it is used for
• 2. Important information before taking Alfurion
• 3. How to take Alfurion
• 4. Possible side effects
• 5. How to store Alfurion
• 6. Other information

1. What Alfurion is and what it is used for

Alfurion belongs to a group of medicines called alpha-1 adrenergic blockers.
Alfurion is used to treat moderate to severe symptoms of benign prostatic hyperplasia (BPH). This is a condition where the prostate gland enlarges (hyperplasia), but the growth is non-cancerous (benign). It usually occurs in older men.
The prostate gland is located below the bladder and surrounds the urethra, which carries urine out of the body. As men age, the prostate gland may enlarge, squeezing the urethra and reducing its diameter. This can cause problems with urination, such as frequent urination and difficulty urinating.
Alfuzosin works by relaxing the muscles in the prostate gland, which helps to reduce the constriction of the urethra and improve urine flow.

2. Important information before taking Alfurion

When not to take Alfurion

• If you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: rash, swelling of the lips, throat or tongue, difficulty swallowing or breathing.
• If you have or have had low blood pressure when standing up from a sitting or lying position (medically known as orthostatic hypotension). This can cause dizziness, fainting or lightheadedness when standing up quickly.
• If you have liver disease.
• If you are taking another alpha-1 adrenergic blocker (such as terazosin, doxazosin). See section below "Alfurion and other medicines". If in doubt, consult your pharmacist or doctor.

Warnings and precautions

Before taking Alfurion, discuss with your doctor or pharmacist if:

• You have severe kidney problems.
• You have heart disease.
• You have chest pain (angina pectoris).
• You have an abnormal heart rhythm (known as QT interval prolongation).

In some patients, especially those taking medicines for high blood pressure or chest pain (angina pectoris), dizziness, weakness or sweating may occur within a few hours of taking the dose. In this case, lie down and stay in bed until the symptoms have completely disappeared. Tell your doctor, as the dose may need to be adjusted.
If you experience a prolonged erection of the penis (often painful) without sexual activity, which lasts longer than 4 hours, seek medical attention immediately, as this condition may require treatment. See section below "Possible side effects".

Alfurion and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken or might take.
Alfurion may affect the way other medicines work. Some medicines may also affect the way Alfurion works.
Do not take Alfurion if you are taking:

• Other alpha-1 adrenergic blockers, such as doxazosin, indoramin, prazosin, terazosin, tamsulosin or phenoxybenzamine.

Before starting to take this medicine, talk to your doctor or pharmacist if:

• You have had a severe drop in blood pressure after taking another alpha-1 adrenergic blocker (including alfuzosin in the past).
• You are taking medicines for high blood pressure, as dizziness, weakness or sweating may occur within a few hours of taking the dose. In this case, lie down and stay in bed until the symptoms have completely disappeared. Tell your doctor, as the dose may need to be adjusted.
• You are taking medicines for chest pain (angina pectoris).
• You are taking medicines for fungal infections (such as itraconazole).
• You are taking medicines for HIV infection (such as ritonavir).
• You are taking medicines for bacterial infections (such as clarithromycin, telithromycin).
• You are taking medicines for depression (such as nefazodone).
• You are taking ketoconazole tablets (a medicine used to treat Cushing's syndrome - when the body produces too much cortisol).

Surgical procedures during Alfurion treatment

• If you are going to have surgery under general anesthesia, tell your doctor before the operation that you are taking Alfurion, as it may be dangerous due to the risk of low blood pressure.
• If you are going to have cataract surgery (clouding of the lens in the eye), tell your eye doctor before the operation that you are taking or have taken Alfurion, as it may cause complications during surgery that can be avoided if the doctor knows about it in advance.

Alfurion with food and drink

Take Alfurion after a meal.

Driving and using machines

While taking Alfurion, dizziness or weakness may occur. If you experience these symptoms, do not drive or operate machinery.

3. How to take Alfurion

Always take Alfurion exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Swallow the tablet whole with a sufficient amount of liquid (e.g. a glass of water).
• Do not break, crush or chew the tablet, as this may affect the release of the medicine.
• Take the medicine after a meal.

Adults
The usual dose is one 10 mg tablet once a day.
Take the tablet after the evening meal.
Elderly patients (> 65 years)
The usual dose is one 10 mg tablet once a day. No dose adjustment is necessary in elderly patients (> 65 years).
Patient with mild to moderate kidney problems
The usual dose is one 10 mg tablet once a day. No dose adjustment is necessary in patients with mild to moderate kidney problems.
If you feel that Alfurion is too strong or too weak, tell your doctor or pharmacist.

Use in children

Alfuzosin is not recommended for children (under 16 years of age).

If you take more Alfurion than you should

Contact your nearest hospital immediately. Tell your doctor how many tablets you have taken. Lie down and stay in bed for as long as possible to avoid side effects. Do not try to drive to the hospital yourself.

If you forget to take Alfurion

Do not take a double dose to make up for a forgotten dose. Skip the missed dose and take the next tablet as prescribed.

If you stop taking Alfurion

Continue taking the tablets even if you feel better. Do not stop treatment unless your doctor tells you to. Symptoms improve more easily if you continue taking the medicine at the same dose.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alfurion can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking Alfurion and contact your doctor or go to your nearest hospital immediately:

• Chest pain (angina pectoris)(may affect up to 1 in 10,000 people)This side effect usually occurs in people with pre-existing angina pectoris. If you experience chest pain, stop taking Alfurion and contact your doctor or go to your nearest hospital immediately.
• Severe allergic reactions(may affect up to 1 in 10,000 people)Symptoms may include swelling of the face, lips, tongue or throat, difficulty swallowing or breathing. These are symptoms of an allergic reaction. If you experience these symptoms, stop taking Alfurion and contact your doctor or go to your nearest hospital immediately.

Prolonged erection of the penis (priapism)

Priapism is a painful and prolonged erection of the penis without sexual activity. If you experience a prolonged erection of the penis, which lasts longer than 4 hours, seek medical attention immediately, as this condition may require treatment.
This condition may lead to permanent impotence if not treated properly.
Other side effects:
Common ( may affect up to 1 in 10 people)

• Dizziness
• Headache
• Nausea (feeling sick)
• Discomfort in the stomach and indigestion (dyspepsia)
• Abdominal pain
• Weakness or feeling tired.

Uncommon ( may affect up to 1 in 100 people)

• Dizziness or lightheadedness when standing up or sitting down
• Fast heartbeat (tachycardia)
• Drowsiness
• Runny nose, itching, sneezing and cough
• Diarrhea and vomiting
• Dry mouth
• Rash and itching
• Fluid retention (may cause swelling of the hands or feet)
• Chest pain
• Hot flushes.

Additional side effects that may occur ( frequency cannot be estimated from the available data):

• Irregular and rapid heartbeat
• Decreased white blood cell count. Symptoms may include frequent infections, sore throat or mouth ulcers.
• Decreased platelet count. Symptoms may include bleeding from the gums or nose, bruising, prolonged bleeding from a wound, rash (small, red, pinpoint spots, known as petechiae).
• Abnormal liver function (liver problems). Symptoms may include yellowing of the skin or the whites of the eyes.
• If you are going to have eye surgery for cataracts (clouding of the lens in the eye) and have taken Alfurion, the pupil may dilate more slowly and the iris may become floppy during the operation. This only happens during surgery. It is important that the eye doctor performing the operation knows that you have taken Alfurion, as they may need to adjust the operation (see section "Surgical procedures during Alfurion treatment").

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor or pharmacist. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw,
Phone: +48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alfurion

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Alfurion contains

• The active substance is alfuzosin hydrochloride. Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
• The other ingredients are: tablet core: hypromellose, hydrogenated vegetable oil, povidone (K-30), calcium hydrogen phosphate, carbomers, silica, colloidal anhydrous, magnesium stearate; tablet coating: hypromellose, propylene glycol, titanium dioxide (E 171).

What Alfurion looks like and contents of the pack

Prolonged-release tablet.
White or almost white, round, biconvex, film-coated tablets with "X" engraved on one side and "47" on the other. The diameter of the tablet is 8.1 mm.
Pack sizes: 30 tablets

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer/Importer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland

For further information about this medicine, contact the local representative of the marketing authorization holder:

Orion Pharma Poland Sp. z o. o.
[email protected]
Date of last revision of the package leaflet:09.01.2023