Alfurion

Package leaflet: Information for the user

Alfurion
10 mg, prolonged-release tablets
Alfuzosini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

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. Contents of the pack and other information

1. What Alfurion is and what it is used for

Alfurion belongs to a group of medicines called alpha-1-adrenolytic agents.
Alfurion is used in the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH). This is a condition in which the prostate gland becomes enlarged (hyperplasia), but the growth is non-cancerous (benign). It most commonly occurs in older men.
The prostate gland is located below the urinary bladder and surrounds the urethra, the tube through which urine leaves the body. With age, the prostate gland may enlarge, pressing on the urethra and thereby reducing its diameter. This may cause urinary problems such as frequent urination and difficulty in urinating.
Alfuzosin works by relaxing the muscles of the prostate gland, which reduces narrowing of the urethra and facilitates urination.

2. Important information before using Alfurion

When not to use Alfurion

• If the patient is allergic to alfuzosin or to 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 the patient currently has or has previously had low blood pressure upon standing up from a sitting or lying position (medically known as orthostatic hypotension). This may cause dizziness, lightheadedness or fainting when standing up quickly.
• If the patient has liver disease.
• If the patient is taking another alpha-1-blocking medicine (such as terazosin, doxazosin). See section below “Alfurion with other medicines”. If in doubt, consult a pharmacist or doctor.
• If the patient is taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir. See section “Alfurion with other medicines” below.

Warnings and precautions
Before taking Alfurion, discuss with a doctor or pharmacist if:

• The patient has severe kidney function impairment.
• The patient has heart disease.
• The patient has chest pain (angina).
• It is known that the patient has an abnormality in the electrocardiogram (ECG) called QT interval prolongation.

In some patients, especially those taking medicines for high blood pressure or chest pain (angina), dizziness, weakness or sweating may occur within a few hours after taking a dose of the medicine. In such a case, the patient should lie down and remain lying until symptoms have completely resolved. Inform the doctor, who may decide to reduce the dose.
If an erection (often painful) occurs without sexual stimulation and lasts longer than 4 hours, immediate medical attention should be sought from a doctor or the nearest hospital, as this condition may require treatment. See section below “Possible side effects”.

Alfurion with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Alfurion may affect the action of certain other medicines. Some medicines may also affect the action of Alfurion.
Alfurion must not be taken if the patient is using:

• Other medicines in the class of alpha-blockers, such as doxazosin, indoramin, prazosin, terazosin, tamsulosin or phenoxybenzamine.
• Ritonavir taken alone or in combination with lopinavir (commonly used in the treatment of HIV), or ritonavir in combination with ombitasvir/paritaprevir (commonly used in the treatment of chronic viral hepatitis C), or ritonavir in combination with nirmatrelvir (commonly used in the treatment of mild to moderate COVID-19).

Before starting treatment with this medicine, talk to a doctor or pharmacist if:

• The patient previously experienced a severe drop in blood pressure after taking another alpha-blocker (including previous use of alfuzosin). Examples of other alpha-blocking medicines are listed in the paragraph above.
• The patient is taking medicines for high blood pressure, as dizziness, weakness or sweating may occur within a few hours after taking a dose. In such a case, the patient should lie down and remain lying until symptoms have completely resolved. Inform the doctor, as a dose adjustment may be necessary.
• The patient is taking medicines for chest pain (angina).
• The patient is taking medicines for fungal infections (such as itraconazole).
• The patient is taking medicines for bacterial infections (such as clarithromycin, telithromycin).
• The patient is taking medicines for depression (such as nefazodone).
• The patient is taking ketoconazole tablets (a medicine used in Cushing's syndrome - when the body produces excessive cortisol).

Surgical procedures while taking Alfurion

• If the patient is scheduled for surgery under general anaesthesia, inform the doctor about taking Alfurion before the procedure, as it may be dangerous due to the risk of reduced blood pressure.
• If the patient is scheduled for cataract surgery (clouding of the eye lens), inform the ophthalmologist about current or previous use of this medicine, as Alfurion may cause complications during surgery that can be avoided if the doctor is aware of the treatment in advance.

Alfurion with food and drink
Alfurion should be taken after a meal.
Driving and operating machinery
Dizziness or weakness may occur during treatment with Alfurion. If such symptoms occur, the patient should not drive or operate machinery.

3. How to use Alfurion

Alfurion should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

• The tablet should be swallowed whole with an adequate 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 drug into the body.
• The medicine should be taken after a meal.

Adults
The usual dose is one 10 mg tablet once daily.
The tablet should be taken after the evening meal.

Elderly patients (> 65 years)
The usual dose is one 10 mg tablet once daily. There is no need to adjust the dose in elderly patients (> 65 years).

Patients with mild to moderate renal impairment
The usual dose is one 10 mg tablet once daily. There is no need to adjust the dose in patients with mild to moderate renal impairment.

If the patient feels that Alfurion is too strong or not strong enough, they should inform their doctor or pharmacist.

Use in children
Alfuzosin is not recommended for use in children (aged 16 years or younger).

Taking more Alfurion than recommended
Seek immediate medical attention at the nearest hospital. Inform the doctor how many tablets have been taken. Lie down and remain in a lying position as long as possible to avoid the occurrence of adverse effects. Do not attempt to drive to the hospital yourself.

If a dose of Alfurion is missed
Do not take a double dose to make up for the missed dose. Omit the forgotten dose and take the next tablet as scheduled.

Stopping treatment with Alfurion
Continue taking the tablets even if symptoms improve. Treatment should only be stopped if advised by a doctor. Symptoms are more likely to resolve when the patient continues taking the medicine at the same dose.

If there are any further questions regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur, stop taking
Alfurion and contact your doctor immediately or go to the nearest
hospital:

• Chest pain (angina pectoris) (may occur in up to 1 in 10,000 people) This adverse reaction usually occurs in individuals who already have existing angina pectoris. If chest pain occurs, stop taking Alfurion and seek medical advice immediately or go to the nearest hospital.
• Severe allergic reactions (may occur in up to 1 in 10,000 people) Symptoms of angioedema may occur, such as red, blotchy rash, swelling (of the eyelids, face, lips, mouth, and tongue), difficulty swallowing and breathing. These are symptoms of an allergic reaction. If such symptoms occur, stop taking Alfurion immediately and seek medical advice or go to the nearest hospital.
• Prolonged penile erection (priapism) Priapism is an abnormal, often painful and prolonged erection unrelated to sexual activity. If a patient experiences an erection as described, lasting longer than 4 hours, seek medical advice immediately or go to the nearest hospital, as this condition may require treatment. This condition may lead to permanent impotence if not treated appropriately.

Other adverse reactions:
Common (may affect up to 1 in 10 people)

• Dizziness
• Headache
• Nausea
• Stomach discomfort and indigestion (dyspepsia)
• Abdominal pain
• Weakness or feeling tired.

Uncommon (may affect up to 1 in 10 people)

• Feeling dizzy, lightheaded, or fainting when standing up or sitting up quickly
• Fast heartbeat (tachycardia)
• Sleepiness
• Watery nasal discharge, itching, sneezing, and nasal congestion
• Diarrhea and vomiting
• Dry mouth
• Rash and itching
• Fluid retention (may cause swelling of the hands or feet)
• Chest pain
• Hot flushes.

Frequency not known (frequency cannot be estimated from available data):

• Irregular and rapid heartbeat
• Decrease in white blood cell count. Symptoms may include more frequent infections, sore throat, or mouth ulcers.
• Decrease in platelet count. Symptoms may include bleeding from gums and nose, bruising, prolonged bleeding from wounds, rash (small red spots, called petechiae).
• Liver function abnormalities (liver disorders). Symptoms may include yellowing of the skin or whites of the eyes.
• If a patient is undergoing cataract surgery (clouding of the eye's lens) and has previously taken Alfurion, during the procedure there may be slower pupil dilation and iris flaccidity (the colored, circular part of the eye). This occurs only during surgery. It is important that the ophthalmologist performing the procedure is aware of the patient's use of this medicine, as they may need to modify the surgical approach (see section “Surgical procedures during treatment with Alfurion”).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Poland
Tel: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Alfurion

Keep the medicine out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the specified month.
No special precautions for storage of the medicinal product are required.
Medicines must 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.
• Other ingredients are: tablet core: hypromellose, hydrogenated vegetable oil, povidone (K-30), calcium hydrogen phosphate, carbomers, colloidal anhydrous silica, 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, embossed with the mark “X” on one side and “47” on the other side. The tablet diameter is 8.1 mm.
Pack size: 30 tablets
Marketing Authorisation 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 medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]