Ofuxal

Package leaflet: Information for the patient

OFUXAL 10 mg prolonged-release tablets

alfuzosin hydrochloride
Equivalent medicine
Please read all of this leaflet carefully before you start 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 give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What OFUXAL is and what it is used for

OFUXAL contains the active substance alfuzosin, which belongs to a group of medicines known as selective alpha1-adrenergic receptor antagonists or alpha1-blockers.
Alfuzosin is used to treat the symptoms of a condition called "Benign Prostatic Hyperplasia" (BPH). "Benign prostatic hyperplasia" means that the prostate gland becomes enlarged (hypertrophy), but this growth is not cancerous (it is benign). Symptoms include: frequent need to urinate (especially at night), difficulty urinating, and the sensation of not having completely emptied the bladder.
Alfuzosin works by relaxing the muscles of the prostate and bladder, thus making urination easier.
OFUXAL is also indicated as an add-on therapy to urethral catheterisation (insertion of a small tube into the bladder through the urethra to allow urine to drain) in the treatment of acute urinary retention (a condition in which the patient is unable to empty the bladder of urine) caused by enlargement of the prostate gland (benign prostatic hypertrophy).

2. What you need to know before taking OFUXAL

Do not take OFUXAL

• if you are allergic (hypersensitive) to alfuzosin or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer or have suffered from sudden drops in blood pressure upon rapidly standing up after sitting or lying down (orthostatic hypotension);
• if you have liver problems (hepatic insufficiency);
• if you are taking any other medicine known as an “alpha-blocker” (e.g. terazosin, doxazosin);
• if you are taking ritonavir alone or in combination with ombitasvir/paritaprevir, lopinavir, or nirmatrelvir. See section “Other medicines and OFUXAL”.

Warnings and precautions
Like all alpha-1 blockers, if you have acute heart failure (a condition in which the heart is unable to pump an adequate amount of blood), your doctor will prescribe OFUXAL with caution.
Consult your doctor before taking OFUXAL:

• if you are taking medicines to treat high blood pressure (antihypertensives) or chest pain (nitrates); your doctor will prescribe OFUXAL with caution.
• Within a few hours after taking OFUXAL, sudden drops in blood pressure may occur when rapidly changing from a sitting or lying position to standing (orthostatic hypotension), with or without symptoms (dizziness, fatigue, sweating). If this happens, you should lie down until symptoms completely disappear. These effects usually occur at the beginning of treatment, last briefly, and generally do not require discontinuation of therapy.
• Your doctor should regularly monitor your blood pressure, especially at the beginning of treatment;
• if you experience a sudden drop in blood pressure when standing up. This may cause dizziness, weakness, or sweating within a few hours after taking OFUXAL. In such cases, you must lie down until symptoms completely resolve. These effects are usually temporary and occur at the beginning of treatment;
• if you have heart disease, are taking medicines to control blood pressure, or are elderly, you have a higher risk of experiencing a significant drop in blood pressure (circulatory collapse) and adverse effects. Therefore, your doctor will prescribe OFUXAL with caution;
• if you have previously been treated with an alpha-blocker that caused a significant decrease in blood pressure. Your doctor will start treatment with a low dose of alfuzosin and gradually increase the dose depending on your response. Blood pressure should be monitored regularly, especially at the beginning of treatment;
• if you have acute heart failure (a condition in which the heart is unable to pump an adequate amount of blood);
• if you have congenital QTc prolongation, a known history of acquired QTc prolongation, or are taking medicines known to increase the QTc interval. Your doctor should evaluate you both before and during alfuzosin treatment;
• if you have coronary artery disease (heart artery disorder), you should continue specific treatment for coronary insufficiency. If angina pectoris recurs or worsens, alfuzosin should be discontinued;
• if you experience chest pain (angina) and are being treated with a "nitrate". Taking alfuzosin may increase the risk of low blood pressure;
• if, while taking OFUXAL, as with other alpha-1 blockers, you experience a persistent, painful erection of the penis unrelated to sexual activity (priapism). In this case, inform your doctor, as failure to properly treat this condition may lead to permanent impotence (see "Possible side effects");
• before undergoing cataract surgery (clouding of the lens), inform your ophthalmologist about current or previous treatment with OFUXAL. This is because OFUXAL may cause complications during surgery, which can be managed if the specialist is informed in advance;
• if you have severe kidney disease (severe renal insufficiency, with creatinine clearance < 30 ml/min), OFUXAL will not be administered, as prolonged-release tablets should not be given to patients with severe kidney problems.

Talk to your doctor if any of these situations apply to you.
The tablet must be swallowed whole. It must not be crushed, chewed, broken, or powdered. Doing so may result in inappropriate release and absorption of the medicine, increasing the risk of early adverse effects.

Other medicines and OFUXAL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Do not take OFUXAL if you are using:

• other medicines belonging to the group of alpha-1 antagonists (see "Do not take OFUXAL"), as this may increase the blood pressure-lowering effect;
• ritonavir alone or in combination with lopinavir (commonly used for HIV treatment), or ritonavir in combination with ombitasvir/paritaprevir (commonly used for chronic hepatitis C infection), or ritonavir in combination with nirmatrelvir (commonly used for mild to moderate COVID-19 treatment).

The effects of OFUXAL may be influenced by, or may influence, the following medicines:

• medicines used to lower blood pressure (antihypertensives) (see "Warnings and precautions");
• medicines used to treat chest pain (nitrates) (see "Warnings and precautions");
• medicines used to treat fungal infections (such as itraconazole), as they increase alfuzosin concentration in the blood;
• ketoconazole tablets (used to treat Cushing's syndrome, when the body produces excess cortisol).
  OFUXAL must not be taken with other "alpha-1 blockers" such as terazosin or doxazosin. Use OFUXAL with caution if you are taking medicines to lower blood pressure due to the risk of further blood pressure reduction, especially if you are elderly.

If you have scheduled surgery requiring administration of anesthetics, inform your doctor that you are taking OFUXAL, as this medicine may affect blood pressure.

OFUXAL with food and drink
OFUXAL should be taken after meals.

Pregnancy, breastfeeding and fertility
Not applicable, as OFUXAL is intended for use in men only.

Driving and using machines
At the beginning of treatment with OFUXAL, you may experience a sensation of light-headedness, dizziness, or fainting.
If you feel this way, do not drive or operate machinery or perform hazardous activities until symptoms have passed.

OFUXAL contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to use OFUXAL

Use this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

For the treatment of enlarged prostate (benign prostatic hyperplasia)
The recommended dose is one tablet daily, taken after a meal.
On the first day, take the tablet in the evening before going to bed.
Thereafter, take the tablet at the same time each day, after a meal.

For the treatment of inability to empty the bladder (acute urinary retention)
The recommended dose is one tablet daily after a meal, starting from the first day of catheter placement (a small tube inserted into the bladder through the urethra to allow urine to drain out).

The tablet must be swallowed whole with a glass of water.

Elderly patients (over 65 years of age) and patients with mild to moderate renal impairment
Your doctor will prescribe a lower starting dose of alfuzosin. If you tolerate the medicine well and require a higher dose, your doctor will prescribe one tablet of OFUXAL daily.

Use in children and adolescents
The efficacy of alfuzosin in children aged between 2 and 16 years has not been demonstrated. Therefore, alfuzosin is not indicated for use in the pediatric population.

If you take more OFUXAL than you should
If you take excessive doses of OFUXAL, your blood pressure may drop suddenly, causing dizziness or even fainting. If you start to feel dizzy, sit or lie down until you feel better. If symptoms do not go away, contact your doctor, as you may require hospital treatment.

If you forget to take OFUXAL
If you forget to take a dose, take the next tablet at your usual time. Do not take a double dose to make up for the missed tablet, as this may cause a sudden drop in blood pressure, especially if you are being treated with medicines that lower blood pressure.

If you stop using OFUXAL
Do not stop treatment without first consulting your doctor. If you wish to discontinue treatment or if you have any doubts about using this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
All medicines can cause allergic reactions, although serious allergic reactions are very rare. If your face or
throat swells after taking these tablets, consult your doctor immediately.
A common side effect when starting treatment is dizziness,
especially when standing up from a chair or bed (orthostatic hypotension). If you begin to feel lightheaded or dizzy, sit or lie down until you feel better.

The following side effects have been reported. If any of these effects worsen, consult your doctor.

Common side effects (may affect up to 1 in 10 people):

• feeling weak or tired
• nausea
• abdominal pain
• indigestion
• dry mouth
• dizziness
• headache

Uncommon side effects (may affect up to 1 in 100 people):

• rapid heartbeat
• swelling of the ankles and feet (edema)
• chest pain
• diarrhea
• vomiting
• incontinence
• fainting (especially at the beginning of treatment)
• vertigo
• runny nose
• skin rash
• itching
• flushing
• marked drop in blood pressure (orthostatic hypotension)

Very rare side effects (may affect up to 1 in 10,000 people):

• worsening or recurrence of chest pain (angina pectoris)
• urticaria
• generalized swelling of the body (angioedema)
• urticaria

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

• changes in heart rhythm (atrial fibrillation)
• Intraoperative Floppy Iris Syndrome (IFIS)
• liver damage (hepatocellular injury)
• interruption or suppression of bile flow (cholestatic liver disease)
• persistent and painful erection (priapism)
• significant drop in blood pressure with various disturbances up to loss of consciousness (circulatory collapse)
• decrease in white blood cells (neutropenia)
• decrease in platelets (thrombocytopenia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 OFUXAL

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 stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OFUXAL contains
The active substance is alfuzosin hydrochloride.
Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
The other excipients are:
Tablet core: lactose monohydrate, hypromellose, microcrystalline cellulose, povidone K25, anhydrous colloidal silica, magnesium stearate.
Tablet coating: Opadry II white: poly(vinyl alcohol), titanium dioxide (E171), macrogol 4000, talc (E553b), ethylcellulose (20cP), medium-chain triglycerides, oleic acid.
Description of the appearance of OFUXAL and contents of the pack
OFUXAL prolonged-release tablets are white, round, film-coated tablets.
Blister pack made of PVC/PVDC/aluminum containing 30 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LAMPUGNANI FARMACEUTICI S.p.A. - Via Gramsci, 4 - 20014 Nerviano (Milan) - Italy
Manufacturer
MIPHARM S.p.A., Via B. Quaranta, 12 – 20141 Milan (Italy)