OFUXAL 10 mg Extended-Release Tablets

Зміст інструкції

1. OFUXAL 10 mg prolonged-release tablets
   1. WHAT OFUXAL IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU USE OFUXAL
   3. HOW TO USE OFUXAL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE OFUXAL
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

OFUXAL 10 mg prolonged-release tablets

Alfuzosin hydrochloride
Generic medicine

• If you have any doubts, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Never give it to others. In fact, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

• 1. What OFUXAL is and what it is used for.
• 2. What you need to know before you use OFUXAL
• 3. How to use 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 ingredient alfuzosin, which belongs to the group of drugs called alpha-adrenergic receptor antagonists or “alpha blockers”.
Alfuzosin is used to treat the symptoms of a condition called “Benign Prostatic Hyperplasia” ( Benign

Prostatic Hyperplasia= BPH). “Benign Prostatic Hyperplasia” means that the prostate gland increases in volume
(hypertrophy), but this formation is not cancerous (it is benign). The symptoms include: frequent need to
urinate (especially at night), difficulty urinating and a feeling of not having completely emptied
the bladder.
Alfuzosin works by relaxing the muscles of the prostate and bladder, making urination easier.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OFUXAL

Do not use OFUXAL

• if you are allergic (hypersensitive) to alfuzosin or other “alpha-blockers” (for example terazosin, doxazosin)
• if you are allergic to any of the other ingredients of OFUXAL (the ingredients are listed in section 6 “Further information”)
• if you have fainted or experienced a feeling of dizziness when sitting or standing up suddenly
• if you have liver problems
• if you are taking any other medicine called "alpha-blocker" (for example terazosin, doxazosin)

Pay particular attention with OFUXAL especially

• if you have severe liver disorders
• if you are taking medicines to treat high blood pressure. Your doctor will need to check your blood pressure regularly, especially at the beginning of treatment.
• if you experience a sudden drop in blood pressure when getting up. This may cause dizziness, weakness or sweating within a few hours of taking OFUXAL. In these cases, you should lie down until the symptoms completely disappear. These effects are usually temporary and occur at the beginning of treatment.
• if you have previously been treated with an alpha-blocker that caused a significant decrease in blood pressure. Your doctor will start treatment with alfuzosin at a low dose and will gradually increase the dose, depending on how you feel. Blood pressure should be monitored regularly, especially at the beginning of treatment.
• if you suffer from acute heart failure
• if you have congenital prolongation of the QTc interval, or have a known history of acquired QTc prolongation or are taking medicines known to increase the QTc interval. Your doctor will need to evaluate you both before and during the use of alfuzosin.
• If you suffer from coronary artery disease, you should continue the specific treatment for coronary insufficiency. If angina pectoris occurs again or worsens, the use of alfuzosin should be discontinued.
• if you experience chest pain (angina) and are being treated with a “nitrate”. Taking alfuzosin may increase the risk of decreased blood pressure.
• before undergoing cataract surgery (clouding of the lens), inform your ophthalmologist about the current or previous treatment with OFUXAL. This is because OFUXAL can cause complications during the operation, which can be treated if the specialist has been warned in time.

Talk to your doctor if any of these situations apply to you.
The tablet must be swallowed whole. It must not be broken, crushed, or chewed, or reduced
to powder. This may result in inappropriate release and absorption of the medicine with the risk of
early side effects.

Taking OFUXAL with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including those
available without a prescription.
It is particularly important to tell your doctor if you are taking any of the following medicines, as they
may interact with your medicine:

• ketoconazole and itraconazole (medicines used to treat fungal infections)
• ritonavir (medicine used to treat HIV)
• medicines to lower blood pressure (see section Before using Ofuxal).
• medicines (nitrates) used to treat the symptoms of chest pain (angina). Concomitant use of OFUXAL with medicines used to treat hypertension or chest pain may cause a drop in blood pressure.

OFUXAL should not be taken with other “alpha1-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
decrease in blood pressure, especially if you are elderly.
If you have scheduled surgery that requires the administration of anesthetics, tell your
doctor that you are taking OFUXAL.

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

Driving and using machines
At the beginning of treatment with OFUXAL, you may experience a feeling of lightheadedness, dizziness or fainting. If you
feel this way, you should not drive vehicles or use machines or perform risky operations until the
symptoms have passed.

Important information about some of the excipients of OFUXAL
This medicine contains lactose. If your doctor has diagnosed you with intolerance to some sugars, contact
them before taking this medicine

3. HOW TO USE OFUXAL

Always use OFUXAL exactly as your doctor has instructed. If you have any doubts, ask your doctor or pharmacist.

How many tablets should you take?
The generally recommended dose is one tablet a day, after eating.
On the first day, take the tablet in the evening before going to bed.
Subsequently, take the tablet at the same time each day, after eating.
The tablet must be swallowed whole with a glass of water.
The tablets must not be crushed, chewed, or divided to avoid the body absorbing too much of the active ingredient, alfuzosin, very quickly; this may lead to
increased exposure to the risk of side effects.
Elderly patients (over 65 years) and patients with mild to moderate renal impairment:
Your doctor will prescribe starting treatment with a lower dose of alfuzosin. If you tolerate the
medicine well and require a higher dose, your doctor will prescribe one OFUXAL tablet a day.

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

If you use more OFUXAL than you should:
If you take high doses of OFUXAL, your blood pressure may drop suddenly and cause
dizziness or even fainting. If you start to feel dizzy, sit or lie down until you feel better. If the symptoms do not disappear, call your doctor, as you may need
hospital treatment.

If you forget to use OFUXAL
If you forget to take a dose, take the next dose at the usual time. Do not take a double
dose to make up for a forgotten 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
You should not stop treatment without first consulting your doctor. If you wish to stop treatment
or if you have any doubts about the medicine you are taking, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, OFUXAL can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions occur very
rarely. If your face or throat swells after taking these tablets, consult your doctor immediately.
A common side effect when starting treatment is a feeling of dizziness, especially
when getting up from a chair or bed (postural 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(more than 1 in 100 and less than 1 in 10 patients):

• dry mouth
• feeling of weakness
• general feeling of discomfort

Uncommon side effects(more than 1 in 1000 and less than 1 in 100 patients)

• fatigue
• headache
• dizziness
• abdominal pain
• indigestion
• nausea
• skin rash
• itching
• swelling of the ankles and feet
• incontinence
• edema
• vertigo

Very rare side effects(less than 1 in 10,000):

• drowsiness
• eye disorders
• fast heartbeat
• facial flushing (hot flushes)
• fainting (especially at the beginning of treatment)
• runny nose
• heart pain
• diarrhea
• significant drop in blood pressure (postural hypotension)
• worsening or recurrence of chest pain (angina pectoris)
• generalised swelling of the body (angioedema)
• urticaria

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

• persistent and painful erection (priapism)
• thrombocytopenia

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.agenziafarmaco.gov.it/it/responsabili
By reporting side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE OFUXAL

Keep out of the reach and sight of children
This medicinal product does not require special storage conditions.
Do not use OFUXAL after the expiry date indicated on the pack and the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.

• iridocyclitis (IFIS)
• change in heart rhythm (atrial fibrillation)
• vomiting
• liver damage
• decrease in white blood cells (neutropenia)

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What OFUXAL contains
The active ingredient is alfuzosin hydrochloride
Each prolonged-release tablet contains 10 mg of alfuzosin hydrochloride.
The excipients are:
Tablet core: lactose monohydrate, hypromellose, microcrystalline cellulose, povidone K25, colloidal anhydrous 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.
They are available in PVC/PVDC/aluminium blister packs of 30 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
LAMPUGNANI FARMACEUTICI S.p.A. - Via Gramsci 4-20014 Nerviano (Milan)-Italy
Manufacturer responsible for batch release:
MIPHARM S.p.A, via B.Quaranta, 12 – 20141 Milan (Italy)