Prostetrol 10 mg, 30 tablets

Trade Name:

Prostetrol

Alfuzosin Hydrochloride 10 mg 

30 modified release tablets

Composition:

Alfuzosin Hydrochloride 10 mg

Properties:

Alfuzosin belongs to a class of drugs known as alpha blockers. It does not shrink the prostate, but it works by relaxing the muscles in the prostate and the bladder. This helps to relieve symptoms of BPH such as difficulty in beginning the flow of urine, weak stream, and the need to urinate often or urgently (including during the middle of the night). Do not use this medication to treat high blood pressure.

Indications:

Alfuzosin is used by men to treat the symptoms of an enlarged prostate (benign prostatic hyperplasia-BPH).

Dosage and administration:

-Take this medication by mouth as directed by your doctor, usually once daily after a meal.

-This medication works best when taken with food. Taking alfuzosin on an empty stomach may make it not work as well.

Swallow the tablets whole. Do not crush or chew the tablets. 

-If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Side Effects:

-Common: Dizziness or lightheadedness may occur. If either of these effects lasts or gets worse, tell your doctor promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

-Very serious: severe dizziness, fainting, fast/irregular heartbeat, chest pain.

-Rare: painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away.

-Get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Contraindications:

– Hypersensitivity to the active substance Prostetrol, other quinazolines (terazosin, doxazosin) or to any of the excipients.

– History of orthostatic hypotension.

– Combination with other alpha 1-blockers and / or dopamine receptor agonists.

– Severe hepatic insufficiency

Warnings and precautions:

-Alfuzosin may cause a sudden drop in your blood pressure, which could lead to dizziness or fainting, usually within a few hours after you take it. This risk is higher when you first start taking this drug or if you restart treatment after you stop taking it. During these times, avoid situations where you may be injured if you faint.

To avoid injury from dizziness or fainting, your doctor may tell you to take your first dose of alfuzosin with food at bedtime so that your body can get used to its effects.

Take this medication regularly to get the most benefit from it. To help you remember, take it after the same meal each day.

• Before taking alfuzosin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
• Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, heart problems (such as chest pain/angina, heart attack), low blood pressure, certain eye problems (cataracts, glaucoma).
• Alfuzosin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away safely.
• This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
• Older adults may be more sensitive to the side effects of this drug, especially dizziness and low blood pressure when getting up from a sitting or lying position, and QT prolongation (see above). These side effects can also increase the risk of falling.
• If you are also taking a drug to treat erectile dysfunction-ED or pulmonary hypertension (such as sildenafil, tadalafil), your blood pressure may get too low which can lead to dizziness or fainting. Your doctor may need to adjust your medications to minimize this risk.
• Other medications can affect the removal of alfuzosin from your body, which may affect how alfuzosin works. Examples include azole antifungals (such as itraconazole, ketoconazole), clarithromycin, cobicistat, hiv protease inhibitors (such as lopinavir), mifepristone, nefazodone, ribociclib, ritonavir, telithromycin, among others.
• Keep all medications away from children and pets.

Storage:

Store at room temperature away from light and moisture. 

Package:

Carton box holds 3 strips each of 10 modified release tablets and an insert leaflet.