Xatral Xl 10mg Tablet

Treatment of functional symptoms of benign prostatic hyperplasia. Adjunctive therapy with urethral catheterisation for acute urinary retention (AUR) related to benign prostatic hyperplasia (BPH).

Benign prostatic hyperplasia (BPH): The recommended dose for XATRAL XL 10 mg tablets is one tablet daily to be taken after meals (as bioavailability in the fasting state is less than half that after a meal).

Acute urinary retention (AUR): One 10 mg tablet daily after a meal to be taken from the first day of catheterisation. Tablets should be swallowed whole.

Hypersensitivity to alfuzosin or any component. Orthostatic hypotension. Combination with other alpha 1 -adrenoceptor blockers. Hepatic insufficiency. Severe renal insufficiency. Not indicated for children.

In some subjects, in particular patients receiving antihypertensive medications, postural hypotension with or without symptoms (dizziness, fatigue, sweating) may develop within a few hours following administration. In such cases, the patient should lie down until the symptoms have completely disappeared. These effects are usually transient, occur at the beginning of treatment, and do not usually prevent the continuation of treatment. The patient should be warned of the possible occurrence of such events.

Care should be taken when XATRAL XL 10 mg is administered to patients with symptomatic orthostatic hypotension.

Combinations contraindicated: Alpha 1 -adrenoceptor blockers (see CONTRAINDICATIONS).

Combinations to be taken into account:

• Antihypertensive drugs (see WARNINGS).
• Nitrates.
• General anaesthetics: Administration of general anaesthetics to a patient treated with XATRAL XL 10 mg may lead to a decrease in blood pressure.
• Potent CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir since XATRAL XL 10 mg blood levels are increased.

There are no data available on the effect of driving vehicles. Adverse reactions such as vertigo, dizziness and asthenia may occur. This should be taken into account when driving vehicles and operating machinery.

There are no data available on the effect of driving vehicles. Adverse reactions such as vertigo, dizziness and asthenia may occur. This should be taken into account when driving vehicles and operating machinery.

The following frequency rating is used, when applicable:

• very common : u2265 1/10;
• common : u2265 1/100 and < 1/10;
• uncommon : u2265 1/1000 and < 1/100;
• rare : u2265 1/10 000 and < 1/1000;
• very rare : u2264 1/10 000.

Gastrointestinal disorders:

• Common: Nausea, gastralgia
• Uncommon: Diarrhoea, dry mouth

Central and peripheral nervous system disorders:

• Common: Faintness/dizziness, headache
• Uncommon: Vertigo, drowsiness, malaise

Cardiovascular disorders, general:

• Uncommon: Tachycardia, symptomatic hypotension (postural), syncope, palpitations
• Very rare: Angina pectoris in patients with pre-existing coronary artery disease (see SPECIAL PRECAUTIONS)
• Unknown: Atrial fibrillation

Eye disorders:

• Unknown: Intraoperative Floppy Iris Syndrome (IFIS) (see SPECIAL PRECAUTIONS).

Respiratory system disorders:

• Uncommon: Rhinitis

Hepato-biliary disorders:

• Unknown: Hepatocellular injury, cholestatic liver disease

Skin and appendages disorders:

• Uncommon: Rash, pruritus
• Very rare: Urticaria, angioedema

Body as a whole - general disorders:

• Common: Asthenia
• Uncommon: Flushes, oedema, chest pain

Reproductive system and breast disorders:

• Unknown: Priapism

In case of overdosage, the patient should be hospitalised, kept in the supine position, and conventional treatment of hypotension should take place. XATRAL XL 10 mg is not dialysable because of its high degree of protein binding. Treatment is symptomatic and supportive.