Xatral Xl 10mg Prolonged release tablets

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

Posology: The recommended dose for XATRAL XL 10 mg is:

BPH: One XATRAL XL 10 mg tablet daily to be taken after meals (as bioavailability in the fasting state is less than half that after a meal).

AUR: One XATRAL XL 10 mg tablet daily after a meal to be taken from the first day of catheterisation.

Method of administration: The XATRAL XL 10 mg tablet must be swallowed whole (see section 4.4).

Special populations XATRAL XL 10 mg is contraindicated in patients with severe renal impairment (creatinine clearance u2264 30 mL/min), hepatic impairment and children below 18 years of age (see section 4.3).

• Hypersensitivity to alfuzosin or any of the excipients of XATRAL XL 10 mg (see section 6.1).
• Orthostatic hypotension (see section 4.4).
• Combination with other alpha-1-blockers (alpha-1-adrenoceptor blockers or antagonists).
• Hepatic impairment.
• Severe renal impairment (see section 4.4).
• Children below 18 years of age.
• Concomitant administration with potent CYP3A4 inhibitors (see section 4.5).

QT prolongation: Patients with acquired or congenital QT prolongation or who are taking medication that prolong the QT interval, should be evaluated before and during the administration of XATRAL XL 10 mg.

Priapism: Alpha-1-blockers, such as XATRAL XL 10 mg, has been associated with priapism (persistent painful penile erection unrelated to sexual activity). Because this condition can lead to permanent impotence if not properly treated, patients should be advised about the seriousness of the condition (see section 4.8).

Hypotension: In some patients, in particular those receiving antihypertensive medication and nitrates (see section 4.5), 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.

Pronounced drop in blood pressure has been reported in post-marketing surveillance in patients with pre-existing risk factors (such as underlying cardiac disease and/or concomitant treatment with anti-hypertensive medication). The risk of developing hypotension and related adverse reactions may be greater in elderly patients. 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 who have had a pronounced hypotensive response to another alpha-1-blocker.

Ischaemic heart disease: In coronary patients, XATRAL XL 10 mg should not be prescribed alone. In patients with ischaemic heart disease/angina pectoris, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or gets worse, XATRAL XL 10 mg should be discontinued.

Potent CYP3A4 inhibitors: Concomitant use of XATRAL XL 10 mg and potent CYP3A4 inhibitors (such as itraconazole, ketoconazole, protease inhibitors, clarithromycin, telithromycin and nefazodone) must be avoided (see section 4.3 and 4.5). XATRAL XL 10 mg should not be used concomitantly with CYP3A4 inhibitors that are known to increase the QT interval (e.g. itraconazole and clarithromycin) and a temporary interruption of XATRAL XL 10 mg treatment is recommended if treatment with such medicinal products is initiated.

Intraoperative floppy iris syndrome: Intraoperative floppy iris syndrome (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with some alpha-1-blockers (including XATRAL XL 10 mg). Although the risk of this event with XATRAL XL 10 mg appears very low, ophthalmic surgeons should be informed in advance of cataract surgery of current or past use of alpha-1-blockers, as IFIS may lead to increased procedural complications.

Mode of administration: Tablet should be swallowed whole. Any other mode of administration, such as crunching, crushing, chewing, grinding or pounding to powder should be prohibited. These actions may lead to inappropriate release and absorption of the medicine and therefore possible early adverse reactions.

Excipients statement: The excipient hydrogenated castor oil may cause stomach upset and diarrhoea.

Combinations contraindicated:

• Alpha-1-blockers (see section 4.3).
• Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, clarithromycin, telithromycin and nefazodone since XATRAL XL 10 mg blood levels are increased (see section 4.3 and 4.4).

Combinations to be taken into account:

• Antihypertensive medicines (see section 4.4).
• Nitrates (see section 4.4).
• General anaesthetics: Administration of general anaesthetics to a patient treated with XATRAL XL 10 mg may lead to a decrease in blood pressure.

Due to the indication area this section is not applicable.

There are no data available on the effect on driving vehicles. Adverse reactions such as vertigo, dizziness, asthenia and hypotension may occur, especially at the beginning of treatment. This should be taken into account when driving vehicles and operating machinery (see section 4.4).

The following frequency rating is used, when applicable: Very common ( u2265 1/10); common ( u2265 1/100, < 1/10); uncommon ( u2265 1/1 000, < 1/100); rare ( u2265 1/10 000, < 1/1 000); very rare (u2264 1/10 000), including isolated reports. Frequency not known: Frequency cannot be estimated from available data.

Blood and the lymphatic system disorders: Frequency not known: thrombocytopenia

Nervous system disorders: Common: faintness/dizziness, headache Uncommon: syncope, vertigo, drowsiness, malaise

Eye disorders: Uncommon: abnormal vision Frequency not known: intraoperative floppy iris syndrome (IFIS) (see section 4.4)

Cardiac disorders: Uncommon: tachycardia Very rare: angina pectoris in patients with pre-existing coronary artery disease (see section 4.4) Frequency not known: atrial fibrillation, palpitations

Vascular disorders: Uncommon: symptomatic hypotension (postural) (see section 4.4), flushing

Respiratory, thoracic and mediastinal disorders: Uncommon: rhinitis

Gastrointestinal disorders: Common: nausea, gastralgia Uncommon: diarrhoea, dry mouth, vomiting

Hepato-biliary disorders: Frequency not known: hepatocellular injury, cholestatic liver disease

Skin and subcutaneous tissue disorders: Uncommon: rash, pruritus Very rare: urticaria, angioedema

Reproductive system and breast disorders: Frequency not known: priapism

General disorders and administrative site conditions: Common: asthenia Uncommon: oedema, chest pain

Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to:

• The Pharmacovigilance Unit at Sanofi: Email: [email protected] or Tel: 011 256 3700, or
• SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

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.