Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, UK or trading as: Sanofi-aventis or Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
As with all alpha-1-blockers in some subjects, in particular patients receiving antihypertensive medications or nitrates, 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 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 patient with pre-existing risk factors (such as underlying cardiac diseases and/or concomitant treatment with anti-hypertensive medication, see section 4.8). 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.
As with all alpha1-receptor blockers, alfuzosin should be used with caution in patients with acute cardiac failure.
Care should be taken when Xatral XL is administered to patients who have had a pronounced hypotensive response to another alpha-1-blocker.
Treatment should be initiated gradually in patients with hypersensitivity to alpha-1-blockers. Xatral XL should be administered carefully to patients being treated with antihypertensive medication or nitrates (see section 4.5). Blood pressure should be monitored regularly, especially at the beginning of treatment.
Patients with congenital QTc prolongation, with a known history of acquired QTc prolongation or who are taking drugs known to increase the QTc interval should be evaluated before and during the administration of alfuzosin.
Prolonged erections and priapism have been reported with alpha-1 blockers including alfuzosin in post marketing experience. If priapism is not treated immediately, it could result in penile tissue damage and permanent loss of potency, therefore the patient should seek immediate medical assistance (see section 4.8).
In coronary patients, the specific treatment for coronary insufficiency should be continued. If angina pectoris reappears or worsens Xatral XL should be discontinued.
As there are no clinical safety data available in patients with severe renal impairment (creatinine clearance < 30ml/min), alfuzosin 10 mg prolonged released tablets should not be administered to this patient group.
Patients should be warned that the 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 drug and therefore possible early adverse reactions.
The ‘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 alpha-1-blockers. Although the risk of this event with alfuzosin 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. The ophthalmologists should be prepared for possible modifications to their surgical technique.
Alfuzosin 10 mg prolonged release tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.
Combinations contra-indicated:
Combinations to be taken into account:
Repeated 200 mg daily dosing of ketoconazole, for seven days resulted in a 2.1-fold increase in Cmax and a 2.5-fold increase in exposure of alfuzosin 10 mg when administered as a single dose under fed conditions (high fat meal). Other parameters such as tmax and t1/2 were not modified.
Cmax and AUC of alfuzosin 10 mg, when administered as a single dose under fed conditions, increased 2.3- fold and 3.0- fold, respectively following 8-day repeated 400 mg ketoconazole daily dosing (see Section 5.2 Pharmacokinetic properties).
The administration of general anaesthetics to patients receiving Xatral XL could cause profound hypotension. It is recommended that the tablets be withdrawn 24 hours before surgery.
No pharmacodynamic or pharmacokinetic interaction has been observed in healthy volunteers between alfuzosin and the following drugs: warfarin, digoxin, hydrochlorothiazide and atenolol.
Due to the type of indication this section is not applicable.
There are no data available on the effect on driving vehicles. Adverse reactions such as vertigo, dizziness and asthenia may occur essentially at the beginning of treatment. This has to be taken into account when driving vehicles and operating machinery.
Classification of expected frequencies: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Common: faintness/dizziness, headache
Uncommon: syncope, vertigo, malaise, drowsiness
Uncommon: vision abnormal
Not known: intraoperative floppy iris syndrome (see section 4.4)
Uncommon: tachycardia, palpitations, hypotension (postural),
Very rare: new onset, aggravation or recurrence of angina pectoris in patients with pre-existing coronary artery disease (see section 4.4.)
Not known: atrial fibrillation
Uncommon: hypotension (postural), flushing
Not known: neutropenia, thrombocytopenia
Uncommon: rhinitis
Common: nausea, abdominal pain
Uncommon: diarrhoea, dry mouth, vomiting
Not known: vomiting
Frequency unknown: hepatocellular injury, cholestatic liver disease
Uncommon: rash, pruritus
Very rare: urticaria, angioedema
Frequency unknown: priapism
Common: asthenia
Uncommon: flushes, oedema, chest pain
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
None known.
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