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4.3. Contraindications
· Hypersensitivity to the active substance or to any of the excipients (see Section 6.1 List of excipients).;
· Hhistory of orthostatic hypotension;.
· cCombination with other alpha-1 receptor blockersblockers.;
· hHepatic insufficiency.
4.4. Special warnings and precautions for use
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.
As with all alpha1-receptor blockers, alfuzosin should be used with caution in patients with acute cardiac failure.
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.
Experience in patients with severe renal impairment is limited and cautious use in these patients is recommended.
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.
Alfuzosin 10 mg prolonged release tablets contain hydrogenated castor oil which may cause stomach upset and diarrhoea.
4.5. Interactions with other medicaments and other forms of interaction
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4.7. Effects on ability to drive and use machines
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.
4.8. Undesirable effects
· Nervous system disorders
Common: faintness/dizziness, headache
Uncommon: syncope, vertigo, malaise, drowsiness
· Cardiac disorders
Uncommon: tachycardia, palpitations, hypotension (postural), syncope
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
· Vascular disorders
Uncommon: hypotension (postural), flushing
· Blood and lymphatic system disorders
Not known: neutropenia
· Gastro-intestinal disorders
Common: nausea, abdominal pain
Uncommon: diarrhoea, dry mouth, vomiting
Not known: vomiting
· Hepatobiliary disorders
Frequency unNot known: hepatocellular injury, cholestatic liver disease.
· Reproductive system and breast disorders
Frequency unknown: priapism
· General disorders and administration site conditions
Common: asthenia
Uncommon: flushes, oedema, chest pain
Although only reported in isolated cases with alfuzosin, occurrence of priapism can not be excluded as it is generally accepted as being attributable to all other alpha adrenoreceptor blockers.
4.9 Overdose
In case of overdosage, the patient should be hospitaliszed, kept in the supine position, and conventional treatment of hypotension should take place.
In case of significant hypotension, the appropriate corrective treatment may be a vasoconstrictor that acts directly on vascular muscle fibres.
Alfuzosin is not dialysable because of its high degree of protein binding.
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