Xatral XL
alfuzosin
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged release tablet contains Alfuzosin hydrochloride 10mg.
PHARMACEUTICAL FORM
Round, biconvex 3-layer tablets: one white layer between two yellow layers.
CLINICAL PARTICULARS
Therapeutic indications
• Treatment of the functional symptoms of benign prostatic hypertrophy.
• Adjuvant treatment to a catheter in acute urinary retention related to
benign prostatic hypertrophy.
Posology and method of administration
Oral use.
The tablet must be swallowed whole with a glass of water (see Special
warnings and precautions for use).
The recommended dosage is one 10mg tablet per day, to be taken immediately
after the evening meal.
Adjuvant treatment to a catheter in acute urinary retention related to
benign prostatic hypertrophy:
The recommended dosage is one 10mg tablet per day, to be taken after a meal,
from the first day of catheterization onwards. The treatment is administered
for 3 to 4 days, i.e. 2 to 3 days while the catheter is in place and one day
after it is removed.
Contraindications
This medicinal product must not be administered in the following situations:
• hypersensitivity to alfuzosin and/or any of the other ingredients;
•
postural hypotension,
• liver failure;
• severe kidney failure (creatinine clearance < 30 ml/min);
• in combination with ritonavir.
Special warnings and precautions for use
Warnings
As with all alpha-1 blockers, some patients, and in particular those treated
with antihypertensives, may experience postural hypotension within a few
hours following administration, possibly with symptoms (dizzy sensations,
fatigue, sweating).
If this occurs, patients should remain lying down until the symptoms have
completely subsided.
These effects are usually transient, occur at the beginning of treatment and
do not generally prevent continued treatment. Patients should be warned of
the possible occurrence of these events.
Caution is recommended, particularly in the elderly.
Intraoperative Floppy Iris Syndrome (IFIS, a small pupil syndrome variant)
has been observed during cataract surgery in some patients previously or
currently treated with tamsulosin. Isolated cases have also been reported
with other alpha-1 blockers, therefore a possible class effect cannot be
ruled out. Considering that IFIS can be the cause
of additional technical difficulties during cataract operations, the surgeon
must be informed of any history or current use of alpha-1 blockers before
the eye surgery. This medicinal product contains castor oil, which can cause
gastrointestinal disorders (mild laxative effect, diarrhea).
Special precautions for use
Care should be taken when alfuzosin is administered to patients who have
experienced marked hypotension following administration of another alpha-1
blocker. In patients with coronary disease, alfuzosin should not be
prescribed alone. The specific coronary insufficiency treatment should be
continued. If angina pectoris recurs or worsens, alfuzosin treatment should
be discontinued. Patients must be informed that the tablets must be
swallowed whole. The tablets must not be crunched, chewed, crushed or ground
into a powder. Doing so could lead to inappropriate release and absorption
of the medicinal product consequently causing unwanted effects which may be
of early onset.
Interaction with other medicinal products and other forms of interactions
Contraindicated combination
+ Ritonavir:
Risk of increased plasma alfuzosin concentrations and increased undesirable
effects.
Inadvisable combinations
+ Anti-hypertensive alpha-receptor blockers (prazosin, trimazosin, urapidil):
Enhanced hypotensive effect. Risk of severe postural hypotension.
+ Ketoconazole, itraconazole:
Risk of increased plasma alfuzosin concentrations and increased undesirable
effects.
+ Clarithromycin, erythromycin
Risk of increased plasma alfuzosin concentrations and increased undesirable
effects.
Combination requiring precautions for use
+ Phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil)
Risk of postural hypotension, particularly in elderly subjects. Treatment
should be initiated at the lowest recommended dose and adjusted gradually if
necessary.
Combinations to be taken into consideration
+ Antihypertensives except alpha-receptor blockers
Enhanced hypotensive
effect. Higher risk of postural hypotension.
+ Nitrates, nitrites and related drugs (isosorbide dinitrate, isosorbide,
linsidomine, molsidomine, nicorandil, nitroglycerin)
Increased risk of hypotension, particularly postural.
Pregnancy and lactation
The therapeutic indication does not apply to women.
The safety of alfuzosin during pregnancy and its passage into breast milk
are not known.
Effects on ability to drive and use machines
Particular caution is required when driving vehicles or using machines due
to the risks of postural hypotension, dizzy sensations, asthenia, visual
disturbances, especially at the start of treatment with alfuzosin.
Undesirable effects
Classification of expected incidence rates:
Common (≥1% - <10%); Uncommon (≥0.1% - <1%); Very rare
(<0.01%).
Nervous system disorders:
• Common: lightheadedness, dizziness, faintness, headache,
• Uncommon: dizzy spells, drowsiness.
Heart disorders:
• Uncommon: tachycardia, palpitations, postural hypotension, syncope,
• Very rare: angina pectoris in patients with a history of coronary artery
disease.
Respiratory, thoracic and mediastinal disorders:
• Uncommon: nasal congestion.
Gastrointestinal disorders:
• Common: nausea, abdominal pain,
• Uncommon: diarrhea, dry mouth.
Skin and subcutaneous tissue disorders:
• Uncommon: skin rashes, pruritus,
• Very rare: urticaria, angioedema.
Systemic disorders:
• Common: asthenia,
• Uncommon: flushing, edema, chest pain.
Hepatobiliary disorders:
• Unknown incidence: hepatocellular injury, cholestatic hepatitis.
Reproductive system and breast disorders:
• Unknown incidence: priapism.
Overdose
In the event of overdose, the patient should be hospitalised and kept lying
down.
Standard treatment for hypotension should be instituted. Due to its high
degree of protein binding, alfuzosin is not easily dialyzable.
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