Generic drug of Xatral LP
Therapeutic class: Urology nephrology
active ingredients: Alfuzosin
laboratory: Sanofi-Aventis France
Sustained release tablet
Box of 30
· Treatment of functional symptoms of benign prostatic hypertrophy.
· Adjunctive bladder catheterization in acute urine retention related to benign prostatic hypertrophy.
Dosage ALFUZOSINE LP ZENTIVA 10 mg prolonged release tablet Box of 30
The tablet should be swallowed whole with a glass of water. (see section 4.4 Special warnings and precautions for use ).
The recommended dosage is 1 10 mg tablet daily, to be taken immediately after the evening meal.
Adjuvant bladder catheterization in acute urine retention related to benign prostatic hypertrophy:
The recommended dosage is 1 10 mg tablet daily, to be taken after the meal, from the first day of urethral catheterization.
The treatment is administered for 3 to 4 days including 2 to 3 days during the catheterization and 1 day after the withdrawal of the latter.
This product should not be administered in the following situations:
Hypersensitivity to alfuzosin and / or any of the other ingredients;
· orthostatic hypotension;
· Hepatic insufficiency;
· Severe renal impairment (creatinine clearance <30 ml / min);
· Combination with potent CYP3A4 inhibitors (see section Interactions with other medicinal products and other forms of interaction ).
Side effects Alfuzosine LP Zentiva
Adverse reactions are classified by frequency of occurrence using the following rule: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1 / 100), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000), frequency unknown (can not be estimated from available data).
(≥ 1% - <10%)
(≥ 0.1% - <1%)
angina pectoris in patients with a history of coronary artery disease
intraoperative flaccid iris syndrome
General disorders and administration site conditions
edema, chest pain
nausea, abdominal pain
Nervous system disorders
dizziness, dizziness, headache
Disorders of reproductive organs and breast
Respiratory, thoracic and mediastinal disorders
Skin and subcutaneous tissue disorders
orthostatic hypotension, flush
Blood and lymphatic system disorders
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.