Medicinal Products

ALFUZOSINE LP ISOMED 10 mg

Generic drug of Xatral LP
Therapeutic class: Urology nephrology
active ingredients: Alfuzosin
laboratory: More Pharmacy

Sustained release tablet
Box of 30
All forms

Indication

· Treatment of functional symptoms of benign prostatic hypertrophy.

· Adjunctive bladder catheterization in acute urine retention related to benign prostatic hypertrophy.

Dosage ALFUZOSINE LP ISOMED 10 mg prolonged release tablet Box of 30

Oral way.

The tablet should be swallowed whole with a glass of water (see Warnings and Precautions ).

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.

Against indications

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 ritonavir;

· Combination with potent CYP3A4 inhibitors (see section Interactions with other medicinal products and other forms of interaction ).

Adverse effects Alfuzosine LP Isomed

Classification of expected frequencies:

Frequent (≥1% - <10%); Uncommon (≥0.1% - <1%); Very rare (<0.01%).

Nervous system disorders:

· Common: dizziness, dizziness, malaise, headache

· Uncommon: dizziness, drowsiness.

Heart conditions:

· Uncommon: tachycardia, palpitations, orthostatic hypotension, syncope;

· Very rare: angina pectoris in patients with a history of coronary artery disease (see Warnings and Precautions section ).

Respiratory, thoracic and mediastinal disorders:

· Uncommon: nasal congestion.

Gastrointestinal disorders:

· Common: nausea, abdominal pain.

· Uncommon: diarrhea, dry mouth.

Skin and subcutaneous tissue disorders:

· Uncommon: rash, pruritus;

· Very rare: urticaria, angioneurotic edema.

General disorders:

· Common: asthenia

· Uncommon: flushes, edema, chest pain (see Warnings and Precautions section ).

Hepatobiliary disorders:

· Unknown frequency: Hepatocellular disease, cholestatic hepatitis.

Disorders of the reproductive organs and the breast:

· Frequency unknown: priapism

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.

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