Medicinal Products

ALFUZOSINE LP RPG 10 mg

Generic drug of Xatral LP
Therapeutic class: Urology nephrology
active ingredients: Alfuzosin
laboratory: Ranbaxy Pharma Generic

Sustained release tablet
Box of 30
All forms

Indication

Treatment of moderate to severe functional symptoms of benign prostatic hypertrophy.

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

Oral way.

The extended-release tablet should be swallowed whole with a glass of water, without being crushed, crushed or divided (see Warnings and Precautions ) section.

The first tablet should be taken at bedtime. Alfuzosin 10mg extended release tablet should be taken daily, immediately after the same meal.

adults

The recommended dosage is one 10 mg tablet daily.

Elderly (over 65 years old)

The recommended dosage is the same as for adults. Studies of pharmacokinetics and safety of use have shown that no dosage adjustment is necessary in the elderly.

Renal failure

Mild to moderate renal impairment (creatinine clearance> 30 ml / min)

Dosage adjustment is not usually necessary (see section 5.2 ).

Severe renal insufficiency (creatinine clearance <30 ml / min)

Due to the lack of safety data, alfuzosin 10 mg prolonged-release tablets should not be prescribed to patients with severe renal impairment (see Warnings and Precautions section ). .

Hepatic insufficiency

Alfuzosin 10 mg prolonged release tablets are contraindicated in patients with hepatic impairment. In patients with mild to moderate hepatic impairment, a drug containing a lower dose of alfuzosin hydrochloride may be prescribed. For dosing recommendations, the SPC of the corresponding specialty should be consulted.

Pediatric population:

The efficacy of alfuzosin has not been established in children aged 2 to 16 years (see section 5.1 ). Therefore, ALFUZOSINE RPG LP 10 mg prolonged-release tablet is contraindicated in the pediatric population.

Against indications

Hypersensitivity to alfuzosin, other quinazolines (eg terazosin, doxazosin) or any of the excipients;

· orthostatic hypotension ;

· Hepatic insufficiency :

· Association with other alpha-1 blockers.

Alfuzosine LP Rpg side effects

The undesirable effects considered to be possibly related to the treatment are listed below by organ system classes and by absolute frequency. The defined frequencies are: very common (³ 1/10); frequent (> 1/100 to 1/1000 to <1/100); rare (> 1/10 000 to <1/1000); very rare (<1/10000); indeterminate frequency (can not be estimated based on available data).

Class of organ system

Frequency

Frequent

Rare

Very rare

Not known frequency

Blood and lymphatic system disorders

neutropenia

Nervous system disorders

Dizziness / tiredness, headache

Drowsiness, dizziness

Eye disorders

Visual disorders

Intraoperative flaccid iris syndrome

Heart conditions

Tachycardia, palpitations, syncope (especially at the beginning of treatment), hot flushes

Occurrence, aggravation or recurrence of angina in patients with coronary artery disease (see Warnings and precautions for use )

Atrial fibrillation

Vascular disorders

Orthostatic hypotension (at the start of treatment, with a high dose or when treatment resumes after a short interruption)

Respiratory, thoracic and mediastinal disorders

rhinitis

Gastrointestinal disorders

Nausea, abdominal pain

Diarrhea, dry mouth

Vomiting

Hepatobiliary disorders

Liver toxicity

Hepatocellular involvement, cholestatic hepatitis

Skin and subcutaneous tissue disorders

Rash, pruritus,

Urticaria, angioneurotic edema

Renal and urinary disorders

Urinary incontinence

General disorders and administration site conditions

Asthenia

edema, chest pain (see section Warnings and precautions for use ), discomfort

Disorders of reproductive organs and breast

priapism *

* The occurrence of priapism, although reported in isolated cases with alfuzosin, can not be ruled out because it is usually attributed to other alpha-1 adrenergic receptor antagonists.

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