Medicinal Products

ALFUZOSINE LP MYLAN 10 mg

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

Sustained release tablet
Box of 30
All forms

Indication

- Treatment of functional symptoms of benign prostatic hypertrophy. - Bladder adjuvant treatment in acute urine retention related to benign prostatic hypertrophy.

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

Oral way.
The tablet should be swallowed whole, without being crunched, with a glass of water (see section warnings and precautions for use).
Adults:
- The recommended dosage is 1 10 mg tablet daily, to be taken immediately after the evening meal.
- Bladder adjuvant treatment 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

Hypersensitivity to alfuzosin and / or any of the excipients.

· Orthostatic hypotension.

· Hepatic insufficiency.

· Severe renal insufficiency (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 Mylan

FREQUENCY

ORGAN SYSTEM

Frequent (≥ 1% - <10%)

Uncommon (≥ 0.1% - <1%)

Very rare (<0.01%)

CNS disorders and psychiatric disorders

dizziness, dizziness, malaise, headache

dizziness, drowsiness

Cardiovascular disorders

tachycardia, palpitations, orthostatic hypotension, syncope

Angina pectoris in patients with a history of coronary heart disease (see Warnings and Precautions section )

Respiratory system disorders

Nasal congestion

Gastro-intestinal disorders

nausea, abdominal pain

diarrhea, dry mouth

Skin manifestations

rashes, pruritus

Urticaria, angioneurotic edema

General events

asthenia

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

FREQUENCY

ORGAN SYSTEM

Frequent (≥ 1% - <10%)

Uncommon (≥ 0.1% - <1%)

Very rare (<0.01%)

CNS disorders and psychiatric disorders

dizziness, dizziness, vertigo, malaise, headache

drowsiness

Visual disorders

abnormal vision

Cardiovascular disorders

orthostatic hypotension

tachycardia, palpitations, syncope

Angina pectoris in patients with a history of coronary heart disease (see Warnings and Precautions section )

Respiratory system disorders

Nasal congestion

Gastro-intestinal disorders

nausea, abdominal pain, diarrhea, dry mouth

Skin manifestations

rashes, pruritus

Urticaria, angioneurotic edema

General events

asthenia

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

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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