Flonor 0.4 mg (Capsule (Modified Release))

Indications

• Treatment of functional symptoms of Benign Prostatic Hyperplasia (BPH)

Pharmacology

• Selective alpha1 adrenoceptor blocking agent
• Relaxation of smooth muscle in bladder neck and prostate
• Improvement in urine flow rate
• Reduction in symptoms of BPH
• Absorption rate under fasting conditions
• Plasma protein binding
• Metabolism by cytochrome P 450 enzymes

Dosage & Administration

• Daily dosage of Tamsulosin Hydrochloride 0.4 mg
• Increase in dosage after 2 to 4 weeks if necessary
• Administration after meal at night
• Swallowing capsule whole with water
• Not to be crunched or chewed

Interaction

• Concurrent administration with other alpha1-adrenoceptor antagonists
• No interactions with atenolol, enalapril or nifedipine
• Cimetidine and frusemide effects on plasma levels
• No interactions at hepatic metabolism level
• Increase in elimination rate with diclofenac and warfarin

Contraindications

• Hypersensitivity to Tamsulosin hydrochloride
• History of orthostatic hypotension
• Severe hepatic insufficiency
• Reduced blood pressure risk
• Sit or lie down at signs of orthostatic hypotension
• Caution in situations where injury could result
• Examination to exclude other conditions with similar symptoms as BPH
• Digital rectal examination and determination of PSA before treatment

Side Effects

• Dizziness
• Abnormal ejaculation
• Headache
• Asthenia
• Postural hypotension
• Palpitations

Pregnancy & Lactation

• Not recommended for use in pregnancy and lactation

Precautions & Warnings

• Transient postural symptoms after first dose
• Not advised in patients with micturition syncope
• Effects on ability to drive and use machines
• Awareness of dizziness risk

Overdose Effects

• Likely acute hypotension after overdosage
• Cardiovascular support
• Volume expanders and vasopressors for restoration
• Renal function monitoring
• General supportive measures
• Impeding absorption with emesis
• Gastric lavage and activated charcoal for large quantities

Therapeutic Class

• BPH/ Urinary retention/ Urinary incontinence

Storage Conditions

• Store in a cool and dry place below 30°C
• Protected from light

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