Compositon/Ingredients: Tamsulosin

Treatment of the syndrome of benign prostatic hyperplasia.

• Known hypersensitivity to tamsulosin hydrochloride or any ingredient in the formulation.
• A history of orthostatic hypotension.
• Severe hepatic insufficiency.

• Usual dose: 1 capsule once daily, if not respond to the 0.4 mg dose after 2 – 4 weeks of dosing, the dose of tamsulosin hydrochloride can be increased to 2 capsules daily.
• If administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg daily.
• Renal impairment: Dosage adjustment is not necessary. Tamsulosin hydrochloride has not been studied in patients with end-stage renal disease (creatinine clearance < 10 ml/minute/1.73 m²).
• Hepatic impairment: Patients with moderate hepatic dysfunction do not require an adjustment.

• Patients should be evaluated prior to start of tamsulosin therapy to rule out the presence of carcinoma of the prostate.
• Tamsulosin may cause a reduction in blood pressure, rarely, syncope can occur. At the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms have disappeared.
• Angio-oedema has been rarely reported after the use of tamsulosin. Treatment should be discontinued immediately, the patient should be monitored until disappearance of the oedema, and tamsulosin should not be re-administered.
• Tamsulosin contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
• Tamsulosin is not indicated for use in women.
• Patients should be told about the possible occurrence of symptoms related to postural hypotension such as dizziness when taking tamsulosin hydrochloride, and they should be cautioned about driving, operating machinery.

Store at temperature below 30°C, protect from light.