TAMSOLIN Capsule

For the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Dosage and administration

TAMSOLIN capsules 0.4mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH. It should be administered approximately one-half hour following the same meal each day. For those patients who fail to respond to the 0.4mg dose after 2-4 weeks of dosing, the dose can be increased to 0.8mg once daily. If TAMSOLIN capsules administration is discontinued or interrupted for several days at either the 0.4mg or 0.8mg dose, therapy should be started again with the 0.4mg once daily dose.

- With known hypersensitivity to Tamsulosin HCl or any component of the product.

- With a history of orthostatic hypotension.

- Taking other alpha-adrenergic blocking agents.

- With severe hepatic insufficiency.

Tamsulosin HCl is not indicated for use in:

- Women.

- The pediatric population.

Body as whole: Headache, infection, asthenia, back pain, chest pain.

Nervous System: Dizziness, somnolence, insomnia, decreased libido.

Respiratory System: Rhinitis, pharyngitis, increased cough, sinusitis.

Digestive System: Diarrhea, nausea, tooth disorder.

Urinogenital System: Abnormal ejaculation.

Special Senses: Blurred vision.

- The pharmacokinetic interaction between cimetidine and tamsulosin HCl was investigated. The results indicate significant changes in tamsulosin HCl clearance (26% decrease) and AUC (44% increase). Therefore, tamsulosin HCl capsules should be used with caution in combination with cimetidine, particularly at doses higher than 0.4mg.

- Caution should be exercised with concomitant administration of warfarin and tamsulosin HCl.

- Tamsulosin HCl should be used with caution in combination with moderate or strong inhibitors of CYP2D6 (e.g., fluoxetine) or CYP3A4 (e.g., ketoconazole), particularly at doses higher than 0.4mg.

Tamsulosin HCl is not indicated for use in women.

- As with other alpha 1 blockers, reduction in blood pressure can occur in individual cases during treatment with Tamsulosin HCl, as a result of which, very 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.

- Before therapy with tamsulosin HCl is initiated, the patient should be examined in order to exclude the presence of other conditions which can cause the same symptoms as benign prostatic hyperplasia. Digital rectal examination and, when necessary, determination of prostate specific antigen (PSA) should be performed before treatment and at regular intervals afterwards.

- Patient with end stage renal disease (creatinine clearance <10mL/min/1.73m2) should be approached with caution as these patients have not been studied.

- Patient should be advised about the possibility of priapism as a result of treatment with tamsulosin and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence).

- Intra-operative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients taking or who have previously been treated with alpha1 adrenoceptor antagonists.

Tamsulosin binds selectively and competitively to postsynaptic α1-adrenoceptors, in particular to subtypes α1A and α1D. It binds about relaxation or prostatic and urethral smooth muscle resulting in an increase in urinary flow rate and a reduction in symptoms of benign prostatic hyperplasia (BPH). It also improves the irritative symptoms in which bladder instability plays an important role.