Tamisol® D Capsule 0.4/0.5 mg: Each capsule contains Tamsulosin Hydrochloride (modified release) and Dutasteride (immediate release) pellets, pharmaceutical grade, equivalent to Tamsulosin Hydrochloride USP 0.4 mg and Dutasteride USP 0.5 mg.

This capsule is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate.

The recommended dose of this capsule is one capsule once daily, approximately 30 minutes after the same meal each day. The capsule should be swallowed whole and should not be crushed or chewed. No dosage adjustment is required for patients with renal impairment or for the elderly. Alternatively, the dosage should be taken as directed by a registered physician.

The following adverse reactions have been reported during the use of this capsule: dizziness, abnormal ejaculation, back pain, chest pain, diarrhea, tooth disorders, decreased libido, insomnia, rhinitis, pharyngitis, sinusitis, and asthenia.

This capsule is contraindicated for use by women and children. It is also contraindicated in patients known to be hypersensitive to Tamsulosin HCl, Dutasteride, or any component of the capsule.

Lower urinary tract symptoms of BPH may be indicative of other urological diseases, including prostate cancer. Patients should be thoroughly assessed to rule out other urological conditions before initiating treatment with this capsule. The treatment of patients with severe renal impairment (creatinine clearance less than 10 mL/min) should be approached with caution, as these patients have not been adequately studied.

This capsule is not indicated for use in women. It is also not intended for use in nursing mothers.

Concurrent administration of other alpha-1 adrenoceptor antagonists may lead to hypotensive effects. This capsule should not be used in combination with other alpha-adrenergic blocking agents. Additionally, caution should be exercised when using this capsule in combination with cimetidine. Patients should also use warfarin with caution when taken concurrently with this capsule.

No data are available regarding overdose with this combination.

Store at a temperature not exceeding 25°C in a dry place. Protect from light and moisture.
