Uropass-D 0.4 mg+0.5 mg Capsule

Uropass-D 0.4 mg+0.5 mg Capsule (Blended Pellets)

COMPOSITION

Each capsule contains Tamsulosin Hydrochloride sustained release & Dutasteride immediate release blended pellets pharma grade equivalent to Tamsulosin Hydrochloride USP 0.4 mg & Dutasteride INN 0.5 mg.

INDICATION

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

DOSAGE AND ADMINISTRATION

The recommended dose of this capsule is one capsule once daily approximately 30 minutes after the same meal each day. This capsule should be swallowed whole with water. No dosage adjustment is required for subjects with renal impairment or for the elderly.

OR AS DIRECTED BY THE PHYSICIAN

CONTRAINDICATION

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

USE IN PREGNANCY AND LACTATION

This capsule is not indicated for use in women. These capsules are not indicated for use in nursing mothers.

SIDE EFFECTS

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

PRECAUTION

Lower Urinary Tract symptoms of BPH can be indicative of urological diseases, including prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with this capsule. The treatment of severely renal impaired patients (creatinine clearance is less than 10ml/min) should be approached with caution as these patients have not been studied.

DRUG INTERACTION

Concurrent administration of other alpha-1 adrenoceptor antagonists could lead to hypotensive effects. This capsule should not be used in combination with other alpha-adrenergic blocking agents. This tablet should be used with caution in combination with cimetidine. Caution should be exercised with concomitant administration of warfarin and this capsule.

OVERDOSE

No data are available with regard to overdose with this combination.

SUPPLY

Each box contains 4x4 capsules in blisters.