omnic-ocas

OMNIC OCAS®

Tamsulosin Hydrochloride 0.4 mg

Prolonged release tablets for oral use

Product leaflet summary

Therapeutic Indications

Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

 

Dosage and Administration

One tablet daily OMNIC OCAS with or without food.

The tablet must be swallowed whole and not be crunched or chewed as this interferes with the prolonged release of the active substance. No dose adjustment is warranted in renal impairment. No dose adjustment is warranted in patients with mild to moderate hepatic insufficiency

 

Contraindications

Hypersensitivity to Tamsulosin hydrochloride , or to any of the excipients.

A history of orthostatic hypotension.

Severe hepatic insufficiency.

 

Pregnancy and Lactation

NOT APPLICABLE, as OMNIC OCAS is intended for male patients only.

 

Pediatric population:

There is no relevant indication for use of OMNIC OCAS in children. The safety and efficacy of Tamsulosin in children <18 years have not been established.

 

Ability to drive and use machinery

No studies on the effects on the ability to drive and use machines have been performed. However, patients should be aware of the fact that dizziness can occur.

 

Package Presentation:

– A box of 30 tablets each contains 0.4 mg Tamsulosin Hydrochloride.