Omnic Ocas

/ CTS

Oral Use One tablet daily. Omnic Ocas 0,4 can be taken independently of 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. Paediatric population: There is no relevant indication for use of Omnic Ocas 0.4 in children. The safety and efficacy of tamsulosin in children <18 years have not been established.

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

Hypersensitivity to tamsulosin hydrochloride, including drug induced angioedema or to any of the excipients. A history of orthostatic hypotension. Severe hepatic insufficiency.

As with other α1-adrenoceptor antagonists, a reduction in blood pressure can occur in individual cases during treatment with Omnic Ocas 0,4, as a result of which, 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 Omnic Ocas 0,4 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. The treatment of patients with severe renal impairment (creatinine clearance of < 10 ml/min) should be approached with caution, as these patients have not been studied.
The ‘Intraoperative Floppy Iris Syndrome’ (IFIS, a variant of small pupil syndrome) has been observed during cataract and glaucoma surgery in some patients on or previously treated with
tamsulosin hydrochloride. IFIS may lead to increase the risk of eye complications during and after the operation. Discontinuing tamsulosin hydrochloride 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit and duration of stopping of therapy prior to cataract or glaucoma surgery has not yet been established. IFIS has also been reported in patients who had discontinued tamsulosin for a longer period to that surgery.
The initiation of therapy with tamsulosin in patients for whom cataract or glaucoma surgery is scheduled is not recommended. Discontinuing tamsulosin 1-2 weeks prior to cataract or glaucoma surgery is anecdotally considered helpful, but the benefit and duration of stopping of therapy prior to cataract or glaucoma surgery has not yet been established. During pre-operative assessment, surgeons and ophthalmic teams should consider whether patients scheduled for cataract or glaucoma surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery. Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 (e.g. ketoconazole) in patients with poor metaboliser CYP2D6 phenotype. Tamsulosin hydrochloride should be used with caution in combination with strong (e.g. ketoconazole) and moderate (e.g. erythromycin) inhibitors of CYP3A4. It is possible that a remnant of the tablet is observed in the feaces.

Common: Dizziness, Ejaculation disorders including retrograde ejaculation and ejaculation failure.
See prescribing information for full details.

Interaction studies have only been performed in adults. No interactions have been seen when tamsulosin hydrochloride was given concomitantly with either atenolol, enalapril, nifedipine or theophylline. Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, while furosemide a fall, but as levels remain within the normal range posology need not be adjusted. In vitro, neither diazepam nor propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change the free fraction of tamsulosin in human plasma. Neither does tamsulosin change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. Diclofenac and warfarin, however, may increase the elimination rate of tamsulosin. Concomitant administration of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead to increased exposure to tamsulosin hydrochloride. Concomitant administration with ketoconazole (a known strong CYP3A4 inhibitor) resulted in an increase in AUC and Cmax of tamsulosin hydrochloride by a factor of 2.8 and 2.2, respectively. Tamsulosin hydrochloride should not be given in combination with strong inhibitors of CYP3A4 in patients with poor metaboliser CYP2D6 phenotype. Tamsulosin hydrochloride should be used with caution in combination with strong and moderate inhibitors of CYP3A4. Concomitant administration of tamsulosin hydrochloride with paroxetine, a strong inhibitor of CYP2D6, resulted in a Cmax and AUC of tamsulosin that had increased by a factor of 1.3 and 1.6, respectively, but these increases are not considered clinically relevant Concurrent administration of other α1-adrenoceptor antagonists could lead to hypotensive effects.

Omnic Ocas is not indicated for use in women. Ejaculation disorders have been observed in short and long term clinical studies with tamsulosin. Events of ejaculation disorder, retrograde ejaculation and ejaculation failure have been reported in the post authorization phase.

Acute overdose with 5 mg tamsulosin hydrochloride has been reported. Acute hypotension (systolic blood pressure 70 mm Hg), vomiting and diarrhoea were observed, which were treated with fluid replacement and the patient could be discharged the same day. In case of acute hypotension occurring after overdose cardiovascular support should be given. Blood pressure can be restored and heart rate brought back to normal by lying the patient down. If this does not help then volume expanders and, when necessary, vasopressors could be employed. Renal function should be monitored and general supportive measures applied. Dialysis is unlikely to be of help as tamsulosin is very highly bound to plasma proteins. Measures, such as emesis, can be taken to impede absorption. When large quantities are involved, gastric lavage can be applied and activated charcoal and an osmotic laxative, such as sodium sulphate, can be administered.