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

Oral use.
One tablet daily.
OMNIC OCAS 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 (see also 4.3, Contraindications).
Paediatric 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. Currently available data are described in section 5.1
 

As with other α1-adrenoceptor antagonists, a reduction in blood pressure can occur
in individual cases during treatment with OMNIC OCAS, 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 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 surgery in some patients on or previously treated
with tamsulosin hydrochloride. IFIS may increase the risk of eye complications during
and after the operation. Discontinuing tamsulosin hydrochloride 1-2 weeks prior to
cataract surgery is anecdotally considered helpful, but the benefit of treatment
discontinuation has not been established. IFIS has also been reported in patients
who had discontinued tamsulosin for a longer period prior to cataract surgery.
The initiation of therapy with tamsulosin hydrochloride in patients for whom
cataract surgery is schedules is not recommended. During pre-operative assessment,
cataract surgeons and ophthalmic teams should consider whether patients
scheduled for cataract 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 in patients with poor metaboliser CYP2D6 phenotype. Tamsulosin
hydrochloride should be used with caution in combination with strong and moderate
inhibitors of CYP3A4 (section 4.5)
It is possible that a remnant of the tablet is observed in the faeces.
 

Interaction studies have only been performed in adults.
No interactions have been seen when tamsulosin hydrochloride was given
concomitantly with either atenolol, enalapril, or theophylline.
Concomitant cimetidine brings about a rise in plasma levels of tamsulosin, whereas
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.
 

Not applicable, as OMNIC OCAS is intended for male patients only.
 

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.
 

Symptoms
Overdosage with tamsulosin hydrochloride can potentially result in severe
hypotensive effects. Severe hypotensive effects have been observed at different
levels of overdosing.
In case of acute hypotension occurring after overdosage 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.
 

Pharmacotherapeutic group: α1-adrenoceptor antagonists.
ATC code: G04C A02. Preparations for the exclusive treatment of prostatic disease.
Mechanism of action
Tamsulosin binds selectively and competitively to the postsynaptic α1-
adrenoceptors, in particular to subtypes α1A and α1D. It brings about relaxation of
prostatic and urethral smooth muscle.
Pharmacodynamic effects
OMNIC OCAS increases the maximum urinary flow rate. It relieves obstruction by
relaxing smooth muscle in prostate and urethra thereby improving voiding
symptoms.
It also improves the storage symptoms in which bladder instability plays an
important role.
These effects on storage and voiding symptoms are maintained during long-term
therapy. The need for surgery or catheterisation is significantly delayed.
α1-adrenoceptor antagonists can reduce blood pressure by lowering peripheral
resistance. No reduction in blood pressure of any clinical significance was observed
during studies with OMNIC OCAS.
Paediatric population
A double-blind, randomized, placebo-controlled, dose ranging study was performed
in children with neuropathic bladder. A total of 161 children (with an age of 2 to 16
years) were randomized and treated at 1 of 3 dose levels of tamsulosin (low [0.001
to 0.0002 mg/kg], medium [0.002 to 0.004mg/kg], and high [0.004 to 0.008mg/kg]),
or placebo.
The primary endpoint was number of patients who decreased their detrusor leak
point pressure (LPP) to <40 cm H20 based upon two evaluations on the same day.
Secondary endpoints were : Actual and percent change from, baseline in detrusor
leak point pressure, improvement or stabilization of hydronephrosis and hydroureter
and change in urine volumes obtained by catheterisation and number of times wet
at time of catheterisation as recorded in catheterisation diaries. No statistically
significant difference was found between the placebo group and any of the 3
tamsulosin dose groups for either the primary or secondary endpoints. No dose
response was observed for any dose level.
 

Absorption
OMNIC OCAS is a prolonged release tablet of the non-ionic gel matrix type. The Ocas
formulation provides slow release of tamsulosin, resulting in an adequate exposure
over 24 hours, with little fluctuation.
Tamsulosin hydrochloride administered as prolonged release tablets is absorbed
from the intestine. Under fasting conditions approximately 57% of the administered
dose is estimated to be absorbed.
The rate and extent of absorption of tamsulosin hydrochloride administered as
prolonged release tablets are not affected by a low fat meal. The extent of
absorption is increase by 64% and 149% (AUC and Cmax respectively) by a high-fat
meal compared to fasted.
Tamsulosin shows linear pharmacokinetics.
After a single dose of OMNIC OCAS in the fasted state, plasma concentrations of
tamsulosin peak at a median time of 6 hours. In steady state, which is reached by
day 4 of multiple dosing, plasma concentrations of tamsulosin peak at 4 to 6 hours,
in the fasted and fed state. Peak plasma concentrations increase from approximately
6 ng/ml after the first dose to 11 ng/ml in steady state.
As a result of the prolonged release characteristics of OMNIC OCAS the trough
concentration of tamsulosin in plasma amounts to 40% of the peak plasma
concentration under fasted and fed conditions.
There is a considerable inter-patient variation in plasma levels both after single and
multiple dosing.
Distribution
In man, tamsulosin is about 99% bound to plasma proteins. The volume of
distribution is small (about 0.2 l/kg).
Biotransformation
Tamsulosin has a low first pass effect, being metabolised slowly. Most tamsulosin is
present in plasma in the form of unchanged active substance. It is metabolised in the
liver.
In rats, hardly any induction of microsomal liver enzymes was seen to be caused by
tamsulosin.
In vitro results suggest that CYP3A4 and also CYP2D6 are involved in metabolism,
with possible minor contributions to tamsulosin hydrochloride metabolism by other
CYP isozymes. Inhibition of CYP3A4 and CYP2D6 drug metabolizing enzymes may
lead to increased exposure to tamsulosin hydrochloride (see section 4.4 and 4.5).
None of the metabolites are more active than the original compound.
Elimination
Tamsulosin and its metabolites are mainly excreted in the urine. The amount
excreted as unchanged active substance is estimated to be about 4 - 6% of the dose,
administered as OMNIC OCAS.
After a single dose of OMNIC OCAS 0.4mg and in steady state, elimination half-lives
of about 19 and 15 hours, respectively, have been measured.
 

Single and repeat dose toxicity studies were performed in mice, rats and dogs. In
addition, reproduction toxicity in rats, carcinogenicity in mice and rats and in vivo
and in vitro genotoxicity were examined.
The general toxicity profile, as seen with high doses of tamsulosin, is consistent with
the known pharmacological actions of the α-adrenoceptor antagonists.
At very high dose levels the ECG was altered in dogs. This response is considered to
be not clinically relevant. Tamsulosin showed no relevant genotoxic properties.
Increased incidences of proliferative changes of mammary glands of female rats and
mice have been reported. These findings, which are probably mediated by
hyperprolactinemia and only occurred at high dose levels, are regarded as irrelevant.
 

Macrogol 7.000.000.
Macrogol 8.000.
Magnesium stearate (E470b).
Opadry yellow 03f22733
 

Not applicable.
 

Store below 30°C.
 

Aluminium / Aluminium foil blister
Packs of 30 tablets.
 

No special requirements.