omnic ocas (new) - SAJA Pharmaceuticals

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OMNIC OCAS ®
Omnic OCAS ® 0.4 mg, film-coated
prolonged release tablet
Tamsulosin hydrochloride
Composition
Omnic OCAS ® contains 0.4 mg tamsulosin
hydrochloride in each film-coated
prolonged release tablet. The tablets also
contain macrogol 7,000,000, macrogel
8,000, magnesium stearate
butylhdroxytoluene. Colloidal silica
anhydrous, hypromellose and yellow iron
oxide.
Package
The tablets are supplied in blister packs of
30.
Pharmacodynamic Properties
Tamsulosin hydrochloride is an Alpha 1
adrenoreceptor antagonist which binds
selectively to subtype Alpha 1A and Alpha
1D adrenoreceptors. It reelieves
obstruction by relaxing smooth muscle in
prostate and urethra thereby improving
voiding symptoms. It also improves the
storage symptoms in which bladder
instability plays and important role.
Pharmacokinetic properties
The OCAS formulation provides consistent
slow release of tamsulosin, resultig in an
adequate exposure, with little fluctuation,
over 24 hours.
Tamsulosin administered as Omnic OCAS
0.4 mg is absorbed from the intestine. Of
the administered dose, approximately 57%
is estimated to be absorbed.
The rate and extent of absorption of
tamsulosin administered as Omnic OCAS
0.4 are not affected by food.
Tamsulosin shows linear
pharmacokinetics.
After a single dose of Omnic OCAS ® 0.4 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 mg/ml after the first dose
to 11 mg/ml in steady state. In man,
tamsulosin is about 99% bound to plasma
proteins. The volume of distribution is small
(about 0.2 l/kg).
Indications
Lower urinary tract symptoms (LUTS)
associated with Benign Prostatic
Hyperplasia (BPH).
Dosage and Method of Administration
Oral use. One tablet daily.
Omnic OCAS ® 0.4 mag 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 active substance.
No dose adjustment is warranted in renal
impairment. No dose adjustment is
warranted in patients with mild to moderate
hepatic insufficiency.
There is no relevant indication for use of
Omnic OCAS ® 0.4 mg in children.
Contraindications
Hypersensitivity to tamsulosin
hydrochloride, including drug induced
angioedema or to any of the excipients. A
history of orthostatic hypotension. Severe
hepatic insufficiency.
Special warnings and precautions for
use
As with other a1-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 sign
of orthostatic hypotension (dizziness,
weakness), the patient should sit or lie
down until the symptoms have
disappeared.
Before therapy with Omnic OCAS ® 0.4 mg
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 necessay, 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
studies. ‘Intraoperative Floppy Iris
Syndrome’ (IFIS, a variant of small pupil
syndrome) considered to be due to α1-blocking
action has been observed during cataract
surgery in some patients on or previously
teated with tamsulosin. Ophthalmologists
should be aware of possible occurance of
IFIS during cataract surgery.
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.
Interaction with other medicinal
products and other forms of interaction
Interaction studies have only been
performed in adults. No interactions have
been seen when tamsulosin hydrochloride
was given concomitantly with either
atenolol, enalapril, nefedipine or
theophyline.
Concomitant cimetidine brings about a rise
in plasma levels of tamsuloson, 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.
No interactions at the level of hepatic
metabolism have been seen during in vitro
studies with liver microsomal fractions
(representative cytochrome P450 - linked
drug metabolising enzyme system),
involving amitriptyline, salbutamol,
glibenclamide and finasteride. Diclofenac
and warfarin, however, may increase the
elimination rate of tamsulosin.
Concurrent administration of other a1-
adrenoceptor antagonists could lead to
hypotensive effects.
Pregnancy and Lactation
Not applicable, as Omnic OCAS ® 0.4 mg is
intended for male patients only.
Effects on ability to drive and use
machines
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.
Undesirable Effects
Dizziness was observed in 1.3% of patients
treated with Omnic OCAS ® 0.4 mg.
The following side effects have been
reported:
Common (>1/100, 1/1000, 1/10000, 1/10000): priaprism.
During cataract surgery a small pupil
situation, known as Intraoperative Floppy
Iris Syndrome (IFIS), has been associated
with therapy of tamsulosin during postmarketing
surveillance.
Overdose
Acute overdose with 5 mg of 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 over dosage cardiovascular support
should be given. Blood pressure can be
restored and heart rate brought back
tonormal by lying the patient down. If
thisdoes 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.
General Information
Keep all medicines out of the reach and
sight of childre.
Do not use the tablets after the expiry date
printed on the pack.
Remember your medicines have been
prescribed for you. Never give your
medicines to others, even if it does seem
that they have the same condition as you.
Storage
Store below 30°C.
Manufactured by:
SAJA Pharmaceutical Co., Ltd.
Saudi Arabian Japanese Pharmaceutical
Company Limited
Under License from:
ASTELLAS PHARMA INC.
Tokyo - Japan
THIS IS A MEDICAMENT
- A drug is a product which acts on your
health and its consumption could be
dangerous when you do not follow the
instructions.
- Follow strictly the doctor's prescriptions,
the method of use and the instructions of
the pharmacist who sold the medicament.
- The doctor and the pharmacist know the
medicine, its benefits and risks.
- Do not by yourself interrupt the period of
treatment prescribed for you.
- Do not repeat the same prescription
without consulting your doctor.
- Keep out of the reach of children.
Council of Arab Health Ministers
Union & Arab Pharmacists
Revision date Aug. 2007 25BTCAA