- Each capsule of Omnistat® contains:
  Tamsulosin hydrochloride 0,4 mg.

  Mechanism of Action:
- Tamsulosin, an alpha1 adrenoceptor blocking agent, exhibits selectivity for alpha1
  receptors in the human prostate. At least three discrete alpha1 - adrenoceptor 
  subtypes have been identified:  alpha1A , alpha1B and alpha1D ; their distribution 
  differs between human organs and tissue.  Approximately 70% of the alpha1- 
  receptors in human prostate are of the alpha1A subtype.
  Pharmacokinetic properties:
- Absorption
  Absorption of tamsulosin hydrochloride from Omnistat® capsules 0.4 mg is 
  essentially complete (>90%) following oral administration under fasting conditions.  
  Tamsulosin hydrochloride exhibits linear kinetics following single and multiple
  dosing, with achievement of steady-state concentrations by the fifth day of 
  once-a-day dosing.
- Distribution 
  The mean steady-state apparent volume of distribution of tamsulosin hydrochloride
  after intravenous administration to ten healthy male adults was 16 L, which is 
  suggestive of distribution into extracellular fluids in the body. Tamsulosin 
  hydrochloride is extensively bound to human plasma proteins (94% to 99%).
- Metabolism
  Tamsulosin hydrochloride is extensively metabolized by cytochrome P450 enzymes
  in the liver and less than 10% of the dose is excreted in urine unchanged. 
- Exceration
  On administration of the radiolabeled dose of tamsulosin hydrochloride to four 
  healthy volunteers, 97% of the administered radioactivity was recovered, with urine 
  (76%) representing the primary route of excretion compared to feces (21%) over 168 
  hours. Following intravenous or oral administration of an immediate-release 
  formulation, the elimination half-life of tamsulosin hydrochloride in plasma range 
  from five to seven hours. Because of absorption rate-controlled pharmacokinetics 
  with Omnistat® capsules, the apparent half-life of tamsulosin hydrochloride is 
  approximately 9 to 13 hours in healthy volunteers and 14 to 15 hours in the target 

- Omnistat® capsules are contraindicated in patients known to be hypersensitive to 
   tamsulosin hydrochloride or any component of Omnistat® capsules.

Cytochrome P450 Inhibition
- Tamsulosin is extensively metabolized, mainly by CYP3A4 and CYP2D6.
  The effects of coadministration of both a CYP3A4 and a CYP2D6 inhibitor with 
  Omnistat® capsules have not been evaluated. However, there is a potential for 
  significant increase in tamsulosin exposure when Omnistat® 0.4 mg is
  coadministered with a combination of both CYP3A4 and CYP2D6 inhibitors.
- Treatment with cimetidine resulted in a significant decrease (26%) in the clearance of 
  tamsulosin hydrochloride, which resulted in a moderate increase in tamsulosin 
  hydrochloride  AUC (44%).
  PDE5 Inhibitors(A phosphodiesterase type 5 inhibitor)
  Caution is advised when alpha adrenergic blocking agents including Omnistat®  are
  coadministered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 
  inhibitors are both vasodilators that can lower blood pressure. Concomitant use of 
  these two drug classes can potentially cause symptomatic hypotension.
  Caution should be exercised with concomitant administration of warfarin and
  Nifedipine, Atenolol, Enalapril
  Dosage adjustments are not necessary when Omnistat® capsules are administered
  concomitantly with nifedipine, atenolol, or enalapril.
  Digoxin and Theophylline
  Dosage adjustments are not necessary when a Omnistat® capsule is administered
  concomitantly with digoxin or theophylline .
  Omnistat® capsules had no effect on the pharmacodynamics (excretion of
  electrolytes) of furosemide. While furosemide produced an 11% to 12% reduction in 
  tamsulosin hydrochloride C max and AUC, these changes are expected to be
  clinically insignificant and do not require adjustment of the Omnistat® capsules dosage 

- Omnistat® is not indicated for use in pregnant and lactating women. Tamsulosin
   hydrochloride is present in the milk of lactating rats.

  Like all medicines, Omnistat®   can cause sides effects, although not everybody gets
  Common (less than 1 in 10, more than 1 in 100 (1 - 10%)):
- Dizziness, particularly when going to sit or stand up.
- Abnormal ejaculation. The latter means that semen does not leave the body via the 
  urethra, but instead goes into the bladder. This phenomenon is harmless.
  Uncommon (More than 1 in 1000, less than 1 in 100 (0,1 - 1%)):
- Headache, palpitations (the heart beats more rapidly than normal and it is also 
  noticeable ), reduced blood pressure e.g. when getting up quickly from a seating or 
  lying position sometimes associated with dizziness; runny or blocked nose 
  (rhinitis), diarrhoea, feeling sick and vomiting, constipation, weakness 
  (asthenia), rashes, itching and hives(urticaria).
  Rare(More than 1 in 10,000, less than 1 in 1000 (0,01 - 0,1%)):
- Faintness and sudden local swelling of the soft tissues of the body (e.g. the throat or 
  tongue) difficult breathing and /or itching and rash, often as an allergic reaction 
  Vary rare (less than 1 in 10,000 (<0,01%)):
- Priapism (painful prolonged unwanted erection for which immediate medical 
  treatment is required).
- Rash, inflammation and blistering of the skin and / or mucous membrane of the lips,
   eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).
- Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), 
  difficult breathing (dyspnoea).

- Overdosage with tamsulosin hydrochloride can potentially result in severe hypotensive 

  effects. Gastric lavage can be applied and activated charcoal and an osmotic laxative.
  Laboratory data indicate that tamsulosin is 94% to 99% protein bound; therefore dialysis
  is unlikely to be of benefit.

* Orthostasis
   Patients beginning treatment with Omnistat®  capsules should be cautioned to avoid 
   situations in which injury could result should syncope occur.
* Screening for Prostate Cancer
   Prostate cancer and BPH frequently coexist; therefore, patients should be screened
   for the presence of prostate cancer prior to treatment with Omnistat®capsules and at 
   regular intervals afterwards.
* Intraoperative Floppy Iris Syndrome (IFIS)
   IFIS may increase the risk of eye complications during and after the operation. 
* Sulfa Allergy
   In patients with sulfa allergy, allergic reaction to Omnistat®capsules has been rarely
   reported. If a patient reports a serious or life-threatening sulfa allergy, caution is
   warranted when administering Omnistat®capsules.

Use in Specific Populations:-
* Renal impairment
   Patients with renal impairment do not require an adjustment in Omnistat® capsules 
   dosing. However, patients with end-stage renal disease have not been studied.
* Hepatic Impairment
   Patients with moderate hepatic impairment do not require an adjustment in 
   Omnistat®capsules dosage. Omnistat® has not been studied in patients with severe
   hepatic impairment.
* Geriatric Use
   Of the total number of subjects (1783) in clinical studies of tamsulosin, 36% were 65 
   years of age and over. No overall differences in safety or effectiveness were observed 
   between these subjects and younger subjects, and the other reported clinical 
   experience has not identified differences in responses between the elderly and 
   younger patients.

- Omnistat® ( Blister of 10 capsules, pack of three Blister).

- Store at a temperature not exceeding 25 °C, protect from light.