Omnik capsules 0.4mg №100

Release form, composition and packaging

Modified release capsules solid gelatin, size No. 2, orange-colored case with "701" marking and graphic image of the company's trademark, olive-green cap with "0.4" marking; the contents of the capsules are granules from white to white with a light yellow shade of color.

Excipients: microcrystalline cellulose, methacrylic acid copolymer (type C), polysorbate 80, sodium lauryl sulfate, triacetin, Calcium stearate, talc, gelatin, indigodin, titanium dioxide, iron yellow oxide, iron red oxide.

Indications

- treatment of dysuric disorders in case of benign prostatic hyperplasia.

Dosage and administration

The drug is prescribed in a dose of 400 μg (1 capsule) 1 time / day.

Capsules are taken orally after breakfast, drinking plenty of water. Capsule is not recommended to chew.

With minor and moderate violations of liver function, as well as violations of renal function, dose adjustment is not required.

Adverse effects

Cardiovascular: rarely - dizziness; in rare cases - orthostatic hypotension, palpitations, tachycardia.

From the side of the central nervous system: in isolated cases - headache, asthenia.

From the reproductive system: rarely - retrograde ejaculation.

Gastrointestinal: rarely - nausea, vomiting, diarrhea, constipation.

Allergic reactions: in some cases - skin rash, itching, angioedema.

Contraindications

- orthostatic hypotension (including in history);

- severe liver failure;

- hypersensitivity to the drug.

WITH caution It should be prescribed for severe renal failure (CC less than 10 ml / min).

Application for violations of the liver

Contraindicated in severe liver failure.

Application for violations of kidney function

WITH caution It should be prescribed for severe renal failure (CC less than 10 ml / min).

Special notes

Omnick should be used with caution in patients with a predisposition to orthostatic hypotension. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid.

Before starting to use the drug, it is necessary to verify the diagnosis and exclude the presence of other diseases that may cause similar symptoms.

A digital rectal examination and, if necessary, the determination of the specific antigen of the prostate gland (PSA) should be performed before and regularly during therapy.

Overdosage

No cases of acute overdose of the drug.

Symptoms: theoretically, the occurrence of acute arterial hypotension and compensatory tachycardia is possible.

Treatment: symptomatic therapy is carried out: giving the patient a horizontal position, if necessary - the introduction of volume-substituting solutions or vasoconstrictor drugs. To prevent further absorption of Tamsulosin, gastric lavage, taking Activated carbon or osmotic laxative is possible. It is necessary to monitor the function of the kidneys. It is unlikely that dialysis will be effective, because tamsulosin is in active communication with plasma proteins.

Drug interaction

With simultaneous use of Omnik with cimetidine, a slight increase in plasma tamsulosin concentration was noted, and with Furosemide a decrease in concentration, however, this does not require changing the dose of omnik.

When used simultaneously with Omnik, Diclofenac and Warfarin may slightly increase the clearance rate of tamsulosin.

Simultaneous use of omnik with other alpha₁-adrenergic blockers can lead to a pronounced decrease in blood pressure.

At the same time taking Omnik with Atenolol, Enalapril, Nifedipine, no drug interaction was found.

Diazepam, propranolol, trichloromethiazide, chlormadinone, Amitriptyline, diclofenac, glibenclamide, Simvastatin and warfarin do not change the free fraction of tamsulosin in plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone.

In in vitro studies, no interaction at the level of hepatic metabolism with amitriptyline, Salbutamol, glibenclamide, and Finasteride was detected.

Terms and conditions of storage

The drug should be stored at a temperature of 15 ° to 25 ° C.