Tamsulosin Canon, 0.4 mg 30 pcs

Treatment of dysuric disorders in benign prostatic hyperplasia.

Active ingredient

Composition

1 capsule contains:

the active ingredient:

Tamsulosin substance-pellet 0.133% – 300 mg:

acting substance:

Tamsulosin hydrochloride 0.4 mg,

accompanies:

Hypromellose E5 (hydroxy-propyl methylcellulose) 1.9132 mg,

dibutyl phthalate 0.2088 mg,

Starch 55 mg,

macrogol 6000 (polyethylene glycol 6000) 6.2058 mg,

methacrylic acid and ethyl acrylate copolymer (1:1) 62.0585 mg,

sodium lauryl sulfate 0.2 mg,

sucrose 165 mg,

talc 7.5358 mg,

ethylcellulose 1.7748 mg,

magnesium stearate 1.5 mg,

talc 1.5 mg.

solid gelatin capsule #2:

Case – gelatin 37.3478 mg, iron oxide yellow 0.3811 mg, titanium dioxide 0.3811 mg;

Cup – gelatin 22.4322 mg, iron oxide yellow 0.2289 mg, titanium dioxide 0.2289 mg.

How to take, the dosage

Adults over 18 years of age and elderly patients

At the mouth, after breakfast, with water, take 1 capsule (0.4 mg) once daily. It is not recommended that the capsule be chewed because this may interfere with the rate of release of the active ingredient.

In patients with hepatic and renal impairment

In patients with renal impairment and mild to moderate hepatic impairment, the dosing regimen does not need to be adjusted.

Interaction

No interactions have been found when prescribing Tamsulosin Canon together with atenololol, enalapril or nifedipine.

When tamsulosin is used concomitantly with cimetidine, a slight increase in plasma tamsulosin concentrations has been observed, and a decrease in concentrations with furosemide, but this does not require changes in the dose of Tamsulosin Canon, because drug concentrations remain within the normal range.

Diazepam, propranololol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not alter the free plasma fraction of tamsulosin in vitro. In turn, tamsulosin also does not alter the free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone.

Diclofenac and warfarin may increase the excretion rate of tamsulosin.

The concomitant administration of tamsulosin with strong CYP3A4 isoenzyme inhibitors may lead to increased tamsulosin concentrations. Concomitant administration with ketoconazole (strong CYP3A4 inhibitor) resulted in 2.8 and 2.2-fold increase in AUC and Cmax of tamsulosin, respectively.

Tamsulosin should not be used in combination with strong CYP3A4 inhibitors in patients with impaired CYP2D6 isoenzyme metabolism. The drug should be used with caution in combination with strong and moderate CYP3A4 inhibitors.

The concomitant administration of tamsulosin and paroxetine, a strong CYP2D6 inhibitor, resulted in 1.3 and 1.6-fold increases in Cmax and AUC of tamsulosin, respectively, but this increase was found to be clinically insignificant.

The concomitant administration of other alpha-l-adrenoreceptor antagonists may decrease BP.

In co-administration of tamsulosin with cholinesterase inhibitors, alprostadiol, anesthetics, diuretics, levodopa, muscle relaxants, nitrates, antidepressants, beta-adrenoblockers, slow calcium channel blockers and ethanol there may be a risk of significant reduction of blood pressure.

Special Instructions

As with other alpha-1-adrenoblockers, treatment with Tamsulosin Canon may occasionally result in a decrease in BP, which may sometimes lead to fainting. At the first signs of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down and remain in this position until these symptoms disappear.

Before initiating therapy with tamsulosin, the patient should be examined to rule out the presence of other diseases that may cause the same symptoms as benign prostatic hyperplasia. A finger rectal examination and, if necessary, a prostate specific antigen (PSA) determination must be performed before starting treatment and regularly during therapy.

There are reports of cases of prolonged erections and priapism on therapy with alpha1-adrenoblockers. If an erection persists for more than 4 hours, medical advice should be sought immediately. If therapy of priapism was not carried out immediately, it may lead to penile tissue damage and permanent loss of potency.

The treatment with Tamsulosin Canon in patients with severe renal impairment (creatinine clearance <10 ml/min) requires caution, since no studies have been performed in this category of patients.

In some patients taking or previously taking tamsulosin during surgical interventions for cataract or glaucoma, development of intraoperative iris instability syndrome (narrow pupil syndrome) is possible, which may lead to complications during surgery or in the postoperative period. It has not been shown to be reasonable to discontinue tamsulosin therapy 1-2 weeks prior to cataract or glaucoma surgery. Cases of intraoperative iris instability have occurred in patients who discontinued the drug and earlier before surgery. It is not recommended to start tamsulosin therapy in patients scheduled for cataract or glaucoma surgery. During the preoperative evaluation of patients, the surgeon and ophthalmologist should consider whether the patient is taking or has taken tamsulosin. This is to prepare for the possibility of intraoperative iris instability syndrome during surgery.

If angioedema develops, therapy with the drug should be discontinued immediately. Reapplication of tamsulosin is contraindicated.

Impact on driving and operating ability

Perhaps caution should be exercised when driving motor transport and engaging in potentially dangerous activities requiring increased concentration and speed of psychomotor reactions because dizziness may develop while taking tamsulosin.

Contraindications

Hypersensitivity to tamsulosin or any other drug component; Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption; orthostatic hypotension (including anamnesis); marked liver failure; childhood under 18 years.

Side effects

The incidence of side effects developing when taking tamsulosin is classified according to the recommendations of the World Health Organization:

very often, at least 10%;

often, at least 1%, but less than 10%;

infrequently, at least 0.1%, but less than 1%;

rarely, at least 0.01%, but less than 0.1%;

very rare – less than 0.01%, including individual reports;

frequency unknown – no information on the frequency of side effects.

Nervous system disorders:

often – dizziness (1.3%);

infrequent – headache;

rarely – fainting;

Heart disorders:

infrequent – sensation of palpitations;

frequency not known – atrial fibrillation, arrhythmia, tachycardia, and shortness of breath;

Vascular disorders:

infrequent – postural hypotension;

Respiratory, thoracic and mediastinal disorders:

infrequent – rhinitis;

Gastrointestinal tract disorders:

infrequent – constipation, diarrhea, nausea, vomiting;

Skin and subcutaneous tissue disorders:

infrequent – rash, itching, urticaria;

rarely – angioedema;

very rare – Stevens-Johnson syndrome;

frequency unknown – erythema multiforme, exfoliative edema.

Genital and mammary disorders:

frequent – impaired ejaculation;

very rare – priapism;

General disorders and disorders at the injection site:

infrequently – asthenia;

Other:

Infrequent – asthenia;

frequency unknown – cases of intraoperative iris instability (narrow pupil syndrome) during cataract and glaucoma surgery in patients taking tamsulosin have been described.

Overdose

No cases of acute tamsulosin overdose have been reported. However, theoretically, in overdose it is possible to develop acute BP decrease and compensatory tachycardia, in which case symptomatic therapy should be carried out. Blood pressure and heart rate may recover when the person takes a horizontal position.

If there is no effect, agents increasing circulating blood volume and, if necessary, vasoconstrictors may be used. Renal function should be monitored. Hemodialysis is unnecessary because tamsulosin is strongly bound to plasma proteins.

In order to prevent further absorption of the drug, gastric lavage, administration of activated charcoal or an osmotic laxative such as magnesium sulfate is advisable.

Similarities