Instruction for use: Glancin

Trade name of the drug – Glancin

Active substance: Tamsulosinum

Dosage Form: The modified-release capsules

Composition (per tablet):

active substance: Tamsulosin hydrochloride - 0.2 mg

Other ingredients: sugar crumbles (sucrose, starch syrup) - 251.33 mg; ethyl cellulose - 0.8 mg; methacrylic acid copolymer - 7.05 mg; makrogol6000 - 0.62 mg

capsule shell: gelatin - 52.8037 mg; water - 9,135 mg; colourant iron oxide red - 0.378 mg; dye iron oxide yellow - 0.2098 mg; titanium dioxide - 0.4231 mg of sodium lauryl sulfate - 0.0504 mg

ink inscription on the shell capsules: ethyl alcohol *; Isopropanol *; * butanol; * propylene glycol; polysorbate 80 *; shellac*; titanium dioxide

* Removed during manufacturing.

active substance: Tamsulosin hydrochloride - 0.4 mg

Other ingredients: sugar crumbles (sucrose, starch syrup) - 242.66 mg; ethyl cellulose - 1.6 mg; methacrylic acid copolymer - 14.1 mg; Macrogol 6000 - 1.24 mg

capsule shell: gelatin - 53.793 mg; water - 9,135 mg; dye azorubin - 0.0216 mg; Sodium lauryl sulfate - 0.0504 mg

ink inscription on the shell capsules: ethyl alcohol *; Isopropanol *; * butanol; * propylene glycol; polysorbate 80 *; shellac*; iron oxide black

* Removed during manufacturing.

Description of Glancin: Capsules modified release, 0.2 mg: hard, gelatin, ¹2, body and lid brown, with white inscription «HiGlance» on the lid.

Capsules modified release, 0.4 mg: hard, gelatin, ¹2, transparent body, a pink cap, with an inscription in black «HiGlance» on the lid.

The contents of capsules - a white or nearly white pellets.

Pharmacotherapeutic group: Alpha-blockers

Drugs affecting the metabolism of the prostate gland and correctors urodynamics

ATX G04CA02 Tamsulosin

The nosological classification (ICD-10)

N40 Hyperplasia of prostate: Prostate adenoma; BPH; Prostatauxe; prostate Hypertrophy; Dysuric disorders caused by benign prostatic hyperplasia; Dizuricheskie disorder with benign prostatic hyperplasia; Dysuria with prostate cancer; Benign prostatic giperpalaziya; Benign prostatic hyperplasia; Benign prostatic hyperplasia stages 1 and 2; Benign prostatic hyperplasia I degree; Benign prostatic hyperplasia II degree; Benign prostatic hypertrophy; The disease of the prostate gland; Acute urinary retention related to benign prostatic hyperplasia; Benign prostatic hyperplasia stages 1 and 2 in combination with prostatitis; paradoxical ischuria

R30.0 Dysuria: Disorders after prostatectomy; dysuric disorder; Dysuric disorders caused by benign prostatic hyperplasia; dysuric symptoms; dizuricheskie disorder; Dizuricheskie disorder in men; Dysuria with prostate cancer; disorders of urination; dysuria; Dizuricheskie disorder with benign prostatic hyperplasia; Acute dysuria

Pharmacological Properties of Glancin

Pharmachologic effect - Mode of action - alpha adrenoliticheskoe, antidizuricescoe.

Pharmacodynamics

Tamsulosin is a specific blocker of postsynaptic α1-adrenoreceptors located in the smooth muscle of the prostate, bladder neck and prostatic urethra. Α1-adrenoceptor blockade tamsulosin reduces the tone of smooth muscles of the prostate, bladder neck and prostatic urethra and improve urine flow. Simultaneously, a decrease symptoms emptying and filling symptoms associated with elevated tone of smooth muscle and detrusor overactivity for benign prostatic hyperplasia.

The ability to influence the tamsulosin α1A-adrenoceptor subtype is 20 times greater than its ability to interact with α1B-adrenergic receptor subtype, located in vascular smooth muscle. Due to its high selectivity, the drug does not cause a clinically significant reduction in systemic blood pressure both in hypertensive patients and in patients with normal baseline BP.

Pharmacokinetics

Tamsulosin is well absorbed in the gut and has almost 100% bioavailability.

Absorption of tamsulosin somewhat slowed down after a meal. The same level of absorption can be achieved when the patient receives the drug each time after normal breakfast. Tamsulosin is characterized by linear kinetics. After a single oral 0.4 mg Tmax of 6 hours in plasma. After repeated oral administration of 0.4 mg per day Css achieved by the 5th day, and its value is about 2/3 higher than the value of this parameter after a single dose . Binding to plasma proteins - 99%. Vd is small and amounts to about 0.2 L / kg.

Tamsulosin is slowly metabolized in the liver with the formation of less active metabolites. Most tamsulosin is present in plasma in unchanged form. Tamsulosin and its metabolites are excreted in the urine with about 9% of the drug is excreted unchanged form. T1 / 2 of the drug at a single dose of 0.4 mg after meals is 10 hours, with multiple dose - 13 hours.

When mild to moderate degrees of hepatic impairment is not required correction mode.

In renal insufficiency, no dose reduction is required, if the patient severe renal insufficiency (Cl creatinine less than 10 mL / min) to appoint tamsulosin must be with caution.

Indications for Glancin

Treatment dizuricheskih disorders in benign prostatic hyperplasia.

Contraindications for Glancin

hypersensitivity to tamsulosin or any other component of the formulation;

orthostatic hypotension (including history);

severe hepatic impairment;

Children up to age 18 years.

Precautions: severe renal impairment (Cl creatinine less than 10 mL / min).

Pregnancy and breast-feeding

No Information.

Glancin Dosage and Administration

Inside, swallowing whole, without chewing, crushing is not (as it may have an impact on the rate of release of tamsulosin).

At 0.4 mg (1 capsule). 1 time per day after the first meal (the time interval between administration of the drug should be 24 hours). For minor to moderate hepatic dysfunction, and renal impairment Dose adjustment is not required.

When intolerance dose of 0.4 mg administered dose of 0.2 mg / day. In the absence of a therapeutic effect after treatment at a dose of 0.4 mg over 2-4 weeks the dose can be increased to 0.8 mg / day.

If administration in a dose of 0.2 or 0.4 mg was interrupted for two weeks (for whatever reason), the treatment should start again with the same dosage. If the drug at a dose of 0.8 mg was interrupted for 2 weeks (for whatever reason), then treatment should start again with a dosage of 0.4 mg / day.

Duration of application is not limited to, a drug administered in the form of continuous therapy.

Side effect of Glancin

The graduation rate of side effects: very often -> 1/10; often - by> 1/100 to <1/10; sometimes - of> 1/1000 to <1/100; rarely - by> 1/10 000 and <1/1000; very rarely, in rare cases - from <1/10000.

From the CCC: in rare cases - orthostatic hypotension, palpitations, tachycardia.

CNS: rarely - dizziness; in rare cases - headache, asthenia.

From the reproductive system: rarely - retrograde ejaculation.

From the digestive system: rarely - nausea, vomiting, diarrhea, constipation.

Allergic reactions: In rare cases - skin rash, itching, angioedema (including angioedema..).

From the respiratory system: rarely - rhinitis.

From the side of view: very rarely - blurred vision; in rare cases - intraoperative instability iris (narrow pupil syndrome) during cataract surgery patients, which increases the risk of complications during and after surgery.

Overdose of Glancin

There were no cases of acute drug overdose.

Symptoms: theoretically possible occurrence of severe hypotension and compensatory tachycardia.

Treatment: symptomatic - giving the horizontal position of the patient, if necessary - introduction obemozameschayuschih solutions or vasoconstrictor drugs. To prevent further absorption of tamsulosin may gastric lavage, the appointment of activated charcoal or osmotic laxative. It is necessary to monitor renal function. It is unlikely that dialysis would be effective, since Tamsulosin is in active connection with plasma proteins.

Interaction

In an application with cimetidine was a slight increase in tamsulosin concentrations in plasma, with furosemide - decreased concentration, but it does not require a change in dose of tamsulosin, since the concentration of the drug remains within the normal range.

Diclofenac and warfarin may slightly increase the elimination rate of tamsulosin.

The simultaneous use of tamsulosin with other α1-adrenoceptor antagonists can cause a reduction in blood pressure.

When concomitantly with atenolol, enalapril, nifedipine drug interaction was found.

Diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin does not alter the free fraction of tamsulosin in plasma in vitro. Tamsulosin does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.

In vitro studies found no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride.

SPECIAL INSTRUCTIONS for Glancin

Precautions should be prescribed the drug in renal failure severe (Cl creatinine less than 10 mL / min), as well as with other α1-blockers. The drug 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 sit or lie down and remain in that position for as long as the above symptoms do not disappear. Before the start of the drug is necessary to verify the diagnosis and exclude other diseases that can cause similar symptoms.

Before the start of and regularly during therapy should be performed digital rectal examination and, if necessary, determination of PSA.

It is advisable to stop taking the drug for 1-2 weeks prior to cataract surgery (in patients receiving the drug may develop the syndrome intraoperative instability iris, it is necessary to take into account the surgeon in the preoperative patient preparation and conduct of the operation).

Effects on ability to drive and use machines. During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and speed of psychomotor reactions, because drug may cause dizziness and other side effects that may affect the ability of these.

Manufacturer

Hayglans Laboratories Pvt. Co., Ltd. E-11, 12 & 13, Site-B, UPSIDC, Surazhpur Industrial Zone, Greater Noida-201306, (U.P.), India.

Tel .: +91 (120) 25-69-742; fax: +91 (120) 25-69-743.

e-mail: [email protected]; [email protected]

Representative manufacturer in Russia: OOO "Pharma Group", 125284, Moscow, ul. Race 13.

Tel. / Fax: +7 (495) 940-33-96 / 940-33-98.

e-mail: [email protected]

Storage conditions of Glancin

In a dry, dark place at a temperature of between 8 and 25 ° C.

Keep out of the reach of children.

Shelf life

4 years.