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TEMPROST   capsules

A tool used in prostate adenoma. Capsules with modified release of the active substance


Capsules that release the active substance in a modified form 
Active substance:0.4 mg of tamsulosin hydrochloride (tamsulosin hydrochloride) in 1 capsule;
Auxiliary substances:Microcrystalline Cellulose (Grade 101), Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) 30% Dispersion (Polysorbate 80%, Sodium Lauryl Sulfate), Triethyl Citrate, Talc, Iron Oxide Yellow, Titanium Dioxide, Iron Oxide Red, Gelatin, Indigo Carmine FD&C Blue 2, black iron oxide
They are capsules with a light orange colored body and a cap that reaches the olive vein. The contents of the capsule are white granules.     

Pharmacological group: α1-adrenoblocker.
ATC code:G04CA02.

Pharmacological properties 
Tamsulosin is a specific blocker of   postsynaptic α1-adrenoceptors in the muscles of the prostate gland, bladder neck and urethra, as well as α1-adrenoreceptors mainly in the body of the bladder. , causes a decrease in the tone of the muscles of the bladder neck and prostate part of the urethra and regulation of urine flow. During benign hyperplasia of the prostate gland, as a result of increased tone of the thigh muscles and detrusor hyperactivity, the symptoms of fullness also decrease.  
The ability of tamsulosin to affect the α1A subtype of adrenoreceptors is 20 times higher than the ability to affect the α1B subtype of adrenoreceptors located in the muscles of the muscles of the vessels. Tamsulosin, which is highly selective, does not reduce total arterial pressure (BP) to a clinically significant degree in either subjects with arterial hypertension or those with normal BP.
Absorption: Tamsulosin is well absorbed in the intestine and has approximately 100% bioavailability. Absorption of tamsulosin is slightly reduced after food intake. If the patient takes the drug at the same time every day after the usual breakfast, then the rate of absorption may be the same. 
After a single intake of the drug in a dose of 0.4 mg, the maximum concentration in the plasma occurs after 6 hours. After a dose of 0.4 mg once a day   the maximum concentration occurs on the 5th day, and its level at this time is 2/3 times higher than the level after a single dose.
Distribution: the combination with plasma proteins is 99%, the volume of distribution is not large (0.2 l/kg-close).
Metabolism: gradually metabolized in the liver, forming inactive metabolites. Most of tamsulosin is found unchanged in plasma. 
In experiments, it was determined that tamsulosin slightly increases the activity of liver microsomal enzymes. 
There is no need to adjust the dose of the drug in case of weak and moderate liver failure.
Excretion: Tamsulosin and its metabolites are mainly excreted in the urine. In this case, about 9% of the drug is excreted unchanged. 
The half-life of the drug is 10 hours after a single dose of 0.4 mg after meals, and 13 hours after multiple doses. 
In the case of renal insufficiency, the dose should be adjusted, and in case of severe renal insufficiency (CK from 10 ml/min), tamsulosin should be prescribed with caution.

Instructions for use 
Treatment of dysuric disorders in benign prostatic hyperplasia.

- hypersensitivity to Tamsulosin or any of the components of the drug;
-    Orthostatic hypotension (including history);
-    Severe liver failure.

Special instructions

Caution: It should be used with caution in case of severe renal failure (CK less than 10 ml/min). During treatment with Temprost, a decrease in arterial pressure can be observed in isolated cases, which can rarely lead to fainting. If the first signs of orthostatic hypotension (dizziness, weakness) are observed, the patient should either sit or lie down and remain in this position until the symptoms disappear. 
Against the background of taking the drug, instability of the cornea (narrow pupil syndrome) may develop during surgical interventions related to cataract or glaucoma, which the surgeon should take into account when preparing the patient for surgery and during surgery. 
Before starting treatment with the drug, other diseases with symptoms similar to those of benign prostatic hyperplasia should be differentiated. A digital rectal examination should be performed regularly before starting treatment and during treatment, and prostate specific antigen (PSA) should be determined if required.

Interaction with other drugs 
When Temprost is used together with atenolol, enalapril or nifedipine, no interaction was observed. A slight increase in the concentration of tamsulosin in the blood plasma was observed when it was used together with cimetidine, and a decrease was observed when it was used with furosemide. In this case, there is no need to reduce the dose of tamsulosin. The concentration of the drug remains within the normal range. Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. 
No interaction with amitriptyline, salbutamol, glibenclamide and finasteride was observed in in vitro studies. Diclofenac and warfarin may increase the rate of elimination of tamsulosin.
At the same time, the appointment of other antagonists of α1-adrenoreceptors can lead to lowering of AT. 
Temprost should be used with caution at the same time as ketoconazole and eriromycin.

Use during pregnancy and lactation 
Not intended for use in women.

Method of use and dosage
Take 1 capsule (0.4 mg) with water once a day after breakfast. Chewing the capsule is not recommended. The safety and efficacy of this drug in adolescents under 18 years of age have not been established. 

Side effects:
Often – dizziness, retrograde ejaculation; sometimes - orthostatic hypotension, tachycardia, asthenia, headache, rhinitis, nausea, vomiting, diarrhea, constipation, skin rash, itching, urticaria. In rare cases, hypersensitivity reactions: angioneurotic edema, fainting may be observed. 
Very rarely: Stevens-Johnson syndrome, priapism. 
Not known: blurred vision, visual disturbances, epistaxis, dry mouth, erythema multiforme, exfoliative dermatitis. 
Instability of the pupil of the eye (narrow pupil syndrome) has been reported during cataract surgery in people who have taken tamsulosin for a long time. 
There is no information on acute overdose with tamsulosin. Theoretically, exceeding the dose limit, a sharp decrease in AT and the development of compensatory tachycardia are possible. At this time, symptomatic treatment is carried out. When a person   takes a horizontal position, arterial pressure and heart rate can normalize. If this does not work, drugs that increase the volume of circulating blood and, if necessary, vasoconstrictor drugs can be used. It is necessary to control the functions of the kidneys. Dialysis is unlikely to be effective, as tamsulosin is strongly bound to plasma proteins. 
To prevent further absorption of the drug, it is necessary to wash the stomach, take activated charcoal or an osmotic laxative. 

Release form  
10 capsules, in a blister. 1 or 3 blisters (10 or 30 capsules) are packed in a cardboard box with an insert.
30 capsules in a high-density polyethylene container. 1 container is packed in a cardboard box with an insert.
Storage  conditions
It should be stored at a temperature not higher than 25°C, in the original box and out of the reach of children.

Expiry date 
3 years. 
  cannot be used after the expiration date.

Condition of release from pharmacy
It is released on the basis of a prescription.

Synthon Hispania SL, Spain
C/Castello, 1 Poligono Las Salinas. 
08830 Sant Boi de Llobregat.
Barcelona, Spain 
Baku city, Nizami district, 
Mehdi Abbasov, house 2,
AZ 1096,  Azerbaijan 


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